WorldWideScience

Sample records for loss optimal trial

  1. Optimal portfolio choice under loss aversion

    NARCIS (Netherlands)

    A.B. Berkelaar (Arjan); R.R.P. Kouwenberg (Roy)

    2000-01-01

    textabstractProspect theory and loss aversion play a dominant role in behavioral finance. In this paper we derive closed-form solutions for optimal portfolio choice under loss aversion. When confronted with gains a loss averse investor behaves similar to a portfolio insurer. When confronted with

  2. Optimal compensation for neuron loss

    Science.gov (United States)

    Barrett, David GT; Denève, Sophie; Machens, Christian K

    2016-01-01

    The brain has an impressive ability to withstand neural damage. Diseases that kill neurons can go unnoticed for years, and incomplete brain lesions or silencing of neurons often fail to produce any behavioral effect. How does the brain compensate for such damage, and what are the limits of this compensation? We propose that neural circuits instantly compensate for neuron loss, thereby preserving their function as much as possible. We show that this compensation can explain changes in tuning curves induced by neuron silencing across a variety of systems, including the primary visual cortex. We find that compensatory mechanisms can be implemented through the dynamics of networks with a tight balance of excitation and inhibition, without requiring synaptic plasticity. The limits of this compensatory mechanism are reached when excitation and inhibition become unbalanced, thereby demarcating a recovery boundary, where signal representation fails and where diseases may become symptomatic. DOI: http://dx.doi.org/10.7554/eLife.12454.001 PMID:27935480

  3. Optimization of fuel cycles: marginal loss values

    International Nuclear Information System (INIS)

    Gaussens, J.; Lasteyrie, B. de; Doumerc, J.

    1965-01-01

    Uranium processing from the pit to the fuel element rod entails metal losses at every step. These losses become more and more expensive with the elaboration of the metal. Some of the uranium must be accepted as definitely lost whilst the rest could be recovered and recycled. The high cost of these losses, whether they are recycled or not, and the fact that the higher the enrichment is the higher their costs are, make it necessary to take them into account when optimizing fuel cycles. It is therefore felt important to determine their most desirable level from an economic point of view at the various nuclear fuel processing stages. However, in France as in some other countries, fissile material production is a state concern, whilst fuel element fabrication is carried out by private enterprise. Optimization criteria and the economic value of losses are therefore different for each of the two links in the fabrication chain. One can try in spite of this to reach an optimum which would conform to public interest, without interfering with the firm's sales policy. This entails using the fact that for a given output marginal costs are equal at the optimum. One can therefore adjust the level of the losses to attain this equation of marginal costs, as these are easier to obtain from the firm than a justification of the actual prices. One notices moreover that, although mainly concerned with losses, this global analysis can bring both the state and the firm to a better use of other production factors. An account is given of the theory of this economic optimization method and practical applications in the field of natural uranium-graphite moderated and CO 2 cooled reactor fuel element fabrication are offered. (authors) [fr

  4. Transmission loss optimization in acoustic sandwich panels

    Science.gov (United States)

    Makris, S. E.; Dym, C. L.; MacGregor Smith, J.

    1986-06-01

    Considering the sound transmission loss (TL) of a sandwich panel as the single objective, different optimization techniques are examined and a sophisticated computer program is used to find the optimum TL. Also, for one of the possible case studies such as core optimization, closed-form expressions are given between TL and the core-design variables for different sets of skins. The significance of these functional relationships lies in the fact that the panel designer can bypass the necessity of using a sophisticated software package in order to assess explicitly the dependence of the TL on core thickness and density.

  5. Optimal Allocation of Renewable Energy Sources for Energy Loss Minimization

    Directory of Open Access Journals (Sweden)

    Vaiju Kalkhambkar

    2017-03-01

    Full Text Available Optimal allocation of renewable distributed generation (RDG, i.e., solar and the wind in a distribution system becomes challenging due to intermittent generation and uncertainty of loads. This paper proposes an optimal allocation methodology for single and hybrid RDGs for energy loss minimization. The deterministic generation-load model integrated with optimal power flow provides optimal solutions for single and hybrid RDG. Considering the complexity of the proposed nonlinear, constrained optimization problem, it is solved by a robust and high performance meta-heuristic, Symbiotic Organisms Search (SOS algorithm. Results obtained from SOS algorithm offer optimal solutions than Genetic Algorithm (GA, Particle Swarm Optimization (PSO and Firefly Algorithm (FFA. Economic analysis is carried out to quantify the economic benefits of energy loss minimization over the life span of RDGs.

  6. Optimal placement of biomass fuelled gas turbines for reduced losses

    International Nuclear Information System (INIS)

    Jurado, Francisco; Cano, Antonio

    2006-01-01

    This paper presents a method for the optimal location and sizing of biomass fuelled gas turbine power plants. Both profitability in using biomass and power loss are considered in the cost function. The first step is to assess the plant size that maximizes the profitability of the project. The second step is to determine the optimal location of the gas turbines in the electric system to minimize the power loss of the system

  7. Weight loss versus muscle loss: re-evaluating inclusion criteria for future cancer cachexia interventional trials.

    Science.gov (United States)

    Roeland, Eric J; Ma, Joseph D; Nelson, Sandahl H; Seibert, Tyler; Heavey, Sean; Revta, Carolyn; Gallivan, Andrea; Baracos, Vickie E

    2017-02-01

    Participation in cancer cachexia clinical trials requires a defined weight loss (WL) over time. A loss in skeletal muscle mass, measured by cross-sectional computed tomography (CT) image analysis, represents a possible alternative. Our aim was to compare WL versus muscle loss in patients who were screened to participate in a cancer cachexia clinical trial. This was a single-center, retrospective analysis in metastatic colorectal cancer patients screened for an interventional cancer cachexia trial requiring a ≥5 % WL over the preceding 6 months. Concurrent CT images obtained as part of standard oncology care were analyzed for changes in total muscle and fat (visceral, subcutaneous, and total). Of patients screened (n = 36), 3 (8 %) enrolled in the trial, 17 (47 %) were excluded due to insufficient WL (20 %), and 16 (44 %) met inclusion criteria for WL. Patients who met screening criteria for WL (5-20 %) had a mean ± SD of 7.7 ± 8.7 % muscle loss, 24.4 ± 37.5 % visceral adipose loss, 21.6 ± 22.3 % subcutaneous adipose loss, and 22.1 ± 24.7 % total adipose loss. Patients excluded due to insufficient WL had 2 ± 6.4 % muscle loss, but a gain of 8.5 ± 39.8 % visceral adipose, and 4.2 ± 28.2 % subcutaneous adipose loss and 0.8 ± 28.4 % total adipose loss. Of the patients excluded due to WL 5 %. Defining cancer cachexia by WL over time may be limited as it does not capture skeletal muscle loss. Cross-sectional CT body composition analysis may improve early detection of muscle loss and patient participation in future cancer cachexia clinical trials.

  8. Dispositional Optimism and Therapeutic Expectations in Early Phase Oncology Trials

    Science.gov (United States)

    Jansen, Lynn A.; Mahadevan, Daruka; Appelbaum, Paul S.; Klein, William MP; Weinstein, Neil D.; Mori, Motomi; Daffé, Racky; Sulmasy, Daniel P.

    2016-01-01

    Purpose Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early phase oncology trials. Optimism, however, is not a unitary construct – it can also be defined as a general disposition, or what is called dispositional optimism. We assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. We also assessed how dispositional optimism related to unrealistic optimism. Methods Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception. Results Dispositional optimism was significantly associated with higher expectations for personal therapeutic benefit (Spearman r=0.333, poptimism was weakly associated with unrealistic optimism (Spearman r=0.215, p=0.005). In multivariate analysis, both dispositional optimism (p=0.02) and unrealistic optimism (poptimism (p=.0001), but not dispositional optimism, was independently associated with the therapeutic misconception. Conclusion High expectations for therapeutic benefit among patient-subjects in early phase oncology trials should not be assumed to result from misunderstanding of specific information about the trials. Our data reveal that these expectations are associated with either a dispositionally positive outlook on life or biased expectations about specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early phase oncology research. PMID:26882017

  9. Fuzzy Adaptive Particle Swarm Optimization for Power Loss Minimisation in Distribution Systems Using Optimal Load Response

    DEFF Research Database (Denmark)

    Hu, Weihao; Chen, Zhe; Bak-Jensen, Birgitte

    2014-01-01

    Consumers may decide to modify the profile of their demand from high price periods to low price periods in order to reduce their electricity costs. This optimal load response to electricity prices for demand side management generates different load profiles and provides an opportunity to achieve...... power loss minimization in distribution systems. In this paper, a new method to achieve power loss minimization in distribution systems by using a price signal to guide the demand side management is proposed. A fuzzy adaptive particle swarm optimization (FAPSO) is used as a tool for the power loss...

  10. Optimizing wind farm cable routing considering power losses

    DEFF Research Database (Denmark)

    Fischetti, Martina; Pisinger, David

    2017-01-01

    that must be spent immediately in cable and installation costs, and the future reduced revenues due to power losses. The latter goal has not been addressed in previous work. We present a Mixed-Integer Linear Programming approach to optimize the routing using both exact and math-heuristic methods....... In the power losses computation, wind scenarios are handled eciently as part of the preprocessing, resulting in a MIP model of only slightly larger size. A library of real-life instances is introduced and made publicly available for benchmarking. Computational results on this testbed show the viability of our...

  11. Loss optimization in distribution networks with distributed generation

    DEFF Research Database (Denmark)

    Pokhrel, Basanta Raj; Nainar, Karthikeyan; Bak-Jensen, Birgitte

    2017-01-01

    This paper presents a novel power loss minimization approach in distribution grids considering network reconfiguration, distributed generation and storage installation. Identification of optimum configuration in such scenario is one of the main challenges faced by distribution system operators...... in highly active distribution grids. This issue is tackled by formulating a hybrid loss optimization problem and solved using the Interior Point Method. Sensitivity analysis is used to identify the optimum location of storage units. Different scenarios of reconfiguration, storage and distributed generation...... penetration are created to test the proposed algorithm. It is tested in a benchmark medium voltage network to show the effectiveness and performance of the algorithm. Results obtained are found to be encouraging for radial distribution system. It shows that we can reduce the power loss by more than 30% using...

  12. A Clinical Trial on Weight Loss among Truck Drivers

    Directory of Open Access Journals (Sweden)

    MS Thiese

    2015-04-01

    Full Text Available Background: The high prevalence of obesity among commercial truck drivers may be related to sedentary nature of the job, lack of healthy eating choices, and lack of exercise. There may be a link between obesity and crash risk, therefore an intervention to reduce obesity in this population is needed. Objective: To assess feasibility of a 12-week weight loss intervention for truck drivers with a weight loss goal of 10% of initial body weight. Methods: Drivers were selected based on age (≥21 years and body mass index (≥30 kg/m2. The drivers participated in a before-after clinical trial. The intervention included a 12-week program that provided information on healthy diet and increasing exercise, and telephone-based coaching using SMART goals. Outcomes included change from baseline in reported energy intake, measured weight, waist, hip, and neck circumference, blood pressure, and point of care capillary blood lipids and hemoglobin A1c. Exit interviews were conducted to gain insight into driver opinions on the program features and usefulness. This study was registered with the NIH Clinical Trials Registry, number NCT02348983. Results: 12 of 13 drivers completed the study. Weight loss was statistically significant (p=0.03. Reported energy (p=0.005, total fat consumption (p=0.04, and saturated fat consumption (p=0.02 intake were also lower after the 12-week intervention. Drivers attributed their weight loss to health coaching and suggested a longer intervention so that they could reach their goal and become accustomed to the changes. Conclusion: This weight loss intervention is feasible for this difficult population. Additional research is needed to compare this intervention with a control group.

  13. Optimizing wind farm cable routing considering power losses

    DEFF Research Database (Denmark)

    Fischetti, Martina; Pisinger, David

    2017-01-01

    Wind energy is the fastest growing source of renewable energy, but as wind farms are getting larger and more remotely located, installation and infrastructure costs are rising. It is estimated that the expenses for electrical infrastructure account for 15-30% of the overall initial costs, hence...... that must be spent immediately in cable and installation costs, and the future reduced revenues due to power losses. The latter goal has not been addressed in previous work. We present a Mixed-Integer Linear Programming approach to optimize the routing using both exact and math-heuristic methods....... In the power losses computation, wind scenarios are handled eciently as part of the preprocessing, resulting in a MIP model of only slightly larger size. A library of real-life instances is introduced and made publicly available for benchmarking. Computational results on this testbed show the viability of our...

  14. Optimizing wind farm cable routing considering power losses

    DEFF Research Database (Denmark)

    Fischetti, Martina; Pisinger, David

    Wind energy is the fastest growing source of renewable energy, but as wind farms are getting larger and more remotely located, installation and infrastructure costs are rising. It is estimated that the expenses for electrical infrastructure account for 15-30% of the overall initial costs, hence...... that must be spent immediately in cable and installation costs, and the future reduced revenues due to power losses. The latter goal has not been addressed in previous work. We present a Mixed-Integer Linear Programming approach to optimize the routing using both exact and math-heuristic methods....... In the power losses computation, wind scenarios are handled eciently as part of the preprocessing, resulting in a MIP model of only slightly larger size. A library of real-life instances is introduced and made publicly available for benchmarking. Computational results on this testbed show the viability of our...

  15. 4500 V SPT+ IGBT optimization on static and dynamic losses

    International Nuclear Information System (INIS)

    Dai Qingyun; Tian Xiaoli; Zhang Wenliang; Lu Shuojin; Zhu Yangjun

    2015-01-01

    This paper concerns the need for improving the static and dynamic performance of the high voltage insulated gate bipolar transistor (HV IGBTs). A novel structure with a carrier stored layer on the cathode side, known as an enhanced planar IGBT of the 4500 V voltage class is investigated. With the adoption of a soft punch through (SPT) concept as the vertical structure and an enhanced planar concept as the top structure, signed as SPT + IGBT, the simulation results indicate the turn-off switching waveform of the 4500 V SPT + IGBT is soft and also realizes an improved trade-off relationship between on-state voltage drop (V on ) and turn-off loss (E off ) in comparison with the SPT IGBT. Attention is also paid to the influences caused by different carrier stored layer doping dose on static and dynamic performances, to optimize on-state and switching losses of SPT + IGBT. (paper)

  16. Hand bone loss in early rheumatoid arthritis during a methotrexate-based treat-to-target strategy with or without adalimumab-a substudy of the optimized treatment algorithm in early RA (OPERA) trial

    DEFF Research Database (Denmark)

    Ørnbjerg, L M; Østergaard, M; Jensen, T

    2017-01-01

    This study aims to investigate 1-year hand bone loss (HBL1-year) in early rheumatoid arthritis (RA) patients treated with a methotrexate (MTX) and intra-articular triamcinolone treat-to-target strategy +/- adalimumab and to determine if HBL6months is associated with radiographic progression after 2...... associated with ∆TSS after 2 years (β = -0.086 (95% confidence interval = -0.15; -0.025) TSS unit/mg/cm(2) increase, p = 0.006) but not with presence of radiographic progression (∆TSS >0) (OR 0.96 (0.92-1.0), p = 0.10). In early RA patients treated with a methotrexate-based treat-to-target strategy...

  17. Loss-Averse Retailer’s Optimal Ordering Policies for Perishable Products with Customer Returns

    Directory of Open Access Journals (Sweden)

    Xu Chen

    2014-01-01

    Full Text Available We investigate the loss-averse retailer’s ordering policies for perishable product with customer returns. With the introduction of the segmental loss utility function, we depict the retailer’s loss aversion decision bias and establish the loss-averse retailer’s ordering policy model. We derive that the loss-averse retailer’s optimal order quantity with customer returns exists and is unique. By comparison, we obtain that both the risk-neutral and the loss-averse retailer’s optimal order quantities depend on the inventory holding cost and the marginal shortage cost. Through the sensitivity analysis, we also discuss the effect of loss-averse coefficient and the ratio of return on the loss-averse retailer’s optimal order quantity with customer returns.

  18. Determining the Optimal Protocol for Measuring an Albuminuria Class Transition in Clinical Trials in Diabetic Kidney Disease

    DEFF Research Database (Denmark)

    Kröpelin, Tobias F; de Zeeuw, Dick; Remuzzi, Giuseppe

    2016-01-01

    Albuminuria class transition (normo- to micro- to macroalbuminuria) is used as an intermediate end point to assess renoprotective drug efficacy. However, definitions of such class transition vary between trials. To determine the most optimal protocol, we evaluated the approaches used in four...... effect increased (decreased precision) with stricter end point definitions, resulting in a loss of statistical significance. In conclusion, the optimal albuminuria transition end point for use in drug intervention trials can be determined with a single urine collection for albuminuria assessment per...... clinical trials testing the effect of renin-angiotensin-aldosterone system intervention on albuminuria class transition in patients with diabetes: the BENEDICT, the DIRECT, the ALTITUDE, and the IRMA-2 Trial. The definition of albuminuria class transition used in each trial differed from the definitions...

  19. Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment.

    Science.gov (United States)

    Abbas, Ismail; Rovira, Joan; Casanovas, Josep

    2007-05-01

    The patient recruitment process of clinical trials is an essential element which needs to be designed properly. In this paper we describe different simulation models under continuous and discrete time assumptions for the design of recruitment in clinical trials. The results of hypothetical examples of clinical trial recruitments are presented. The recruitment time is calculated and the number of recruited patients is quantified for a given time and probability of recruitment. The expected delay and the effective recruitment durations are estimated using both continuous and discrete time modeling. The proposed type of Monte Carlo simulation Markov models will enable optimization of the recruitment process and the estimation and the calibration of its parameters to aid the proposed clinical trials. A continuous time simulation may minimize the duration of the recruitment and, consequently, the total duration of the trial.

  20. The Optimal Strategy to Research Pension Funds in China Based on the Loss Function

    Directory of Open Access Journals (Sweden)

    Jian-wei Gao

    2007-10-01

    Full Text Available Based on the theory of actuarial present value, a pension fund investment goal can be formulated as an objective function. The mean-variance model is extended by defining the objective loss function. Furthermore, using the theory of stochastic optimal control, an optimal investment model is established under the minimum expectation of loss function. In the light of the Hamilton-Jacobi-Bellman (HJB equation, the analytic solution of the optimal investment strategy problem is derived.

  1. The Optimal Strategy to Research Pension Funds in China Based on the Loss Function

    OpenAIRE

    Gao, Jian-wei; Guo, Hong-zhen; Ye, Yan-cheng

    2007-01-01

    Based on the theory of actuarial present value, a pension fund investment goal can be formulated as an objective function. The mean-variance model is extended by defining the objective loss function. Furthermore, using the theory of stochastic optimal control, an optimal investment model is established under the minimum expectation of loss function. In the light of the Hamilton-Jacobi-Bellman (HJB) equation, the analytic solution of the optimal investment strategy problem is derived.

  2. Defining the Optimal Dietary Approach for Safe, Effective and Sustainable Weight Loss in Overweight and Obese Adults

    Directory of Open Access Journals (Sweden)

    Chrysi Koliaki

    2018-06-01

    Full Text Available Various dietary approaches with different caloric content and macronutrient composition have been recommended to treat obesity in adults. Although their safety and efficacy profile has been assessed in numerous randomized clinical trials, reviews and meta-analyses, the characteristics of the optimal dietary weight loss strategy remain controversial. This mini-review will provide general principles and practical recommendations for the dietary management of obesity and will further explore the components of the optimal dietary intervention. To this end, various dietary plans are critically discussed, including low-fat diets, low-carbohydrate diets, high-protein diets, very low-calorie diets with meal replacements, Mediterranean diet, and diets with intermittent energy restriction. As a general principle, the optimal diet to treat obesity should be safe, efficacious, healthy and nutritionally adequate, culturally acceptable and economically affordable, and should ensure long-term compliance and maintenance of weight loss. Setting realistic goals for weight loss and pursuing a balanced dietary plan tailored to individual needs, preferences, and medical conditions, are the key principles to facilitate weight loss in obese patients and most importantly reduce their overall cardiometabolic risk and other obesity-related comorbidities.

  3. The relationship between prevalence and duration of weight loss strategies and weight loss among overweight managed care organization members enrolled in a weight loss trial

    Directory of Open Access Journals (Sweden)

    Jeffery Robert W

    2006-02-01

    Full Text Available Abstract Background Many adults in the United States report engaging in weight loss behaviors. The current study examined weight loss strategies among managed care organization members, to determine the prevalence and impact of weight loss behaviors in this population. We hypothesized that greater engagement in weight loss strategies would be associated with greater weight loss success. Methods Data were taken from Weigh-to-Be (WTB, a two-year weight loss trial (N = 1801, 72% female, mean age = 50.7 years, mean weight = 95.9 kg, mean BMI = 34.2 kg/m2. Every six months, participants completed a questionnaire assessing frequency and duration of weight loss strategies (calorie reduction, fat reduction, increased fruit/vegetable intake, increased exercise, elimination of sweets, consumption of less food. General linear models and structural equation methods were used to examine associations between weight loss strategy use and weight change over time. Results Weight loss strategy prevalence rates ranged from 68% to 76% over two years. For all dietary strategies, any use of the strategy between baseline and 24 months was associated with weight loss at 24 months; those who did not engage in the strategy showed weight gains during that period. Results of general linear models and structural equation models indicated that increased use of weight loss strategies was significantly associated with greater 24-month weight loss. Conclusion The prevalence of weight loss strategies in this obese adult managed care population was quite high, and use of these strategies was associated in dose-response fashion with better weight loss. Future interventions may benefit from emphasis on persistence of similar strategies to achieve more successful outcomes.

  4. Tax-Optimal Step-Up and Imperfect Loss Offset

    Directory of Open Access Journals (Sweden)

    Markus Diller

    2012-05-01

    Full Text Available In the field of mergers and acquisitions, German and international tax law allow for several opportunities to step up a firm's assets, i.e., to revaluate the assets at fair market values. When a step-up is performed the taxpayer recognizes a taxable gain, but also obtains tax benefits in the form of higher future depreciation allowances associated with stepping up the tax base of the assets. This tax-planning problem is well known in taxation literature and can also be applied to firm valuation in the presence of taxation. However, the known models usually assume a perfect loss offset. If this assumption is abandoned, the depreciation allowances may lose value as they become tax effective at a later point in time, or even never if there are not enough cash flows to be offset against. This aspect is especiallyrelevant if future cash flows are assumed to be uncertain. This paper shows that a step-up may be disadvantageous or a firm overvalued if these aspects are not integrated into the basic calculus. Compared to the standard approach, assets should be stepped up only in a few cases and - under specific conditions - at a later point in time. Firm values may be considerably lower under imperfect loss offset.

  5. Overcoming obstacles in the design of cancer anorexia/weight loss trials.

    Science.gov (United States)

    Le-Rademacher, Jennifer G; Crawford, Jeffrey; Evans, William J; Jatoi, Aminah

    2017-09-01

    Most advanced cancer patients suffer loss of appetite (anorexia) and loss of weight. Despite the fact that cancer anorexia and weight loss are associated with a poor prognosis and detract from quality of life, no interventions have been demonstrated to palliate this syndrome in its entirety, particularly in patients with treatment-refractory malignancies. Recently, two registration trials - one with anamorelin and another with enobosarm - failed to reach their primary endpoints, thus raising questions. Were both these agents ineffective? Alternatively, did study design issues compromise the ability of these trials to identify effective agents? Thus, this review is timely insofar it serves as an introduction to study design, offers guidance on how to test promising agents for cancer anorexia/weight loss, and provides advice for overcoming trial design obstacles. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. A Hybrid Optimization Method for Reactive Power and Voltage Control Considering Power Loss Minimization

    DEFF Research Database (Denmark)

    Liu, Chengxi; Qin, Nan; Bak, Claus Leth

    2015-01-01

    This paper proposes a hybrid optimization method to optimally control the voltage and reactive power with minimum power loss in transmission grid. This approach is used for the Danish automatic voltage control (AVC) system which is typically a non-linear non-convex problem mixed with both...

  7. Effect of Local Junction Losses in the Optimization of T-shaped Flow Channels

    Science.gov (United States)

    Kosaraju, Srinivas

    2015-11-01

    T-shaped channels are extensively used in flow distribution applications such as irrigation, chemical dispersion, gas pipelines and space heating and cooling. The geometry of T-shaped channels can be optimized to reduce the overall pressure drop in stem and branch sections. Results of such optimizations are in the form of geometric parameters such as the length and diameter ratios of the stem and branch sections. The traditional approach of this optimization accounts for the pressure drop across the stem and branch sections, however, ignores the pressure drop in the T-junction. In this paper, we conduct geometry optimization while including the effect of local junction losses in laminar flows. From the results, we are able to identify a non-dimensional parameter that can be used to predict the optimal geometric configurations. This parameter can also be used to identify the conditions in which the local junction losses can be ignored during the optimization.

  8. Brief Self-Efficacy Scales for use in Weight-Loss Trials: Preliminary Evidence of Validity

    Science.gov (United States)

    Wilson, Kathryn E.; Harden, Samantha M.; Almeida, Fabio A.; You, Wen; Hill, Jennie L.; Goessl, Cody; Estabrooks, Paul A.

    2015-01-01

    Self-efficacy is a commonly included cognitive variable in weight-loss trials, but there is little uniformity in its measurement. Weight-loss trials frequently focus on physical activity (PA) and eating behavior, as well as weight loss, but no survey is available that offers reliable measurement of self-efficacy as it relates to each of these targeted outcomes. The purpose of this study was to test the psychometric properties of brief, pragmatic self-efficacy scales specific to PA, healthful eating and weight-loss (4 items each). An adult sample (n=1790) from 28 worksites enrolled in a worksite weight-loss program completed the self-efficacy scale, as well as measures of PA, dietary fat intake, and weight, at baseline, 6-, and 12-months. The hypothesized factor structure was tested through confirmatory factor analysis, which supported the expected factor structure for three latent self-efficacy factors, specific to PA, healthful eating, and weight-loss. Measurement equivalence/invariance between relevant demographic groups, and over time was also supported. Parallel growth processes in self-efficacy factors and outcomes (PA, fat intake, and weight) support the predictive validity of score interpretations. Overall, this initial series of psychometric analyses supports the interpretation that scores on these scales reflect self-efficacy for PA, healthful eating, and weight-loss. The use of this instrument in large-scale weight-loss trials is encouraged. PMID:26619093

  9. Optimization of Monochromated TEM for Ultimate Resolution Imaging and Ultrahigh Resolution Electron Energy Loss Spectroscopy

    KAUST Repository

    Lopatin, Sergei; Cheng, Bin; Liu, Wei-Ting; Tsai, Meng-Lin; He, Jr-Hau; Chuvilin, Andrey

    2017-01-01

    The performance of a monochromated transmission electron microscope with Wien type monochromator is optimized to achieve an extremely narrow energy spread of electron beam and an ultrahigh energy resolution with spectroscopy. The energy spread in the beam is improved by almost an order of magnitude as compared to specified values. The optimization involves both the monochromator and the electron energy loss detection system. We demonstrate boosted capability of optimized systems with respect to ultra-low loss EELS and sub-angstrom resolution imaging (in a combination with spherical aberration correction).

  10. Optimization of Monochromated TEM for Ultimate Resolution Imaging and Ultrahigh Resolution Electron Energy Loss Spectroscopy

    KAUST Repository

    Lopatin, Sergei

    2017-09-01

    The performance of a monochromated transmission electron microscope with Wien type monochromator is optimized to achieve an extremely narrow energy spread of electron beam and an ultrahigh energy resolution with spectroscopy. The energy spread in the beam is improved by almost an order of magnitude as compared to specified values. The optimization involves both the monochromator and the electron energy loss detection system. We demonstrate boosted capability of optimized systems with respect to ultra-low loss EELS and sub-angstrom resolution imaging (in a combination with spherical aberration correction).

  11. Tranexamic acid: optimal blood loss management in surface replacement arthroplasty.

    Science.gov (United States)

    Sassoon, A; Nam, D; Jackups, R; Johnson, S R; Nunley, R M; Barrack, R L

    2016-02-01

    This study investigated whether the use of tranexamic acid (TXA) decreased blood loss and transfusion related cost following surface replacement arthroplasty (SRA). A retrospective review of patients treated with TXA during a SRA, who did not receive autologous blood (TXA group) was performed. Two comparison groups were established; the first group comprised of patients who donated their own blood pre-operatively (auto group) and the second of patients who did not donate blood pre-operatively (control). Outcomes included transfusions, post-operative haemoglobin (Hgb), complications, and length of post-operative stay. Between 2009 and 2013, 150 patients undergoing SRA were identified for inclusion: 51 in the auto, 49 in the control, and 50 in the TXA group. There were no differences in the pre-operative Hgb concentrations between groups. The mean post-operative Hgb was 11.3 g/dL (9.1 to 13.6) in the auto and TXA groups, and 10.6 g/dL (8.1 to 12.1)in the control group (p = 0.001). Accounting for cost of transfusions, administration of TXA, and length of stay, the cost per patient was $1731, $339, and $185 for the auto, control and TXA groups, respectively. TXA use demonstrated higher post-operative Hgb concentrations when compared with controls and decreased peri-operative costs. Tranexamic acid safely limits allogeneic transfusion, maintains post-operative haemoglobin, and decreases direct and indirect transfusion related costs in surface replacement arthroplasty. ©2016 The British Editorial Society of Bone & Joint Surgery.

  12. Optimizing real power loss and voltage stability limit of a large transmission network using firefly algorithm

    Directory of Open Access Journals (Sweden)

    P. Balachennaiah

    2016-06-01

    Full Text Available This paper proposes a Firefly algorithm based technique to optimize the control variables for simultaneous optimization of real power loss and voltage stability limit of the transmission system. Mathematically, this issue can be formulated as nonlinear equality and inequality constrained optimization problem with an objective function integrating both real power loss and voltage stability limit. Transformers taps, unified power flow controller and its parameters have been included as control variables in the problem formulation. The effectiveness of the proposed algorithm has been tested on New England 39-bus system. Simulation results obtained with the proposed algorithm are compared with the real coded genetic algorithm for single objective of real power loss minimization and multi-objective of real power loss minimization and voltage stability limit maximization. Also, a classical optimization method known as interior point successive linear programming technique is considered here to compare the results of firefly algorithm for single objective of real power loss minimization. Simulation results confirm the potentiality of the proposed algorithm in solving optimization problems.

  13. Diet Type and Changes in Food Cravings following Weight Loss: Findings from the POUNDS LOST Trial

    OpenAIRE

    Anton, Stephen D.; Gallagher, Jacqueline; Carey, Vincent J.; Laranjo, Nancy; Cheng, Jing; Champagne, Catherine M.; Ryan, Donna H.; McManus, Kathy; Loria, Catherine M.; Bray, George A.; Sacks, Frank M.; Williamson, Donald A.

    2012-01-01

    Few well-controlled trials have evaluated the effects that macronutrient composition has on changes in food cravings during weight loss treatment. The present study, which was part of the POUNDS LOST trial, investigated whether the fat and protein content of four different diets affected changes in specific food cravings in overweight and obese adults. A sample of 811 adults were recruited across two clinical sites, and each participant was randomly assigned to one of four macronutrient presc...

  14. Optimizing Policymakers' Loss Functions in Crisis Prediction: Before, Within or After?

    OpenAIRE

    Sarlin, Peter; von Schweinitz, Gregor

    2015-01-01

    Early-warning models most commonly optimize signaling thresholds on crisis probabilities. The expost threshold optimization is based upon a loss function accounting for preferences between forecast errors, but comes with two crucial drawbacks: unstable thresholds in recursive estimations and an in-sample overfit at the expense of out-of-sample performance. We propose two alternatives for threshold setting: (i) including preferences in the estimation itself and (ii) setting thresholds ex-ante ...

  15. Optimization of loss and gain multilayers for reducing the scattering of a perfect conducting cylinder

    Science.gov (United States)

    Zhen-Zhong, Yu; Guo-Shu, Zhao; Gang, Sun; Hai-Fei, Si; Zhong, Yang

    2016-07-01

    Reduction of electromagnetic scattering from a conducting cylinder could be achieved by covering it with optimized multilayers of normal dielectric and plasmonic material. The plasmonic material with intrinsic losses could degrade the cloaking effect. Using a genetic algorithm, we present the optimized design of loss and gain multilayers for reduction of the scattering from a perfect conducting cylinder. This multilayered structure is theoretically and numerically analyzed when the plasmonic material with low loss and high loss respectively is considered. We demonstrate by full-wave simulation that the optimized nonmagnetic gain-loss design can greatly compensate the decreased cloaking effect caused by loss material, which facilitates the realization of practical electromagnetic cloaking, especially in the optical range. Project supported by the Research Foundation of Jinling Institute of Technology, China (Grant No. JIT-B-201426), the Jiangsu Modern Education and Technology Key Project, China (Grant No. 2014-R-31984), the Jiangsu 333 Project Funded Research Project, China (Grant No. BRA2010004), and the University Science Research Project of Jiangsu Province, China (Grant No. 15KJB520010).

  16. Computational Approach to Profit Optimization of a Loss-Queueing System

    Directory of Open Access Journals (Sweden)

    Dinesh Kumar Yadav

    2010-01-01

    Full Text Available Objective of the paper is to deal with the profit optimization of a loss queueing system with the finite capacity. Here, we define and compute total expected cost (TEC, total expected revenue (TER and consequently we compute the total optimal profit (TOP of the system. In order to compute the total optimal profit of the system, a computing algorithm has been developed and a fast converging N-R method has been employed which requires least computing time and lesser memory space as compared to other methods. Sensitivity analysis and its observations based on graphics have added a significant value to this model.

  17. Clinical trial experience with fat-restricted vs. carbohydrate-restricted weight-loss diets.

    Science.gov (United States)

    Klein, Samuel

    2004-11-01

    It is unlikely that one diet is optimal for all overweight or obese persons. Both low-fat and low-carbohydrate diets have been shown to induce weight loss and reduce obesity-related comorbidities. Low-carbohydrate diets cause greater short-term (up to 6 months) weight loss than low-fat diets, but the long-term clinical safety and efficacy of these diets has not been studied.

  18. Optimal reconfiguration-based dynamic tariff for congestion management and line loss reduction in distribution networks

    DEFF Research Database (Denmark)

    Huang, Shaojun; Wu, Qiuwei; Cheng, Lin

    2016-01-01

    This paper presents an optimal reconfiguration-based dynamic tariff (DT) method for congestion management and line loss reduction in distribution networks with high penetration of electric vehicles. In the proposed DT concept, feeder reconfiguration (FR) is employed through mixed integer programm...

  19. The optimal design of stepped wedge trials with equal allocation to sequences and a comparison to other trial designs.

    Science.gov (United States)

    Thompson, Jennifer A; Fielding, Katherine; Hargreaves, James; Copas, Andrew

    2017-12-01

    Background/Aims We sought to optimise the design of stepped wedge trials with an equal allocation of clusters to sequences and explored sample size comparisons with alternative trial designs. Methods We developed a new expression for the design effect for a stepped wedge trial, assuming that observations are equally correlated within clusters and an equal number of observations in each period between sequences switching to the intervention. We minimised the design effect with respect to (1) the fraction of observations before the first and after the final sequence switches (the periods with all clusters in the control or intervention condition, respectively) and (2) the number of sequences. We compared the design effect of this optimised stepped wedge trial to the design effects of a parallel cluster-randomised trial, a cluster-randomised trial with baseline observations, and a hybrid trial design (a mixture of cluster-randomised trial and stepped wedge trial) with the same total cluster size for all designs. Results We found that a stepped wedge trial with an equal allocation to sequences is optimised by obtaining all observations after the first sequence switches and before the final sequence switches to the intervention; this means that the first sequence remains in the control condition and the last sequence remains in the intervention condition for the duration of the trial. With this design, the optimal number of sequences is [Formula: see text], where [Formula: see text] is the cluster-mean correlation, [Formula: see text] is the intracluster correlation coefficient, and m is the total cluster size. The optimal number of sequences is small when the intracluster correlation coefficient and cluster size are small and large when the intracluster correlation coefficient or cluster size is large. A cluster-randomised trial remains more efficient than the optimised stepped wedge trial when the intracluster correlation coefficient or cluster size is small. A

  20. A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pellegrini Christine A

    2012-11-01

    Full Text Available Abstract Background Obesity remains a major public health challenge, demanding cost-effective and scalable weight management programs. Delivering key treatment components via mobile technology offers a potential way to reduce expensive in-person contact, thereby lowering the cost and burden of intensive weight loss programs. The ENGAGED study is a theory-guided, randomized controlled trial designed to examine the feasibility and efficacy of an abbreviated smartphone-supported weight loss program. Methods/design Ninety-six obese adults (BMI 30–39.9 kg/m2 will be randomized to one of three treatment conditions: (1 standard behavioral weight loss (STND, (2 technology-supported behavioral weight loss (TECH; or (3 self-guided behavioral weight loss (SELF. All groups will aim to achieve a 7% weight loss goal by reducing calorie and fat intake and progressively increasing moderate intensity physical activity to 175 minutes/week. STND and TECH will attend 8 group sessions and receive regular coaching calls during the first 6 months of the intervention; SELF will receive the Group Lifestyle Balance Program DVD’s and will not receive coaching calls. During months 1–6, TECH will use a specially designed smartphone application to monitor dietary intake, body weight, and objectively measured physical activity (obtained from a Blue-tooth enabled accelerometer. STND and SELF will self-monitor on paper diaries. Linear mixed modeling will be used to examine group differences on weight loss at months 3, 6, and 12. Self-monitoring adherence and diet and activity goal attainment will be tested as mediators. Discussion ENGAGED is an innovative weight loss intervention that integrates theory with emerging mobile technologies. We hypothesize that TECH, as compared to STND and SELF, will result in greater weight loss by virtue of improved behavioral adherence and goal achievement. Trial registration NCT01051713

  1. Optimism in prolonged grief and depression following loss: A three-wave longitudinal study.

    Science.gov (United States)

    Boelen, Paul A

    2015-06-30

    There is considerable evidence that optimism, the predisposition to have generalized favorable expectancies for the future, is associated with numerous desirable outcomes. Few studies have examined the association of optimism with emotional distress following the death of a loved one. Doing so is important, because optimism may be an important target for interventions for post-loss psychopathology. In the current study, we examined the degree to which optimism, assessed in the first year post-loss (Time 1, T1), was associated with symptom levels of prolonged grief and depression six months (Time 2, T2) and fifteen months (Time 3, T3) later, controlling for baseline symptoms and also taking into account positive automatic cognitions at T1. Findings showed that higher optimism at T1 was associated with lower concurrent prolonged grief and depression severity. Higher optimism at T1 was also inversely related with depression symptom severity at T2 and T3, but not prolonged grief severity at T2 and T3. Implications of these findings are discussed. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  2. Effects of manipulating eating frequency during a behavioral weight loss intervention: a pilot randomized controlled trial.

    Science.gov (United States)

    Bachman, Jessica L; Raynor, Hollie A

    2012-05-01

    Eating frequency has been inversely related to BMI but the impact of eating frequency on weight loss is unclear. This randomized controlled trial pilot study examined the effect of eating frequency on hunger, energy intake, and weight loss during a 6-month behavioral weight loss intervention. Participants (age: 51.0 ± 9.9 years, BMI: 35.5 ± 4.8 kg/m(2), 57.8% female, 94.1% white) were randomized to one of two eating frequency prescriptions: Three meal (n = 25): three eating bouts/day; or grazing (n = 26): eat at least 100 kcals every 2-3 h. Both groups attended 20 sessions and had identical dietary (1,200-1,500 kcals/day, frequency than three meal at 6 months (5.8 ± 1.1 eating bouts/day vs. 3.2 ± 0.6 eating bouts/day, P weight loss intervention.

  3. A concurrent optimization model for supplier selection with fuzzy quality loss

    International Nuclear Information System (INIS)

    Rosyidi, C.; Murtisari, R.; Jauhari, W.

    2017-01-01

    The purpose of this research is to develop a concurrent supplier selection model to minimize the purchasing cost and fuzzy quality loss considering process capability and assembled product specification. Design/methodology/approach: This research integrates fuzzy quality loss in the model to concurrently solve the decision making in detailed design stage and manufacturing stage. Findings: The resulted model can be used to concurrently select the optimal supplier and determine the tolerance of the components. The model balances the purchasing cost and fuzzy quality loss. Originality/value: An assembled product consists of many components which must be purchased from the suppliers. Fuzzy quality loss is integrated in the supplier selection model to allow the vagueness in final assembly by grouping the assembly into several grades according to the resulted assembly tolerance.

  4. A concurrent optimization model for supplier selection with fuzzy quality loss

    Energy Technology Data Exchange (ETDEWEB)

    Rosyidi, C.; Murtisari, R.; Jauhari, W.

    2017-07-01

    The purpose of this research is to develop a concurrent supplier selection model to minimize the purchasing cost and fuzzy quality loss considering process capability and assembled product specification. Design/methodology/approach: This research integrates fuzzy quality loss in the model to concurrently solve the decision making in detailed design stage and manufacturing stage. Findings: The resulted model can be used to concurrently select the optimal supplier and determine the tolerance of the components. The model balances the purchasing cost and fuzzy quality loss. Originality/value: An assembled product consists of many components which must be purchased from the suppliers. Fuzzy quality loss is integrated in the supplier selection model to allow the vagueness in final assembly by grouping the assembly into several grades according to the resulted assembly tolerance.

  5. Optimal Tax-Timing and Asset Allocation when Tax Rebates on Capital Losses are Limited

    DEFF Research Database (Denmark)

    Marekwica, Marcel

    2012-01-01

    to realize capital gains immediately and pay capital gain taxes to regain the option to use potential future losses against a higher tax rate. This incentive adds an entirely new and as yet unstudied dimension to the portfolio problem. It causes risk averse investors to hold more equity and attain higher......This article studies the portfolio problem with realization-based capital gain taxation when limited amounts of losses qualify for tax rebate payments, as is the case under current US tax law. When the tax rate applicable to realized losses exceeds that on realized capital gains, it can be optimal...... welfare levels than is the case when trading under a tax system that seeks to collect the same amount of taxes, but does not allow for tax rebate payments. This is because the benefit to these investors from having their losses subsidized is greater than the suffering from having profits taxed at a higher...

  6. Dispositional optimism and therapeutic expectations in early-phase oncology trials.

    Science.gov (United States)

    Jansen, Lynn A; Mahadevan, Daruka; Appelbaum, Paul S; Klein, William M P; Weinstein, Neil D; Mori, Motomi; Daffé, Racky; Sulmasy, Daniel P

    2016-04-15

    Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early-phase oncology trials. However, optimism is not a unitary construct; it also can be defined as a general disposition, or what is called dispositional optimism. The authors assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. The authors also assessed how dispositional optimism related to unrealistic optimism. Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception. Dispositional optimism was found to be significantly associated with higher expectations for personal therapeutic benefit (Spearman rank correlation coefficient [r], 0.333; Poptimism was found to be weakly associated with unrealistic optimism (Spearman r, 0.215; P = .005). On multivariate analysis, both dispositional optimism (P = .02) and unrealistic optimism (Poptimism (P = .0001), but not dispositional optimism, was found to be independently associated with the therapeutic misconception. High expectations for therapeutic benefit among patient-subjects in early-phase oncology trials should not be assumed to result from misunderstanding of specific information regarding the trials. The data from the current study indicate that these expectations are associated with either a dispositionally positive outlook on life or biased expectations concerning specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early-phase oncology research. © 2016 American Cancer Society.

  7. Using data mining to predict success in a weight loss trial.

    Science.gov (United States)

    Batterham, M; Tapsell, L; Charlton, K; O'Shea, J; Thorne, R

    2017-08-01

    Traditional methods for predicting weight loss success use regression approaches, which make the assumption that the relationships between the independent and dependent (or logit of the dependent) variable are linear. The aim of the present study was to investigate the relationship between common demographic and early weight loss variables to predict weight loss success at 12 months without making this assumption. Data mining methods (decision trees, generalised additive models and multivariate adaptive regression splines), in addition to logistic regression, were employed to predict: (i) weight loss success (defined as ≥5%) at the end of a 12-month dietary intervention using demographic variables [body mass index (BMI), sex and age]; percentage weight loss at 1 month; and (iii) the difference between actual and predicted weight loss using an energy balance model. The methods were compared by assessing model parsimony and the area under the curve (AUC). The decision tree provided the most clinically useful model and had a good accuracy (AUC 0.720 95% confidence interval = 0.600-0.840). Percentage weight loss at 1 month (≥0.75%) was the strongest predictor for successful weight loss. Within those individuals losing ≥0.75%, individuals with a BMI (≥27 kg m -2 ) were more likely to be successful than those with a BMI between 25 and 27 kg m -2 . Data mining methods can provide a more accurate way of assessing relationships when conventional assumptions are not met. In the present study, a decision tree provided the most parsimonious model. Given that early weight loss cannot be predicted before randomisation, incorporating this information into a post randomisation trial design may give better weight loss results. © 2017 The British Dietetic Association Ltd.

  8. Energy loss optimization of run-off-road wheels applying imperialist competitive algorithm

    Directory of Open Access Journals (Sweden)

    Hamid Taghavifar

    2014-08-01

    Full Text Available The novel imperialist competitive algorithm (ICA has presented outstanding fitness on various optimization problems. Application of meta-heuristics has been a dynamic studying interest of the reliability optimization to determine idleness and reliability constituents. The application of a meta-heuristic evolutionary optimization method, imperialist competitive algorithm (ICA, for minimization of energy loss due to wheel rolling resistance in a soil bin facility equipped with single-wheel tester is discussed. The required data were collected thorough various designed experiments in the controlled soil bin environment. Local and global searching of the search space proposed that the energy loss could be reduced to the minimum amount of 15.46 J at the optimized input variable configuration of wheel load at 1.2 kN, tire inflation pressure of 296 kPa and velocity of 2 m/s. Meanwhile, genetic algorithm (GA, particle swarm optimization (PSO and hybridized GA–PSO approaches were benchmarked among the broad spectrum of meta-heuristics to find the outperforming approach. It was deduced that, on account of the obtained results, ICA can achieve optimum configuration with superior accuracy in less required computational time.

  9. Systematic design of photonic crystal structures using topology optimization: Low-loss waveguide bends

    DEFF Research Database (Denmark)

    Jensen, Jakob Søndergaard; Sigmund, Ole

    2004-01-01

    Topology optimization is a promising method for systematic design of optical devices. As an example, we demonstrate how the method can be used to design a 90degrees bend in a two-dimensional photonic crystal waveguide with a transmission loss of less than 0.3% in almost the entire frequency range...... of the guided mode. The method can directly be applied to the design of other optical devices, e.g., multiplexers and wave splitters, with optimized performance. (C) 2004 American Institute of Physics....

  10. Challenges of a community based pragmatic, randomised controlled trial of weight loss maintenance.

    Science.gov (United States)

    Randell, Elizabeth; McNamara, Rachel; Shaw, Christine; Espinasse, Aude; Simpson, Sharon Anne

    2015-12-18

    Randomised controlled trials (RCTs) have a reputation for being inherently difficult to deliver as planned and often face unforeseen challenges and delays, particularly in relation to organisational and governance difficulties, participant interest, constraints due to allocation of costs, local investigator interest and lengthy bureaucracy. Recruitment is often difficult and the challenges faced often impact on the cost and delivery of a successful trial within the funded period. This paper reflects upon the challenges faced in delivering a pragmatic RCT of weight loss maintenance in a community setting and suggests some potential solutions. The weight loss maintenance in adults trial aimed to evaluate the impact of a 12 month, individually tailored weight maintenance intervention on BMI 3 years from randomisation. Participants were recruited primarily from participant identification centres (PICs)-GP surgeries, exercise on referral schemes and slimming world. The intervention was delivered in community settings. A recruitment strategy implementation plan was drafted to address and monitor poor recruitment. Delays in opening and recruitment were experienced early on. Some were beyond the control of the study team such as; disagreement over allocation of national health service costs and PIC classification as well as difficulties in securing support from research networks. That the intervention was delivered in community settings was often at the root of these issues. Key items to address at the design stage of future trials include feasibility of eligibility criteria. The most effective element of the recruitment implementation plan was to refocus sources of recruitment and target only those who could fulfil the eligibility criteria immediately. Learnings from this trial should be kept in mind by those designing similar studies in the future. Considering potential governance, cost and research network support implications at the design stage of pragmatic trials of

  11. Fuzzy-TLBO optimal reactive power control variables planning for energy loss minimization

    International Nuclear Information System (INIS)

    Moghadam, Ahmad; Seifi, Ali Reza

    2014-01-01

    Highlights: • A new approach to the problem of optimal reactive power control variables planning is proposed. • The energy loss minimization problem has been formulated by modeling the load of system as a Load Duration Curve. • To solving the energy loss problem, the classic methods and the evolutionary methods are used. • A new proposed fuzzy teaching–learning based algorithm is applied to energy loss problem. • Simulations are done to show the effectiveness and superiority of the proposed algorithm compared with other methods. - Abstract: This paper offers a new approach to the problem of optimal reactive power control variables planning (ORPVCP). The basic idea is division of Load Duration Curve (LDC) into several time intervals with constant active power demand in each interval and then solving the energy loss minimization (ELM) problem to obtain an optimal initial set of control variables of the system so that is valid for all time intervals and can be used as an initial operating condition of the system. In this paper, the ELM problem has been solved by the linear programming (LP) and fuzzy linear programming (Fuzzy-LP) and evolutionary algorithms i.e. MHBMO and TLBO and the results are compared with the proposed Fuzzy-TLBO method. In the proposed method both objective function and constraints are evaluated by membership functions. The inequality constraints are embedded into the fitness function by the membership function of the fuzzy decision and the problem is modeled by fuzzy set theory. The proposed Fuzzy-TLBO method is performed on the IEEE 30 bus test system by considering two different LDC; and it is shown that using this method has further minimized objective function than original TLBO and other optimization techniques and confirms its potential to solve the ORPCVP problem with considering ELM as the objective function

  12. The Effect of Cost Sharing on an Employee Weight Loss Program: A Randomized Trial.

    Science.gov (United States)

    John, Leslie K; Troxel, Andrea B; Yancy, William S; Friedman, Joelle; Zhu, Jingsan; Yang, Lin; Galvin, Robert; Miller-Kovach, Karen; Halpern, Scott D; Loewenstein, George; Volpp, Kevin

    2018-01-01

    To test the effects of employer subsidies on employee enrollment, attendance, and weight loss in a nationally available weight management program. A randomized trial tested the impact of employer subsidy: 100%; 80%, 50%, and a hybrid 50% subsidy that could become a 100% subsidy by attaining attendance targets. NCT01756066. Twenty three thousand twenty-three employees of 2 US companies. The primary outcome was the percentage of employees who enrolled in the weight management program. We also tested whether the subsidies were associated with differential attendance and weight loss over 12 months, as might be predicted by the expectation that they attract employees with differing degrees of motivation. Analysis and Results: Enrollment differed significantly by subsidy level ( P < .0001). The 100% subsidy produced the highest enrollment (7.7%), significantly higher than each of the lower subsidies (vs 80% subsidy: 6.2%, P = .002; vs 50% subsidy: 3.9%, P < .0001; vs hybrid: 3.7%, P < .0001). Enrollment in the 80% subsidy group was significantly higher than both lower subsidy groups (vs 50% subsidy: 3.9%, P < .0001; vs hybrid: 3.7%, P < .0001). Among enrollees, there were no differences among the 4 groups in attendance or weight loss. This pragmatic trial, conducted in a real-world workplace setting, suggests that higher rates of employer subsidization help individuals to enroll in weight loss programs, without a decrement in program effectiveness. Future research could explore the cost-effectiveness of such subsidies or alternative designs.

  13. A Multivariate Quality Loss Function Approach for Optimization of Spinning Processes

    Science.gov (United States)

    Chakraborty, Shankar; Mitra, Ankan

    2018-05-01

    Recent advancements in textile industry have given rise to several spinning techniques, such as ring spinning, rotor spinning etc., which can be used to produce a wide variety of textile apparels so as to fulfil the end requirements of the customers. To achieve the best out of these processes, they should be utilized at their optimal parametric settings. However, in presence of multiple yarn characteristics which are often conflicting in nature, it becomes a challenging task for the spinning industry personnel to identify the best parametric mix which would simultaneously optimize all the responses. Hence, in this paper, the applicability of a new systematic approach in the form of multivariate quality loss function technique is explored for optimizing multiple quality characteristics of yarns while identifying the ideal settings of two spinning processes. It is observed that this approach performs well against the other multi-objective optimization techniques, such as desirability function, distance function and mean squared error methods. With slight modifications in the upper and lower specification limits of the considered quality characteristics, and constraints of the non-linear optimization problem, it can be successfully applied to other processes in textile industry to determine their optimal parametric settings.

  14. Enhanced GSA-Based Optimization for Minimization of Power Losses in Power System

    Directory of Open Access Journals (Sweden)

    Gonggui Chen

    2015-01-01

    Full Text Available Gravitational Search Algorithm (GSA is a heuristic method based on Newton’s law of gravitational attraction and law of motion. In this paper, to further improve the optimization performance of GSA, the memory characteristic of Particle Swarm Optimization (PSO is employed in GSAPSO for searching a better solution. Besides, to testify the prominent strength of GSAPSO, GSA, PSO, and GSAPSO are applied for the solution of optimal reactive power dispatch (ORPD of power system. Conventionally, ORPD is defined as a problem of minimizing the total active power transmission losses by setting control variables while satisfying numerous constraints. Therefore ORPD is a complicated mixed integer nonlinear optimization problem including many constraints. IEEE14-bus, IEEE30-bus, and IEEE57-bus test power systems are used to implement this study, respectively. The obtained results of simulation experiments using GSAPSO method, especially the power loss reduction rates, are compared to those yielded by the other modern artificial intelligence-based techniques including the conventional GSA and PSO methods. The results presented in this paper reveal the potential and effectiveness of the proposed method for solving ORPD problem of power system.

  15. Optimization of the Hockey Fans in Training (Hockey FIT) weight loss and healthy lifestyle program for male hockey fans.

    Science.gov (United States)

    Blunt, Wendy; Gill, Dawn P; Sibbald, Shannon L; Riggin, Brendan; Pulford, Roseanne W; Scott, Ryan; Danylchuk, Karen; Gray, Cindy M; Wyke, Sally; Bunn, Christopher; Petrella, Robert J

    2017-11-28

    The health outcomes of men continue to be poorer than women globally. Challenges in addressing this problem include difficulties engaging men in weight loss programs as they tend to view these programs as contrary to the masculine narrative of independence and self-reliance. Researchers have been turning towards sports fans to engage men in health promotion programs as sports fans are typically male, and tend to have poor health habits. Developed from the highly successful gender-sensitized Football Fans in Training program, Hockey Fans in Training (Hockey FIT) recruited 80 male hockey fans of the London Knights and Sarnia Sting who were overweight or obese into a weekly, 90-minute classroom education and group exercise program held over 12 weeks; a 40-week minimally-supported phase followed. A process evaluation of the Hockey FIT program was completed alongside a pragmatic randomized controlled trial and outcome evaluation in order to fully explore the acceptability of the Hockey FIT program from the perspectives of coaches delivering and participants engaged in the program. Data sources included attendance records, participant focus groups, coach interviews, assessment of fidelity (program observations and post-session coach reflections), and 12-month participant interviews. Coaches enjoyed delivering the program and found it simple to deliver. Men valued being among others of similar body shape and similar weight loss goals, and found the knowledge they gained through the program helped them to make and maintain health behaviour changes. Suggested improvements include having more hockey-related information and activities, greater flexibility with timing of program delivery, and greater promotion of technology support tools. We confirmed Hockey FIT was an acceptable "gender-sensitized" health promotion program for male hockey fans who were overweight or obese. Minor changes were required for optimization, which will be evaluated in a future definitive trial

  16. Intramyocellular triacylglycerol accumulation across weight loss strategies; Sub-study of the CENTRAL trial.

    Science.gov (United States)

    Gepner, Yftach; Shelef, Ilan; Schwarzfuchs, Dan; Cohen, Noa; Bril, Nitzan; Rein, Michal; Tsaban, Gal; Zelicha, Hila; Yaskolka Meir, Anat; Tene, Lilac; Sarusy, Benjamin; Rosen, Philip; Hoffman, Jay R; Stout, Jeffrey R; Thiery, Joachim; Ceglarek, Uta; Stumvoll, Michael; Blüher, Matthias; Stampfer, Meir J; Shai, Iris

    2017-01-01

    Intramyocellular triacylglycerol (IMTG) is utilized as metabolic fuel during exercise and is linked to insulin resistance, but the long-term effect of weight loss strategies on IMTG among participants with abdominal fat, remain unclear. In an 18-month trial, sedentary participants with abdominal fat/dyslipidemia were randomized to either a low-fat (LF) or Mediterranean/low-carbohydrate (MED/LC) diet (including 28g·day-1 of walnuts). After 6-months, the participants were re-randomized to moderate intense physical activity (PA+) or non-physical activity (PA-). Magnetic resonance imaging (MRI) was used to quantify changes of IMTG, abdominal sub-depots, hepatic and intermuscular fats. Across the 277 participants [86% men, age = 48 years, body-mass-index (BMI) = 31kg/m2, visceral fat = 33%] 86% completed the 18-m trial. At baseline, women had higher IMTG than men (3.4% vs. 2.3%, pvs. 9.5-18.5%, p<0.05). Changes in IMTG were associated with visceral and intermuscular fat, metabolic syndrome, insulin and leptin (p<0.05 for all), however, these associations did not remain after adjustment for visceral fat changes. Lifestyle strategies differentially affect IMTG accumulation; combination of exercise with decreased carbohydrate/increased unsaturated fat proportion intake greatly increase IMTG. Our findings suggest that increased IMTG during diet-induced moderate weight loss may not be directly related to cardiometabolic risk. ClinicalTrials.gov NCT01530724.

  17. Long-term weight-loss maintenance in obese patients with knee osteoarthritis: a randomized trial.

    Science.gov (United States)

    Christensen, Pia; Henriksen, Marius; Bartels, Else M; Leeds, Anthony R; Meinert Larsen, Thomas; Gudbergsen, Henrik; Riecke, Birgit F; Astrup, Arne; Heitmann, Berit L; Boesen, Mikael; Christensen, Robin; Bliddal, Henning

    2017-09-01

    Background: A formula low-energy diet (LED) reduces weight effectively in obese patients with knee osteoarthritis, but the role of LED in long-term weight-loss maintenance is unclear. Objective: We aimed to determine the effect of intermittent LED compared with daily meal replacements on weight-loss maintenance and number of knee replacements over 3 y. Design: The design was a randomized trial with participants aged >50 y who had knee osteoarthritis and a body mass index [BMI (in kg/m 2 )] ≥30. Participants were recruited from the osteoarthritis outpatient clinic at Copenhagen University Hospital in Frederiksberg, Denmark; they had previously completed a 68-wk lifestyle intervention trial and achieved an average weight loss of 10.5 kg (10% of initial body weight). Participants were randomly assigned to either the intermittent treatment (IN) group with LED for 5 wk every 4 mo for 3 y or to daily meal replacements of 1-2 meals for 3 y [regular (RE) group]. Attention by dietitians and the amount of formula products were similar. Primary outcomes were changes in body weight and proportion of participants receiving knee replacements. Outcomes were analyzed on the intention-to-treat-population with the use of baseline-carried-forward imputation for missing data. Results: A total of 153 participants (means ± SDs: BMI: 33.3 ± 4.6; age: 63.8 ± 6.3 y; 83% women) were recruited between June and December 2009 and randomly assigned to the IN ( n = 76) or RE ( n = 77) group. A total of 53 and 56 participants, respectively, completed the trial. Weight increased by 0.68 and 1.75 kg in the IN and RE groups, respectively (mean difference: -1.06 kg; 95% CI: -2.75, 0.63 kg; P = 0.22). Alloplasty rates were low and did not differ (IN group: 8 of 76 participants; RE group: 12 of 77 participants; P = 0.35). Conclusions: After a mean 10% weight-loss and 1-y maintenance, additional use of daily meal replacements or intermittent LED resulted in weight-loss maintenance for 3 y. These

  18. The Breathe Easier through Weight Loss Lifestyle (BE WELL Intervention: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Buist A

    2010-03-01

    Full Text Available Abstract Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324 are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke. The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical

  19. Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

    OpenAIRE

    Rushing, J.; Wing, R.; Wadden, T. A.; Knowler, W. C.; Lawlor, M.; Evans, M.; Killean, T.; Montez, M.; Espeland, M. A.; Zhang, P.

    2017-01-01

    Summary Objective The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10?years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. Methods The ...

  20. Effects of weight loss and insulin reduction on arterial stiffness in the SAVE trial

    Directory of Open Access Journals (Sweden)

    Hughes Timothy M

    2012-09-01

    Full Text Available Abstract Background Chronic arterial stiffness contributes to the negative health effects of obesity and insulin resistance, which include hypertension, stroke, and increased cardiovascular and all-cause mortality. Weight loss and improved insulin sensitivity are individually associated with improved central arterial stiffness; however, their combined effects on arterial stiffness are poorly understood. The purpose of this study was to determine how insulin levels modify the improvements in arterial stiffness seen with weight loss in overweight and obese young adults. Methods To assess the effects of weight loss and decreased fasting insulin on vascular stiffness, we studied 339 participants in the Slow the Adverse Effects of Vascular Aging (SAVE trial. At study entry, the participants were aged 20–45, normotensive, non-diabetic, and had a body-mass index of 25–39.9 kg/m2. Measures of pulse wave velocity (PWV in the central (carotid-femoral (cfPWV, peripheral (femoral-ankle (faPWV, and mixed (brachial-ankle (baPWV vascular beds were collected at baseline and 6 months. The effects of 6-month change in weight and insulin on measures of PWV were estimated using multivariate regression. Results After adjustment for baseline risk factors and change in systolic blood pressure, 6-month weight loss and 6-month change in fasting insulin independently predicted improvement in baPWV but not faPWV or cfPWV. There was a significant interaction between 6-month weight change and change in fasting insulin when predicting changes in baPWV (p baPWV. Conclusions Young adults with excess weight who both lower their insulin levels and lose weight see the greatest improvement in vascular stiffness. This improvement in vascular stiffness with weight loss and insulin declines may occur throughout the vasculature and may not be limited to individual vascular beds. Trial registration NCT00366990

  1. Maintained intentional weight loss reduces cardiovascular outcomes: results from the Sibutramine Cardiovascular OUTcomes (SCOUT) trial.

    Science.gov (United States)

    Caterson, I D; Finer, N; Coutinho, W; Van Gaal, L F; Maggioni, A P; Torp-Pedersen, C; Sharma, A M; Legler, U F; Shepherd, G M; Rode, R A; Perdok, R J; Renz, C L; James, W P T

    2012-06-01

    The Sibutramine Cardiovascular OUTcomes trial showed that sibutramine produced greater mean weight loss than placebo but increased cardiovascular morbidity but not mortality. The relationship between 12-month weight loss and subsequent cardiovascular outcomes is explored. Overweight/obese subjects (N = 10 744), ≥55 years with cardiovascular disease and/or type 2 diabetes mellitus, received sibutramine plus weight management during a 6-week Lead-in Period before randomization to continue sibutramine (N = 4906) or to receive placebo (N = 4898). The primary endpoint was the time from randomization to first occurrence of a primary outcome event (non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest or cardiovascular death). For the total population, mean weight change during Lead-in Period (sibutramine) was -2.54 kg. Post-randomization, mean total weight change to Month 12 was -4.18 kg (sibutramine) or -1.87 kg (placebo). Degree of weight loss during Lead-in Period or through Month 12 was associated with a progressive reduction in risk for the total population in primary outcome events and cardiovascular mortality over the 5-year assessment. Although more events occurred in the randomized sibutramine group, on an average, a modest weight loss of approximately 3 kg achieved in the Lead-in Period appeared to offset this increased event rate. Moderate weight loss (3-10 kg) reduced cardiovascular deaths in those with severe, moderate or mild cardiovascular disease. Modest weight loss over short-term (6 weeks) and longer-term (6-12 months) periods is associated with reduction in subsequent cardiovascular mortality for the following 4-5 years even in those with pre-existing cardiovascular disease. While the sibutramine group experienced more primary outcome events than the placebo group, greater weight loss reduced overall risk of these occurring in both groups. © 2011 Blackwell Publishing Ltd.

  2. A new global particle swarm optimization for the economic emission dispatch with or without transmission losses

    International Nuclear Information System (INIS)

    Zou, Dexuan; Li, Steven; Li, Zongyan; Kong, Xiangyong

    2017-01-01

    Highlights: • A new global particle swarm optimization (NGPSO) is proposed. • NGPSO has strong convergence and desirable accuracy. • NGPSO is used to handle the economic emission dispatch with or without transmission losses. • The equality constraint can be satisfied by solving a quadratic equation. • The inequality constraints can be satisfied by using penalty function method. - Abstract: A new global particle swarm optimization (NGPSO) algorithm is proposed to solve the economic emission dispatch (EED) problems in this paper. NGPSO is different from the traditional particle swarm optimization (PSO) algorithm in two aspects. First, NGPSO uses a new position updating equation which relies on the global best particle to guide the searching activities of all particles. Second, it uses the randomization based on the uniform distribution to slightly disturb the flight trajectories of particles during the late evolutionary process. The two steps enable NGPSO to effectively execute a number of global searches, and thus they increase the chance of exploring promising solution space, and reduce the probabilities of getting trapped into local optima for all particles. On the other hand, the two objective functions of EED are normalized separately according to all candidate solutions, and then they are incorporated into one single objective function. The transformation steps are very helpful in eliminating the difference caused by the different dimensions of the two functions, and thus they strike a balance between the fuel cost and emission. In addition, a simple and common penalty function method is employed to facilitate the satisfactions of EED’s constraints. Based on these improvements in PSO, objective functions and constraints handling, high-quality solutions can be obtained for EED problems. Five examples are chosen to testify the performance of three improved PSOs on solving EED problems with or without transmission losses. Experimental results show that

  3. Intramyocellular triacylglycerol accumulation across weight loss strategies; Sub-study of the CENTRAL trial.

    Directory of Open Access Journals (Sweden)

    Yftach Gepner

    Full Text Available Intramyocellular triacylglycerol (IMTG is utilized as metabolic fuel during exercise and is linked to insulin resistance, but the long-term effect of weight loss strategies on IMTG among participants with abdominal fat, remain unclear.In an 18-month trial, sedentary participants with abdominal fat/dyslipidemia were randomized to either a low-fat (LF or Mediterranean/low-carbohydrate (MED/LC diet (including 28g·day-1 of walnuts. After 6-months, the participants were re-randomized to moderate intense physical activity (PA+ or non-physical activity (PA-. Magnetic resonance imaging (MRI was used to quantify changes of IMTG, abdominal sub-depots, hepatic and intermuscular fats.Across the 277 participants [86% men, age = 48 years, body-mass-index (BMI = 31kg/m2, visceral fat = 33%] 86% completed the 18-m trial. At baseline, women had higher IMTG than men (3.4% vs. 2.3%, p<0.001 and increased IMTG was associated with aging and higher BMI, visceral and intermuscular fats, HbA1c%, HDL-c and leptin(p<0.05, but not with intra-hepatic fat. After 18 month of intervention and a -3 kg mean weight loss, participants significantly increased IMTG by 25%, with a distinct effect in the MED/LCPA+ group as compared to the other intervention groups (57% vs. 9.5-18.5%, p<0.05. Changes in IMTG were associated with visceral and intermuscular fat, metabolic syndrome, insulin and leptin (p<0.05 for all, however, these associations did not remain after adjustment for visceral fat changes.Lifestyle strategies differentially affect IMTG accumulation; combination of exercise with decreased carbohydrate/increased unsaturated fat proportion intake greatly increase IMTG. Our findings suggest that increased IMTG during diet-induced moderate weight loss may not be directly related to cardiometabolic risk.ClinicalTrials.gov NCT01530724.

  4. The optimization of treatment and management of schizophrenia in Europe (OPTiMiSE) trial

    DEFF Research Database (Denmark)

    Leucht, Stefan; Winter-van Rossum, Inge; Heres, Stephan

    2015-01-01

    Commission sponsored "Optimization of Treatment and Management of Schizophrenia in Europe" (OPTiMiSE) trial which aims to provide a treatment algorithm for patients with a first episode of schizophrenia. METHODS: We searched Pubmed (October 29, 2014) for randomized controlled trials (RCTs) that examined...... switching the drug in nonresponders to another antipsychotic. We described important methodological choices of the OPTiMiSE trial. RESULTS: We found 10 RCTs on switching antipsychotic drugs. No trial was conclusive and none was concerned with first-episode schizophrenia. In OPTiMiSE, 500 first episode...

  5. A weight loss intervention using a commercial mobile application in Latino Americans-Adelgaza Trial.

    Science.gov (United States)

    Fukuoka, Yoshimi; Vittinghoff, Eric; Hooper, Julie

    2018-02-21

    More than half of Latino adults living in the USA are expected to develop type 2 diabetes in their lifetime. Despite the growing interest in smartphone use for weight loss and diabetes prevention, relatively few clinical trials have evaluated the efficacy of mobile app-based interventions in Latino populations. The aim of this study was to evaluate the potential efficacy of an in-person weight loss intervention in conjunction with a commercially available Fitbit app in a Latino sample at risk for type 2 diabetes and explore significant predictors associated with weight loss. After the run-in period, 54 self-identified Latinos with body mass index (BMI) > 24.9 kg/m2 were enrolled in an 8-week uncontrolled pilot study, and received a Fitbit Zip, its app, and two in-person weight loss sessions adapted from the Diabetes Prevention Program. Mean age was 45.3 (SD ± 10.8) years, 61.1% were born in the USA, and mean BMI was 31.4 (SD ± 4.1) kg/m2. Participants lost an average of 3.3 (SD ± 3.4) % of their body weight (p < .0005). We also observed statistically significant reductions in hip and waist circumferences, and systolic and diastolic blood pressure (p < .001). After controlling for demographic factors, use of the mobile app weight diary at least twice a week (p = .01) and change in the International Physical Activity Questionnaire score (p = .03) were associated with change in percent body weight. The intervention showed the potential efficacy of this intervention, which should be formally evaluated in a randomized controlled trial.

  6. Dairy-Rich Diets Augment Fat Loss on an Energy-Restricted Diet: A Multicenter Trial

    Directory of Open Access Journals (Sweden)

    Michael B. Zemel

    2009-09-01

    Full Text Available A 12-week randomized controlled multi-center clinical trial was conducted in 106 overweight and obese adults. Diets were designed to produce a 2,093 kJ/day energy deficit with either low calcium (LC; ~600 mg/day, high calcium (HC; ~1,400 mg/day, or high dairy (HD; three dairy servings, diet totaling ~1,400 mg/day. Ninety-three subjects completed the trial, and 68 met all a priori weekly compliance criteria. Both HC and HD contained comparable levels of calcium, but HC was only ~30% as effective as HD in suppressing 1,25-(OH2D and exerted no significant effects on weight loss or body composition compared to LC. In the group that met compliance criteria, HD resulted in ~two-fold augmentation of fat loss compared to LC and HC (HD: -4.43 ± 0.53 kg; LC: -2.69 ± 0.0.53 kg; HC: -2.23 ± 0.73kg, p < 0.025; assessment of all completers and an intent-to-treat analysis produced similar trends. HD augmentated central (trunk fat loss (HD: -2.38 ± 0.30 kg; HC: -1.42 ± 0.30 kg; LC: -1.36 ± 0.42 kg, p < 0.05 and waist circumference (HD: -7.65 ± 0.75 cm; LC: -4.92 ± 0.74 cm; LC: -4.95 ± 1.05 cm, p < 0.025. Similar effects were noted among all subjects completing the study and in an intent-to-treat analysis. These data indicate that dairy-rich diets augment weight loss by targeting the fat compartment during energy restriction.

  7. Optimized evaporative cooling for sodium Bose-Einstein condensation against three-body loss

    International Nuclear Information System (INIS)

    Shobu, Takahiko; Yamaoka, Hironobu; Imai, Hiromitsu; Morinaga, Atsuo; Yamashita, Makoto

    2011-01-01

    We report on a highly efficient evaporative cooling optimized experimentally. We successfully created sodium Bose-Einstein condensates with 6.4x10 7 atoms starting from 6.6x10 9 thermal atoms trapped in a magnetic trap by employing a fast linear sweep of radio frequency at the final stage of evaporative cooling so as to overcome the serious three-body losses. The experimental results such as the cooling trajectory and the condensate growth quantitatively agree with the numerical simulations of evaporative cooling on the basis of the kinetic theory of a Bose gas carefully taking into account our specific experimental conditions. We further discuss theoretically a possibility of producing large condensates, more than 10 8 sodium atoms, by simply increasing the number of initial thermal trapped atoms and the corresponding optimization of evaporative cooling.

  8. Optimized VBM in patients with Alzheimer's disease: gray matter loss and its correlation with cognitive function

    International Nuclear Information System (INIS)

    Choi, Seon Hyeong; Moon, Won Jin; Chung, Eun Chul; Lee, Min Hee; Roh, Hong Gee; Park, Kwang Bo; Na, Duck Ryul

    2005-01-01

    To investigate the regional changes in gray matter volume by using optimized voxel based morphometry in the whole brain of patients with Alzheimer's disease (AD) and to determine its correlation with cognitive function. Nineteen patients with AD (mean mini mental state examination (MMSE) score = 20.4) and 19 age-matched control subjects (mean MMSE score 29) participated in this prospective study. T1-weighted 3D-SPGR scans were obtained for each subject. These T1-weighted images were spatially normalized into study-specific T1 template and segmented into gray matter, white matter and CSF. After the images were modulated and smoothed, all of the gray matter images were compared with control images by using voxel-wise statistical parametric test (two-sample-test). In patients with AD, total gray matter volume was significantly smaller than normal control (552 ± 39 mL vs. 632 ± 51 mL, ρ 0.001). Significant gray matter loss was seen in both the hippocampus and amygdala complexs, and the parahippocampi and frontoparietal cortices (ρ < 0.01, family wise error corrected). Left cerebral atrophy was more prominent than the right. Loss of gray matter volume in both the superior frontal gyri and left inferior temporal gyrus had a strong correlation with lower MMSE score. Optimized VBM was able to visualize pathologic changes of AD in vivo. In AD there was widespread gray matter volume loss in the frontoparietal lobes as well as the medial temporal lobes and had a strong correlation between volume loss of specific cortical areas and MMSE score

  9. Behavioral self-regulation for weight loss in young adults: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wing Rena R

    2009-02-01

    Full Text Available Abstract Objective To determine the feasibility of recruiting and retaining young adults in a brief behavioral weight loss intervention tailored for this age group, and to assess the preliminary efficacy of an intervention that emphasizes daily self-weighing within the context of a self-regulation model. Methods Forty young adults (29.1 ± 3.9 years, range 21–35, average BMI of 33.36 ± 3.4 were randomized to one of two brief behavioral weight loss interventions: behavioral self-regulation (BSR or adapted standard behavioral treatment (SBT. Assessments were conducted at baseline, post-treatment (10 weeks, and follow-up (20 weeks. Intent to treat analyses were conducted using general linear modeling in SPSS version 14.0. Results Participants in both groups attended an average of 8.7 out of 10 group meetings, and retention rates were 93% and 88% for post-treatment and follow-up assessments, respectively. Both groups achieved significant weight losses at post-treatment (BSR = -6.4 kg (4.0; SBT = -6.2 kg (4.5 and follow-up (BSR = -6.6 kg (5.5; SBT = -5.8 kg (5.2, p p = .84. Across groups, there was a positive association between frequency of weighing at follow-up and overall weight change at follow-up (p = .01. Daily weighing was not associated with any adverse changes in psychological symptoms. Conclusion Young adults can be recruited and retained in a behavioral weight loss program tailored to their needs, and significant weight losses can be achieved and maintained through this brief intervention. Future research on the longer-term efficacy of a self-regulation approach using daily self-weighing for weight loss in this age group is warranted. Clinical Trials Registration # NCT00488228

  10. The relationship between weight loss and time and risk preference parameters: a randomized controlled trial.

    Science.gov (United States)

    Takada, Akemi; Nakamura, Ryota; Furukawa, Masakazu; Takahashi, Yoshimitsu; Nishimura, Shuzo; Kosugi, Shinji

    2011-07-01

    This study aimed to assess the effectiveness of intervention (specifically, intervention by telephone and mails, known as 'tele-care') relative to self-help as a weight-loss method. The question of whether there is a correlation between changes in two preference parameters--time discounting (i.e. impatience) and risk aversion--and the level of commitment was examined. The study, spanning a period of 24 weeks in 2006-2007, comprised 118 participants, each of whom was randomly assigned to either the tele-care or the self-help group. A public-health nurse provided support through telephone and mail communications to the tele-care group, aiming to reduce their calorie intake and increase exercise via this intervention. There was a significant decrease in the body weight of the participants of the tele-care group from the baseline; however, there were no significant differences in the weight loss, median time discounting or risk aversion between the two groups. The subsequent analysis for weight loss with changes in time and risk parameters revealed a significant difference in the weight loss in the time-discounting-loss and risk-aversion-gain groups. From the results of the multiple regression analysis, the time discounting was noted to be associated with age, initial BMI and marital status among men, and risk aversion was associated with age and job status among women. There is a possibility that a decrease in time discounting and increase in risk aversion might correlate with the weight loss or effectiveness of commitment in this trial. This study suggests that time discounting and risk aversion may be useful in anti-obesity efforts, since they are accurate criteria of behavioural patterns associated with weight problems. © Cambridge University Press, 2011

  11. Clinical trials in hospitalized heart failure patients: targeting interventions to optimal phenotypic subpopulations.

    Science.gov (United States)

    Vaduganathan, Muthiah; Butler, Javed; Roessig, Lothar; Fonarow, Gregg C; Greene, Stephen J; Metra, Marco; Cotter, Gadi; Kupfer, Stuart; Zalewski, Andrew; Sato, Naoki; Filippatos, Gerasimos; Gheorghiade, Mihai

    2015-07-01

    With one possible exception, the last decade of clinical trials in hospitalized heart failure (HHF) patients has failed to demonstrate improvement in long-term clinical outcomes. This trend necessitates a need to evaluate optimal drug development strategies and standards of trial conduct. It has become increasingly important to recognize the heterogeneity among HHF patients and the differential characterization of novel drug candidates. Targeting these agents to specific subpopulations may afford optimal net response related to the particular mode of action of the drug. Analyses of previous trials demonstrate profound differences in the baseline characteristics of patients enrolled across global regions and participating sites. Such differences may influence risks for events and interpretation of results. Therefore, the actual execution of trials and the epidemiology of HHF populations at the investigative sites must be taken into consideration. Collaboration among participating sites including the provision of registry data tailored to the planned development program will optimize trial conduct. Observational data prior to study initiation may enable sites to feedback and engage in protocol development to allow for feasible and valid clinical trial conduct. This site-centered, epidemiology-based network environment may facilitate studies in specific patient populations and promote optimal data collection and clear interpretation of drug safety and efficacy. This review summarizes the roundtable discussion held by a multidisciplinary team of representatives from academia, National Institutes of Health, industry, regulatory agencies, payers, and contract and academic research organizations to answer the question: Who should be targeted for novel therapies in HHF?

  12. Measurement of Self-Monitoring Web Technology Acceptance and Use in an e-Health Weight-Loss Trial

    OpenAIRE

    Ma, Jun; Xiao, Lan; Blonstein, Andrea C.

    2013-01-01

    Background: Research on technology acceptance and use in e-health weight-loss interventions is limited. Using data from a randomized controlled trial of two e-health interventions, we evaluated the acceptance and use of a self-monitoring Web site for weight loss. Materials and Methods: We examined eight theoretical constructs about technology acceptance using adapted 5-point Likert scales and the association of measured Web site usage and weight loss. Results: All scales had hi...

  13. Vitamin D Supplementation in Elderly Black Women Does Not Prevent Bone Loss, a Randomized Controlled Trial.

    Science.gov (United States)

    Aloia, John F; Fazzari, Melissa; Islam, Shahidul; Mikhail, Mageda; Katumuluwa, Subhashini; Dhaliwal, Ruban; Stolberg, Alexandra; Usera, Gianina; Ragolia, Louis

    2018-06-15

    Black Americans have lower levels of serum 25(OH)D but superior bone health compared to white Americans. There is controversy over whether they should be screened for vitamin D deficiency and have higher vitamin D requirements than recommended by the Institute of Medicine (IOM). The purpose of this trial was to determine whether Vitamin D supplementation in elderly black women prevents bone loss. 260 healthy black American women, 60 years of age and older were recruited to take part in a two arm, double-dummy 3 year RCT of vitamin D 3 vs. placebo. The study was conducted in an ambulatory clinical research center. Vitamin D 3 dose was adjusted to maintain serum 25(OH)D above 75 nmol/L. Bone mineral density (BMD) and serum were measured for [parathyroid hormone (PTH), C-terminal crosslink telopeptide (CTX) and bone specific alkaline phosphatase (BSAP) every 6 months. Baseline serum 25(OH)D 3 was 54.8 ± 16.8 nmol/L. There was no group xtime interaction effect for any BMD measurement. For all BMD measurements, except for total body and spine, there was a statistically significant negative effect of time (P D above 75 nmol/L is comparable to the rate of loss with serum 25(OH)D at the RDA of 50 nmol/L. Black Americans should have the same exposure to vitamin D as white Americans. The trial was registered at clinical trials.gov: NCT01153568. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  14. Weight loss in a UK commercial all meal provision study: a randomised controlled trial.

    Science.gov (United States)

    Mellor, D D; Whitham, C; Goodwin, S; Morris, M; Reid, M; Atkin, S L

    2014-08-01

    Effective approaches are needed to address the increasing prevalence of overweight and obesity. The present study investigated whether all meal provision was a more effective and acceptable method for weight loss than a self-directed diet. This randomised controlled trial recruited 112 men and women with a body mass index in the range 27-35 kg m(-2), who had no comorbidities, from the local area of Hull. Participants were randomised to receive either meal provision or follow a self-directed diet for a 12-week period that resulted in an estimated 2928 kJ day(-1) (700 kcal day(-1)) deficit. A dietitian supervised both dietary interventions. At 12 weeks [mean (SEM)], percentage weight loss in the meal provision group was 6.6% (0.5%) compared to 4.3% (0.6%) for those on the self-directed diet. In terms of clinically relevant weight loss, 61% of participants lost 5% or more of their body weight with meal provision compared to 22% on the self-directed diet (P meal provision withdrawing from the study compared to 41% of those following the self-directed diet (P Meal provision was a more effective and accepted method for weight loss over a 12-week period compared to a self-directed diet. This may in part represent the difference between being given the meal provision food free of charge. However, longer-term maintenance studies need to be undertaken to ascertain their effects on the maintenance of weight loss. © 2013 The Authors. Journal of Human Nutrition and Dietetics published by John Wiley & Sons Ltd on behalf of British Dietetic Association Ltd.

  15. Finite time thermodynamic analysis and optimization of solar-dish Stirling heat engine with regenerative losses

    Directory of Open Access Journals (Sweden)

    Sharma Arjun

    2011-01-01

    Full Text Available The present study investigates the performance of the solar-driven Stirling engine system to maximize the power output and thermal efficiency using the non-linearized heat loss model of the solar dish collector and the irreversible cycle model of the Stirling engine. Finite time thermodynamic analysis has been done for combined system to calculate the finite-rate heat transfer, internal heat losses in the regenerator, conductive thermal bridging losses and finite regeneration process time. The results indicate that exergy efficiency of dish system increases as the effectiveness of regenerator increases but decreases with increase in regenerative time coefficient. It is also found that optimal range of collector temperature and corresponding concentrating ratio are 1000 K~1400 K and 1100~1400, respectively in order to get maximum value of exergy efficiency. It is reported that the exergy efficiency of this dish system can reach the maximum value when operating temperature and concentrating ratio are 1150 K and 1300, respectively.

  16. Who responds to financial incentives for weight loss? Evidence from a randomized controlled trial.

    Science.gov (United States)

    Paloyo, Alfredo R; Reichert, Arndt R; Reuss-Borst, Monika; Tauchmann, Harald

    2015-11-01

    There is a paucity of evidence on the heterogeneous impacts of financial incentives on weight loss. Between March 2010 and January 2012, in a randomized controlled trial, we assigned 700 obese persons to three experimental arms. We test whether particular subgroups react differently to financial incentives for weight loss. Two treatment groups obtained a cash reward (€150 and €300 with 237 and 229 participants, respectively) for achieving an individually-assigned target weight within four months; the control group (234 participants) was not incentivized. Participants and administrators were not blinded to the intervention. We find that monetary rewards effectively induced obese individuals to reduce weight across all subgroups. However, there is no evidence for treatment-effect heterogeneity for those groups that were incentivized. Among those who were in the €300 group, statistically significant and large weight losses were observed for women, singles, and those who are not working (all above 4 kg in four months). In addition, the magnitude of the reward matters only for women and migrants. The effectiveness of financial incentives to reduce weight nevertheless raises sensitive ethical issues that should be taken into consideration by policymakers. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Self-determination theory and weight loss in a Diabetes Prevention Program translation trial.

    Science.gov (United States)

    Trief, Paula M; Cibula, Donald; Delahanty, Linda M; Weinstock, Ruth S

    2017-06-01

    We examined self-determination theory (SDT) and weight loss, and hypothesized that the Diabetes Prevention Program's (DPP) intervention would result in an increase in autonomous regulation of motivation (AR) in participants. Further, that those with higher AR, and those who perceived educators as supporting SDT-defined needs, would lose more weight. Support, Health Information, Nutrition and Exercise (SHINE) Study data (N = 257) were analyzed. SHINE was a randomized, controlled DPP translation trial (2-years, telephonic, primary care staff). Autonomous motivation in males increased significantly, while females showed no change. Males with high AR, but not females, lost more weight. However, the significance of these relationships varied over time. Participants who perceived educators as more supportive of psychological needs lost more weight (especially males). However, effect of support on weight loss was not mediated by AR change. Autonomous motivation and educator support are relevant to male weight loss. Future research might develop interventions to enhance autonomous motivation and educator support, and understand change pathways.

  18. Optimizing the District Heating Primary Network from the Perspective of Economic-Specific Pressure Loss

    Directory of Open Access Journals (Sweden)

    Haichao Wang

    2017-07-01

    Full Text Available A district heating (DH system is one of the most important components of infrastructures in cold areas. Proper DH network design should balance the initial investment and the heat distribution cost of the DH network. Currently, this design is often based on a recommended value for specific pressure loss (R = ∆P/L in the main lines. This will result in a feasible network design, but probably not be optimal in most cases. The paper develops a novel optimization model to facilitate the design by considering the initial investment in the pipes and the heat distribution costs. The model will generate all possible network scenarios consisting of different series of diameters for each pipe in the flow direction of the network. Then, the annuity on the initial investment, the heat distribution cost, and the total annual cost will be calculated for each network scenario, taking into account the uncertainties of the material prices and the yearly operating time levels. The model is applied to a sample DH network and the results indicate that the model works quite well, clearly identifying the optimal network design and demonstrating that the heat distribution cost is more important than the initial investment in DH network design.

  19. Optimizing treatment with tumour necrosis factor inhibitors in rheumatoid arthritis—a proof of principle and exploratory trial: is dose tapering practical in good responders?

    OpenAIRE

    Ibrahim, Fowzia; Lorente-Cánovas, Beatriz; Doré, Caroline J; Bosworth, Ailsa; Ma, Margaret H; Galloway, James B; Cope, Andrew P; Pande, Ira; Walker, David; Scott, David L

    2017-01-01

    Objectives: RA patients receiving TNF inhibitors (TNFi) usually maintain their initial doses. The aim of the Optimizing Treatment with Tumour Necrosis Factor Inhibitors in Rheumatoid Arthritis trial was to evaluate whether tapering TNFi doses causes loss of clinical response.Methods: We enrolled RA patients receiving etanercept or adalimumab and a DMARD with DAS28 under 3.2 for over 3 months. Initially (months 0-6) patients were randomized to control (constant TNFi) or two experimental groups...

  20. Optimization of fuel cycles: marginal loss values; Optimisation des cycles de combustibles: valeurs marginales des pertes

    Energy Technology Data Exchange (ETDEWEB)

    Gaussens, J [Commissariat a l' Energie Atomique, 75 - Paris (France); Lasteyrie, B de; Doumerc, J [Compagnie pour l' Etude et la Realisation de Combustibles Atomiques, 75 - Paris (France)

    1965-07-01

    Uranium processing from the pit to the fuel element rod entails metal losses at every step. These losses become more and more expensive with the elaboration of the metal. Some of the uranium must be accepted as definitely lost whilst the rest could be recovered and recycled. The high cost of these losses, whether they are recycled or not, and the fact that the higher the enrichment is the higher their costs are, make it necessary to take them into account when optimizing fuel cycles. It is therefore felt important to determine their most desirable level from an economic point of view at the various nuclear fuel processing stages. However, in France as in some other countries, fissile material production is a state concern, whilst fuel element fabrication is carried out by private enterprise. Optimization criteria and the economic value of losses are therefore different for each of the two links in the fabrication chain. One can try in spite of this to reach an optimum which would conform to public interest, without interfering with the firm's sales policy. This entails using the fact that for a given output marginal costs are equal at the optimum. One can therefore adjust the level of the losses to attain this equation of marginal costs, as these are easier to obtain from the firm than a justification of the actual prices. One notices moreover that, although mainly concerned with losses, this global analysis can bring both the state and the firm to a better use of other production factors. An account is given of the theory of this economic optimization method and practical applications in the field of natural uranium-graphite moderated and CO{sub 2} cooled reactor fuel element fabrication are offered. (authors) [French] L'elaboration de l'uranium, de la mine a la cartouche d'element combustible, s'accompagne, a tous les stades, de pertes, de plus en plus onereuses, a mesure que le metal devient plus elabore. Une certaine proportion de l'uranium doit etre consideree

  1. A Cross-Layer Optimized Opportunistic Routing Scheme for Loss-and-Delay Sensitive WSNs

    Science.gov (United States)

    Xu, Xin; Yuan, Minjiao; Liu, Xiao; Cai, Zhiping; Wang, Tian

    2018-01-01

    In wireless sensor networks (WSNs), communication links are typically error-prone and unreliable, so providing reliable and timely data routing for loss- and delay-sensitive applications in WSNs it is a challenge issue. Additionally, with specific thresholds in practical applications, the loss and delay sensitivity implies requirements for high reliability and low delay. Opportunistic Routing (OR) has been well studied in WSNs to improve reliability for error-prone and unreliable wireless communication links where the transmission power is assumed to be identical in the whole network. In this paper, a Cross-layer Optimized Opportunistic Routing (COOR) scheme is proposed to improve the communication link reliability and reduce delay for loss-and-delay sensitive WSNs. The main contribution of the COOR scheme is making full use of the remaining energy in networks to increase the transmission power of most nodes, which will provide a higher communication reliability or further transmission distance. Two optimization strategies referred to as COOR(R) and COOR(P) of the COOR scheme are proposed to improve network performance. In the case of increasing the transmission power, the COOR(R) strategy chooses a node that has a higher communication reliability with same distance in comparison to the traditional opportunistic routing when selecting the next hop candidate node. Since the reliability of data transmission is improved, the delay of the data reaching the sink is reduced by shortening the time of communication between candidate nodes. On the other hand, the COOR(P) strategy prefers a node that has the same communication reliability with longer distance. As a result, network performance can be improved for the following reasons: (a) the delay is reduced as fewer hops are needed while the packet reaches the sink in longer transmission distance circumstances; (b) the reliability can be improved since it is the product of the reliability of every hop of the routing path

  2. A Cross-Layer Optimized Opportunistic Routing Scheme for Loss-and-Delay Sensitive WSNs.

    Science.gov (United States)

    Xu, Xin; Yuan, Minjiao; Liu, Xiao; Liu, Anfeng; Xiong, Neal N; Cai, Zhiping; Wang, Tian

    2018-05-03

    In wireless sensor networks (WSNs), communication links are typically error-prone and unreliable, so providing reliable and timely data routing for loss- and delay-sensitive applications in WSNs it is a challenge issue. Additionally, with specific thresholds in practical applications, the loss and delay sensitivity implies requirements for high reliability and low delay. Opportunistic Routing (OR) has been well studied in WSNs to improve reliability for error-prone and unreliable wireless communication links where the transmission power is assumed to be identical in the whole network. In this paper, a Cross-layer Optimized Opportunistic Routing (COOR) scheme is proposed to improve the communication link reliability and reduce delay for loss-and-delay sensitive WSNs. The main contribution of the COOR scheme is making full use of the remaining energy in networks to increase the transmission power of most nodes, which will provide a higher communication reliability or further transmission distance. Two optimization strategies referred to as COOR(R) and COOR(P) of the COOR scheme are proposed to improve network performance. In the case of increasing the transmission power, the COOR(R) strategy chooses a node that has a higher communication reliability with same distance in comparison to the traditional opportunistic routing when selecting the next hop candidate node. Since the reliability of data transmission is improved, the delay of the data reaching the sink is reduced by shortening the time of communication between candidate nodes. On the other hand, the COOR(P) strategy prefers a node that has the same communication reliability with longer distance. As a result, network performance can be improved for the following reasons: (a) the delay is reduced as fewer hops are needed while the packet reaches the sink in longer transmission distance circumstances; (b) the reliability can be improved since it is the product of the reliability of every hop of the routing path

  3. A Cross-Layer Optimized Opportunistic Routing Scheme for Loss-and-Delay Sensitive WSNs

    Directory of Open Access Journals (Sweden)

    Xin Xu

    2018-05-01

    Full Text Available In wireless sensor networks (WSNs, communication links are typically error-prone and unreliable, so providing reliable and timely data routing for loss- and delay-sensitive applications in WSNs it is a challenge issue. Additionally, with specific thresholds in practical applications, the loss and delay sensitivity implies requirements for high reliability and low delay. Opportunistic Routing (OR has been well studied in WSNs to improve reliability for error-prone and unreliable wireless communication links where the transmission power is assumed to be identical in the whole network. In this paper, a Cross-layer Optimized Opportunistic Routing (COOR scheme is proposed to improve the communication link reliability and reduce delay for loss-and-delay sensitive WSNs. The main contribution of the COOR scheme is making full use of the remaining energy in networks to increase the transmission power of most nodes, which will provide a higher communication reliability or further transmission distance. Two optimization strategies referred to as COOR(R and COOR(P of the COOR scheme are proposed to improve network performance. In the case of increasing the transmission power, the COOR(R strategy chooses a node that has a higher communication reliability with same distance in comparison to the traditional opportunistic routing when selecting the next hop candidate node. Since the reliability of data transmission is improved, the delay of the data reaching the sink is reduced by shortening the time of communication between candidate nodes. On the other hand, the COOR(P strategy prefers a node that has the same communication reliability with longer distance. As a result, network performance can be improved for the following reasons: (a the delay is reduced as fewer hops are needed while the packet reaches the sink in longer transmission distance circumstances; (b the reliability can be improved since it is the product of the reliability of every hop of the

  4. A randomized controlled trial testing an Internet delivered cost-benefit approach to weight loss maintenance.

    Science.gov (United States)

    Leahey, Tricia M; Fava, Joseph L; Seiden, Andrew; Fernandes, Denise; Doyle, Caroline; Kent, Kimberly; La Rue, Molly; Mitchell, Marc; Wing, Rena R

    2016-11-01

    Weight loss maintenance is a significant challenge in obesity treatment. During maintenance the "costs" of adhering to weight management behaviors may outweigh the "benefits." This study examined the efficacy of a novel approach to weight loss maintenance based on modifying the cost-benefit ratio. Individuals who achieved a 5% weight loss (N=75) were randomized to one of three, 10-month maintenance interventions. All interventions were delivered primarily via the Internet. The Standard arm received traditional weight maintenance strategies. To increase benefits, or rewards, for maintenance behaviors, the two cost-benefit intervention conditions received weekly monetary rewards for self-monitoring and social reinforcement via e-coaching. To decrease behavioral costs (boredom) and increase novelty, participants in the cost-benefit conditions also monitored different evidence-based behaviors every two weeks (e.g., Weeks 1 & 2: steps; Week 3 & 4: red foods). The primary difference between the cost-benefit interventions was type of e-coach providing social reinforcement: Professional (CB Pro) or Peer (CB Peer). Study procedures took place in Providence, RI from 2013 to 2014. Retention was 99%. There were significant group differences in weight regain (p=.01). The Standard arm gained 3.5±5.7kg. In contrast, participants in CB Pro and CB Peer lost an additional 1.8±7.0kg and 0.5±6.4kg, respectively. These results suggest that an Internet delivered cost-benefit approach to weight loss maintenance may be effective for long-term weight control. In addition, using peer coaches to provide reinforcement may be a particularly economic alternative to professionals. These data are promising and provide support for a larger, longer trial. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Racial and ethnic minority enrollment in randomized clinical trials of behavioural weight loss utilizing technology: a systematic review.

    Science.gov (United States)

    Rosenbaum, D L; Piers, A D; Schumacher, L M; Kase, C A; Butryn, M L

    2017-07-01

    Many racial and ethnic minority groups (minorities) are disproportionately affected by overweight and obesity; however, minorities are often under-represented in clinical trials of behavioural weight loss (BWL) treatment, potentially limiting the generalizability of these trials' conclusions. Interventions involving technology may be particularly well suited to overcoming the barriers to minority enrollment in BWL trials, such as demanding or unpredictable work schedules, caregiving responsibilities and travel burdens. Thus, this systematic review aimed to describe minority enrollment in trials utilizing technology in interventions, as well as to identify which form(s) of technology yield the highest minority enrollment. Results indicated relatively low enrollment of minorities. Trials integrating smartphone use exhibited significantly greater racial minority enrollment than trials that did not; trials with both smartphone and in-person components exhibited the highest racial minority enrollment. This review is the first to explore how the inclusion of technology in BWL trials relates to minority enrollment and can help address the need to improve minority enrollment in weight loss research. © 2017 World Obesity Federation.

  6. Comparing methods to combine functional loss and mortality in clinical trials for amyotrophic lateral sclerosis

    Directory of Open Access Journals (Sweden)

    van Eijk RPA

    2018-03-01

    increases false-negative rates among all treatment scenarios. To detect a 15% reduction in ALSFRS-R decline and 34% decline in hazard with 80% power after 18 months, the Cox model requires 524 patients, the LME model 794 patients, the omnibus test 526 patients, the composite end point 1,274 patients, the CAFS 576 patients and the joint model 464 patients. Conclusion: Joint models have superior statistical power to analyze simultaneous effects on survival and function and may circumvent pitfalls encountered by other end points. Optimizing trial end points is essential, as selecting suboptimal outcomes may disguise important treatment clues. Keywords: joint models, CAFS, clinical trials, amyotrophic lateral sclerosis

  7. A randomized controlled trial of behavioral weight loss treatment versus combined weight loss/depression treatment among women with comorbid obesity and depression.

    Science.gov (United States)

    Linde, Jennifer A; Simon, Gregory E; Ludman, Evette J; Ichikawa, Laura E; Operskalski, Belinda H; Arterburn, David; Rohde, Paul; Finch, Emily A; Jeffery, Robert W

    2011-02-01

    Obesity is associated with clinical depression among women. However, depressed women are often excluded from weight loss trials. This study examined treatment outcomes among women with comorbid obesity and depression. Two hundred three (203) women were randomized to behavioral weight loss (n = 102) or behavioral weight loss combined with cognitive-behavioral depression management (n = 101). Average participant age was 52 years; mean baseline body mass index was 39 kg/m(2). Mean Patient Health Questionnaire and Hopkins Symptom Checklist (SCL-20) scores indicated moderate to severe baseline depression. Weight loss and SCL-20 changes did not differ between groups at 6 or 12 months in intent-to-treat analyses (p = 0.26 and 0.55 for weight, p = 0.70 and 0.25 for depressive symptoms). Depressed obese women lost weight and demonstrated improved mood in both treatment programs. Future weight loss trials are encouraged to enroll depressed women.

  8. Diet Type and Changes in Food Cravings following Weight Loss: Findings from the POUNDS LOST Trial

    Science.gov (United States)

    Anton, Stephen D.; Gallagher, Jacqueline; Carey, Vincent J.; Laranjo, Nancy; Cheng, Jing; Champagne, Catherine M.; Ryan, Donna H.; McManus, Kathy; Loria, Catherine M.; Bray, George A.; Sacks, Frank M.; Williamson, Donald A.

    2014-01-01

    Few well-controlled trials have evaluated the effects that macronutrient composition has on changes in food cravings during weight loss treatment. The present study, which was part of the POUNDS LOST trial, investigated whether the fat and protein content of four different diets affected changes in specific food cravings in overweight and obese adults. A sample of 811 adults were recruited across two clinical sites, and each participant was randomly assigned to one of four macronutrient prescriptions: (1) Low fat (20% of energy), average protein (15% of energy); (2) Moderate fat (40%), average protein (15%); (3) Low fat (20%), high protein (25%); (4) Moderate fat (40%), high protein (25%). With few exceptions, the type of diet that participants were assigned did not differentially affect changes in specific food cravings. Participants assigned to the high fat diets, however, had reduced cravings for carbohydrates at Month12 (p< .05) and fruits and vegetables at Month 24. Also, participants assigned to high protein diets had increased cravings for sweets at Month 6 (p< .05). Participants in all four dietary conditions reported significant reductions in food cravings for specific types of foods (i.e., high fat foods, fast food fats, sweets, and carbohydrates/starches; all ps< .05). Cravings for fruits and vegetables, however, were increased at Month 24 (p< .05). Calorically restricted diets (regardless of their macronutrient composition) yielded significant reductions in cravings for fats, sweets, and starches whereas cravings for fruits and vegetables were increased. PMID:23010779

  9. Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial.

    Science.gov (United States)

    Rushing, J; Wing, R; Wadden, T A; Knowler, W C; Lawlor, M; Evans, M; Killean, T; Montez, M; Espeland, M A; Zhang, P

    2017-03-01

    The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost-effectiveness of the ILI and will contain additional follow-up data.

  10. A randomised controlled trial of expectant management versus surgical evacuation of early pregnancy loss.

    Science.gov (United States)

    Nadarajah, Ravichandran; Quek, Yek Song; Kuppannan, Kaliammah; Woon, Shu Yuan; Jeganathan, Ravichandran

    2014-07-01

    To show whether a clinically significant difference in success rates exists between expectant and surgical management of early pregnancy loss. Randomised controlled trial comparing expectant versus surgical management of early pregnancy loss over a 1-year period from 1st January to 31st December 2009 at Sultanah Aminah Hospital, Johor Bahru. Pregnant women with missed or incomplete miscarriages at gestations up to 14 weeks were recruited in this study. The success rate in the surgical group was measured as curettage performed without any complications during or after the procedure, while the success rate in the expectant group was defined as complete spontaneous expulsion of products of conception within 6 weeks without any complication. A total of 360 women were recruited and randomised to expectant or surgical management, with 180 women in each group. There was no statistically significant difference in the success rate between the groups and between the different types of miscarriage. With expectant management, 131 (74%) patients had a complete spontaneous expulsion of products of conception, of whom 106 (83%) women miscarried within 7 days. However, the rates of unplanned admissions (18.1%) and unplanned surgical evacuations (17.5%) in the expectant group were significantly higher than the rates (7.4% and 8% respectively) in the surgical group. The complications in both groups were similar. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  11. Weight loss with a modified Mediterranean-type diet using fat modification: a randomized controlled trial.

    Science.gov (United States)

    Austel, A; Ranke, C; Wagner, N; Görge, J; Ellrott, T

    2015-08-01

    There is evidence that Mediterranean diets with a high proportion of olive oil and nuts can be effective for weight management and prevention of cardiovascular disease. It might be difficult for populations with other eating habits to follow such diets. Therefore, a modified Mediterranean-type diet using fat modification through neutral and butter-flavored canola oil, walnuts and walnut oil with two portion-controlled sweet daily snacks was tested in Germany. Randomized waiting-list control study with overweight/grade 1 obese subjects: 12-week self-help modified Mediterranean-type diet, 6 weeks of diet plans and 6 weeks of weight loss maintenance training. Trial duration was 12 months. Intervention group (IG) included 100 participants (average age of 52.4 years, weight 85.1 kg and body mass index (BMI) 30.1 kg/m(2)), waiting-list control group (CG) included 112 participants (52.6 years, 84.1 kg and 30.1 kg/m(2)). Per-protocol weight loss after 12 weeks was 5.2 kg in IG vs 0.4 kg in CG (P ⩽ 0.0001), BMI -1.8 vs -0.1 kg/m(2) (P ⩽ 0.0001), waist circumference -4.7 vs -0.9 cm (P ⩽ 0.0001). Triglycerides, total cholesterol and LDL cholesterol improved significantly in IG but not in CG. One-year dropouts: 44% in IG and 53% in CG. Weight loss after 12 months: 4.2 kg (pooled data). A five-meal modified Mediterranean-type diet with two daily portion-controlled sweet snacks was effective for weight management in a self-help setting for overweight and grade 1 obese subjects. Fat modification through canola oil, walnuts and walnut oil improved blood lipids even at 12 months.

  12. The optimal injection technique for the osteoarthritic ankle: A randomized, cross-over trial

    NARCIS (Netherlands)

    Witteveen, Angelique G. H.; Kok, Aimee; Sierevelt, Inger N.; Kerkhoffs, Gino M. M. J.; van Dijk, C. Niek

    2013-01-01

    Background: To optimize the injection technique for the osteoarthritic ankle in order to enhance the effect of intra-articular injections and minimize adverse events. Methods: Randomized cross-over trial. Comparing two injection techniques in patients with symptomatic ankle osteoarthritis. Patients

  13. Bright Light for Weight Loss: Results of a Controlled Crossover Trial

    Directory of Open Access Journals (Sweden)

    Konstantin V. Danilenko

    2013-02-01

    Full Text Available Objective: To investigate whether bright light treatment can reduce body mass in overweight subjects irrespective of their seasonal (= light dependence. Methods: A crossover, placebo-controlled, randomized clinical trial was performed between November and April in Novosibirsk, Russia (55° N. The trial comprised a 3-week in-home session of morning bright light treatment using a device of light-emitting diodes and a 3-week placebo session by means of a deactivated ion generator, separated by an off-protocol period of at least 23 days. The number of placebo and light sessions was matched with respect to season. Data were obtained from 34 overweight women, aged 20-54 years, 10 were seasonal-dependent according to the Seasonal Pattern Assessment Questionnaire. Weekly measures included body weight, percentage body fat by bioimpedancemetry, and subjective scores (appetite, mood, energy levels. Results: Motivation and expectation towards weight loss were similar for the two intervention sessions. With light, compared to the placebo session, weight did not reduce significantly, but percentage fat, fat mass, and appetite were significantly lower (average fat reduction 0.35 kg. The latter two results remained significant after excluding seasonal-dependent subjects from the analysis. Irrespective of the type of intervention, seasonal-dependent subjects had greater weight and fat mass changes during treatment (decline p 0.036 or between sessions (regain p 0.003. Photoperiod (p = 0.0041, air temperature to a lesser extent (p = 0.012, but not sunshine (p = 0.29 was associated with the weight change (greater weight reduction if the second session was in spring. Conclusion: Morning bright light treatment reduces body fat and appetite in overweight women and may be included in weight control programs.

  14. Optimal Scheduling of Integrated Energy Systems with Combined Heat and Power Generation, Photovoltaic and Energy Storage Considering Battery Lifetime Loss

    Directory of Open Access Journals (Sweden)

    Yongli Wang

    2018-06-01

    Full Text Available Integrated energy systems (IESs are considered a trending solution for the energy crisis and environmental problems. However, the diversity of energy sources and the complexity of the IES have brought challenges to the economic operation of IESs. Aiming at achieving optimal scheduling of components, an IES operation optimization model including photovoltaic, combined heat and power generation system (CHP and battery energy storage is developed in this paper. The goal of the optimization model is to minimize the operation cost under the system constraints. For the optimization process, an optimization principle is conducted, which achieves maximized utilization of photovoltaic by adjusting the controllable units such as energy storage and gas turbine, as well as taking into account the battery lifetime loss. In addition, an integrated energy system project is taken as a research case to validate the effectiveness of the model via the improved differential evolution algorithm (IDEA. The comparison between IDEA and a traditional differential evolution algorithm shows that IDEA could find the optimal solution faster, owing to the double variation differential strategy. The simulation results in three different battery states which show that the battery lifetime loss is an inevitable factor in the optimization model, and the optimized operation cost in 2016 drastically decreased compared with actual operation data.

  15. Optimization of fuel cycles: marginal loss values; Optimisation des cycles de combustibles: valeurs marginales des pertes

    Energy Technology Data Exchange (ETDEWEB)

    Gaussens, J. [Commissariat a l' Energie Atomique, 75 - Paris (France); Lasteyrie, B. de; Doumerc, J. [Compagnie pour l' Etude et la Realisation de Combustibles Atomiques, 75 - Paris (France)

    1965-07-01

    Uranium processing from the pit to the fuel element rod entails metal losses at every step. These losses become more and more expensive with the elaboration of the metal. Some of the uranium must be accepted as definitely lost whilst the rest could be recovered and recycled. The high cost of these losses, whether they are recycled or not, and the fact that the higher the enrichment is the higher their costs are, make it necessary to take them into account when optimizing fuel cycles. It is therefore felt important to determine their most desirable level from an economic point of view at the various nuclear fuel processing stages. However, in France as in some other countries, fissile material production is a state concern, whilst fuel element fabrication is carried out by private enterprise. Optimization criteria and the economic value of losses are therefore different for each of the two links in the fabrication chain. One can try in spite of this to reach an optimum which would conform to public interest, without interfering with the firm's sales policy. This entails using the fact that for a given output marginal costs are equal at the optimum. One can therefore adjust the level of the losses to attain this equation of marginal costs, as these are easier to obtain from the firm than a justification of the actual prices. One notices moreover that, although mainly concerned with losses, this global analysis can bring both the state and the firm to a better use of other production factors. An account is given of the theory of this economic optimization method and practical applications in the field of natural uranium-graphite moderated and CO{sub 2} cooled reactor fuel element fabrication are offered. (authors) [French] L'elaboration de l'uranium, de la mine a la cartouche d'element combustible, s'accompagne, a tous les stades, de pertes, de plus en plus onereuses, a mesure que le metal devient plus elabore. Une certaine proportion de l

  16. Randomized trial of weight-loss-diets for young adults varying in fish and fish oil content

    NARCIS (Netherlands)

    Thorsdottir, I.; Tomasson, H.; Gunnarsdottir, I.; Gisladottir, E.; Kiely, M.; Parra, M.D.; Bandarra, N.M.; Schaafsma, G.; Martinez, J.A.

    2007-01-01

    Objective: To investigate the effect of including seafood and fish oils, as part of an energy-restricted diet, on weight loss in young overweight adults. Design: Randomized controlled trial of energy-restricted diet varying in fish and fish oil content was followed for 8 weeks. Subjects were

  17. Text Message Support for Weight Loss in Patients With Prediabetes: A Randomized Clinical Trial.

    Science.gov (United States)

    Fischer, Henry H; Fischer, Ilana P; Pereira, Rocio I; Furniss, Anna L; Rozwadowski, Jeanne M; Moore, Susan L; Durfee, Michael J; Raghunath, Silvia G; Tsai, Adam G; Havranek, Edward P

    2016-08-01

    Although the benefits of in-person Diabetes Prevention Program (DPP) classes for diabetes prevention have been demonstrated in trials, effectiveness in clinical practice is limited by low participation rates. This study explores whether text message support enhances weight loss in patients offered DPP classes. English- and Spanish-speaking patients with prediabetes (n = 163) were randomized to the control group, which only received an invitation to DPP classes as defined by the Centers for Disease Control and Prevention, or to the text message-augmented intervention group, which also received text messages adapted from the DPP curriculum for 12 months. Mean weight decreased 0.6 pounds (95% CI -2.7 to 1.6) in the control group and 2.6 pounds (95% CI -5.5 to 0.2) in the intervention group (P value 0.05). Three percent weight loss was achieved by 21.5% of participants in the control group (95% CI 12.5-30.6), compared with 38.5% in the intervention group (95% CI 27.7-49.3) (absolute difference 17.0%; P value 0.02). Mean glycated hemoglobin (HbA1c) increased by 0.19% or 2.1 mmol/mol (95% CI -0.1 to 0.5%) and decreased by 0.09% or 1.0 mmol/mol (95% CI -0.2 to 0.0%) in the control group and intervention participants, respectively (absolute difference 0.28%; P value 0.07). Stratification by language demonstrated a significant treatment effect in Spanish speakers but not in English speakers. Text message support can lead to clinically significant weight loss in patients with prediabetes. Further study assessing effect by primary language and in an operational setting is warranted. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  18. Effects of protein intake and gender on body composition changes: a randomized clinical weight loss trial

    Directory of Open Access Journals (Sweden)

    Evans Ellen M

    2012-06-01

    Full Text Available Abstract Limited data on sex differences in body composition changes in response to higher protein diets (PRO compared to higher carbohydrate diets (CARB suggest that a PRO diet helps preserve lean mass (LM in women more so than in men. Objective To compare male and female body composition responses to weight loss diets differing in macronutrient content. Design Twelve month randomized clinical trial with 4mo of weight loss and 8mo weight maintenance. Subjects Overweight (N = 130; 58 male (M, 72 female (F; BMI = 32.5 ± 0.5 kg/m2 middle-aged subjects were randomized to energy-restricted (deficit ~500 kcal/d diets providing protein at 1.6 g.kg-1.d-1 (PRO or 0.8 g.kg-1.d-1 (CARB. LM and fat mass (FM were measured using dual X-ray absorptiometry. Body composition outcomes were tested in a repeated measures ANOVA controlling for sex, diet, time and their two- and three-way interactions at 0, 4, 8 and 12mo. Results When expressed as percent change from baseline, males and females lost similar amounts of weight at 12mo (M:-11.2 ± 7.1 %, F:-9.9 ± 6.0 %, as did diet groups (PRO:-10.7 ± 6.8 %, CARB:-10.1 ± 6.2 %, with no interaction of gender and diet. A similar pattern emerged for fat mass and lean mass, however percent body fat was significantly influenced by both gender (M:-18.0 ± 12.8 %, F:-7.3 ± 8.1 %, p  Conclusion PRO was more effective in reducing percent body fat vs. CARB over 12mo weight loss and maintenance. Men lost percent total body fat and trunk fat more effectively than women. No interactive effects of protein intake and gender are evident.

  19. Phase II prospective randomized trial of weight loss prior to radical prostatectomy.

    Science.gov (United States)

    Henning, Susanne M; Galet, Colette; Gollapudi, Kiran; Byrd, Joshua B; Liang, Pei; Li, Zhaoping; Grogan, Tristan; Elashoff, David; Magyar, Clara E; Said, Jonathan; Cohen, Pinchas; Aronson, William J

    2017-12-04

    Obesity is associated with poorly differentiated and advanced prostate cancer and increased mortality. In preclinical models, caloric restriction delays prostate cancer progression and prolongs survival. We sought to determine if weight loss (WL) in men with prostate cancer prior to radical prostatectomy affects tumor apoptosis and proliferation, and if WL effects other metabolic biomarkers. In this Phase II prospective trial, overweight and obese men scheduled for radical prostatectomy were randomized to a 5-8 week WL program consisting of standard structured energy-restricted meal plans (1200-1500 Kcal/day) and physical activity or to a control group. The primary endpoint was apoptotic index in the radical prostatectomy malignant epithelium. Secondary endpoints were proliferation (Ki67) in the radical prostatectomy tissue, body weight, body mass index (BMI), waist to hip ratio, body composition, and serum PSA, insulin, triglyceride, cholesterol, testosterone, estradiol, leptin, adiponectin, interleukin 6, interleukin 8, insulin-like growth factor 1, and IGF binding protein 1. In total 23 patients were randomized to the WL intervention and 21 patients to the control group. Subjects in the intervention group had significantly more weight loss (WL:-3.7 ± 0.5 kg; Control:-1.6 ± 0.5 kg; p = 0.007) than the control group and total fat mass was significantly reduced (WL:-2.1 ± 0.4; Control: 0.1 ± 0.3; p = 0.015). There was no significant difference in apoptotic or proliferation index between the groups. Among the other biomarkers, triglyceride, and insulin levels were significantly decreased in the WL compared with the control group. In summary, this short-term WL program prior to radical prostatectomy resulted in significantly more WL in the intervention vs. the control group and was accompanied by significant reductions in body fat mass, circulating triglycerides, and insulin. However, no significant changes were observed in malignant

  20. Method for optimal design of pipes for low-energy district heating, with focus on heat losses

    DEFF Research Database (Denmark)

    Dalla Rosa, Alessandro; Li, Hongwei; Svendsen, Svend

    2011-01-01

    The synergy between highly energy-efficient buildings and low-energy district heating (DH) systems is a promising concept for the optimal integration of energy-saving policies and energy supply systems based on renewable energy (RE). Network transmission and distribution heat loss is one of the k...

  1. A 12-week commercial web-based weight-loss program for overweight and obese adults: randomized controlled trial comparing basic versus enhanced features.

    Science.gov (United States)

    Collins, Clare E; Morgan, Philip J; Jones, Penelope; Fletcher, Kate; Martin, Julia; Aguiar, Elroy J; Lucas, Ashlee; Neve, Melinda J; Callister, Robin

    2012-04-25

    The development and use of Web-based programs for weight loss is increasing rapidly, yet they have rarely been evaluated using randomized controlled trials (RCTs). Interestingly, most people who attempt weight loss use commercially available programs, yet it is very uncommon for commercial programs to be evaluated independently or rigorously. To compare the efficacy of a standard commercial Web-based weight-loss program (basic) versus an enhanced version of this Web program that provided additional personalized e-feedback and contact from the provider (enhanced) versus a wait-list control group (control) on weight outcomes in overweight and obese adults. This purely Web-based trial using a closed online user group was an assessor-blinded RCT with participants randomly allocated to the basic or enhanced 12-week Web-based program, based on social cognitive theory, or the control, with body mass index (BMI) as the primary outcome. We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m(2)) with 84.1% (260/309) retention at 12 weeks. Intention-to-treat analysis showed that both intervention groups reduced their BMI compared with the controls (basic: -0.72, SD 1.1 kg/m(2), enhanced: -1.0, SD 1.4, control: 0.15, SD 0.82; P 3.0, SD 4.1, control: 0.4, SD 2.3; P 3.0; P Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve clinically important weight loss. Although the provision of additional personalized feedback did not facilitate greater weight loss after 12 weeks, the impact of superior participant retention on longer-term outcomes requires further study. Further research is required to determine the optimal mix of program features that lead to the biggest treatment impact over time. Australian New Zealand Clinical Trials Registry (ANZCTR): 12610000197033.

  2. A Method to Optimize Geometric Errors of Machine Tool based on SNR Quality Loss Function and Correlation Analysis

    Directory of Open Access Journals (Sweden)

    Cai Ligang

    2017-01-01

    Full Text Available Instead improving the accuracy of machine tool by increasing the precision of key components level blindly in the production process, the method of combination of SNR quality loss function and machine tool geometric error correlation analysis to optimize five-axis machine tool geometric errors will be adopted. Firstly, the homogeneous transformation matrix method will be used to build five-axis machine tool geometric error modeling. Secondly, the SNR quality loss function will be used for cost modeling. And then, machine tool accuracy optimal objective function will be established based on the correlation analysis. Finally, ISIGHT combined with MATLAB will be applied to optimize each error. The results show that this method is reasonable and appropriate to relax the range of tolerance values, so as to reduce the manufacturing cost of machine tools.

  3. Screen-Time Weight-loss Intervention Targeting Children at Home (SWITCH): a randomized controlled trial.

    Science.gov (United States)

    Maddison, Ralph; Marsh, Samantha; Foley, Louise; Epstein, Leonard H; Olds, Timothy; Dewes, Ofa; Heke, Ihirangi; Carter, Karen; Jiang, Yannan; Mhurchu, Cliona Ni

    2014-09-10

    Screen-based activities, such as watching television (TV), playing video games, and using computers, are common sedentary behaviors among young people and have been linked with increased energy intake and overweight. Previous home-based sedentary behaviour interventions have been limited by focusing primarily on the child, small sample sizes, and short follow-up periods. The SWITCH (Screen-Time Weight-loss Intervention Targeting Children at Home) study aimed to determine the effect of a home-based, family-delivered intervention to reduce screen-based sedentary behaviour on body composition, sedentary behaviour, physical activity, and diet over 24 weeks in overweight and obese children. A two-arm, parallel, randomized controlled trial was conducted. Children and their primary caregiver living in Auckland, New Zealand were recruited via schools, community centres, and word of mouth. The intervention, delivered over 20 weeks, consisted of a face-to-face meeting with the parent/caregiver and the child to deliver intervention content, which focused on training and educating them to use a wide range of strategies designed to reduce their child's screen time. Families were given Time Machine TV monitoring devices to assist with allocating screen time, activity packages to promote alternative activities, online support via a website, and monthly newsletters. Control participants were given the intervention material on completion of follow-up. The primary outcome was change in children's BMI z-score from baseline to 24 weeks. Children (n = 251) aged 9-12 years and their primary caregiver were randomized to receive the SWITCH intervention (n = 127) or no intervention (controls; n = 124). There was no significant difference in change of zBMI between the intervention and control groups, although a favorable trend was observed (-0.016; 95% CI: -0.084, 0.051; p = 0.64). There were also no significant differences on secondary outcomes, except for a trend towards

  4. Case Example of Dose Optimization Using Data From Bortezomib Dose-Finding Clinical Trials.

    Science.gov (United States)

    Lee, Shing M; Backenroth, Daniel; Cheung, Ying Kuen Ken; Hershman, Dawn L; Vulih, Diana; Anderson, Barry; Ivy, Percy; Minasian, Lori

    2016-04-20

    The current dose-finding methodology for estimating the maximum tolerated dose of investigational anticancer agents is based on the cytotoxic chemotherapy paradigm. Molecularly targeted agents (MTAs) have different toxicity profiles, which may lead to more long-lasting mild or moderate toxicities as well as to late-onset and cumulative toxicities. Several approved MTAs have been poorly tolerated during long-term administration, leading to postmarketing dose optimization studies to re-evaluate the optimal treatment dose. Using data from completed bortezomib dose-finding trials, we explore its toxicity profile, optimize its dose, and examine the appropriateness of current designs for identifying an optimal dose. We classified the toxicities captured from 481 patients in 14 bortezomib dose-finding studies conducted through the National Cancer Institute Cancer Therapy Evaluation Program, computed the incidence of late-onset toxicities, and compared the incidence of dose-limiting toxicities (DLTs) among groups of patients receiving different doses of bortezomib. A total of 13,008 toxicities were captured: 46% of patients' first DLTs and 88% of dose reductions or discontinuations of treatment because of toxicity were observed after the first cycle. Moreover, for the approved dose of 1.3 mg/m(2), the estimated cumulative incidence of DLT was > 50%, and the estimated cumulative incidence of dose reduction or treatment discontinuation because of toxicity was nearly 40%. When considering the entire course of treatment, the approved bortezomib dose exceeds the conventional ceiling DLT rate of 20% to 33%. Retrospective analysis of trial data provides an opportunity for dose optimization of MTAs. Future dose-finding studies of MTAs should take into account late-onset toxicities to ensure that a tolerable dose is identified for future efficacy and comparative trials. © 2016 by American Society of Clinical Oncology.

  5. Chaotic improved PSO-based multi-objective optimization for minimization of power losses and L index in power systems

    International Nuclear Information System (INIS)

    Chen, Gonggui; Liu, Lilan; Song, Peizhu; Du, Yangwei

    2014-01-01

    Highlights: • New method for MOORPD problem using MOCIPSO and MOIPSO approaches. • Constrain-prior Pareto-dominance method is proposed to meet the constraints. • The limits of the apparent power flow of transmission line are considered. • MOORPD model is built up for MOORPD problem. • The achieved results by MOCIPSO and MOIPSO approaches are better than MOPSO method. - Abstract: Multi-objective optimal reactive power dispatch (MOORPD) seeks to not only minimize power losses, but also improve the stability of power system simultaneously. In this paper, the static voltage stability enhancement is achieved through incorporating L index in MOORPD problem. Chaotic improved PSO-based multi-objective optimization (MOCIPSO) and improved PSO-based multi-objective optimization (MOIPSO) approaches are proposed for solving complex multi-objective, mixed integer nonlinear problems such as minimization of power losses and L index in power systems simultaneously. In MOCIPSO and MOIPSO based optimization approaches, crossover operator is proposed to enhance PSO diversity and improve their global searching capability, and for MOCIPSO based optimization approach, chaotic sequences based on logistic map instead of random sequences is introduced to PSO for enhancing exploitation capability. In the two approaches, constrain-prior Pareto-dominance method (CPM) is proposed to meet the inequality constraints on state variables, the sorting and crowding distance methods are considered to maintain a well distributed Pareto optimal solutions, and moreover, fuzzy set theory is employed to extract the best compromise solution over the Pareto optimal curve. The proposed approaches have been examined and tested in the IEEE 30 bus and the IEEE 57 bus power systems. The performances of MOCIPSO, MOIPSO, and multi-objective PSO (MOPSO) approaches are compared with respect to multi-objective performance measures. The simulation results are promising and confirm the ability of MOCIPSO and

  6. Genotype by environment interaction in sunflower (Helianthus annus L.) to optimize trial network efficiency

    Energy Technology Data Exchange (ETDEWEB)

    Gonzalez-Barrios, P.; Castro, M.; Pérez, O.; Vilaró, D.; Gutiérrez, L.

    2017-07-01

    Modeling genotype by environment interaction (GEI) is one of the most challenging aspects of plant breeding programs. The use of efficient trial networks is an effective way to evaluate GEI to define selection strategies. Furthermore, the experimental design and the number of locations, replications, and years are crucial aspects of multi-environment trial (MET) network optimization. The objective of this study was to evaluate the efficiency and performance of a MET network of sunflower (Helianthus annuus L.). Specifically, we evaluated GEI in the network by delineating mega-environments, estimating genotypic stability and identifying relevant environmental covariates. Additionally, we optimized the network by comparing experimental design efficiencies. We used the National Evaluation Network of Sunflower Cultivars of Uruguay (NENSU) in a period of 20 years. MET plot yield and flowering time information was used to evaluate GEI. Additionally, meteorological information was studied for each sunflower physiological stage. An optimal network under these conditions should have three replications, two years of evaluation and at least three locations. The use of incomplete randomized block experimental design showed reasonable performance. Three mega-environments were defined, explained mainly by different management of sowing dates. Late sowings dates had the worst performance in grain yield and oil production, associated with higher temperatures before anthesis and fewer days allocated to grain filling. The optimization of MET networks through the analysis of the experimental design efficiency, the presence of GEI, and appropriate management strategies have a positive impact on the expression of yield potential and selection of superior cultivars.

  7. Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial

    Directory of Open Access Journals (Sweden)

    Scott A. Shikora

    2015-01-01

    Full Text Available Background/Objectives. Vagal block therapy (vBloc is effective for moderate to severe obesity at one year. Subjects/Methods. The ReCharge trial is a double-blind, randomized controlled clinical trial of 239 participants with body mass index (BMI of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions. Interventions were implantation of either vBloc or Sham devices and weight management counseling. Mixed models assessed percent excess weight loss (%EWL and total weight loss (%TWL in intent-to-treat analyses. At 18 months, 142 (88% vBloc and 64 (83% Sham patients remained enrolled in the study. Results. 18-month weight loss was 23% EWL (8.8% TWL for vBloc and 10% EWL (3.8% TWL for Sham (P<0.0001. vBloc patients largely maintained 12-month weight loss of 26% EWL (9.7% TWL. Sham regained over 40% of the 17% EWL (6.4% TWL by 18 months. Most weight regain preceded unblinding. Common adverse events of vBloc through 18 months were heartburn/dyspepsia and abdominal pain; 98% of events were reported as mild or moderate and 79% had resolved. Conclusions. Weight loss with vBloc was sustained through 18 months, while Sham regained weight between 12 and 18 months. vBloc is effective with a low rate of serious complications.

  8. An Optimal Domestic Electric Vehicle Charging Strategy for Reducing Network Transmission Loss While Taking Seasonal Factors into Consideration

    Directory of Open Access Journals (Sweden)

    Yuancheng Zhao

    2018-01-01

    Full Text Available With the rapid growth of domestic electric vehicle charging loads, the peak-valley gap and power fluctuation rate of power systems increase sharply, which can lead to the increase of network losses and energy efficiency reduction. This paper tries to regulate network loads and reduce power system transmission loss by optimizing domestic electric vehicle charging loads. In this paper, a domestic electric vehicle charging loads model is first developed by analyzing the key factors that can affect users’ charging behavior. Subsequently, the Monte Carlo method is proposed to simulate the power consumption of a cluster of domestic electric vehicles. After that, an optimal electric vehicle charging strategy based on the 0-1 integer programming is presented to regulate network daily loads. Finally, by taking the IEEE33 distributed power system as an example, this paper tries to verify the efficacy of the proposed optimal charging strategy and the necessity for considering seasonal factors when scheduling electric vehicle charging loads. Simulation results show that the proposed 0-1 integer programming method does have good performance in reducing the network peak-valley gap, voltage fluctuation rate, and transmission loss. Moreover, it has some potential to further reduce power system transmission loss when seasonal factors are considered.

  9. Beneficial effect of high energy intake at lunch rather than dinner on weight loss in healthy obese women in a weight-loss program: a randomized clinical trial.

    Science.gov (United States)

    Madjd, Ameneh; Taylor, Moira A; Delavari, Alireza; Malekzadeh, Reza; Macdonald, Ian A; Farshchi, Hamid R

    2016-10-01

    The association between the time of nutrient intake and health has been described in a few studies. To our knowledge, no study has evaluated the relation between high energy intakes at lunch compared with at dinner on weight loss in overweight and obese subjects. We compared the effect of high energy intake at lunch with that at dinner on weight loss and cardiometabolic risk factors in women during a weight-loss program. Overweight and obese women [n = 80; body mass index (BMI; in kg/m 2 ): 27-35; age: 18-45 y] were asked to eat either a main meal at lunch (LM) or a main meal at dinner (DM) for 12 wk while in a weight-loss program. A total of 80 participants were randomly assigned to one of 2 intervention groups. Sixty-nine subjects (86%) completed the trial (34 subjects in the DM group, and 35 subjects in the LM group). Baseline variables were not significantly different between groups. A significant reduction in anthropometric measurements and significant improvements in cardiometabolic risk characteristics were observed over 12 wk in both groups. Compared with the DM group, the LM group had greater mean ± SD reductions in weight (LM: -5.85 ± 1.96 kg; DM: -4.35 ± 1.98 kg; P = 0.003), BMI (LM: 2.27± 0.76; DM: 1.68 ± 0.76; P = 0.003), homeostasis model assessment of insulin resistance (LM: -0.66 ± 0.33; DM: -0.46 ± 0.24; P = 0.001), and fasting insulin (LM: -2.01 ± 1.10 mIU/mL; DM: -1.16 ± 0.72 mIU/mL; P dinner may result in favorable changes in weight loss in overweight and obese women after a weight-loss program of 12 wk. The consumption may also offer clinical benefits to improve insulin resistance. This trial was registered at clinicaltrials.gov as NCT02399280. © 2016 American Society for Nutrition.

  10. Clinical Trials

    Medline Plus

    Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

  11. Investigating the Impact of Hearing Aid Use and Auditory Training on Cognition, Depressive Symptoms, and Social Interaction in Adults With Hearing Loss: Protocol for a Crossover Trial

    Science.gov (United States)

    Meyer, Denny; Blamey, Peter J; Pipingas, Andrew; Bhar, Sunil

    2018-01-01

    Background Sensorineural hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression, and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. Hearing aids have been proven as successful interventions to alleviate sensorineural hearing loss. In addition to hearing aid use, the positive effects of auditory training—formal listening activities designed to optimize speech perception—are now being documented among adults with hearing loss who use hearing aids, especially new hearing aid users. Auditory training has also been shown to produce prolonged cognitive performance improvements. However, there is still little evidence to support the benefits of simultaneous hearing aid use and individualized face-to-face auditory training on cognitive performance in adults with hearing loss. Objective This study will investigate whether using hearing aids for the first time will improve the impact of individualized face-to-face auditory training on cognition, depression, and social interaction for adults with sensorineural hearing loss. The rationale for this study is based on the hypothesis that, in adults with sensorineural hearing loss, using hearing aids for the first time in combination with individualized face-to-face auditory training will be more effective for improving cognition, depressive symptoms, and social interaction rather than auditory training on its own. Methods This is a crossover trial targeting 40 men and women between 50 and 90 years of age with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will be recruited from either an independent living accommodation or via a community database to undergo a 6-month intensive face-to-face auditory training program (active control). Participants will be assigned in random order to receive

  12. Determination of the optimal sample size for a clinical trial accounting for the population size.

    Science.gov (United States)

    Stallard, Nigel; Miller, Frank; Day, Simon; Hee, Siew Wan; Madan, Jason; Zohar, Sarah; Posch, Martin

    2017-07-01

    The problem of choosing a sample size for a clinical trial is a very common one. In some settings, such as rare diseases or other small populations, the large sample sizes usually associated with the standard frequentist approach may be infeasible, suggesting that the sample size chosen should reflect the size of the population under consideration. Incorporation of the population size is possible in a decision-theoretic approach either explicitly by assuming that the population size is fixed and known, or implicitly through geometric discounting of the gain from future patients reflecting the expected population size. This paper develops such approaches. Building on previous work, an asymptotic expression is derived for the sample size for single and two-arm clinical trials in the general case of a clinical trial with a primary endpoint with a distribution of one parameter exponential family form that optimizes a utility function that quantifies the cost and gain per patient as a continuous function of this parameter. It is shown that as the size of the population, N, or expected size, N∗ in the case of geometric discounting, becomes large, the optimal trial size is O(N1/2) or O(N∗1/2). The sample size obtained from the asymptotic expression is also compared with the exact optimal sample size in examples with responses with Bernoulli and Poisson distributions, showing that the asymptotic approximations can also be reasonable in relatively small sample sizes. © 2016 The Author. Biometrical Journal published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  13. An overview of the Families Improving Together (FIT) for weight loss randomized controlled trial in African American families.

    Science.gov (United States)

    Wilson, Dawn K; Kitzman-Ulrich, Heather; Resnicow, Ken; Van Horn, M Lee; St George, Sara M; Siceloff, E Rebekah; Alia, Kassandra A; McDaniel, Tyler; Heatley, VaShawn; Huffman, Lauren; Coulon, Sandra; Prinz, Ron

    2015-05-01

    The Families Improving Together (FIT) randomized controlled trial tests the efficacy of integrating cultural tailoring, positive parenting, and motivational strategies into a comprehensive curriculum for weight loss in African American adolescents. The overall goal of the FIT trial is to test the effects of an integrated intervention curriculum and the added effects of a tailored web-based intervention on reducing z-BMI in overweight African American adolescents. The FIT trial is a randomized group cohort design the will involve 520 African American families with an overweight adolescent between the ages of 11-16 years. The trial tests the efficacy of an 8-week face-to-face group randomized program comparing M + FWL (Motivational Plus Family Weight Loss) to a comprehensive health education program (CHE) and re-randomizes participants to either an 8-week on-line tailored intervention or control on-line program resulting in a 2 (M + FWL vs. CHE group) × 2 (on-line intervention vs. control on-line program) factorial design to test the effects of the intervention on reducing z-BMI at post-treatment and at 6-month follow-up. The interventions for this trial are based on a theoretical framework that is novel and integrates elements from cultural tailoring, Family Systems Theory, Self-Determination Theory and Social Cognitive Theory. The intervention targets positive parenting skills (parenting style, monitoring, communication); cultural values; teaching parents to increase youth motivation by encouraging youth to have input and choice (autonomy-support); and provides a framework for building skills and self-efficacy through developing weight loss action plans that target goal setting, monitoring, and positive feedback. Copyright © 2015. Published by Elsevier Inc.

  14. Optimization of brain PET imaging for a multicentre trial: the French CATI experience.

    Science.gov (United States)

    Habert, Marie-Odile; Marie, Sullivan; Bertin, Hugo; Reynal, Moana; Martini, Jean-Baptiste; Diallo, Mamadou; Kas, Aurélie; Trébossen, Régine

    2016-12-01

    CATI is a French initiative launched in 2010 to handle the neuroimaging of a large cohort of subjects recruited for an Alzheimer's research program called MEMENTO. This paper presents our test protocol and results obtained for the 22 PET centres (overall 13 different scanners) involved in the MEMENTO cohort. We determined acquisition parameters using phantom experiments prior to patient studies, with the aim of optimizing PET quantitative values to the highest possible per site, while reducing, if possible, variability across centres. Jaszczak's and 3D-Hoffman's phantom measurements were used to assess image spatial resolution (ISR), recovery coefficients (RC) in hot and cold spheres, and signal-to-noise ratio (SNR). For each centre, the optimal reconstruction parameters were chosen as those maximizing ISR and RC without a noticeable decrease in SNR. Point-spread-function (PSF) modelling reconstructions were discarded. The three figures of merit extracted from the images reconstructed with optimized parameters and routine schemes were compared, as were volumes of interest ratios extracted from Hoffman acquisitions. The net effect of the 3D-OSEM reconstruction parameter optimization was investigated on a subset of 18 scanners without PSF modelling reconstruction. Compared to the routine parameters of the 22 PET centres, average RC in the two smallest hot and cold spheres and average ISR remained stable or were improved with the optimized reconstruction, at the expense of slight SNR degradation, while the dispersion of values was reduced. For the subset of scanners without PSF modelling, the mean RC of the smallest hot sphere obtained with the optimized reconstruction was significantly higher than with routine reconstruction. The putamen and caudate-to-white matter ratios measured on 3D-Hoffman acquisitions of all centres were also significantly improved by the optimization, while the variance was reduced. This study provides guidelines for optimizing quantitative

  15. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mujagic, Edin; Zwimpfer, Tibor; Marti, Walter R; Zwahlen, Marcel; Hoffmann, Henry; Kindler, Christoph; Fux, Christoph; Misteli, Heidi; Iselin, Lukas; Lugli, Andrea Kopp; Nebiker, Christian A; von Holzen, Urs; Vinzens, Fabrizio; von Strauss, Marco; Reck, Stefan; Kraljević, Marko; Widmer, Andreas F; Oertli, Daniel; Rosenthal, Rachel; Weber, Walter P

    2014-05-24

    Surgical site infections are the most common hospital-acquired infections among surgical patients. The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate. While most studies suggest that it should be given as close to the incision time as possible, others conclude that this may be too late for optimal prevention of surgical site infections. A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery. The aim of this article is to report the design and protocol of a randomized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis. In this bi-center randomized controlled trial conducted at two tertiary referral centers in Switzerland, we plan to include 5,000 patients undergoing general, oncologic, vascular and orthopedic trauma procedures. Patients are randomized in a 1:1 ratio into two groups: one receiving surgical antimicrobial prophylaxis in the anesthesia room (75 to 30 minutes before incision) and the other receiving surgical antimicrobial prophylaxis in the operating room (less than 30 minutes before incision). We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision. The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period (one year with an implant in place). When assuming a 5% surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room, the planned sample size has an 80% power to detect a relative risk reduction for surgical site infections of 33% when administering surgical antimicrobial prophylaxis in the anesthesia room (with a two-sided type I error of 5%). We expect the study to be completed within three years. The results of this

  16. Utility of Urinary Biomarkers in Predicting Loss of Residual Renal Function: The balANZ Trial

    Science.gov (United States)

    Cho, Yeoungjee; Johnson, David W.; Vesey, David A.; Hawley, Carmel M.; Clarke, Margaret; Topley, Nicholas

    2015-01-01

    ♦ Background: The ability of urinary biomarkers to predict residual renal function (RRF) decline in peritoneal dialysis (PD) patients has not been defined. The present study aimed to explore the utility of established biomarkers from kidney injury models for predicting loss of RRF in incident PD patients, and to evaluate the impact on RRF of using neutral-pH PD solution low in glucose degradation products. ♦ Methods: The study included 50 randomly selected participants from the balANZ trial who had completed 24 months of follow-up. A change in glomerular filtration rate (GFR) was used as the primary clinical outcome measure. In a mixed-effects general linear model, baseline measurements of 18 novel urinary biomarkers and albumin were used to predict GFR change. The model was further used to evaluate the impact of biocompatible PD solution on RRF, adjusted for each biomarker. ♦ Results: Baseline albuminuria was not a useful predictor of change in RRF in PD patients (p = 0.84). Only clusterin was a significant predictor of GFR decline in the whole population (p = 0.04, adjusted for baseline GFR and albuminuria). However, the relationship was no longer apparent when albuminuria was removed from the model (p = 0.31). When the effect of the administered PD solutions was examined using a model adjusted for PD solution type, baseline albuminuria, and GFR, higher baseline urinary concentrations of trefoil factor 3 (TFF3, p = 0.02), kidney injury molecule 1 (KIM-1, p = 0.04), and interferon γ-induced protein 10 (IP-10, p = 0.03) were associated with more rapid decline of RRF in patients receiving conventional PD solution compared with biocompatible PD solution. ♦ Conclusions: Higher urinary levels of kidney injury biomarkers (TFF3, KIM-1, IP-10) at baseline predicted significantly slower RRF decline in patients receiving biocompatible PD solutions. Findings from the present investigation should help to guide future studies to validate the utility of urinary

  17. Effects of Popular Diets without Specific Calorie Targets on Weight Loss Outcomes: Systematic Review of Findings from Clinical Trials

    Directory of Open Access Journals (Sweden)

    Stephen D. Anton

    2017-07-01

    Full Text Available The present review examined the evidence base for current popular diets, as listed in the 2016 U.S. News & World Report, on short-term (≤six months and long-term (≥one year weight loss outcomes in overweight and obese adults. For the present review, all diets in the 2016 U.S. News & World Report Rankings for “Best Weight-Loss Diets”, which did not involve specific calorie targets, meal replacements, supplementation with commercial products, and/or were not categorized as “low-calorie” diets were examined. Of the 38 popular diets listed in the U.S. News & World Report, 20 met our pre-defined criteria. Literature searches were conducted through PubMed, Cochrane Library, and Web of Science using preset key terms to identify all relevant clinical trials for these 20 diets. A total of 16 articles were identified which reported findings of clinical trials for seven of these 20 diets: (1 Atkins; (2 Dietary Approaches to Stop Hypertension (DASH; (3 Glycemic-Index; (4 Mediterranean; (5 Ornish; (6 Paleolithic; and (7 Zone. Of the diets evaluated, the Atkins Diet showed the most evidence in producing clinically meaningful short-term (≤six months and long-term (≥one-year weight loss. Other popular diets may be equally or even more effective at producing weight loss, but this is unknown at the present time since there is a paucity of studies on these diets.

  18. Hope, optimism and survival in a randomised trial of chemotherapy for metastatic colorectal cancer.

    Science.gov (United States)

    Schofield, Penelope E; Stockler, M R; Zannino, D; Tebbutt, N C; Price, T J; Simes, R J; Wong, N; Pavlakis, N; Ransom, D; Moylan, E; Underhill, C; Wyld, D; Burns, I; Ward, R; Wilcken, N; Jefford, M

    2016-01-01

    Psychological responses to cancer are widely believed to affect survival. We investigated associations between hope, optimism, anxiety, depression, health utility and survival in patients starting first-line chemotherapy for metastatic colorectal cancer. Four hundred twenty-nine subjects with metastatic colorectal cancer in a randomised controlled trial of chemotherapy completed baseline questionnaires assessing the following: hopefulness, optimism, anxiety and depression and health utility. Hazard ratios (HRs) and P values were calculated with Cox models for overall survival (OS) and progression-free survival (PFS) in univariable and multivariable analyses. Median follow-up was 31 months. Univariable analyses showed that OS was associated negatively with depression (HR 2.04, P optimism, anxiety or hopefulness. PFS was not associated with hope, optimism, anxiety or depression in any analyses. Depression and health utility, but not optimism, hope or anxiety, were associated with survival after controlling for known prognostic factors in patients with advanced colorectal cancer. Further research is required to understand the nature of the relationship between depression and survival. If a causal mechanism is identified, this may lead to interventional possibilities.

  19. One-year health-related quality of life outcomes in weight loss trial participants: comparison of three measures

    Directory of Open Access Journals (Sweden)

    Kolotkin Ronette L

    2009-06-01

    Full Text Available Abstract Background The literature on changes in health-related quality of life (HRQOL in weight loss studies is inconsistent, and few studies use more than one type of measure. The purpose of the current study was to compare one-year changes in HRQOL as a function of weight change using three different measures: a weight-related measure (Impact of Weight on Quality of Life-Lite [IWQOL-Lite] and two generic measures (SF-36; EQ-5D. Methods Data were obtained from 926 participants (mean Body Mass Index (BMI (kg/m2 = 35.4; 84% female; mean age = 49.5 years in a placebo-controlled randomized trial for weight loss. At baseline and one-year, participants completed all three HRQOL measures. HRQOL was compared across weight change categories (≥ 5% and 0–4.9% gain, 0–4.9%, 5.0–9.9% and ≥ 10% loss, using effect sizes. Results The weight-related measure of HRQOL exhibited greater improvements with one-year weight loss than either of the generic instruments, with effect sizes ranging from 0.24 to 0.62 for 5–9.9% weight reductions and 0.44 to 0.95 for ≥ 10% reductions. IWQOL-Lite Self-Esteem also showed a small improvement with weight gain. Changes in the two generic measures of HRQOL were inconsistent with each other, and in the case of the SF-36, variable across domains. For participants gaining ≥ 5% of weight, the greatest reductions in HRQOL occurred with respect to SF-36 Mental Health, MCS, and Vitality, with effect sizes of -0.82, -0.70, and -0.63 respectively. Conclusion This study found differences between weight-related and generic measures of health-related quality of life in a one-year weight loss trial, reflecting the potential value of using more than one measure in a trial. Although weight loss was generally associated with improved IWQOL-Lite, physical SF-36 subscale and EQ-5D scores, a small amount of weight gain was associated with a slight improvement on weight-specific HRQOL and almost no change on the EQ-5D, suggesting the

  20. Calibrated delivery drape versus indirect gravimetric technique for the measurement of blood loss after delivery: a randomized trial.

    Science.gov (United States)

    Ambardekar, Shubha; Shochet, Tara; Bracken, Hillary; Coyaji, Kurus; Winikoff, Beverly

    2014-08-15

    Trials of interventions for PPH prevention and treatment rely on different measurement methods for the quantification of blood loss and identification of PPH. This study's objective was to compare measures of blood loss obtained from two different measurement protocols frequently used in studies. Nine hundred women presenting for vaginal delivery were randomized to a direct method (a calibrated delivery drape) or an indirect method (a shallow bedpan placed below the buttocks and weighing the collected blood and blood-soaked gauze/pads). Blood loss was measured from immediately after delivery for at least one hour or until active bleeding stopped. Significantly greater mean blood loss was recorded by the direct than by the indirect measurement technique (253.9 mL and 195.3 mL, respectively; difference = 58.6 mL (95% CI: 31-86); p 500 mL (8.7% vs. 4.7%, p = 0.02). The study suggests a real and significant difference in blood loss measurement between these methods. Research using blood loss measurement as an endpoint needs to be interpreted taking measurement technique into consideration. This study has been registered at clinicaltrials.gov as NCT01885845.

  1. Derivative load voltage and particle swarm optimization to determine optimum sizing and placement of shunt capacitor in improving line losses

    Directory of Open Access Journals (Sweden)

    Mohamed Milad Baiek

    2016-12-01

    Full Text Available The purpose of this research is to study optimal size and placement of shunt capacitor in order to minimize line loss. Derivative load bus voltage was calculated to determine the sensitive load buses which further being optimum with the placement of shunt capacitor. Particle swarm optimization (PSO was demonstrated on the IEEE 14 bus power system to find optimum size of shunt capacitor in reducing line loss. The objective function was applied to determine the proper placement of capacitor and get satisfied solutions towards constraints. The simulation was run over Matlab under two scenarios namely base case and increasing 100% load. Derivative load bus voltage was simulated to determine the most sensitive load bus. PSO was carried out to determine the optimum sizing of shunt capacitor at the most sensitive bus. The results have been determined that the most sensitive bus was bus number 14 for the base case and increasing 100% load. The optimum sizing was 8.17 Mvar for the base case and 23.98 Mvar for increasing load about 100%. Line losses were able to reduce approximately 0.98% for the base case and increasing 100% load reduced about 3.16%. The proposed method was also proven as a better result compared with harmony search algorithm (HSA method. HSA method recorded loss reduction ratio about 0.44% for the base case and 2.67% when the load was increased by 100% while PSO calculated loss reduction ratio about 1.12% and 4.02% for the base case and increasing 100% load respectively. The result of this study will support the previous study and it is concluded that PSO was successfully able to solve some engineering problems as well as to find a solution in determining shunt capacitor sizing on the power system simply and accurately compared with other evolutionary optimization methods.

  2. The SHED-IT community trial study protocol: a randomised controlled trial of weight loss programs for overweight and obese men

    Directory of Open Access Journals (Sweden)

    Young Myles D

    2010-11-01

    Full Text Available Abstract Background Obesity is a major cause of preventable death in Australia with prevalence increasing at an alarming rate. Of particular concern is that approximately 68% of men are overweight/obese, yet are notoriously difficult to engage in weight loss programs, despite being more susceptible than women to adverse weight-related outcomes. There is a need to develop and evaluate obesity treatment programs that target and appeal to men. The primary aim of this study is to evaluate the efficacy of two relatively low intensity weight loss programs developed specifically for men. Methods and Design The study design is an assessor blinded, parallel-group randomised controlled trial that recruited 159 overweight and obese men in Newcastle, Australia. Inclusion criteria included: BMI 25-40 (kg/m2; no participation in other weight loss programs during the study; pass a health-screening questionnaire and pre-exercise risk assessment; available for assessment sessions; access to a computer with e-mail and Internet facilities; and own a mobile phone. Men were recruited to the SHED-IT (Self-Help, Exercise and Diet using Internet Technology study via the media and emails sent to male dominated workplaces. Men were stratified by BMI category (overweight, obese class I, obese class II and randomised to one of three groups: (1 SHED-IT Resources - provision of materials (DVD, handbooks, pedometer, tape measure with embedded behaviour change strategies to support weight loss; (2 SHED-IT Online - same materials as SHED-IT Resources plus access to and instruction on how to use the study website; (3 Wait-list Control. The intervention programs are three months long with outcome measures taken by assessors blinded to group allocation at baseline, and 3- and 6-months post baseline. Outcome measures include: weight (primary outcome, % body fat, waist circumference, blood pressure, resting heart rate, objectively measured physical activity, self-reported dietary

  3. Optimism in prolonged grief and depression following loss : A three-wave longitudinal study

    NARCIS (Netherlands)

    Boelen, Paul A

    2015-01-01

    There is considerable evidence that optimism, the predisposition to have generalized favorable expectancies for the future, is associated with numerous desirable outcomes. Few studies have examined the association of optimism with emotional distress following the death of a loved one. Doing so is

  4. Wake losses optimization of offshore wind farms with moveable floating wind turbines

    International Nuclear Information System (INIS)

    Rodrigues, S.F.; Teixeira Pinto, R.; Soleimanzadeh, M.; Bosman, Peter A.N.; Bauer, P.

    2015-01-01

    Highlights: • We present a layout optimization framework for wind farms with moveable turbines. • Using moveable wind turbines in optimized layouts maximizes energy production. • Turbine and wind farm designers should cooperate to optimize offshore wind projects. - Abstract: In the future, floating wind turbines could be used to harvest energy in deep offshore areas where higher wind mean speeds are observed. Currently, several floating turbine concepts are being designed and tested in small scale projects; in particular, one concept allows the turbine to move after installation. This article presents a novel layout optimization framework for wind farms composed of moveable floating turbines. The proposed framework uses an evolutionary optimization strategy in a nested configuration which simultaneously optimizes the anchoring locations and the wind turbine position within the mooring lines for each individual wind direction. The results show that maximum energy production is obtained when moveable wind turbines are deployed in an optimized layout. In conclusion, the framework represents a new design optimization tool for future offshore wind farms composed of moveable floating turbines

  5. On the optimization of a CAPM portfolio using lower partial moments as measure of risk and using the possibility of safeguarding its loss

    Science.gov (United States)

    Spreitzer, U. W.; Reznik, V.

    2007-05-01

    Using a portfolio built from bonds (investment without volatility) and shares (investment with volatility) corresponding to the CAPM we calculate the possible loss of this portfolio. The loss is measured by a so-called lower partial moment of the rate of return of the portfolio. Using this loss, we optimize the composition of the portfolio with respect to this loss. Also we investigate the optimization of the portfolio when the loss can be underwritten by an insurance. Concerning the premium of this insurance contract, we show that when the premium is defined inadequate, e.g. proportional to the investment or proportional to the amount of investment in shares, the optimal portfolio consists only of investment in shares. When the premium is defined more suitable, e.g. proportional to the loss, the optimal portfolio is built by an investment in bonds and shares.

  6. Investigating the Impact of Hearing Aid Use and Auditory Training on Cognition, Depressive Symptoms, and Social Interaction in Adults With Hearing Loss: Protocol for a Crossover Trial.

    Science.gov (United States)

    Nkyekyer, Joanna; Meyer, Denny; Blamey, Peter J; Pipingas, Andrew; Bhar, Sunil

    2018-03-23

    Sensorineural hearing loss is the most common sensory deficit among older adults. Some of the psychosocial consequences of this condition include difficulty in understanding speech, depression, and social isolation. Studies have shown that older adults with hearing loss show some age-related cognitive decline. Hearing aids have been proven as successful interventions to alleviate sensorineural hearing loss. In addition to hearing aid use, the positive effects of auditory training-formal listening activities designed to optimize speech perception-are now being documented among adults with hearing loss who use hearing aids, especially new hearing aid users. Auditory training has also been shown to produce prolonged cognitive performance improvements. However, there is still little evidence to support the benefits of simultaneous hearing aid use and individualized face-to-face auditory training on cognitive performance in adults with hearing loss. This study will investigate whether using hearing aids for the first time will improve the impact of individualized face-to-face auditory training on cognition, depression, and social interaction for adults with sensorineural hearing loss. The rationale for this study is based on the hypothesis that, in adults with sensorineural hearing loss, using hearing aids for the first time in combination with individualized face-to-face auditory training will be more effective for improving cognition, depressive symptoms, and social interaction rather than auditory training on its own. This is a crossover trial targeting 40 men and women between 50 and 90 years of age with either mild or moderate symmetric sensorineural hearing loss. Consented, willing participants will be recruited from either an independent living accommodation or via a community database to undergo a 6-month intensive face-to-face auditory training program (active control). Participants will be assigned in random order to receive hearing aid (intervention) for

  7. Optimization of multiple performance characteristics in turning using Taguchi’s quality loss function: An experimental investigation

    Directory of Open Access Journals (Sweden)

    Tanmaya Mohanty

    2013-06-01

    Full Text Available Cutting force and chip reduction coefficient is the important index of machinability as it determines the power consumption and amount of energy invested in machining actions. It is primarily influenced by process parameters like cutting speed, feed and depth of cut. This paper presents the application of Taguchi’s parameter design to optimize the parameters for individual responses. For multi-response optimization, Taguchi’s quality loss function approach is proposed. In the present investigation, optimal values of cutting speed, feed and depth of cut are determined to minimize cutting force and chip reduction coefficient during orthogonal turning. The effectiveness of the proposed methodology is illustrated through an experimental investigation in turning mild steel workpiece using high speed steel tool.

  8. SINGLE VERSUS MULTIPLE TRIAL VECTORS IN CLASSICAL DIFFERENTIAL EVOLUTION FOR OPTIMIZING THE QUANTIZATION TABLE IN JPEG BASELINE ALGORITHM

    Directory of Open Access Journals (Sweden)

    B Vinoth Kumar

    2017-07-01

    Full Text Available Quantization Table is responsible for compression / quality trade-off in baseline Joint Photographic Experts Group (JPEG algorithm and therefore it is viewed as an optimization problem. In the literature, it has been found that Classical Differential Evolution (CDE is a promising algorithm to generate the optimal quantization table. However, the searching capability of CDE could be limited due to generation of single trial vector in an iteration which in turn reduces the convergence speed. This paper studies the performance of CDE by employing multiple trial vectors in a single iteration. An extensive performance analysis has been made between CDE and CDE with multiple trial vectors in terms of Optimization process, accuracy, convergence speed and reliability. The analysis report reveals that CDE with multiple trial vectors improves the convergence speed of CDE and the same is confirmed using a statistical hypothesis test (t-test.

  9. Prothrombin complex concentrate in the reduction of blood loss during orthotopic liver transplantation: PROTON-trial

    NARCIS (Netherlands)

    F. Arshad (Freeha); B. Ickx (Brigitte); R.T. van Beem (Rachel); W.G. Polak (Wojciech); F. Grüne (Frank); F. Nevens (Frederik); M. Ilmakunnas (Minna); A.M. Koivusalo (Anna-Maria); H. Isoniemi (Helena); P.F.W. Strengers; H.J.M. Groen (Henk); H.G.D. Hendriks (Herman); T. Lisman (Ton); J. Pirenne (Jacques); R.J. Porte (Robert)

    2013-01-01

    textabstractBackground: In patients with cirrhosis, the synthesis of coagulation factors can fall short, reflected by a prolonged prothrombin time. Although anticoagulants factors are decreased as well, blood loss during orthotopic liver transplantation can still be excessive. Blood loss during

  10. Prothrombin complex concentrate in the reduction of blood loss during orthotopic liver transplantation : PROTON-trial

    NARCIS (Netherlands)

    Arshad, Freeha; Ickx, Brigitte; van Beem, Rachel T.; Polak, Wojciech; Grune, Frank; Nevens, Frederik; Ilmakunnas, Minna; Koivusalo, Anna-Maria; Isoniemi, Helena; Strengers, Paul F. W.; Groen, Henk; Hendriks, Herman G. D.; Lisman, Ton; Pirenne, Jacques; Porte, Robert J.

    2013-01-01

    Background: In patients with cirrhosis, the synthesis of coagulation factors can fall short, reflected by a prolonged prothrombin time. Although anticoagulants factors are decreased as well, blood loss during orthotopic liver transplantation can still be excessive. Blood loss during orthotopic liver

  11. Tranexamic acid reduces blood loss during and after cesarean section: A double blinded, randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Amr H. Yehia

    2014-03-01

    Conclusions: Tranexamic acid can be used safely to reduce blood loss during cesarean section. Reduced blood loss after tranexamic acid was associated with improvement of post-operative hemoglobin, hematocrit and with reduction of post-partum need for iron replacement.

  12. Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial.

    Science.gov (United States)

    Takahashi, Fumihiro; Morita, Satoshi

    2018-02-08

    Phase II clinical trials are conducted to determine the optimal dose of the study drug for use in Phase III clinical trials while also balancing efficacy and safety. In conducting these trials, it may be important to consider subpopulations of patients grouped by background factors such as drug metabolism and kidney and liver function. Determining the optimal dose, as well as maximizing the effectiveness of the study drug by analyzing patient subpopulations, requires a complex decision-making process. In extreme cases, drug development has to be terminated due to inadequate efficacy or severe toxicity. Such a decision may be based on a particular subpopulation. We propose a Bayesian utility approach (BUART) to randomized Phase II clinical trials which uses a first-order bivariate normal dynamic linear model for efficacy and safety in order to determine the optimal dose and study population in a subsequent Phase III clinical trial. We carried out a simulation study under a wide range of clinical scenarios to evaluate the performance of the proposed method in comparison with a conventional method separately analyzing efficacy and safety in each patient population. The proposed method showed more favorable operating characteristics in determining the optimal population and dose.

  13. A cost analysis of implementing a behavioral weight loss intervention in community mental health settings: Results from the ACHIEVE trial.

    Science.gov (United States)

    Janssen, Ellen M; Jerome, Gerald J; Dalcin, Arlene T; Gennusa, Joseph V; Goldsholl, Stacy; Frick, Kevin D; Wang, Nae-Yuh; Appel, Lawrence J; Daumit, Gail L

    2017-06-01

    In the ACHIEVE randomized controlled trial, an 18-month behavioral intervention accomplished weight loss in persons with serious mental illness who attended community psychiatric rehabilitation programs. This analysis estimates costs for delivering the intervention during the study. It also estimates expected costs to implement the intervention more widely in a range of community mental health programs. Using empirical data, costs were calculated from the perspective of a community psychiatric rehabilitation program delivering the intervention. Personnel and travel costs were calculated using time sheet data. Rent and supply costs were calculated using rent per square foot and intervention records. A univariate sensitivity analysis and an expert-informed sensitivity analysis were conducted. With 144 participants receiving the intervention and a mean weight loss of 3.4 kg, costs of $95 per participant per month and $501 per kilogram lost in the trial were calculated. In univariate sensitivity analysis, costs ranged from $402 to $725 per kilogram lost. Through expert-informed sensitivity analysis, it was estimated that rehabilitation programs could implement the intervention for $68 to $85 per client per month. Costs of implementing the ACHIEVE intervention were in the range of other intensive behavioral weight loss interventions. Wider implementation of efficacious lifestyle interventions in community mental health settings will require adequate funding mechanisms. © 2017 The Obesity Society.

  14. Optimization and scale up of microfluidic nanolipomer production method for preclinical and potential clinical trials.

    Science.gov (United States)

    Gdowski, Andrew; Johnson, Kaitlyn; Shah, Sunil; Gryczynski, Ignacy; Vishwanatha, Jamboor; Ranjan, Amalendu

    2018-02-12

    synthesized and easily scaled up through a high flow microfluidic system with optimal characteristics. The process of developing nanolipomers using this methodology is significant as the same optimized parameters used for small batches could be translated into manufacturing large scale batches for clinical trials through parallel flow systems.

  15. Low losses left-handed materials with optimized electric and magnetic resonance

    Science.gov (United States)

    Zhou, Xin; Liu, Yahong; Zhao, Xiaopeng

    2010-03-01

    We propose that the losses in left-handed materials (LHMs) can be significantly affected by changing the coupling relationship between electric and magnetic resonance. A double bowknot shaped structure (DBS) is used to construct the LHMs. And the magnetic resonance of the DBS, which resonated in the case of lower and higher frequencies than the electric resonant dip, is studied in simulation and experiment by tailoring the structural parameters. The case of magnetic resonance located at low electric resonance frequencies band is confirmed to have relatively low losses. Using full wave simulation of prism shaped structure composed of DBS unit cells, we prove the negative refraction behavior in such a frame. This study can serve as a guide for designing other similar metal-dielectric-metal (MDM) in low losses at terahertz or higher frequencies.

  16. Low-Dose Epinephrine Plus Tranexamic Acid Reduces Early Postoperative Blood Loss and Inflammatory Response: A Randomized Controlled Trial.

    Science.gov (United States)

    Zeng, Wei-Nan; Liu, Jun-Li; Wang, Fu-You; Chen, Cheng; Zhou, Qiang; Yang, Liu

    2018-02-21

    The reductions of perioperative blood loss and inflammatory response are important in total knee arthroplasty. Tranexamic acid reduced blood loss and the inflammatory response in several studies. However, the effect of epinephrine administration plus tranexamic acid has not been intensively investigated, to our knowledge. In this study, we evaluated whether the combined administration of low-dose epinephrine plus tranexamic acid reduced perioperative blood loss or inflammatory response further compared with tranexamic acid alone. This randomized placebo-controlled trial consisted of 179 consecutive patients who underwent primary total knee arthroplasty. Patients were randomized into 3 interventions: Group IV received intravenous low-dose epinephrine plus tranexamic acid, Group TP received topical diluted epinephrine plus tranexamic acid, and Group CT received tranexamic acid alone. The primary outcome was perioperative blood loss on postoperative day 1. Secondary outcomes included perioperative blood loss on postoperative day 3, coagulation and fibrinolysis parameters (measured by thromboelastography), inflammatory cytokine levels, transfusion values (rate and volume), thromboembolic complications, length of hospital stay, wound score, range of motion, and Hospital for Special Surgery (HSS) score. The mean calculated total blood loss (and standard deviation) in Group IV was 348.1 ± 158.2 mL on postoperative day 1 and 458.0 ± 183.4 mL on postoperative day 3, which were significantly reduced (p 0.05). The combined administration of low-dose epinephrine and tranexamic acid demonstrated an increased effect in reducing perioperative blood loss and the inflammatory response compared with tranexamic acid alone, with no apparent increased incidence of thromboembolic and other complications. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

  17. Loss aversion, large deviation preferences and optimal portfolio weights for some classes of return processes

    Science.gov (United States)

    Duffy, Ken; Lobunets, Olena; Suhov, Yuri

    2007-05-01

    We propose a model of a loss averse investor who aims to maximize his expected wealth under certain constraints. The constraints are that he avoids, with high probability, incurring an (suitably defined) unacceptable loss. The methodology employed comes from the theory of large deviations. We explore a number of fundamental properties of the model and illustrate its desirable features. We demonstrate its utility by analyzing assets that follow some commonly used financial return processes: Fractional Brownian Motion, Jump Diffusion, Variance Gamma and Truncated Lévy.

  18. BOP2: Bayesian optimal design for phase II clinical trials with simple and complex endpoints.

    Science.gov (United States)

    Zhou, Heng; Lee, J Jack; Yuan, Ying

    2017-09-20

    We propose a flexible Bayesian optimal phase II (BOP2) design that is capable of handling simple (e.g., binary) and complicated (e.g., ordinal, nested, and co-primary) endpoints under a unified framework. We use a Dirichlet-multinomial model to accommodate different types of endpoints. At each interim, the go/no-go decision is made by evaluating a set of posterior probabilities of the events of interest, which is optimized to maximize power or minimize the number of patients under the null hypothesis. Unlike other existing Bayesian designs, the BOP2 design explicitly controls the type I error rate, thereby bridging the gap between Bayesian designs and frequentist designs. In addition, the stopping boundary of the BOP2 design can be enumerated prior to the onset of the trial. These features make the BOP2 design accessible to a wide range of users and regulatory agencies and particularly easy to implement in practice. Simulation studies show that the BOP2 design has favorable operating characteristics with higher power and lower risk of incorrectly terminating the trial than some existing Bayesian phase II designs. The software to implement the BOP2 design is freely available at www.trialdesign.org. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  19. Cognitive and Self-regulatory Mechanisms of Obesity Study (COSMOS): Study protocol for a randomized controlled weight loss trial examining change in biomarkers, cognition, and self-regulation across two behavioral treatments.

    Science.gov (United States)

    Hawkins, M A W; Colaizzi, Janna; Gunstad, John; Hughes, Joel W; Mullins, Larry L; Betts, Nancy; Smith, Caitlin E; Keirns, Natalie G; Vohs, Kathleen D; Moore, Shirley M; Forman, Evan M; Lovallo, William R

    2018-03-01

    Obesity is a global epidemic, yet successful interventions are rare. Up to 60% of people fail to achieve clinically meaningful, short-term weight loss (5-10% of start weight), whereas up to 72% are unsuccessful at achieving long-term weight loss (5-10% loss for ≥5years). Understanding how biological, cognitive, and self-regulatory factors work together to promote or to impede weight loss is clearly needed to optimize obesity treatment. This paper describes the methodology of the Cognitive and Self-regulatory Mechanisms of Obesity Study (the COSMOS trial). COSMOS is the first randomized controlled trial to investigate how changes in multiple biopsychosocial and cognitive factors relate to weight loss and one another across two weight loss treatments. The specific aims are to: 1) Confirm that baseline obesity-related physiological dysregulation is linked to cognitive deficits and poorer self-regulation, 2) Evaluate pre- to post-treatment change across time to assess individual differences in biomarkers, cognition, and self-regulation, and 3) Evaluate whether the acceptance-based treatment (ABT) group has greater improvements in outcomes (e.g., greater weight loss and less weight regain, improvements in biomarkers, cognition, and self-regulation), than the standard behavioral treatment group (SBT) from pre- to post-treatment and 1-year follow-up. The results of COSMOS will provide critical information about how dysregulation in biomarkers, cognition, and/or self-regulation is related to weight loss and whether weight loss treatments are differentially associated with these factors. This information will be used to identify promising treatment targets that are informed by biological, cognitive, and self-regulatory factors in order to advance obesity treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. Cardiac output-based fluid optimization for kidney transplant recipients: a proof-of-concept trial.

    Science.gov (United States)

    Corbella, Davide; Toppin, Patrick Jason; Ghanekar, Anand; Ayach, Nour; Schiff, Jeffery; Van Rensburg, Adrian; McCluskey, Stuart A

    2018-04-10

    Intravenous fluid management for deceased donor kidney transplantation is an important, modifiable risk factor for delayed graft function (DGF). The primary objective of this study was to determine if goal-directed fluid therapy using esophageal Doppler monitoring (EDM) to optimize stroke volume (SV) would alter the amount of fluid given. This randomized, proof-of-concept trial enrolled 50 deceased donor renal transplant recipients. Data collected included patient characteristics, fluid administration, hemodynamics, and complications. The EDM was used to optimize SV in the EDM group. In the control group, fluid management followed the current standard of practice. The groups were compared for the primary outcome of total intraoperative fluid administered. There was no difference in the mean (standard deviation) volume of intraoperative fluid administered to the 24 control and 26 EDM patients [2,307 (750) mL vs 2,675 (842) mL, respectively; mean difference, 368 mL; 95% confidence interval (CI), - 87 to + 823; P = 0.11]. The incidence of complications in the control and EDM groups was similar (15/24 vs 17/26, respectively; P = 0.99), as was the incidence of delayed graft failure (8/24 vs 11/26, respectively; P = 0.36). Goal-directed fluid therapy did not alter the volume of fluid administered or the incidence of complications. This proof-of-concept trial provides needed data for conducting a larger trial to determine the influence of fluid therapy on the incidence in DGF in deceased donor kidney transplantation. www.clinicaltrials.gov (NCT02512731). Registered 31 July 2015.

  1. Optimization of the conditions for the precipitation of thorium oxalate. II. Minimization of the product losses

    International Nuclear Information System (INIS)

    Pazukhin, E.M.; Smirnova, E.A.; Krivokhatskii, A.S.; Pazukhina, Yu.L.; Kiselev, P.P.

    1987-01-01

    The precipitation of thorium as a poorly soluble oxalate was investigated. An equation relating the concentrations of the metal and nitric acid in the initial solution and the amount of precipitant required to minimize the product losses was derived. A graphical solution of the equation is presented for the case where the precipitant is oxalic acid at a concentration of 0.78 M

  2. Applying economic incentives to increase effectiveness of an outpatient weight loss program (TRIO) - A randomized controlled trial.

    Science.gov (United States)

    Finkelstein, Eric A; Tham, Kwang-Wei; Haaland, Benjamin A; Sahasranaman, Aarti

    2017-07-01

    The prevalence of overweight and obesity has more than doubled in the past three decades, leading to rising rates of non-communicable diseases. This study tests whether adding a payment/rewards (term reward) program to an existing evidence-based weight loss program can increase weight loss and weight loss maintenance. We conducted a parallel-group randomized controlled trial from October 2012 to October 2015 with 161 overweight or obese individuals randomized to either control or reward arm in a 1:2 ratio. Control and reward arm participants received a four month weight loss program at the LIFE (Lifestyle Improvement and Fitness Enhancement) Centre at Singapore General Hospital. Those in the reward arm paid a fee of S$165.00 (1US$ = 1.35S$) to access a program that provided rewards of up to S$660 for meeting weight loss and physical activity goals. Participants could choose to receive rewards as guaranteed cash payments or a lottery ticket with a 1 in 10 chance of winning but with the same expected value. The primary outcome was weight loss at months 4, 8, and 12. 161 participants were randomized to control (n = 54) or reward (n = 107) arms. Average weight loss was more than twice as great in the reward arm compared to the control arm at month 4 when the program concluded (3.4 kg vs 1.4 kg, p rewards concluded (3.3 kg vs 1.8 kg, p rewards program can be used to improve weight loss and weight loss maintenance when combined with an evidence-based weight loss program. Future efforts should attempt to replicate this approach and identify how to cost effectively expand these programs to maximize their reach. This study is registered at www.clinicaltrials.gov (Identifier: NCT01533454). Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. MEAL-BASED ENHANCEMENT OF PROTEIN QUALITY AND QUANTITY DURING WEIGHT LOSS IN OBESE OLDER ADULTS WITH MOBILITY LIMITATIONS: RATIONALE AND DESIGN FOR THE MEASUR-UP TRIAL

    Science.gov (United States)

    McDonald, Shelley R.; Starr, Kathryn N. Porter; Mauceri, Luisa; Orenduff, Melissa; Granville, Esther; Ocampo, Christine; Payne, Martha E.; Pieper, Carl F.; Bales, Connie W.

    2015-01-01

    Obese older adults with even modest functional limitations are at a disadvantage for maintaining their independence into late life. However, there is no established intervention for obesity in older individuals. The Measuring Eating, Activity and Strength: Understanding the Response --Using Protein (MEASUR-UP) trial is a randomized controlled pilot study of obese women and men aged ≥60 years with mild to moderate functional impairments. Changes in body composition (lean and fat mass) and function (Short Physical Performance Battery) in an enhanced protein weight reduction (Protein) arm will be compared to those in a traditional weight loss (Control) arm. The Protein intervention is based on evidence that older adults achieve optimal rates of muscle protein synthesis when consuming about 25-30 grams of high quality protein per meal; these participants will consume −30 g of animal protein at each meal via a combination of provided protein (beef) servings and diet counseling. This trial will provide information on the feasibility and efficacy of enhancing protein quantity and quality in the context of a weight reduction regimen and determine the impact of this intervention on body weight, functional status, and lean muscle mass. We hypothesize that the enhancement of protein quantity and quality in the Protein arm will result in better outcomes for function and/or lean muscle mass than in the Control arm. Ultimately, we hope our findings will help identify a safe weight loss approach that can delay or prevent late life disability by changing the trajectory of age-associated functional impairment associated with obesity. PMID:25461495

  4. Optimal cost-effective designs of Phase II proof of concept trials and associated go-no go decisions.

    Science.gov (United States)

    Chen, Cong; Beckman, Robert A

    2009-01-01

    This manuscript discusses optimal cost-effective designs for Phase II proof of concept (PoC) trials. Unlike a confirmatory registration trial, a PoC trial is exploratory in nature, and sponsors of such trials have the liberty to choose the type I error rate and the power. The decision is largely driven by the perceived probability of having a truly active treatment per patient exposure (a surrogate measure to development cost), which is naturally captured in an efficiency score to be defined in this manuscript. Optimization of the score function leads to type I error rate and power (and therefore sample size) for the trial that is most cost-effective. This in turn leads to cost-effective go-no go criteria for development decisions. The idea is applied to derive optimal trial-level, program-level, and franchise-level design strategies. The study is not meant to provide any general conclusion because the settings used are largely simplified for illustrative purposes. However, through the examples provided herein, a reader should be able to gain useful insight into these design problems and apply them to the design of their own PoC trials.

  5. Optimization of multi-environment trials for genomic selection based on crop models.

    Science.gov (United States)

    Rincent, R; Kuhn, E; Monod, H; Oury, F-X; Rousset, M; Allard, V; Le Gouis, J

    2017-08-01

    We propose a statistical criterion to optimize multi-environment trials to predict genotype × environment interactions more efficiently, by combining crop growth models and genomic selection models. Genotype × environment interactions (GEI) are common in plant multi-environment trials (METs). In this context, models developed for genomic selection (GS) that refers to the use of genome-wide information for predicting breeding values of selection candidates need to be adapted. One promising way to increase prediction accuracy in various environments is to combine ecophysiological and genetic modelling thanks to crop growth models (CGM) incorporating genetic parameters. The efficiency of this approach relies on the quality of the parameter estimates, which depends on the environments composing this MET used for calibration. The objective of this study was to determine a method to optimize the set of environments composing the MET for estimating genetic parameters in this context. A criterion called OptiMET was defined to this aim, and was evaluated on simulated and real data, with the example of wheat phenology. The MET defined with OptiMET allowed estimating the genetic parameters with lower error, leading to higher QTL detection power and higher prediction accuracies. MET defined with OptiMET was on average more efficient than random MET composed of twice as many environments, in terms of quality of the parameter estimates. OptiMET is thus a valuable tool to determine optimal experimental conditions to best exploit MET and the phenotyping tools that are currently developed.

  6. Improvement of DC Optimal Power Flow Problem Based on Nodal Approximation of Transmission Losses

    Directory of Open Access Journals (Sweden)

    M. R. Baghayipour

    2012-03-01

    3-\tIts formulation is simple and easy to understand. Moreover, it can simply be realized in the form of Lagrange representation, makes it possible to be considered as some constraints in the body of any bi-level optimization problem, with its internal level including the OPF problem satisfaction.

  7. BEAM-LOSS DRIVEN DESIGN OPTIMIZATION FOR THE SPALLATION NEUTRON SOURCE (SNS) RING.

    Energy Technology Data Exchange (ETDEWEB)

    WEI,J.; BEEBE-WANG,J.; BLASKIEWICZ,M.; CAMERON,P.; DANBY,G.; GARDNER,C.J.; JACKSON,J.; LEE,Y.Y.; LUDEWIG,H.; MALITSKY,N.; RAPARIA,D.; TSOUPAS,N.; WENG,W.T.; ZHANG,S.Y.

    1999-03-29

    This paper summarizes three-stage design optimization for the Spallation Neutron Source (SNS) ring: linear machine design (lattice, aperture, injection, magnet field errors and misalignment), beam core manipulation (painting, space charge, instabilities, RF requirements), and beam halo consideration (collimation, envelope variation, e-p issues etc.).

  8. Beam-Loss Driven Design Optimization for the Spallation Neutron Source (SNS) Ring

    International Nuclear Information System (INIS)

    Wei, J.

    1999-01-01

    This paper summarizes three-state design optimization for the Spallation Neutron Source (SNS) ring: linear machine design (lattice, aperture, injection, magnet field errors and misalignment), beam core manipulation (painting, space charge, instabilities, RF requirements), and beam halo consideration (collimation, envelope variation, e-p issues etc.)

  9. Thyroid hormones and changes in body weight and metabolic parameters in response to weight loss diets: the POUNDS LOST trial.

    Science.gov (United States)

    Liu, G; Liang, L; Bray, G A; Qi, L; Hu, F B; Rood, J; Sacks, F M; Sun, Q

    2017-06-01

    The role of thyroid hormones in diet-induced weight loss and subsequent weight regain is largely unknown. To examine the associations between thyroid hormones and changes in body weight and resting metabolic rate (RMR) in a diet-induced weight loss setting. Data analysis was conducted among 569 overweight and obese participants aged 30-70 years with normal thyroid function participating in the 2-year Prevention of Obesity Using Novel Dietary Strategies (POUNDS) LOST randomized clinical trial. Changes in body weight and RMR were assessed during the 2-year intervention. Thyroid hormones (free triiodothyronine (T3), free thyroxine (T4), total T3, total T4 and thyroid-stimulating hormone (TSH)), anthropometric measurements and biochemical parameters were assessed at baseline, 6 months and 24 months. Participants lost an average of 6.6 kg of body weight during the first 6 months and subsequently regained an average of 2.7 kg of body weight over the remaining period from 6 to 24 months. Baseline free T3 and total T3 were positively associated, whereas free T4 was inversely associated, with baseline body weight, body mass index and RMR. Total T4 and TSH were not associated with these parameters. Higher baseline free T3 and free T4 levels were significantly associated with a greater weight loss during the first 6 months (Ppressure, glucose, insulin, triglycerides and leptin at 6 months and 24 months (all P<0.05). In this diet-induced weight loss setting, higher baseline free T3 and free T4 predicted more weight loss, but not weight regain among overweight and obese adults with normal thyroid function. These findings reveal a novel role of thyroid hormones in body weight regulation and may help identify individuals more responsive to weight loss diets.

  10. Optimized VBM in patients with Alzheimer's disease: gray matter loss and its correlation with cognitive function

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Seon Hyeong; Moon, Won Jin; Chung, Eun Chul; Lee, Min Hee; Roh, Hong Gee; Park, Kwang Bo; Na, Duck Ryul [Sungkyunkwan University School of Medicine, Seoul (Korea, Republic of)

    2005-11-15

    To investigate the regional changes in gray matter volume by using optimized voxel based morphometry in the whole brain of patients with Alzheimer's disease (AD) and to determine its correlation with cognitive function. Nineteen patients with AD (mean mini mental state examination (MMSE) score = 20.4) and 19 age-matched control subjects (mean MMSE score 29) participated in this prospective study. T1-weighted 3D-SPGR scans were obtained for each subject. These T1-weighted images were spatially normalized into study-specific T1 template and segmented into gray matter, white matter and CSF. After the images were modulated and smoothed, all of the gray matter images were compared with control images by using voxel-wise statistical parametric test (two-sample-test). In patients with AD, total gray matter volume was significantly smaller than normal control (552 {+-} 39 mL vs. 632 {+-} 51 mL, {rho} 0.001). Significant gray matter loss was seen in both the hippocampus and amygdala complexs, and the parahippocampi and frontoparietal cortices ({rho} < 0.01, family wise error corrected). Left cerebral atrophy was more prominent than the right. Loss of gray matter volume in both the superior frontal gyri and left inferior temporal gyrus had a strong correlation with lower MMSE score. Optimized VBM was able to visualize pathologic changes of AD in vivo. In AD there was widespread gray matter volume loss in the frontoparietal lobes as well as the medial temporal lobes and had a strong correlation between volume loss of specific cortical areas and MMSE score.

  11. On scaling and optimization of high-intensity, low-beam-loss RF linacs for neutron source drivers

    International Nuclear Information System (INIS)

    Jameson, R.A.

    1992-01-01

    RF linacs providing cw proton beams of 30--250 mA at 800--1600 MeV, and cw deuteron beams of 100--250 mA at 35--40 MeV, are needed as drivers for factory neutron sources applied to radioactive waste transmutation, advanced energy production, materials testing facilities, and spallation neutron sources. The maintenance goals require very low beam loss along the linac. Optimization of such systems is complex; status of beam dynamics aspects presently being investigated is outlined

  12. Optimization of the structure of gallium-arsenide-based detectors with taking into account recombination losses

    International Nuclear Information System (INIS)

    Katsoev, L. V.; Katsoev, V. V.; Il'ichev, E. A.

    2009-01-01

    The model describing the physical processes accompanying the interaction of heavy charged particles with an ionizing-radiation semiconductor detector is proposed. The problem of optimization of electrical characteristics and construction of the detector cell is solved. The model makes it possible to calculate the output current of the detector as a function of its active-region's thickness and the voltage applied across the sensor under conditions of the presence of recombination processes.

  13. Cross-Layer optimization of the packet loss rate in mobile videoconferencing applications

    OpenAIRE

    Rivera-Rodríguez, R.; Olivares-Domínguez, O. E.; Serrano-Santoyo, A.

    2010-01-01

    Videoconferencing transmission over wireless channels presents relevant challenges in mobile scenarios at vehicular speeds. Previous contributions are focused on the optimization of the transmission of multimedia and delay-sensitive applications over the forward link. In this paper, a new Quality of Service (QoS) parameter adaptation scheme is proposed. This scheme applies the Cross-Layer Design technique on the reverse link of an 1xEV-DO Revision 0 channel. As the wireless channel parameters...

  14. Design and protocol of the weight loss lottery- a cluster randomized trial.

    Science.gov (United States)

    van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Polder, Johan J; Prast, Henriëtte M

    2016-07-01

    People often intend to exercise but find it difficult to attend their gyms on a regular basis. At times, people seek and accept deadlines with consequences to realize their own goals (i.e. commitment devices). The aim of our cluster randomized controlled trial is to test whether a lottery-based commitment device can promote regular gym attendance. The winners of the lottery always get feedback on the outcome but can only claim their prize if they attended their gyms on a regular basis. In this paper we present the design and baseline characteristics of a three-arm trial which is performed with 163 overweight participants in six in-company fitness centers in the Netherlands. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Phase 2 Clinical Trials: D-Methionine to Reduce Noise-Induced Hearing Loss

    Science.gov (United States)

    2016-07-01

    Pharmaceuticals: Task completed. KP Pharmaceutical Technology, Indianapolis , Indiana is the drug manufacturer for this clinical trial. e. FDA/Regulatory...and Open House at Fort Jackson. j. June 8-9: Dr. Campbell interviewed with the Wall Street Journal at Fort Jackson. k. June 10-11, 2015: Dr...recommended by DoD Operational Medicine, Dr. Campbell, in conjunction with her business partner Jennifer Seibert, started a new biotech company, MetArmor

  16. Effects of medium-chain triglycerides on weight loss and body composition: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Mumme, Karen; Stonehouse, Welma

    2015-02-01

    Medium-chain triglycerides (MCTs) may result in negative energy balance and weight loss through increased energy expenditure and lipid oxidation. However, results from human intervention studies investigating the weight reducing potential of MCTs, have been mixed. To conduct a systematic review and meta-analysis of randomized controlled trials comparing the effects of MCTs, specifically C8:0 and C10:0, to long-chain triglycerides (LCTs) on weight loss and body composition in adults. Changes in blood lipid levels were secondary outcomes. Randomized controlled trials >3 weeks' duration conducted in healthy adults were identified searching Web of Knowledge, Discover, PubMed, Scopus, New Zealand Science, and Cochrane CENTRAL until March 2014 with no language restriction. Identified trials were assessed for bias. Mean differences were pooled and analyzed using inverse variance models with fixed effects. Heterogeneity between studies was calculated using I(2) statistic. An I(2)>50% or P<0.10 indicated heterogeneity. Thirteen trials (n=749) were identified. Compared with LCTs, MCTs decreased body weight (-0.51 kg [95% CI-0.80 to -0.23 kg]; P<0.001; I(2)=35%); waist circumference (-1.46 cm [95% CI -2.04 to -0.87 cm]; P<0.001; I(2)=0%), hip circumference (-0.79 cm [95% CI -1.27 to -0.30 cm]; P=0.002; I(2)=0%), total body fat (standard mean difference -0.39 [95% CI -0.57 to -0.22]; P<0.001; I(2)=0%), total subcutaneous fat (standard mean difference -0.46 [95% CI -0.64 to -0.27]; P<0.001; I(2)=20%), and visceral fat (standard mean difference -0.55 [95% CI -0.75 to -0.34]; P<0.001; I(2)=0%). No differences were seen in blood lipid levels. Many trials lacked sufficient information for a complete quality assessment, and commercial bias was detected. Although heterogeneity was absent, study designs varied with regard to duration, dose, and control of energy intake. Replacement of LCTs with MCTs in the diet could potentially induce modest reductions in body weight and composition

  17. Statistical design of personalized medicine interventions: The Clarification of Optimal Anticoagulation through Genetics (COAG trial

    Directory of Open Access Journals (Sweden)

    Gage Brian F

    2010-11-01

    Full Text Available Abstract Background There is currently much interest in pharmacogenetics: determining variation in genes that regulate drug effects, with a particular emphasis on improving drug safety and efficacy. The ability to determine such variation motivates the application of personalized drug therapies that utilize a patient's genetic makeup to determine a safe and effective drug at the correct dose. To ascertain whether a genotype-guided drug therapy improves patient care, a personalized medicine intervention may be evaluated within the framework of a randomized controlled trial. The statistical design of this type of personalized medicine intervention requires special considerations: the distribution of relevant allelic variants in the study population; and whether the pharmacogenetic intervention is equally effective across subpopulations defined by allelic variants. Methods The statistical design of the Clarification of Optimal Anticoagulation through Genetics (COAG trial serves as an illustrative example of a personalized medicine intervention that uses each subject's genotype information. The COAG trial is a multicenter, double blind, randomized clinical trial that will compare two approaches to initiation of warfarin therapy: genotype-guided dosing, the initiation of warfarin therapy based on algorithms using clinical information and genotypes for polymorphisms in CYP2C9 and VKORC1; and clinical-guided dosing, the initiation of warfarin therapy based on algorithms using only clinical information. Results We determine an absolute minimum detectable difference of 5.49% based on an assumed 60% population prevalence of zero or multiple genetic variants in either CYP2C9 or VKORC1 and an assumed 15% relative effectiveness of genotype-guided warfarin initiation for those with zero or multiple genetic variants. Thus we calculate a sample size of 1238 to achieve a power level of 80% for the primary outcome. We show that reasonable departures from these

  18. Habit-based interventions for weight loss maintenance in adults with overweight and obesity: a randomized controlled trial.

    Science.gov (United States)

    Cleo, Gina; Glasziou, Paul; Beller, Elaine; Isenring, Elisabeth; Thomas, Rae

    2018-04-23

    The objective of this study was to determine whether habit-based interventions are clinically beneficial in achieving long-term (12-month) weight loss maintenance and explore whether making new habits or breaking old habits is more effective. Volunteer community members aged 18-75 years who had overweight or obesity (BMI ≥ 25 kg/m 2 ) were randomized in a single-blind, three-arm, randomized controlled trial. Ten Top Tips (TTT), Do Something Different (DSD), and the attention-only waitlist (WL) control groups were conducted for 12 weeks from July to October 2015. Participants were followed up post-intervention (all groups) and at 6 and 12-month post-intervention (Ten Top Tips and Do Something Different only). The primary outcome was weight-loss maintenance at 12-month follow-up. Secondary outcomes included weight loss at all time points, fruit and vegetable consumption, exercise, wellbeing, depression, anxiety, habit strength, and openness to change. Of the 130 participants assessed for eligibility, 75 adults (mean BMI 34.5 kg/m 2 [SD 6.2]), with a mean age of 51 years were recruited. Assessments were completed post-intervention by 66/75 (88%) of participants and by 43/50 (86%) at 12 months. At post-intervention, participants in the Ten Top Tips (-3.3 kg; 95% CI -5.2, -1.4) and Do Something Different (-2.9 kg; 95% CI -4.3, -1.4) interventions lost significantly more weight (P = Habit-based weight-loss interventions-forming new habits (TTT) and breaking old habits (DSD), resulted in clinically important weight-loss maintenance at 12-month follow-up.

  19. Optimization of CRISPR/Cas9 genome editing for loss-of-function in the early chick embryo.

    Science.gov (United States)

    Gandhi, Shashank; Piacentino, Michael L; Vieceli, Felipe M; Bronner, Marianne E

    2017-12-01

    The advent of CRISPR/Cas9 has made genome editing possible in virtually any organism, including those not previously amenable to genetic manipulations. Here, we present an optimization of CRISPR/Cas9 for application to early avian embryos with improved efficiency via a three-fold strategy. First, we employed Cas9 protein flanked with two nuclear localization signal sequences for improved nuclear localization. Second, we used a modified guide RNA (gRNA) scaffold that obviates premature termination of transcription and unstable Cas9-gRNA interactions. Third, we used a chick-specific U6 promoter that yields 4-fold higher gRNA expression than the previously utilized human U6. For rapid screening of gRNAs for in vivo applications, we also generated a chicken fibroblast cell line that constitutively expresses Cas9. As proof of principle, we performed electroporation-based loss-of-function studies in the early chick embryo to knock out Pax7 and Sox10, key transcription factors with known functions in neural crest development. The results show that CRISPR/Cas9-mediated deletion causes loss of their respective proteins and transcripts, as well as predicted downstream targets. Taken together, the results reveal the utility of this optimized CRISPR/Cas9 method for targeted gene knockout in chicken embryos in a manner that is reproducible, robust and specific. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. COAST (Cisplatin ototoxicity attenuated by aspirin trial): A phase II double-blind, randomised controlled trial to establish if aspirin reduces cisplatin induced hearing-loss.

    Science.gov (United States)

    Crabb, Simon J; Martin, Karen; Abab, Julia; Ratcliffe, Ian; Thornton, Roger; Lineton, Ben; Ellis, Mary; Moody, Ronald; Stanton, Louise; Galanopoulou, Angeliki; Maishman, Tom; Geldart, Thomas; Bayne, Mike; Davies, Joe; Lamb, Carolynn; Popat, Sanjay; Joffe, Johnathan K; Nutting, Chris; Chester, John; Hartley, Andrew; Thomas, Gareth; Ottensmeier, Christian; Huddart, Robert; King, Emma

    2017-12-01

    Cisplatin is one of the most ototoxic chemotherapy drugs, resulting in a permanent and irreversible hearing loss in up to 50% of patients. Cisplatin and gentamicin are thought to damage hearing through a common mechanism, involving reactive oxygen species in the inner ear. Aspirin has been shown to minimise gentamicin-induced ototoxicity. We, therefore, tested the hypothesis that aspirin could also reduce ototoxicity from cisplatin-based chemotherapy. A total of 94 patients receiving cisplatin-based chemotherapy for multiple cancer types were recruited into a phase II, double-blind, placebo-controlled trial and randomised in a ratio of 1:1 to receive aspirin 975 mg tid and omeprazole 20 mg od, or matched placebos from the day before, to 2 days after, their cisplatin dose(s), for each treatment cycle. Patients underwent pure tone audiometry before and at 7 and 90 days after their final cisplatin dose. The primary end-point was combined hearing loss (cHL), the summed hearing loss at 6 kHz and 8 kHz, in both ears. Although aspirin was well tolerated, it did not protect hearing in patients receiving cisplatin (p-value = 0.233, 20% one-sided level of significance). In the aspirin arm, patients demonstrated mean cHL of 49 dB (standard deviation [SD] 61.41) following cisplatin compared with placebo patients who demonstrated mean cHL of 36 dB (SD 50.85). Women had greater average hearing loss than men, and patients treated for head and neck malignancy experienced the greatest cHL. Aspirin did not protect from cisplatin-related ototoxicity. Cisplatin and gentamicin may therefore have distinct ototoxic mechanisms, or cisplatin-induced ototoxicity may be refractory to the aspirin regimen used here. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Optimizing clinical trial supply requirements: simulation of computer-controlled supply chain management.

    Science.gov (United States)

    Peterson, Magnus; Byrom, Bill; Dowlman, Nikki; McEntegart, Damian

    2004-01-01

    Computer-controlled systems are commonly used in clinical trials to control dispensing and manage site inventories of trial supplies. Typically such systems are used with an interactive telephone or web system that provide an interface with the study site. Realizing the maximum savings in medication associated with this approach has, in the past, been problematic as it has been difficult to fully estimate medication requirements due to the complexities of these algorithms and the inherent variation in the clinical trial recruitment process. We describe the traditional and automated methods of supplying sites. We detail a simulation approach that models the automated system. We design a number of simulation experiments using this model to investigate the supply strategy properties that influence medication overage and other strategy performance metrics. The computer-controlled medication system gave superior performance to the traditional method. In one example, a 75% overage of wasted medication in the traditional system was associated with higher supply failure than an automated system strategy with an overage of 47%. In a further example, we demonstrate that the impact of using a country stratified as opposed to site stratified scheme affects the number of deliveries and probability of supply failures more than the amount of drug wasted with respective increases of 20, 2300 and 4%. Medication savings with automated systems are particularly significant in repeat dispensing designs. We show that the number of packs required can fall by as much as 50% if one uses a predictive medication algorithm. We conclude that a computer-controlled supply chain enables medication savings to be realized and that it is possible to quantify the distribution of these savings using a simulation model. The simulation model can be used to optimize the prestudy medication supply strategy and for midstudy monitoring using real-time data contained in the study database.

  2. Weight-loss intervention using implementation intentions and mental imagery: a randomised control trial study protocol

    OpenAIRE

    Hattar, Anne; Hagger, Martin S; Pal, Sebely

    2015-01-01

    Background Overweight and obesity are major health problems worldwide. This protocol describes the HEALTHI (Healthy Eating and Active LifesTyle Health Intervention) Program, a 12-week randomised-controlled weight-loss intervention that adopts two theory-based intervention techniques, mental imagery and implementation intentions, a behaviour-change technique based on planning that have been shown to be effective in promoting health-behaviour change in previous research. The effectiveness of go...

  3. Return to work in sick-listed cancer survivors with job loss: design of a randomised controlled trial.

    Science.gov (United States)

    van Egmond, Martine P; Duijts, Saskia F A; Vermeulen, Sylvia J; van der Beek, Allard J; Anema, Johannes R

    2015-02-18

    Despite long-term or permanent health problems, cancer survivors are often motivated to return to work. For cancer survivors who have lost their job, return to work can be more challenging compared to employed survivors, as they generally find themselves in a more vulnerable social and financial position. Cancer survivors with job loss may therefore be in need of tailored return to work support. However, there is a lack of return to work intervention programs specifically targeting these cancer survivors. The number of cancer survivors with job loss in developed countries is rising due to, amongst others, increases in the incidence and survivor rate of cancer, the retirement age and the proportion of flexible employment contracts. Hence, we consider it important to develop a tailored return to work intervention program for cancer survivors with job loss, and to evaluate its effectiveness compared to usual care. This study employs a two-armed randomised controlled trial with a follow-up period of 12 months. The study population (n = 164) will be recruited from a national sample of cancer survivors (18-60 years), who have been sick-listed for 12-36 months. Participants will be randomised by using computerized blocked randomisation (blocks of four). All participants will receive usual care as provided by the Dutch Social Security Agency. Additionally, participants in the intervention group will receive a tailored return to work intervention program, which includes vocational rehabilitation and supportive psychosocial components, as well as (therapeutic) placement at work. The primary outcome measure is duration until sustainable return to work; the secondary outcome measure is rate of return to work. Other parameters include, amongst others, fatigue, coping strategy and quality of life. We will perform Cox regression analyses to estimate hazard ratios for time to sustainable return to work. The hypothesis of this study is that a tailored approach for cancer

  4. Randomised, double-blinded, placebo-controlled, clinical trial of ozone therapy as treatment of sudden sensorineural hearing loss.

    Science.gov (United States)

    Ragab, A; Shreef, E; Behiry, E; Zalat, S; Noaman, M

    2009-01-01

    To investigate the safety and efficacy of ozone therapy in adult patients with sudden sensorineural hearing loss. Prospective, randomised, double-blinded, placebo-controlled, parallel group, clinical trial. Forty-five adult patients presented with sudden sensorineural hearing loss, and were randomly allocated to receive either placebo (15 patients) or ozone therapy (auto-haemotherapy; 30 patients). For the latter treatment, 100 ml of the patient's blood was treated immediately with a 1:1 volume, gaseous mixture of oxygen and ozone (from an ozone generator) and re-injected into the patient by intravenous infusion. Treatments were administered twice weekly for 10 sessions. The following data were recorded: pre- and post-treatment mean hearing gains; air and bone pure tone averages; speech reception thresholds; speech discrimination scores; and subjective recovery rates. Significant recovery was observed in 23 patients (77 per cent) receiving ozone treatment, compared with six (40 per cent) patients receiving placebo (p < 0.05). Mean hearing gains, pure tone averages, speech reception thresholds and subjective recovery rates were significantly better in ozone-treated patients compared with placebo-treated patients (p < 0.05). Ozone therapy is a significant modality for treatment of sudden sensorineural hearing loss; no complications were observed.

  5. Optimization of Coding of AR Sources for Transmission Across Channels with Loss

    DEFF Research Database (Denmark)

    Arildsen, Thomas

    Source coding concerns the representation of information in a source signal using as few bits as possible. In the case of lossy source coding, it is the encoding of a source signal using the fewest possible bits at a given distortion or, at the lowest possible distortion given a specified bit rate....... Channel coding is usually applied in combination with source coding to ensure reliable transmission of the (source coded) information at the maximal rate across a channel given the properties of this channel. In this thesis, we consider the coding of auto-regressive (AR) sources which are sources that can...... compared to the case where the encoder is unaware of channel loss. We finally provide an extensive overview of cross-layer communication issues which are important to consider due to the fact that the proposed algorithm interacts with the source coding and exploits channel-related information typically...

  6. A double-blind, placebo-controlled randomized trial of creatine for the cancer anorexia/weight loss syndrome (N02C4): an Alliance trial.

    Science.gov (United States)

    Jatoi, A; Steen, P D; Atherton, P J; Moore, D F; Rowland, K M; Le-Lindqwister, N A; Adonizio, C S; Jaslowski, A J; Sloan, J; Loprinzi, C

    2017-08-01

    Multiple pilot studies, including one in colorectal cancer patients, suggest that creatine, an amino acid derivative, augments muscle, improves strength, and thereby could palliate the cancer anorexia/weight loss syndrome. In this randomized, double-blind, placebo-controlled trial, incurable patients with this syndrome were assigned creatine (20 g/day load×5 days followed by 2 g/day orally) versus identical placebo. Patients were weighed once a week for 1 month and then monthly. Patients were also assessed over 1 month for appetite and quality of life (validated questionnaires), fist grip strength, body composition (bioelectrical impedance), and adverse events. The primary endpoint was 10% or greater weight gain from baseline during the first month. Within this combined cohort of 263 evaluable patients (134 received creatine and 129 placebo), only 3 gained ≥10% of their baseline weight by 1 month: two creatine-treated and the other placebo-exposed (P = 1.00). Questionnaire data on appetite, quality of life, and activities of daily living showed no statistically significant differences between groups. Similarly, no statistically significant differences between groups were observed for fist-grip strength or body composition. Rates and severity of adverse events were comparable between groups. Finally, a median survival of 230 and 239 days were observed in the creatine and placebo groups, respectively (P = 0.70). Creatine, as prescribed in this trial, had no effect on the cancer anorexia/weight loss syndrome. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  7. HNF1A variant, energy-reduced diets and insulin resistance improvement during weight loss: The POUNDS Lost trial and DIRECT.

    Science.gov (United States)

    Huang, Tao; Wang, Tiange; Heianza, Yoriko; Sun, Dianjianyi; Ivey, Kerry; Durst, Ronen; Schwarzfuchs, Dan; Stampfer, Meir J; Bray, George A; Sacks, Frank M; Shai, Iris; Qi, Lu

    2018-06-01

    To determine whether weight-loss diets varying in macronutrients modulate the genetic effect of hepatocyte nuclear factor 1α (HNF1A) rs7957197 on weight loss and improvement of insulin resistance. We analysed the interaction between HNF1A rs7957197 and weight-loss diets with regard to weight loss and insulin resistance improvement among 722 overweight/obese adults from a 2-year randomized weight-loss trial, the POUNDS Lost trial. The findings were replicated in another independent 2-year weight-loss trial, the Dietary Intervention Randomized Controlled Trial (DIRECT), in 280 overweight/obese adults. In the POUNDS Lost trial, we found that a high-fat diet significantly modified the genetic effect of HNF1A on weight loss and reduction in waist circumference (P for interaction = .006 and .005, respectively). Borderline significant interactions for fasting insulin and insulin resistance (P for interaction = .07 and .06, respectively) were observed. We replicated the results in DIRECT. Pooled results showed similar significant interactions with weight loss, waist circumference reduction, and improvement in fasting insulin and insulin resistance (P values for interaction = .001, .005, .02 and .03, respectively). Greater decreases in weight, waist circumference, fasting insulin level and insulin resistance were observed in participants with the T allele compared to those without the T allele in the high-fat diet group (P = .04, .03 and .01, respectively). Our replicable findings provide strong evidence that individuals with the HNF1A rs7957197 T allele might obtain more benefits in weight loss and improvement of insulin resistance by choosing a hypocaloric and high-fat diet. © 2018 John Wiley & Sons Ltd.

  8. Fluctuating Charge-Order in Optimally Doped Bi- 2212 Revealed by Momentum-resolved Electron Energy Loss Spectroscopy

    Science.gov (United States)

    Husain, Ali; Vig, Sean; Kogar, Anshul; Mishra, Vivek; Rak, Melinda; Mitrano, Matteo; Johnson, Peter; Gu, Genda; Fradkin, Eduardo; Norman, Michael; Abbamonte, Peter

    Static charge order is a ubiquitous feature of the underdoped cuprates. However, at optimal doping, charge-order has been thought to be completely suppressed, suggesting an interplay between the charge-ordering and superconducting order parameters. Using Momentum-resolved Electron Energy Loss Spectroscopy (M-EELS) we show the existence of diffuse fluctuating charge-order in the optimally doped cuprate Bi2Sr2CaCu2O8+δ (Bi-2212) at low-temperature. We present full momentum-space maps of both elastic and inelastic scattering at room temperature and below the superconducting transition with 4meV resolution. We show that the ``rods'' of diffuse scattering indicate nematic-like fluctuations, and the energy width defines a fluctuation timescale of 160 fs. We discuss the implications of fluctuating charge-order on the dynamics at optimal doping. This work was supported by the Gordon and Betty Moore Foundation's EPiQS Initiative through Grant GBMF-4542. An early prototype of the M-EELS instrument was supported by the DOE Center for Emergent Superconductivity under Award No. DE-AC02-98CH10886.

  9. Prevention of aromatase inhibitor-induced bone loss with alendronate in postmenopausal women: The BATMAN Trial.

    Science.gov (United States)

    Lomax, Anna J; Yee Yap, Saw; White, Karen; Beith, Jane; Abdi, Ehtesham; Broad, Adam; Sewak, Sanjeev; Lee, Chooi; Sambrook, Philip; Pocock, Nicholas; Henry, Margaret J; Yeow, Elaine G; Bell, Richard

    2013-12-01

    Postmenopausal women on aromatase inhibitors (AI) are at risk of aromatase inhibitor-associated bone loss (AIBL) and fractures. In 2005 Osteoporosis Australia proposed an algorithm for bisphosphonate intervention. Three hundred and three postmenopausal women with early breast cancer (EBC) were enrolled (osteoporotic, n=25; osteopaenic, n=146; normal bone mineral density (BMD), n=126). Weekly alendronate (70 mg) treatment efficacy as triggered by the algorithm in preventing bone loss was evaluated. All patients received anastrozole (1 mg daily), calcium and vitamin D. All osteoporotic patients received alendronate at baseline. Eleven out of the 146 (7.5%) osteopaenic patients commenced alendronate within 18 months of participation and eleven commenced after. One hundred and twenty four out of the 146 (84.9%) osteopaenic patients and all 126 with normal baseline BMD did not trigger the algorithm. At three years, lumbar spine mean BMD increased (15.6%, p<0.01) in the osteoporotic group. BMD in the osteopaenic group with early intervention significantly increased at three years (6.3%, p=0.02). No significant change was seen in the late intervention group. No change was observed in those with osteopaenia without alendronate. There was a significant drop in lumbar spine (-5.4%) and hip (-4.5%) mean BMD, in the normal BMD group, none of whom received alendronate. Fracture data will be presented. In postmenopausal women with endocrine-responsive EBC, BMD improved over time when a bisphosphonate is administered with anastrozole in osteoporotic patients using an osteoporosis schedule. Subjects with normal baseline BMD experienced the greatest BMD loss, although none became osteoporotic.

  10. Active Mothers Postpartum: a randomized controlled weight-loss intervention trial.

    Science.gov (United States)

    Østbye, Truls; Krause, Katrina M; Lovelady, Cheryl A; Morey, Miriam C; Bastian, Lori A; Peterson, Bercedis L; Swamy, Geeta K; Brouwer, Rebecca J N; McBride, Colleen M

    2009-09-01

    Pregnancy may contribute to overweight and obesity. The primary objective of Active Mothers Postpartum was to promote a reduction in BMI through 24-months postpartum via sustainable lifestyle changes. Behavioral intervention RCT to enhance postpartum weight loss. A total of 450 overweight or obese women, enrolled 6-weeks postpartum, were recruited through obstetrics clinics and community posters in the Durham NC area. Intervention participants were offered eight healthy-eating classes, ten physical-activity classes, and six telephone-counseling sessions over 9 months. Changes from baseline (6-weeks postpartum) to 1-month post-intervention (12-months postpartum) in: (1) diet (caloric intake, calories from fat, intake of certain foods); (2) physical activity (self-reported physical activity, television time); and (3) weight (collected 2004-2007, analyzed 2007-2008). Mean weight loss was 0.90 kg (+/-5.1 kg) in the intervention group and 0.36 kg (+/-4.9 kg) in the control group; this difference was not significant. There were also no significant group differences in improvement of diet or increased physical activity. In secondary analyses, there was a positive bivariate relationship between classes attended and weight loss (p=0.01). There were no significant differences among the arms in diet, physical activity, or weight change. Home-based interventions via mail, telephone, or Internet/e-mail may be more feasible and successful in this population. The postpartum period is an important phase in women's lives with regard to weight retention, but engaging them during this busy period remains a challenge. NCT00212251.

  11. Whey Protein Supplementation Enhances Body Fat and Weight Loss in Women Long After Bariatric Surgery: a Randomized Controlled Trial.

    Science.gov (United States)

    Lopes Gomes, Daniela; Moehlecke, Milene; Lopes da Silva, Fernanda Bassan; Dutra, Eliane Said; D'Agord Schaan, Beatriz; Baiocchi de Carvalho, Kenia Mara

    2017-02-01

    The ideal nutritional approach for weight regain after bariatric surgery remains unclear. The objective of this study is to assess the effect of whey protein supplementation on weight loss and body composition of women who regained weight 24 or more months after bariatric surgery. This is a 16-week open-label, parallel-group, randomized controlled trial of women who regained at least 5 % of their lowest postoperative weight after a Roux-en-Y gastric bypass (RYGB). A total of 34 participants were treated with hypocaloric diet and randomized (1:1) to receive or not supplementation with whey protein, 0.5 g/kg of the ideal body weight. The primary outcomes were changes in body weight, fat free mass (FFM), and fat mass (FM), evaluated by tetrapolar bioelectrical impedance analysis (BIA). Secondary outcomes included resting energy expenditure, blood glucose, lipids, adiponectin, interleukin 6 (IL-6), and cholecystokinin levels. Statistical analyses included generalized estimating equations adjusted for age and physical activity. Fifteen patients in each group were evaluated: mean age was 45 ± 11 years, body mass index (BMI) was 35.7 ± 5.2 kg/m 2 , and time since surgery was 69 ± 23 months. Protein intake during follow-up increased by approximately 75 % in the intervention group (p = 0.01). The intervention group presented more body weight loss (1.86 kg, p = 0.017), accounted for FM loss (2.78, p = 0.021) and no change in FFM, as compared to controls (gain of 0.42 kg of body weight and 0.6 kg of FM). No differences in secondary outcomes were observed between groups. Whey protein supplementation promoted body weight and FM loss in women with long-term weight regain following RYGB.

  12. Smartphone Technology and Text Messaging for Weight Loss in Young Adults: A Randomized Controlled Trial.

    Science.gov (United States)

    Stephens, Janna D; Yager, Allison M; Allen, Jerilyn

    Using smartphone technology and text messaging for health is a growing field. This type of technology is well integrated into the lives of young adults. However, few studies have tested the effect of this type of technology to promote weight loss in young adults OBJECTIVE:: The purpose of this study is to test the effectiveness of a behaviorally based smartphone application for weight loss combined with text messaging from a health coach on weight, body mass index (BMI), and waist circumference in young adults as compared with a control condition. Sixty-two young adults, aged 18 to 25 years, were randomized to receive (1) a smartphone application + health coach intervention and counseling sessions or (2) control condition with a counseling session. All outcome measures were tested at baseline and 3 months. These included weight, BMI, waist circumference, dietary habits, physical activity habits, and self-efficacy for healthy eating and physical activity. The sample was 71% female and 39% white, with an average age of 20 years and average BMI of 28.5 kg/m. Participants in the smartphone + health coach group lost significantly more weight (P = .026) and had a significant reduction in both BMI (P = .024) and waist circumference (P technology and feedback from a health coach on improving weight in a group of diverse young adults.

  13. Differences in Weight Loss Between Persons on Standard Balanced vs Nutrigenetic Diets in a Randomized Controlled Trial.

    Science.gov (United States)

    Frankwich, Karen A; Egnatios, Jeremy; Kenyon, Mandy L; Rutledge, Thomas R; Liao, Patricia S; Gupta, Samir; Herbst, Karen L; Zarrinpar, Amir

    2015-09-01

    Many companies provide genetic tests for obesity-related polymorphisms (nutrigenetics) and make dietary recommendations for weight loss that are based on the results. We performed a randomized controlled trial to determine whether more participants who followed a nutrigenetic-guided diet lost ≥5% of their body weight than participants on a standard balanced diet for 8 and 24 weeks. We performed a prospective study of 51 obese or overweight U.S. veterans on an established weight management program at the Veterans Administration San Diego Healthcare System (the MOVE! program). Participants were randomly assigned to groups placed on a nutrigenetic-guided diet (balanced, low-carbohydrate, low-fat, or Mediterranean; n = 30) or a standard balanced diet (n = 21). Nutrigenetic diets were selected on the basis of results from the Pathway FIT test. There was no significant difference in the percentage of participants on the balanced diet vs the nutrigenetic-guided diet who lost 5% of their body weight at 8 weeks (35.0% ± 20.9% vs 26.9% ± 17.1%, respectively; P = .28) or at 24 weeks. Both groups had difficulty adhering to the diets. However, adherence to the nutrigenetic-guided diet correlated with weight loss (r = 0.74; P = 4.0 × 10(-5)), but not adherence to standard therapy (r = 0.34; P = .23). Participants who had low-risk polymorphisms for obesity lost more weight than all other participants at 8 weeks (5.0% vs 2.9%, respectively; P = .02) and had significantly greater reductions in body mass index (6.4% vs 3.6%, respectively; P = .03) and waist circumference (6.5% vs 2.6%, respectively; P = .02) at 24 weeks. In a prospective study, a nutrigenetic-based diet did not increase weight loss compared with a standard balanced diet. However, genetic features can identify individuals most likely to benefit from a balanced diet weight loss strategy; these findings require further investigation. ClinicalTrials.gov number: NCT01859403. Copyright © 2015 AGA

  14. Adherence and success in long-term weight loss diets: the dietary intervention randomized controlled trial (DIRECT).

    Science.gov (United States)

    Greenberg, Ilana; Stampfer, Meir J; Schwarzfuchs, Dan; Shai, Iris

    2009-04-01

    Data are limited as to whether participants in diet trials truly adhere to their assigned diet and the factors that affect their adherence. We evaluated success and adherence in a two-year dietary intervention randomized controlled trial (DIRECT) in which 322 moderately obese participants (mean age 52 yrs, mean body-mass-index (BMI) 31 kg/m(2), 86% men) were randomized to one of three groups: low-fat, Mediterranean, or low-carbohydrate diets. Overall compliance at month-24 was 85%, with 90% in low-fat, 85% in Mediterranean, and 78% in low-carbohydrate diet (p = .042 between groups). Attrition was higher in women (29% vs. 14% men, p = .001) and current smokers (25% vs. 14% among maintainers, p = 0.04). In a multivariate model, independent predictors of dropping-out were: higher baseline BMI (OR = 1.11; CI: 1.03-1.21) and less weight loss at month-6 (OR = 1.20; CI: 1.1-1.3). In a multivariate model, greater weight loss achieved at month-6 was the main predictor associated with success in weight loss (> 5%) over 2 years (OR = 1.5; CI: 1.35-1.67). Self-reported complete adherence score to diet was greater on low-carbohydrate diet (p low-fat) until month-6, but dropped overall from 81% at month-1 to 57% at month-24. Holidays were a trigger to a significant decrease in adherence followed by a partial rebound. Changes in diet composition from month-1 to month-12 were more pronounced in the multi-stage low-carbohydrate diet-group (p < .05). Generally, the most irresistible restricted food items were cookies (45% of dieters) and fruits (30%). Among the physically active (n = 107), 44% reported a tendency to eat less after exercising compared to 10% who tended to eat more. Initial 6-month reduction in weight is the main predictor of both long-term retention and success in weight loss. Special attention is needed for women, current smokers, and during holidays. Physical activity is associated with subsequent reduction in energy intake.

  15. Differences in Weight Loss Between Persons on Standard Balanced vs Nutrigenetic Diets in a Randomized Controlled Trial

    Science.gov (United States)

    Kenyon, Mandy L.; Rutledge, Thomas R.; Liao, Patricia S.; Gupta, Samir; Herbst, Karen L.; Zarrinpar, Amir

    2015-01-01

    Background & Aims Many companies provide genetic tests for obesity-related polymorphisms (nutrigenetics) and make dietary recommendations for weight loss based on the results. We performed a randomized controlled trial to determine whether more participants who followed a nutrigenetic-guided diet lost ≥5% of their body weight than participants on a standard balanced diet, for 8 and 24 weeks. Methods We performed a prospective study of 51 obese or overweight US veterans on an established weight management program at the Veterans Administration San Diego Healthcare System (the MOVE! Program). Participants were randomly assigned to groups placed on a nutrigenetic-guided diet (balanced, low-carbohydrate, low-fat, or Mediterranean; n=30) or a standard balanced diet (n=21). Nutrigenetic diets were selected based on results from the Pathway FIT test (Pathway Genomics; San Diego, CA). Results There was no significant difference in the percentage of participants on the balanced diet vs the nutrigenetic-guided diet who lost 5% of their body weight at 8 weeks (35.0%±20.9% vs 26.9%±17.1%, respectively; P=.28) or at 24 weeks. Both groups had difficulty adhering to the diets. However, adherence to the nutrigenetic-guided diet correlated with weight loss (r=0.74; P= 4.0 × 10−5), but not adherence to standard therapy (r=0.34; P=.23). Participants who had low-risk polymorphisms for obesity lost more weight than all other participants at 8 weeks (5.0% vs 2.9%, respectively; P=.02), and had significantly greater reductions in body mass index (6.4% vs 3.6% respectively; P=.03) and waist circumference (6.5% vs 2.6% respectively; P=.02) at 24 weeks. Conclusions In a prospective study, a nutrigenetic-based diet did not increase weight loss compared with a standard balanced diet. However, genetic features can identify individuals most likely to benefit from a balanced diet weight loss strategy; these findings require further investigation. ClincialTrials.gov number: NCT01859403

  16. Effect of an Internet-Based Program on Weight Loss for Low-Income Postpartum Women: A Randomized Clinical Trial.

    Science.gov (United States)

    Phelan, Suzanne; Hagobian, Todd; Brannen, Anna; Hatley, Karen E; Schaffner, Andrew; Muñoz-Christian, Karen; Tate, Deborah F

    2017-06-20

    Postpartum weight retention increases lifetime risk of obesity and related morbidity. Few effective interventions exist for multicultural, low-income women. To test whether an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) for low-income postpartum women could produce greater weight loss than the WIC program alone over 12 months. A 12-month, cluster randomized, assessor-blind, clinical trial enrolling 371 adult postpartum women at 12 clinics in WIC programs from the California central coast between July 2011 and May 2015 with data collection completed in May 2016. Clinics were randomized to the WIC program (standard care group) or the WIC program plus a 12-month primarily internet-based weight loss program (intervention group), including a website with weekly lessons, web diary, instructional videos, computerized feedback, text messages, and monthly face-to-face groups at the WIC clinics. The primary outcome was weight change over 12 months, based on measurements at baseline, 6 months, and 12 months. Secondary outcomes included proportion returning to preconception weight and changes in physical activity and diet. Participants included 371 women (mean age, 28.1 years; Hispanic, 81.6%; mean weight above prepregnancy weight, 7.8 kg; mean months post partum, 5.2 months) randomized to the intervention group (n = 174) or standard care group (n = 197); 89.2% of participants completed the study. The intervention group produced greater mean 12-month weight loss compared with the standard care group (3.2 kg in the intervention group vs 0.9 kg in standard care group, P income postpartum women, an internet-based weight loss program in addition to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC program) compared with the WIC program alone resulted in a statistically significant greater weight loss over 12 months. Further research is needed to

  17. NLP modeling for the optimization of LiBr-H2O absorption refrigeration systems with exergy loss rate, heat transfer area, and cost as single objective functions

    DEFF Research Database (Denmark)

    Mussati, Sergio F.; Gernaey, Krist; Morosuk, Tatiana

    2016-01-01

    exergy loss rate, the total heat transfer area, and the total annual cost of the system. It was found that the optimal solution obtained by minimization of the total exergy loss rate provides “theoretical” upper bounds not only for the total heat transfer area of the system but also for each process unit...... and all stream temperatures, while the optimal solution obtained by minimization of the total heat transfer area provides the lower bounds for these model variables, to solve a cost optimization problem. The minimization of the total exergy loss rate by varying parametrically the available total heat...... transfer area between these bounds was also performed, allowing to see how the optimal distribution of the available total heat transfer area among the system components, as well as the operating conditions (stream temperature, pressure, composition, and mass flow rate) and heat loads, vary qualitatively...

  18. Optimizing body contour in massive weight loss patients: the modified vertical abdominoplasty.

    Science.gov (United States)

    Costa, Luiz Fernando da; Landecker, Alan; Manta, Anísio Marinho

    2004-12-01

    In morbid obesity, contour deformities of the abdomen are common after bariatric surgery and radical weight loss. Traditional abdominoplasty techniques often fail to maximally improve body contour in these cases because adjacent sites such as the hip rolls and flanks are not treated, leaving the patient with large lateral tissue redundancies and dog-ears. In an attempt to solve these challenging problems, the authors present the modified vertical abdominoplasty technique, a single-stage procedure that involves a combined vertical and transverse approach in which an "en bloc" resection of the redundant tissues is performed without undermining, drainage, or reinforcement of the abdominal wall. The latter is only carried out when diastasis and/or hernias are present, and Marlex mesh may be utilized when indicated. In patients with simultaneous large umbilical hernias and/or excessively long stalks, neoumbilicoplasty is recommended. A significant improvement of abdominal contour was obtained in the vast majority of patients because the resection design offers simultaneous treatment of both vertical and transverse tissue redundancies in the abdomen and neighboring regions, with more harmonic results when compared with purely vertical or transverse approaches. The modified vertical abdominoplasty technique is an easy, fast, and reliable alternative for treating these patients, with less intraoperative bleeding, reduced overall cost, and low morbidity rates. In selected cases, the technique is capable of offering excellent results in terms of contouring and maximizes the overall outcome of treatment protocols for these patients, who can then be integrated into normal life with heightened self-esteem, happiness, and productivity.

  19. Design and implementation of a randomized controlled social and mobile weight loss trial for young adults (project SMART).

    Science.gov (United States)

    Patrick, K; Marshall, S J; Davila, E P; Kolodziejczyk, J K; Fowler, J H; Calfas, K J; Huang, J S; Rock, C L; Griswold, W G; Gupta, A; Merchant, G; Norman, G J; Raab, F; Donohue, M C; Fogg, B J; Robinson, T N

    2014-01-01

    To describe the theoretical rationale, intervention design, and clinical trial of a two-year weight control intervention for young adults deployed via social and mobile media. A total of 404 overweight or obese college students from three Southern California universities (M(age) = 22( ± 4) years; M(BMI) = 29( ± 2.8); 70% female) were randomized to participate in the intervention or to receive an informational web-based weight loss program. The intervention is based on behavioral theory and integrates intervention elements across multiple touch points, including Facebook, text messaging, smartphone applications, blogs, and e-mail. Participants are encouraged to seek social support among their friends, self-monitor their weight weekly, post their health behaviors on Facebook, and e-mail their weight loss questions/concerns to a health coach. The intervention is adaptive because new theory-driven and iteratively tailored intervention elements are developed and released over the course of the two-year intervention in response to patterns of use and user feedback. Measures of body mass index, waist circumference, diet, physical activity, sedentary behavior, weight management practices, smoking, alcohol, sleep, body image, self-esteem, and depression occur at 6, 12, 18, and 24 months. Currently, all participants have been recruited, and all are in the final year of the trial. Theory-driven, evidence-based strategies for physical activity, sedentary behavior, and dietary intake can be embedded in an intervention using social and mobile technologies to promote healthy weight-related behaviors in young adults. Copyright © 2013 Elsevier Inc. All rights reserved.

  20. Blocking carbohydrate absorption and weight loss: a clinical trial using a proprietary fractionated white bean extract.

    Science.gov (United States)

    Udani, Jay; Singh, Betsy B

    2007-01-01

    A proprietary fractionated white bean extract of Phaseolus vulgaris has been shown in vitro to inhibit the digestive enzyme alpha-amylase. This may prevent or delay the digestion of complex carbohydrates, potentially resulting in weight loss. A 4-week randomized, double-blind, placebo-controlled study of 25 healthy subjects consuming 1000 mg of a proprietary fractioned white bean extract or an identical placebo twice a day before meals in conjunction with a multi-component weight-loss program, including diet, exercise, and behavioral intervention, was conducted. Both groups reduced their weight and waist size significantly from baseline. The active group lost 6.0 lbs (P=.0002) and 2.2 in (P=.0050), and the placebo group lost 4.7 lbs (P=.0016) and 2.1 in (P=.0001). The differences between groups were not significant (weight P=.4235, waist size P=.8654). Through subsequent exploratory analysis to investigate group findings further, subjects were stratified by total dietary carbohydrate intake. This probative analysis revealed that the tertile of subjects who had consumed the most carbohydrates demonstrated significant reductions in both weight (8.7 lbs vs 1.7 lbs, P=.0412) and waist size (3.3 in vs 1.3 in P=.0100) compared with placebo subjects in the same tertile of carbohydrate intake. Subjects who adhere to a program including dietary modification, exercise, and behavioral intervention can significantly reduce their weight and waist size in a short period of time. In an exploratory analysis of data, the tertile of subjects who ate the most carbohydrates experienced a significant reduction in both weight and waist size with the addition of the white bean extract compared to the placebo group of the same tertile of carbohydrate consumption. Longer studies with a larger pool of subjects are required to validate these findings.

  1. Optimizing the supply chain of biomass and biogas for a single plant considering mass and energy losses

    DEFF Research Database (Denmark)

    Jensen, Ida Græsted; Münster, Marie; Pisinger, David

    2017-01-01

    plants. In this paper, a mixed integer programming (MIP) model for finding the optimal production and investment plan for a biogas supply chain is presented to ensure better economy for the full chain hopefully stimulating future investments in biogas. The model makes use of step-wise linear functions...... to represent capital and operational expenditures at the biogas plant; considers the chain from the farmer to the end market; and includes changes of mass and energy content along the chain by modeling the losses and gains for all processes in the chain. Biomass inputs are scheduled on a weekly basis whereas...... energy outputs are scheduled on an hourly basis to better capture the changes of energy prices and potentially take advantage of these changes. The model is tested on a case study with co-digestion of straw, sugar beet and manure, considering natural gas, heat, and electricity as end products. The model...

  2. Accounting for disagreements on average cone loss rates in retinitis pigmentosa with a new kinetic model: Its relevance for clinical trials.

    Science.gov (United States)

    Baumgartner, W A; Baumgartner, A M

    2016-04-01

    contrast to this, we show that cone loss occurs in patients with increasing -k values during RP progression. And as the Hopkins' protocol selects more advanced RP cases than Harvard's to assure avoidance of ceiling effects (Harvard does this by kinetic monitoring), we show increasing -k kinetics to be the reason Harvard obtains more +k and small -k values. Thus the combined effects of (i) and (ii) produce Harvard's smaller average -k value. The relevance of the increasing biochemical stress model for optimizing clinical trials is discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Effect of tranexamic acid irrigation on perioperative blood loss during orthognathic surgery: a double-blind, randomized controlled clinical trial.

    Science.gov (United States)

    Eftekharian, Hamidreza; Vahedi, Ruhollah; Karagah, Tuba; Tabrizi, Reza

    2015-01-01

    Perioperative hemorrhage is an important concern during orthognathic surgery. The purpose of this study was to assess the effect of tranexamic acid (TXA) irrigation on perioperative hemorrhage during orthognathic surgery. In this double-blind, randomized controlled clinical trial, 56 participants who underwent orthognathic surgery were divided into 2 groups. The patients in the first group received TXA irrigation with normal saline (1 mg/mL), and the patients in the second group had normal saline for irrigation during orthognathic surgery. Age, gender, operation duration, the amount of irrigation solution used, and preoperative hemoglobin, hematocrit, and weight were the variables that were studied. The use of TXA solution for irrigation was the predictive factor of the study. Each group consisted of 28 patients. Group 1 consisted of 15 male patients (53.6%) and 13 female patients (46.4%) and group 2 consisted of 14 male patients (50%) and 14 female patients (50%). There was no difference in the distributions of the variables between the 2 groups, except for the duration of the operation. The mean duration of the operation was 3.94 ± 0.61 hours in group 1 and 4.17 ± 0.98 hours in group 2, and the difference in this respect between the 2 groups was statistically significant (P .05). TXA is effective in reducing intraoperative blood loss in patients for whom substantial blood loss is anticipated. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  4. Exercise training and weight loss, not always a happy marriage: single blind exercise trials in females with diverse BMI.

    Science.gov (United States)

    Jackson, Matthew; Fatahi, Fardin; Alabduljader, Kholoud; Jelleyman, Charlotte; Moore, Jonathan P; Kubis, Hans-Peter

    2018-04-01

    Individuals show high variability in body weight responses to exercise training. Expectations and motivation towards effects of exercise on body weight might influence eating behaviour and could conceal regulatory mechanisms. We conducted 2 single-blind exercise trials (4 weeks (study 1) and 8 weeks (study 2)) with concealed objectives and exclusion of individuals with weight loss intention. Circuit exercise training programs (3 times a week (45-90 min), intensity 50%-90% peak oxygen uptake for 4 and 8 weeks) were conducted. Thirty-four females finished the 4-week intervention and 36 females the 8-week intervention. Overweight/obese (OV/OB) and lean female participants' weight/body composition responses were assessed and fasting and postprandial appetite hormone levels (PYY, insulin, amylin, leptin, ghrelin) were measured before and after the intervention for understanding potential contribution to individuals' body weight response to exercise training (study 2). Exercise training in both studies did not lead to a significant reduction of weight/body mass index (BMI) in the participants' groups; however, lean participants gained muscle mass. Appetite hormones levels were significantly (p training did not lead to weight loss in female participants, while a considerable proportion of variance in body weight response to training could be explained by individuals' appetite hormone levels and BMI.

  5. Optimization of ITER Nb3Sn CICCs for coupling loss, transverse electromagnetic load and axial thermal contraction

    International Nuclear Information System (INIS)

    Nijhuis, A; Van Lanen, E P A; Rolando, G

    2012-01-01

    by the distinct difference in mechanical response of the cable during axial contraction for short and long pitches. For short pitches periodic bending in different directions with relatively short wavelength is imposed because of a lack of sufficient lateral restraint of radial pressure. This can lead to high bending strain and eventually buckling. Whereas for cables with long twist pitches, the strands are only able to react as coherent bundles, being tightly supported by the surrounding strands, providing sufficient lateral restraint of radial pressure in combination with enough slippage to avoid single strand bending along detrimental short wavelengths. Experimental evidence of good performance was already provided with the test of the long pitch TFPRO2-OST2, which is still until today, the best ITER-type cable to strand performance ever without any cyclic load (electromagnetic and thermal contraction) degradation. For reduction of the coupling loss, specific choices of the cabling twist sequence are needed to minimize the area of linked strands and bundles that are coupled and form loops with the applied changing magnetic field, instead of simply avoiding longer pitches. In addition we recommend increasing the wrap coverage of the CS conductor from 50% to at least 70%. A larger wrap coverage fraction enhances the overall strand bundle lateral restraint. The long pitch design seems the best solution to optimize the ITER CS conductor within the given restrictions of the present coil design envelope, only allowing marginal changes. The models predict significant improvement against strain sensitivity and substantial decrease of the AC coupling loss in Nb 3 Sn CICCs, but also for NbTi CICCs minimization of the coupling loss can obviously be achieved. Although the success of long pitches to transverse load degradation was already demonstrated, the prediction of the elegant innovative combination with low coupling loss needs to be validated by a short sample test.

  6. Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results.

    Science.gov (United States)

    Zahnert, Thomas; Löwenheim, Hubert; Beutner, Dirk; Hagen, Rudolf; Ernst, Arneborg; Pau, Hans-Wilhelm; Zehlicke, Thorsten; Kühne, Hilke; Friese, Natascha; Tropitzsch, Anke; Lüers, Jan-Christoffer; Mlynski, Robert; Todt, Ingo; Hüttenbrink, Karl-Bernd

    2016-01-01

    To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant. This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warble-tone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction. Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71% at 65 dB SPL. The postimplantation mean SRT50 (speech reception in quiet for 50% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA)quality-of-life questionnaire was scored very positively by all patients. A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery. © 2016 S. Karger AG, Basel.

  7. Comparative effectiveness of plant-based diets for weight loss: a randomized controlled trial of five different diets.

    Science.gov (United States)

    Turner-McGrievy, Gabrielle M; Davidson, Charis R; Wingard, Ellen E; Wilcox, Sara; Frongillo, Edward A

    2015-02-01

    The aim of this study was to determine the effect of plant-based diets on weight loss. Participants were enrolled in a 6-mo, five-arm, randomized controlled trial in 2013 in South Carolina. Participants attended weekly group meetings, with the exception of the omnivorous group, which served as the control and attended monthly meetings augmented with weekly e-mail lessons. All groups attended monthly meetings for the last 4 mo of the study. Diets did not emphasize caloric restriction. Overweight adults (body mass index 25-49.9 kg/m(2); age 18-65 y, 19% non-white, and 27% men) were randomized to a low-fat, low-glycemic index diet: vegan (n = 12), vegetarian (n = 13), pesco-vegetarian (n = 13), semi-vegetarian (n = 13), or omnivorous (n = 12). Fifty (79%) participants completed the study. In intention-to-treat analysis, the linear trend for weight loss across the five groups was significant at both 2 (P vegan group (-7.5% ± 4.5%) was significantly different from the omnivorous (-3.1% ± 3.6%; P = 0.03), semi-vegetarian (-3.2% ± 3.8%; P = 0.03), and pesco-vegetarian (-3.2% ± 3.4%; P = 0.03) groups. Vegan participants decreased their fat and saturated fat more than the pesco-vegetarian, semi-vegetarian, and omnivorous groups at both 2 and 6 mo (P Vegan diets may result in greater weight loss than more modest recommendations. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Effectiveness of web-based self-disclosure peer-to-peer support for weight loss: randomized controlled trial.

    Science.gov (United States)

    Imanaka, Mie; Ando, Masahiko; Kitamura, Tetsuhisa; Kawamura, Takashi

    2013-07-09

    Obesity is one of the most common public health problems in the industrialized world as a cause of noncommunicable diseases. Although primarily used for one-on-one communication, email is available for uninterrupted support for weight loss, but little is known about the effects of dietitian group counseling for weight control via the Internet. We developed a Web-based self-disclosure health support (WSHS) system for weight loss. This study aims to compare the effect of weight change between those using the WSHS and those using the email health support (EHS). This study was designed as an open prospective individual randomized controlled trial. Eligible participants were aged 35 to 65 years with a body mass index (BMI) of ≥25.0 in their latest health examination. Participants were randomly assigned to either the WSHS group or the EHS group. Thirteen registered dietitians under the direction of a principal dietitian each instructed 6 to 8 participants from the respective groups. All participants in the WSHS group could receive nutritional advice and calculate their nutritive intake from a photograph of a meal on their computer screen from the Internet sent to them by their dietitian, receive supervision from the registered dietitian, and view fellow participants' weight changes and lifestyle modifications. In the EHS group, a participant could receive one-on-one nutritional advice and calculate his/her nutritive intake from the photograph of a meal on computer screen sent by email from his/her dietitian, without being able to view fellow participants' status. The follow-up period was 12 weeks for both groups. The primary outcome measure was change in body weight. The secondary outcome measure included changes in BMI and waist circumference. The intergroup comparison of the changes before and after intervention was evaluated using analysis of covariance. A total of 193 participants were randomly assigned to either the WSHS group (n=97) or the EHS group (n=96). Ten

  9. Effectiveness of conventional versus virtual reality based vestibular rehabilitation in the treatment of dizziness, gait and balance impairment in adults with unilateral peripheral vestibular loss: a randomised controlled trial.

    Science.gov (United States)

    Meldrum, Dara; Herdman, Susan; Moloney, Roisin; Murray, Deirdre; Duffy, Douglas; Malone, Kareena; French, Helen; Hone, Stephen; Conroy, Ronan; McConn-Walsh, Rory

    2012-03-26

    Unilateral peripheral vestibular loss results in gait and balance impairment, dizziness and oscillopsia. Vestibular rehabilitation benefits patients but optimal treatment remains unknown. Virtual reality is an emerging tool in rehabilitation and provides opportunities to improve both outcomes and patient satisfaction with treatment. The Nintendo Wii Fit Plus® (NWFP) is a low cost virtual reality system that challenges balance and provides visual and auditory feedback. It may augment the motor learning that is required to improve balance and gait, but no trials to date have investigated efficacy. In a single (assessor) blind, two centre randomised controlled superiority trial, 80 patients with unilateral peripheral vestibular loss will be randomised to either conventional or virtual reality based (NWFP) vestibular rehabilitation for 6 weeks. The primary outcome measure is gait speed (measured with three dimensional gait analysis). Secondary outcomes include computerised posturography, dynamic visual acuity, and validated questionnaires on dizziness, confidence and anxiety/depression. Outcome will be assessed post treatment (8 weeks) and at 6 months. Advances in the gaming industry have allowed mass production of highly sophisticated low cost virtual reality systems that incorporate technology previously not accessible to most therapists and patients. Importantly, they are not confined to rehabilitation departments, can be used at home and provide an accurate record of adherence to exercise. The benefits of providing augmented feedback, increasing intensity of exercise and accurately measuring adherence may improve conventional vestibular rehabilitation but efficacy must first be demonstrated. Clinical trials.gov identifier: NCT01442623.

  10. Impact of food supplementation on weight loss in randomised-controlled dietary intervention trials: a systematic review and meta-analysis.

    Science.gov (United States)

    Wibisono, Cinthya; Probst, Yasmine; Neale, Elizabeth; Tapsell, Linda

    2016-04-01

    Dietary trials provide evidence for practice and policy guidelines, but poor adherence may confound results. Food supplementation may improve adherence to dietary interventions, but the impact of supplementation on study outcomes is not known. The aim of this review was to examine the impact of food supplementation on weight loss in dietary intervention trials. The databases Scopus, PubMed and the Cochrane Library were searched for dietary intervention trials published between January 2004 and March 2015 using the following keyword combinations: 'trial' OR 'intervention', 'food' OR 'diet', 'weight loss' and 'adherence' OR 'adherence'. Studies were included if food was provided to at least one study group and both 'weight change' and 'adherence' were reported. Random effects meta-analyses were conducted to assess weighted mean differences (WMD) in body weight (change or final mean values). The included studies formed two groups: trials involving an intervention group supplemented with a food and a control without food supplementation (food v. no food), and trials in which food was provided to all subjects (food v. food) (PROSPERO registration: CRD42015017563). In total, sixteen studies were included. Significant weight reduction was reported in the food v. no food studies (WMD -0·74 kg; 95 % CI -1·40, -0·08; P=0·03, I 2=63 %). A non-significant increase in weight was found among the food v. food studies (WMD 0·84 kg; 95 % CI -0·60, 2·27; P=0·25, I 2=0 %). Food supplementation appeared to result in greater weight loss in dietary trials. Energy restrictions and intensity of interventions were other significant factors influencing weight loss.

  11. The Dietary Intervention to Enhance Tracking with Mobile Devices (DIET Mobile) Study: A 6-Month Randomized Weight Loss Trial.

    Science.gov (United States)

    Turner-McGrievy, Gabrielle M; Wilcox, Sara; Boutté, Alycia; Hutto, Brent E; Singletary, Camelia; Muth, Eric R; Hoover, Adam W

    2017-08-01

    To examine the use of two different mobile dietary self-monitoring methods for weight loss. Adults with overweight (n = 81; mean BMI 34.7 ± 5.6 kg/m 2 ) were randomized to self-monitor their diet with a mobile app (App, n = 42) or wearable Bite Counter device (Bite, n = 39). Both groups received the same behavioral weight loss information via twice-weekly podcasts. Weight, physical activity (International Physical Activity Questionnaire), and energy intake (two dietary recalls) were assessed at 0, 3, and 6 months. At 6 months, 75% of participants completed the trial. The App group lost significantly more weight (-6.8 ± 0.8 kg) than the Bite group (-3.0 ± 0.8 kg; group × time interaction: P < 0.001). Changes in energy intake (kcal/d) (-621 ± 157 App, -456 ± 167 Bite; P = 0.47) or number of days diet was tracked (90.7 ± 9.1 App, 68.4 ± 9.8 Bite; P = 0.09) did not differ between groups, but the Bite group had significant increases in physical activity metabolic equivalents (+2015.4 ± 684.6 min/wk; P = 0.02) compared to little change in the App group (-136.5 ± 630.6; P = 0.02). Total weight loss was significantly correlated with number of podcasts downloaded (r = -0.33, P < 0.01) and number of days diet was tracked (r = -0.33, P < 0.01). While frequency of diet tracking was similar between the App and Bite groups, there was greater weight loss observed in the App group. © 2017 The Obesity Society.

  12. The REVAMP trial to evaluate HIV resistance testing in sub-Saharan Africa: a case study in clinical trial design in resource limited settings to optimize effectiveness and cost effectiveness estimates.

    Science.gov (United States)

    Siedner, Mark J; Bwana, Mwebesa B; Moosa, Mahomed-Yunus S; Paul, Michelle; Pillay, Selvan; McCluskey, Suzanne; Aturinda, Isaac; Ard, Kevin; Muyindike, Winnie; Moodley, Pravikrishnen; Brijkumar, Jaysingh; Rautenberg, Tamlyn; George, Gavin; Johnson, Brent; Gandhi, Rajesh T; Sunpath, Henry; Marconi, Vincent C

    2017-07-01

    In sub-Saharan Africa, rates of sustained HIV virologic suppression remain below international goals. HIV resistance testing, while common in resource-rich settings, has not gained traction due to concerns about cost and sustainability. We designed a randomized clinical trial to determine the feasibility, effectiveness, and cost-effectiveness of routine HIV resistance testing in sub-Saharan Africa. We describe challenges common to intervention studies in resource-limited settings, and strategies used to address them, including: (1) optimizing generalizability and cost-effectiveness estimates to promote transition from study results to policy; (2) minimizing bias due to patient attrition; and (3) addressing ethical issues related to enrollment of pregnant women. The study randomizes people in Uganda and South Africa with virologic failure on first-line therapy to standard of care virologic monitoring or immediate resistance testing. To strengthen external validity, study procedures are conducted within publicly supported laboratory and clinical facilities using local staff. To optimize cost estimates, we collect primary data on quality of life and medical resource utilization. To minimize losses from observation, we collect locally relevant contact information, including Whatsapp account details, for field-based tracking of missing participants. Finally, pregnant women are followed with an adapted protocol which includes an increased visit frequency to minimize risk to them and their fetuses. REVAMP is a pragammatic randomized clinical trial designed to test the effectiveness and cost-effectiveness of HIV resistance testing versus standard of care in sub-Saharan Africa. We anticipate the results will directly inform HIV policy in sub-Saharan Africa to optimize care for HIV-infected patients.

  13. Development of Near Optimal Rule-Based Control for Plug-In Hybrid Electric Vehicles Taking into Account Drivetrain Component Losses

    Directory of Open Access Journals (Sweden)

    Hanho Son

    2016-05-01

    Full Text Available A near-optimal rule-based mode control (RBC strategy was proposed for a target plug-in hybrid electric vehicle (PHEV taking into account the drivetrain losses. Individual loss models were developed for drivetrain components including the gears, planetary gear (PG, bearings, and oil pump, based on experimental data and mathematical governing equations. Also, a loss model for the power electronic system was constructed, including loss from the motor-generator while rotating in the unloaded state. To evaluate the effect of the drivetrain losses on the operating mode control strategy, backward simulations were performed using dynamic programming (DP. DP selects the operating mode, which provides the highest efficiency for given driving conditions. It was found that the operating mode selection changes when drivetrain losses are included, depending on driving conditions. An operating mode schedule was developed with respect to the wheel power and vehicle speed, and based on the operating mode schedule, a RBC was obtained, which can be implemented in an on-line application. To evaluate the performance of the RBC, a forward simulator was constructed for the target PHEV. The simulation results show near-optimal performance of the RBC compared with dynamic-programming-based mode control in terms of the mode operation time and fuel economy. The RBC developed with drivetrain losses taken into account showed a 4%–5% improvement of the fuel economy over a similar RBC, which neglected the drivetrain losses.

  14. Optimized design of polarizers with low ohmic loss and any polarization state for the 28 GHz QUEST ECH/ECCD system

    Energy Technology Data Exchange (ETDEWEB)

    Tsujimura, Toru Ii, E-mail: tsujimura.tohru@nifs.ac.jp [National Institute for Fusion Science, National Institutes of Natural Sciences, Toki 509-5292 (Japan); Idei, Hiroshi [Research Institute for Applied Mechanics, Kyushu University, Kasuga 816-8580 (Japan); Kubo, Shin; Kobayashi, Sakuji [National Institute for Fusion Science, National Institutes of Natural Sciences, Toki 509-5292 (Japan)

    2017-01-15

    Highlights: • Ohmic loss was calculated on the grooved mirror surface in simulated polarizers. • Polarizers with a low ohmic loss feature were optimally designed for 28 GHz. • Smooth rounded-rectangular grooves were made by mechanical machining. • The designed polarizers can realize all polarization states. - Abstract: In a high-power long-pulse millimeter-wave transmission line for electron cyclotron heating and current drive (ECH/ECCD), the ohmic loss on the grooved mirror surface of polarizers is one of the important issues for reducing the transmission loss. In this paper, the ohmic loss on the mirror surface is evaluated in simulated real-scale polarizer miter bends for different groove parameters under a linearly-polarized incident wave excitation. The polarizers with low ohmic loss are optimally designed for a new 28 GHz transmission line on the QUEST spherical tokamak. The calculated optimum ohmic loss is restricted to only less than 1.5 times as large as the theoretical loss for a copper flat mirror at room temperature. The copper rounded-rectangular grooves of the polarizers were relatively easy to make smooth in mechanical machining and the resultant surface roughness was not more than 0.15 μm, which is only 0.38 times as large as the skin depth. The combination of the designed elliptical polarizer and the polarization rotator can also realize any polarization state of the reflected wave.

  15. Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial.

    Science.gov (United States)

    Knowles, Simon R; Ski, Chantal F; Langham, Robyn; O'Flaherty, Emmet; Thompson, David R; Rossell, Susan L; Moore, Gaye; Hsueh, Ya-Seng Arthur; Castle, David J

    2016-09-09

    Chronic kidney disease (CKD) and end-stage kidney disease (ESKD) are serious and growing health problems with enormous impact on psychological and social functioning. Despite high rates of comorbid depression and anxiety in these patient populations, and the adverse impact these have upon treatment adherence, quality of life, social connectedness and healthcare costs there has been little attention focused on the prevention or management of these problems. Thus, our aim was to evaluate the Dialysis Optimal Health Program (DOHP) that adopts a person-centred approach and engages collaborative therapy to educate and support those diagnosed with ESKD who are commencing dialysis. The study design is a randomised controlled trial. Ninety-six adult patients initiating haemodialysis or peritoneal dialysis will be randomly allocated to either the intervention (DOHP) or usual care group. Participants receiving the intervention will receive nine (8 + 1 booster session) sequential sessions based on a structured information/workbook, psychosocial and educational supports and skills building. The primary outcome measures are depression and anxiety (assessed by the Hospital Anxiety and Depression Scale; HADS). Secondary outcomes include health-related quality of life (assessed by the Kidney Disease Quality of Life instrument; KDQOL), self-efficacy (assessed by General Self-Efficacy Scale) and clinical indices (e.g. albumin and haemoglobin levels). Cost-effectiveness analysis and process evaluation will also be performed to assess the economic value and efficacy of the DOHP. Primary and secondary measures will be collected at baseline and at 3-, 6-, and 12-month follow-up time points. We believe that this innovative trial will enhance knowledge of interventions aimed at supporting patients in the process of starting dialysis, and will broaden the focus from physical symptoms to include psychosocial factors such as depression, anxiety, self-efficacy, wellbeing and community

  16. Portion controlled ready-to-eat meal replacement is associated with short term weight loss: a randomised controlled trial.

    Science.gov (United States)

    Kuriyan, Rebecca; Lokesh, Deepa P; D'Souza, Ninoshka; Priscilla, Divya J; Peris, Chandni Halcyon; Selvam, Sumithra; Kurpad, Anura V

    2017-01-01

    Strategies to prevent and treat overweight/obesity are urgently needed. This study assessed the effect of a short-term intake of ready-to-eat cereal on body weight and waist circumference of overweight/obese individuals in comparison to a control group. A randomized, controlled 2-arm trial was carried out on 101 overweight/obese (Body Mass Index - 29.2±2.4 kg/m2) females aged 18 to 44 years, at St. John's Medical College Hospital. The intervention group received a low fat, ready to eat cereal, replacing two meals/day for two weeks. The control group was provided with standard dietary guidelines for weight loss and energy requirements for both groups were calculated similarly. Anthropometric, dietary, appetite and health status assessments were carried out at baseline and at the end of two weeks. At the end of two weeks, the mean reductions in body weight and waist circumference were significantly greater in the intervention group, -0.53 kg; 95% CI (-0.86 to -0.19) for body weight and -1.39 cm; 95% CI (-1.78, -0.99) for waist circumference. The intervention group had a significantly higher increase in dietary intakes of certain vitamins, fiber and sugar, and significantly higher reductions in total and polyunsaturated fats and sodium intakes, as compared to the control group (peat cereal could be effective for short-term weight loss, with some improvements in the nutrient intake profile. However, studies of longer duration are needed.

  17. Acupuncture therapy for sudden sensorineural hearing loss: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhang, Xin-chang; Xu, Xiu-ping; Xu, Wen-tao; Hou, Wen-zhen; Cheng, Ying-ying; Li, Chang-xi; Ni, Guang-xia

    2015-01-01

    Acupuncture has commonly been used in China, either alone or in combination with Western medicine, to treat sudden sensorineural hearing loss (SSHL). The purpose of this systematic review is to assess the efficacy and safety of acupuncture therapy for patients with SSHL. We searched PubMed, the Cochrane Library, Embase, China National Knowledge Internet (CNKI), Database for Chinese Technical Periodicals (VIP), and Chinese Biomedical literature service system (SinoMed) to collect randomized controlled trials of acupuncture for SSHL published before July 2014. A meta-analysis was conducted according to the Cochrane systematic review method using RevMan 5.2 software. The evidence level for each outcome was assessed using the GRADE methodology. Twelve trials involving 863 patients were included. A meta-analysis showed that the effect of manual acupuncture combined with Western medicine comprehensive treatment (WMCT) was better than WMCT alone (RR 1.33, 95%CI 1.19-1.49) and the same as the effect of electroacupuncture combined with WMCT (RR 1.33, 95%CI 1.19-1.50). One study showed a better effect of electroacupuncture than of WMCT (RR 1.34, 95%CI 1.24-1.45). For mean changes in hearing over all frequencies, the meta-analysis showed a better effect with the combination of acupuncture and WMCT than with WMCT alone (MD 10.85, 95%CI 6.84-14.86). However, the evidence levels for these interventions were low or very low due to a high risk of bias and small sample sizes in the included studies. There was not sufficient evidence showing that acupuncture therapy alone was beneficial for treating SSHL. However, interventions combining acupuncture with WMCT had more efficacious results in the treatment of SSHL than WMCT alone. Electroacupuncture alone might be a viable alternative treatment besides WMCT for SSHL. However, given that there were fewer eligible RCTs and limitations in the included trials, such as methodological drawbacks and small sample sizes, large-scale RCTs are

  18. Acupuncture therapy for sudden sensorineural hearing loss: a systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Xin-chang Zhang

    Full Text Available Acupuncture has commonly been used in China, either alone or in combination with Western medicine, to treat sudden sensorineural hearing loss (SSHL. The purpose of this systematic review is to assess the efficacy and safety of acupuncture therapy for patients with SSHL.We searched PubMed, the Cochrane Library, Embase, China National Knowledge Internet (CNKI, Database for Chinese Technical Periodicals (VIP, and Chinese Biomedical literature service system (SinoMed to collect randomized controlled trials of acupuncture for SSHL published before July 2014. A meta-analysis was conducted according to the Cochrane systematic review method using RevMan 5.2 software. The evidence level for each outcome was assessed using the GRADE methodology.Twelve trials involving 863 patients were included. A meta-analysis showed that the effect of manual acupuncture combined with Western medicine comprehensive treatment (WMCT was better than WMCT alone (RR 1.33, 95%CI 1.19-1.49 and the same as the effect of electroacupuncture combined with WMCT (RR 1.33, 95%CI 1.19-1.50. One study showed a better effect of electroacupuncture than of WMCT (RR 1.34, 95%CI 1.24-1.45. For mean changes in hearing over all frequencies, the meta-analysis showed a better effect with the combination of acupuncture and WMCT than with WMCT alone (MD 10.85, 95%CI 6.84-14.86. However, the evidence levels for these interventions were low or very low due to a high risk of bias and small sample sizes in the included studies.There was not sufficient evidence showing that acupuncture therapy alone was beneficial for treating SSHL. However, interventions combining acupuncture with WMCT had more efficacious results in the treatment of SSHL than WMCT alone. Electroacupuncture alone might be a viable alternative treatment besides WMCT for SSHL. However, given that there were fewer eligible RCTs and limitations in the included trials, such as methodological drawbacks and small sample sizes, large

  19. A randomized phase III prospective trial of bethanechol to prevent mucositis, candidiasis, and taste loss in patients with head and neck cancer undergoing radiotherapy. A secondary analysis

    International Nuclear Information System (INIS)

    Jham, B.C.; Chen, H.; Carvalho, A.L.; Freire, A.R.

    2009-01-01

    The aim of this study was to determine the impact of bethanechol administration concomitant to radiotherapy (RT) on oral mucositis, candidiasis and taste loss. We performed a secondary analysis of a previously conducted prospective randomized trial which evaluated the effect of bethanechol on salivary gland dysfunction before, during, and after RT for head and neck cancer (HNC), in comparison to artificial saliva. Mucositis, candidiasis and taste loss were analyzed in 36 patients. Mucositis was scored using the World Health Organization (WHO) method; candidiasis was diagnosed by means of clinical examination, whereas taste loss was assessed by the patients' subjective report of absence of taste. No significant differences were observed between groups in relation to frequency and severity of mucositis or frequency of candidiasis and taste loss. In conclusion, bethanechol does not appear to reduce the incidence of mucositis, candidiasis, and taste loss when administered during RT. (author)

  20. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

    Science.gov (United States)

    Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

    2014-03-01

    The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

  1. Optimizing therapeutic efficacy of chemopreventive agents: A critical review of delivery strategies in oral cancer chemoprevention clinical trials

    OpenAIRE

    Andrew S Holpuch; Kashappa-Goud H Desai; Steven P Schwendeman; Susan R Mallery

    2011-01-01

    Due to its characterized progression from recognized premalignant oral epithelial changes (i.e., oral epithelial dysplasia) to invasive cancer, oral squamous cell carcinoma represents an optimal disease for chemopreventive intervention prior to malignant transformation. The primary goal of oral cancer chemoprevention is to reverse, suppress, or inhibit the progression of premalignant lesions to cancer. Over the last several decades, numerous oral cancer chemoprevention clinical trials have as...

  2. Web-based interventions for weight loss and weight maintenance among rural midlife and older women: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Boeckner Linda S

    2011-06-01

    Full Text Available Abstract Background Weight loss is challenging and maintenance of weight loss is problematic among midlife and older rural women. Finding effective interventions using innovative delivery methods that can reach underserved and vulnerable populations of overweight and obese rural women is a public health challenge. Methods/Design This Women Weigh-In for Wellness (The WWW study randomized-controlled trial is designed to compare the effectiveness of theory-based behavior-change interventions using (1 website only, (2 website with peer-led support, or (3 website with professional email-counseling to facilitate initial weight loss (baseline to 6 months, guided continuing weight loss and maintenance (7-18 months and self-directed weight maintenance (19-30 months among rural women ages 45-69 with a BMI of 28-45. Recruitment efforts using local media will target 306 rural women who live within driving distance of a community college site where assessments will be conducted at baseline, 3, 6, 12, 18, 24 and 30 months by research nurses blinded to group assignments. Primary outcomes include changes in body weight, % weight loss, and eating and activity behavioral and biomarkers from baseline to each subsequent assessment. Secondary outcomes will be percentage of women achieving at least 5% and 10% weight loss without regain from baseline to 6, 18, and 30 months and achieving healthy eating and activity targets. Data analysis will use generalized estimating equations to analyze average change across groups and group differences in proportion of participants achieving target weight loss levels. Discussion The Women Weigh-In for Wellness study compares innovative web-based alternatives for providing lifestyle behavior-change interventions for promoting weight loss and weight maintenance among rural women. If effective, such interventions would offer potential for reducing overweight and obesity among a vulnerable, hard-to-reach, population of rural women

  3. Full body photography in the massive weight loss population: an inquiry to optimize patient-centered care.

    Science.gov (United States)

    Wasicek, Philip; Kaswan, Sumesh; Messing, Susan; Gusenoff, Jeffrey A

    2013-11-01

    Medical photography of body contouring patients often requires complete nudity, placing patients in a vulnerable situation. We investigated patient perspectives on full body photography in an effort to better protect the patients and enhance comfort with the photography process. Sixty-five massive weight loss patients were identified who underwent body contouring surgery with full body photography. Photographs were taken at the time of initial consult, time of marking, and postoperatively. A retrospective chart review was performed to assess body mass indices and comorbidities, and a telephone survey inquired about several aspects of the photographic process. Fifty-six (86%) patients participated. Patients were more comfortable at the time of markings (P = 0.0004) and at the postoperative session (P = 0.0009). Patients' perception of positive body image increased after body contouring surgery (P photography improves quickly as they move through the surgical process. Maintaining professionalism is the most important factor in achieving patient trust and comfort. Limiting the number of observers in the room, providing explicit details of the photography process, and having at least 1 person of the same sex in the room can optimize patient safety and comfort.

  4. Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bouwense Stefan A

    2012-11-01

    Full Text Available Abstract Background After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy. Methods/Design PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy, and uncomplicated biliary colics occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs. Discussion The PONCHO trial is designed to show that early

  5. Changes of renal sinus fat and renal parenchymal fat during an 18-month randomized weight loss trial.

    Science.gov (United States)

    Zelicha, Hila; Schwarzfuchs, Dan; Shelef, Ilan; Gepner, Yftach; Tsaban, Gal; Tene, Lilac; Yaskolka Meir, Anat; Bilitzky, Avital; Komy, Oded; Cohen, Noa; Bril, Nitzan; Rein, Michal; Serfaty, Dana; Kenigsbuch, Shira; Chassidim, Yoash; Sarusi, Benjamin; Thiery, Joachim; Ceglarek, Uta; Stumvoll, Michael; Blüher, Matthias; Haviv, Yosef S; Stampfer, Meir J; Rudich, Assaf; Shai, Iris

    2018-08-01

    Data regarding the role of kidney adiposity, its clinical implications, and its dynamics during weight-loss are sparse. We investigated the effect of long-term weight-loss induced intervention diets on dynamics of renal-sinus-fat, an ectopic fat depot, and %renal-parenchymal-fat, lipid accumulation within the renal parenchyma. We randomized 278 participants with abdominal obesity/dyslipidemia to low-fat or Mediterranean/low-carbohydrate diets, with or without exercise. We quantified renal-sinus-fat and %renal-parenchymal-fat by whole body magnetic-resonance-imaging. Participants (age = 48 years; 89% men; body-mass-index = 31 kg/m 2 ) had 86% retention to the trial after 18 months. Both increased renal-sinus-fat and %renal-parenchymal-fat were directly associated with hypertension, and with higher abdominal deep-subcutaneous-adipose-tissue and visceral-adipose-tissue (p of trend vs. baseline) but not %renal-parenchymal-fat (-1.7%; p = 0.13 vs. baseline) significantly decreased, and similarly across the intervention groups. Renal-sinus-fat and %renal-parenchymal-fat changes were correlated with weight-loss per-se (p < 0.05). In a model adjusted for age, sex, and visceral-adipose-tissue changes, 18 months reduction in renal-sinus-fat associated with decreased pancreatic, hepatic and cardiac fats (p < 0.05 for all) and with decreased cholesterol/high-density lipoprotein-cholesterol (HDL-c) (β = 0.13; p = 0.05), triglycerides/HDL-c (β = 0.13; p = 0.05), insulin (β = 0.12; p = 0.05) and gamma glutamyl transpeptidase (β = 0.24; p = 0.001), but not with improved renal function parameters or blood pressure. Decreased intake of sodium was associated with a reduction in %renal-parenchymal-fat, after adjustment for 18 months weight-loss (β = 0.15; p = 0.026) and hypertension (β = 0.14; p = 0.04). Renal-sinus-fat and renal-parenchymal-fat are fairly related to weight-loss. Decreased renal-sinus-fat is associated with improved hepatic

  6. NLP modeling for the optimization of LiBr-H_2O absorption refrigeration systems with exergy loss rate, heat transfer area, and cost as single objective functions

    International Nuclear Information System (INIS)

    Mussati, Sergio F.; Gernaey, Krist V.; Morosuk, Tatiana; Mussati, Miguel C.

    2016-01-01

    Highlights: • A NLP model is used for simultaneous optimization of sizes and operating conditions. • Total exergy loss rate and transfer area are optimized as single objective functions. • Theoretical and practical bounds for cost optimization problems are computed. • A systematic solution strategy is proposed for total annual cost optimization. • Relevance of components is ranked by heat transfer area, exergy loss rate, and cost. - Abstract: Based on a nonlinear mathematical programming model, the sizes and operating conditions of the process units of single-effect absorption refrigeration systems operating with a LiBr–H_2O solution are optimized for a specified cooling capacity by minimizing three single objective functions: the total exergy loss rate, the total heat transfer area, and the total annual cost of the system. It was found that the optimal solution obtained by minimization of the total exergy loss rate provides “theoretical” upper bounds not only for the total heat transfer area of the system but also for each process unit and all stream temperatures, while the optimal solution obtained by minimization of the total heat transfer area provides the lower bounds for these model variables, to solve a cost optimization problem. The minimization of the total exergy loss rate by varying parametrically the available total heat transfer area between these bounds was also performed, allowing to see how the optimal distribution of the available total heat transfer area among the system components, as well as the operating conditions (stream temperature, pressure, composition, and mass flow rate) and heat loads, vary qualitatively and quantitatively with increasing available total heat transfer area. These optimization results allowed to find a “practical” value of the total heat transfer area, i.e. no benefits can be obtained by increasing the available total heat transfer area above this value since the minimal total exergy loss value cannot

  7. Predictors of weight loss and maintenance during 2 years of treatment by sibutramine in obesity. Results from the European multi-centre STORM trial. Sibutramine Trial of Obesity Reduction and Maintenance

    DEFF Research Database (Denmark)

    Hansen, D; Astrup, A; Toubro, S

    2001-01-01

    In this report we assess pre-treatment determinants of weight loss and maintenance outcome in The Sibutramine Trial of Obesity Reduction and Maintenance (STORM), a 2 y randomized, double-blind, placebo-controlled, European multicenter study examining the effect of sibutramine (Sib) on inducing...

  8. The role of therapeutic optimism in recruitment to a clinical trial in a peripartum setting: balancing hope and uncertainty.

    Science.gov (United States)

    Hallowell, Nina; Snowdon, Claire; Morrow, Susan; Norman, Jane E; Denison, Fiona C; Lawton, Julia

    2016-06-01

    Hope has therapeutic value because it enables people to cope with uncertainty about their future health. Indeed, hope, or therapeutic optimism (TO), is seen as an essential aspect of the provision and experience of medical care. The role of TO in clinical research has been briefly discussed, but the concept, and whether it can be transferred from care to research and from patients to clinicians, has not been fully investigated. The role played by TO in research emerged during interviews with staff involved in a peripartum trial. This paper unpacks the concept of TO in this setting and considers the role it may play in the wider delivery of clinical trials. The Got-it trial is a UK-based, randomised placebo-controlled trial that investigates the use of sublingual glyceryl trinitrate (GTN) spray to treat retained placenta. Qualitative data were collected in open-ended interviews with obstetricians, research and clinical midwives (n =27) involved in trial recruitment. Data were analysed using the method of constant comparison. TO influenced staff engagement with Got-it at different points in the trial and in different ways. Prior knowledge of, and familiarity with, GTN meant that from the outset staff perceived the trial as low risk. TO facilitated staff involvement in the trial; staff who already understood GTN's effects were optimistic that it would work, and staff collaborated because they hoped that the trial would address what they identified as an important clinical need. TO could fluctuate over the course of the trial, and was sustained or undermined by unofficial observation of clinical outcomes and speculations about treatment allocation. Thus, TO appeared to be influenced by key situational factors: prior knowledge and experience, clinical need and observed participant outcomes. Situational TO plays a role in facilitating staff engagement with clinical research. TO may affect trial recruitment by enabling staff to sustain the levels of uncertainty, or

  9. Quality of Life after Diet or Exercise-Induced Weight Loss in Overweight to Obese Postmenopausal Women: The SHAPE-2 Randomised Controlled Trial.

    Science.gov (United States)

    van Gemert, Willemijn A M; van der Palen, Job; Monninkhof, Evelyn M; Rozeboom, Anouk; Peters, Roelof; Wittink, Harriet; Schuit, Albertine J; Peeters, Petra H

    2015-01-01

    This study investigates the effect of a modest weight loss either by a calorie restricted diet or mainly by increased physical exercise on health related quality of life (HRQoL) in overweight-to-obese and inactive postmenopausal women. We hypothesize that HRQoL improves with weight loss, and that exercise-induced weight loss is more effective for this than diet-induced weight loss. The SHAPE-2 trial was primarily designed to evaluate any additional effect of weight loss by exercise compared with a comparable amount of weight loss by diet on biomarkers relevant for breast cancer risk. In the present analysis we focus on HRQoL. We randomly assigned 243 eligible women to a diet (n = 97), exercise (n = 98), or control group (n = 48). Both interventions aimed for 5-6 kg weight loss. HRQoL was measured at baseline and after 16 weeks by the SF-36 questionnaire. Data of 214 women were available for analysis. Weight loss was 4.9 kg (6.1%) and 5.5 kg (6.9%) with diet and exercise, respectively. Scores of the SF-36 domain 'health change' increased significantly by 8.8 points (95% CI 1.6;16.1) with diet, and by 20.5 points (95% CI 13.2;27.7) with exercise when compared with control. Direct comparison of diet and exercise showed a statistically significantly stronger improvement with exercise. Both intervention groups showed a tendency towards improvements in most other domains, which were more pronounced in the exercise group, but not statistically different from control or each other. In a randomized trial in overweight-to-obese and inactive postmenopausal women a comparable 6%-7% weight loss was achieved by diet-only or mainly by exercise and showed improvements in physical and mental HRQoL domains, but results were not statistically significant in either the diet or exercise group. However, a modest weight loss does lead to a positive change in self-perceived health status. This effect was significantly larger with exercise-induced weight loss than with comparable diet

  10. Quality of Life after Diet or Exercise-Induced Weight Loss in Overweight to Obese Postmenopausal Women: The SHAPE-2 Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Willemijn A M van Gemert

    Full Text Available This study investigates the effect of a modest weight loss either by a calorie restricted diet or mainly by increased physical exercise on health related quality of life (HRQoL in overweight-to-obese and inactive postmenopausal women. We hypothesize that HRQoL improves with weight loss, and that exercise-induced weight loss is more effective for this than diet-induced weight loss.The SHAPE-2 trial was primarily designed to evaluate any additional effect of weight loss by exercise compared with a comparable amount of weight loss by diet on biomarkers relevant for breast cancer risk. In the present analysis we focus on HRQoL. We randomly assigned 243 eligible women to a diet (n = 97, exercise (n = 98, or control group (n = 48. Both interventions aimed for 5-6 kg weight loss. HRQoL was measured at baseline and after 16 weeks by the SF-36 questionnaire.Data of 214 women were available for analysis. Weight loss was 4.9 kg (6.1% and 5.5 kg (6.9% with diet and exercise, respectively. Scores of the SF-36 domain 'health change' increased significantly by 8.8 points (95% CI 1.6;16.1 with diet, and by 20.5 points (95% CI 13.2;27.7 with exercise when compared with control. Direct comparison of diet and exercise showed a statistically significantly stronger improvement with exercise. Both intervention groups showed a tendency towards improvements in most other domains, which were more pronounced in the exercise group, but not statistically different from control or each other.In a randomized trial in overweight-to-obese and inactive postmenopausal women a comparable 6%-7% weight loss was achieved by diet-only or mainly by exercise and showed improvements in physical and mental HRQoL domains, but results were not statistically significant in either the diet or exercise group. However, a modest weight loss does lead to a positive change in self-perceived health status. This effect was significantly larger with exercise-induced weight loss than with comparable

  11. Effectiveness of conventional versus virtual reality based vestibular rehabilitation in the treatment of dizziness, gait and balance impairment in adults with unilateral peripheral vestibular loss: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dara Meldrum

    2012-03-01

    Full Text Available Abstract Background Unilateral peripheral vestibular loss results in gait and balance impairment, dizziness and oscillopsia. Vestibular rehabilitation benefits patients but optimal treatment remains unkown. Virtual reality is an emerging tool in rehabilitation and provides opportunities to improve both outcomes and patient satisfaction with treatment. The Nintendo Wii Fit Plus® (NWFP is a low cost virtual reality system that challenges balance and provides visual and auditory feedback. It may augment the motor learning that is required to improve balance and gait, but no trials to date have investigated efficacy. Methods/Design In a single (assessor blind, two centre randomised controlled superiority trial, 80 patients with unilateral peripheral vestibular loss will be randomised to either conventional or virtual reality based (NWFP vestibular rehabilitation for 6 weeks. The primary outcome measure is gait speed (measured with three dimensional gait analysis. Secondary outcomes include computerised posturography, dynamic visual acuity, and validated questionnaires on dizziness, confidence and anxiety/depression. Outcome will be assessed post treatment (8 weeks and at 6 months. Discussion Advances in the gaming industry have allowed mass production of highly sophisticated low cost virtual reality systems that incorporate technology previously not accessible to most therapists and patients. Importantly, they are not confined to rehabilitation departments, can be used at home and provide an accurate record of adherence to exercise. The benefits of providing augmented feedback, increasing intensity of exercise and accurately measuring adherence may improve conventional vestibular rehabilitation but efficacy must first be demonstrated. Trial registration Clinical trials.gov identifier: NCT01442623

  12. Design and construction of an injector for an electron/positron Linac optimized for positron yield and minimal particle loss

    International Nuclear Information System (INIS)

    Liebig, Clemens

    2014-11-01

    The Linac II is the first part of the accelerator chain supplying PETRA III. Since the start of PETRA III operation, highest reliability is demanded and several updates are required. Part of these is the new injection system. Beam loss at high energies and the associated activation have to be avoided. At energies above 80 MeV particle loss of 20% occurred. Additionally, an alternative to the old gun, operating in an oil bath and for which cathode preparation is not available, is required. The new system will be commissioned while the old bombarder gun injector is kept for redundancy. In order to obtain the space for joining the beam lines of both electron sources, one accelerator section must be removed. Electron pulses of 6 A beam current and 2 to 30 ns length are provided by the new injection system. The gun uses a thermionic cathode, 100 kV voltage for acceleration and is built as a triode. Longitudinal focusing is performed by a prebuncher and a hybrid buncher structure, both operating at 3 GHz. The buncher is a traveling wave structure to which a short cell has been added, operated in π mode with a standing wave. That way, better electron capture is achieved. A magnetic chicane serves for energy filtering. The design of the injection system, as well as the old injector, have been optimized in simulations and transmission in the linac has been compared. Possible reasons for beam loss are beam loading and misaligned components. For the bombarder gun particle tracking, a loss of 1% at high energies was observed due to beam loading. The additional beam optics and steering options in the beam line allow for compensation of the misalignment of preceding and succeeding components. The complete new injection system has been operated in a test stand and has undergone extensive tests. After successive enhancement of technically critical components, reliable operation was possible. Investigations of the electron capture and bunching procedure have been carried out by

  13. Optimal scheme of postoperative chemoradiotherapy in rectal cancer: phase III prospective randomized trial

    International Nuclear Information System (INIS)

    Kim, Young Seok; Kim, Jong Hoon; Choi, Eun Kyung

    2002-01-01

    To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, patterns of failure, toxicities in early and late radiotherapy groups using a phase III randomized prospective clinical trial. From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm I)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU 375 mg/m 2 /day, leucovorin 20 mg/m 2 , IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were 78.3% and 68.7% in arm I, and 78.4% and 67.5% in arm II. The local recurrence rate was 6.6% and 6.4% (ρ = 0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms (23.8% and 29.5%, ρ = 0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in 63.0% and 58.2% of the respective arms (ρ = N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only 1.3% and 2.6% of patients in each respective arm. There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed

  14. Deploying a Route Optimization EFB Application for Commercial Airline Operational Trials

    Science.gov (United States)

    Roscoe, David A.; Vivona, Robert A.; Woods, Sharon E.; Karr, David A.; Wing, David J.

    2016-01-01

    The Traffic Aware Planner (TAP), developed for NASA Langley Research Center to support the Traffic Aware Strategic Aircrew Requests (TASAR) project, is a flight-efficiency software application developed for an Electronic Flight Bag (EFB). Tested in two flight trials and planned for operational testing by two commercial airlines, TAP is a real-time trajectory optimization application that leverages connectivity with onboard avionics and broadband Internet sources to compute and recommend route modifications to flight crews to improve fuel and time performance. The application utilizes a wide range of data, including Automatic Dependent Surveillance Broadcast (ADS-B) traffic, Flight Management System (FMS) guidance and intent, on-board sensors, published winds and weather, and Special Use Airspace (SUA) schedules. This paper discusses the challenges of developing and deploying TAP to various EFB platforms, our solutions to some of these challenges, and lessons learned, to assist commercial software developers and hardware manufacturers in their efforts to implement and extend TAP functionality in their environments. EFB applications (such as TAP) typically access avionics data via an ARINC 834 Simple Text Avionics Protocol (STAP) server hosted by an Aircraft Interface Device (AID) or other installed hardware. While the protocol is standardized, the data sources, content, and transmission rates can vary from aircraft to aircraft. Additionally, the method of communicating with the AID may vary depending on EFB hardware and/or the availability of onboard networking services, such as Ethernet, WIFI, Bluetooth, or other mechanisms. EFBs with portable and installed components can be implemented using a variety of operating systems, and cockpits are increasingly incorporating tablet-based technologies, further expanding the number of platforms the application may need to support. Supporting multiple EFB platforms, AIDs, avionics datasets, and user interfaces presents a

  15. Benefits of bariatric surgery before elective total joint arthroplasty: is there a role for weight loss optimization?

    Science.gov (United States)

    Nearing, Emanuel E; Santos, Tyler M; Topolski, Mark S; Borgert, Andrew J; Kallies, Kara J; Kothari, Shanu N

    2017-03-01

    The association between obesity and osteoarthritis is well established, as is the increased risk of postoperative complications after total knee arthroplasty (TKA) and total hip arthroplasty (THA) among patients with obesity. To evaluate the outcomes after TKA/THA based on whether the surgery was performed before or after bariatric surgery. Integrated, multispecialty, community teaching hospital. The medical records of all patients who underwent bariatric surgery from 2001 to 2014 were reviewed. Statistical analysis included χ 2 test and t tests. A P valuebariatric procedure, 66 underwent TKA/THA after their bariatric procedure. TKAs/THAs were performed at a mean of 4.9±3.2 years before and 4.3±3.3 years after bariatric surgery. Body mass index for those undergoing TKA/THA after bariatric surgery was lower than those with TKA/THA before bariatric surgery (37.6±7.4 versus 43.7±5.7 kg/m 2 ; Pbariatric surgery: 81.7±33.9 min versus 117±38.1 min; Pbariatric surgery. Patients who underwent TKA/THA after bariatric surgery had lower body mass index before and 1 year after TKA/THA. Postoperative complication rates were similar. Benefits of bariatric surgery and subsequent weight loss should be considered among patients with obesity requiring TKA/THA. Optimal timing of TKA/THA and bariatric surgery has yet to be established. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  16. Preventing Loss of Independence through Exercise (PLIÉ): qualitative analysis of a clinical trial in older adults with dementia.

    Science.gov (United States)

    Wu, Eveline; Barnes, Deborah E; Ackerman, Sara L; Lee, Jennifer; Chesney, Margaret; Mehling, Wolf E

    2015-01-01

    Preventing Loss of Independence through Exercise (PLIÉ) is a novel, integrative exercise program for individuals with dementia that combines elements of different conventional and complementary exercise modalities (e.g. tai-chi, yoga, Feldenkrais, and dance movement therapy) and focuses on training procedural memory for basic functional movements (e.g., sit-to-stand) while increasing mindful body awareness and facilitating social connection. This study presents analyses of qualitative data collected during a 36-week cross-over pilot clinical trial in 11 individuals. Qualitative data included exercise instructors' written notes, which were prepared after each class and also following biweekly telephone calls with caregivers and monthly home visits; three video-recorded classes; and written summaries prepared by research assistants following pre- and post-intervention quantitative assessments. Data were extracted for each study participant and placed onto a timeline for month of observation. Data were coded and analyzed to identify themes that were confirmed and refined through an iterative, collaborative process by the entire team including a qualitative researcher (SA) and the exercise instructors. Three overarching themes emerged: (1) Functional changes included increasing body awareness, movement memory and functional skill. (2) Emotional changes included greater acceptance of resting, sharing of personal stories and feelings, and positive attitude toward exercise. (3) Social changes included more coherent social interactions and making friends. These qualitative results suggest that the PLIÉ program may be associated with beneficial functional, emotional, and social changes for individuals with mild to moderate dementia. Further study of the PLIÉ program in individuals with dementia is warranted.

  17. Renal function following three distinct weight loss dietary strategies during 2 years of a randomized controlled trial.

    Science.gov (United States)

    Tirosh, Amir; Golan, Rachel; Harman-Boehm, Ilana; Henkin, Yaakov; Schwarzfuchs, Dan; Rudich, Assaf; Kovsan, Julia; Fiedler, Georg M; Blüher, Matthias; Stumvoll, Michael; Thiery, Joachim; Stampfer, Meir J; Shai, Iris

    2013-08-01

    This study addressed the long-term effect of various diets, particularly low-carbohydrate high-protein, on renal function on participants with or without type 2 diabetes. In the 2-year Dietary Intervention Randomized Controlled Trial (DIRECT), 318 participants (age, 51 years; 86% men; BMI, 31 kg/m(2); mean estimated glomerular filtration rate [eGFR], 70.5 mL/min/1.73 m(2); mean urine microalbumin-to-creatinine ratio, 12:12) with serum creatinine low-fat, Mediterranean, or low-carbohydrate diets. The 2-year compliance was 85%, and the proportion of protein intake significantly increased to 22% of energy only in the low-carbohydrate diet (P vs. low-fat and Mediterranean). We examined changes in urinary microalbumin and eGFR, estimated by Modification of Diet in Renal Disease and Chronic Kidney Disease Epidemiology Collaboration formulas. Significant (P low-carbohydrate (+5.3% [95% CI 2.1-8.5]), Mediterranean (+5.2% [3.0-7.4]), and low-fat diets (+4.0% [0.9-7.1]) with similar magnitude (P > 0.05) across diet groups. The increased eGFR was at least as prominent in participants with (+6.7%) or without (+4.5%) type 2 diabetes or those with lower baseline renal function of eGFR low-carbohydrate diet is as safe as Mediterranean or low-fat diets in preserving/improving renal function among moderately obese participants with or without type 2 diabetes, with baseline serum creatinine <176 μmol/L. Potential improvement is likely to be mediated by weight loss-induced improvements in insulin sensitivity and blood pressure.

  18. Genetic Polymorphisms and Weight Loss in Obesity: A Randomised Trial of Hypo-Energetic High- versus Low-Fat Diets

    Science.gov (United States)

    Sørensen, Thorkild I. A; Boutin, Philippe; Taylor, Moira A; Larsen, Lesli H; Verdich, Camilla; Petersen, Liselotte; Holst, Claus; Echwald, Søren M; Dina, Christian; Toubro, Søren; Petersen, Martin; Polak, Jan; Clément, Karine; Martínez, J. Alfredo; Langin, Dominique; Oppert, Jean-Michel; Stich, Vladimir; Macdonald, Ian; Arner, Peter; Saris, Wim H. M; Pedersen, Oluf; Astrup, Arne; Froguel, Philippe

    2006-01-01

    Objectives: To study if genes with common single nucleotide polymorphisms (SNPs) associated with obesity-related phenotypes influence weight loss (WL) in obese individuals treated by a hypo-energetic low-fat or high-fat diet. Design: Randomised, parallel, two-arm, open-label multi-centre trial. Setting: Eight clinical centres in seven European countries. Participants: 771 obese adult individuals. Interventions: 10-wk dietary intervention to hypo-energetic (−600 kcal/d) diets with a targeted fat energy of 20%–25% or 40%–45%, completed in 648 participants. Outcome Measures: WL during the 10 wk in relation to genotypes of 42 SNPs in 26 candidate genes, probably associated with hypothalamic regulation of appetite, efficiency of energy expenditure, regulation of adipocyte differentiation and function, lipid and glucose metabolism, or production of adipocytokines, determined in 642 participants. Results: Compared with the noncarriers of each of the SNPs, and after adjusting for gender, age, baseline weight and centre, heterozygotes showed WL differences that ranged from −0.6 to 0.8 kg, and homozygotes, from −0.7 to 3.1 kg. Genotype-dependent additional WL on low-fat diet ranged from 1.9 to −1.6 kg in heterozygotes, and from 3.8 kg to −2.1 kg in homozygotes relative to the noncarriers. Considering the multiple testing conducted, none of the associations was statistically significant. Conclusions: Polymorphisms in a panel of obesity-related candidate genes play a minor role, if any, in modulating weight changes induced by a moderate hypo-energetic low-fat or high-fat diet. PMID:16871334

  19. Using pilot data to size a two-arm randomized trial to find a nearly optimal personalized treatment strategy.

    Science.gov (United States)

    Laber, Eric B; Zhao, Ying-Qi; Regh, Todd; Davidian, Marie; Tsiatis, Anastasios; Stanford, Joseph B; Zeng, Donglin; Song, Rui; Kosorok, Michael R

    2016-04-15

    A personalized treatment strategy formalizes evidence-based treatment selection by mapping patient information to a recommended treatment. Personalized treatment strategies can produce better patient outcomes while reducing cost and treatment burden. Thus, among clinical and intervention scientists, there is a growing interest in conducting randomized clinical trials when one of the primary aims is estimation of a personalized treatment strategy. However, at present, there are no appropriate sample size formulae to assist in the design of such a trial. Furthermore, because the sampling distribution of the estimated outcome under an estimated optimal treatment strategy can be highly sensitive to small perturbations in the underlying generative model, sample size calculations based on standard (uncorrected) asymptotic approximations or computer simulations may not be reliable. We offer a simple and robust method for powering a single stage, two-armed randomized clinical trial when the primary aim is estimating the optimal single stage personalized treatment strategy. The proposed method is based on inverting a plugin projection confidence interval and is thereby regular and robust to small perturbations of the underlying generative model. The proposed method requires elicitation of two clinically meaningful parameters from clinical scientists and uses data from a small pilot study to estimate nuisance parameters, which are not easily elicited. The method performs well in simulated experiments and is illustrated using data from a pilot study of time to conception and fertility awareness. Copyright © 2015 John Wiley & Sons, Ltd.

  20. Long-Term Weight Maintenance after a 17-Week Weight Loss Intervention with or without a One-Year Maintenance Program: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Tuula Pekkarinen

    2015-01-01

    Full Text Available Background. Weight lost by obese patients is almost always regained over time. Extended treatment may improve maintenance, but solid evidence is lacking. Purpose. We determined effectiveness of maintenance therapy after a weight loss program. Methods. Together 201 patients (mean age 47 years and BMI 42 kg/m2, 71% women were randomly assigned to either a 17-week weight loss program followed by a one-year maintenance program or to a weight loss program without subsequent maintenance intervention. The weight loss program included behavior modification and a very-low-calorie diet, and maintenance program behavior modification. The primary outcome measure was percentage of patients with 5% or more weight loss at the end of maintenance (week 69 and one year later (week 121. Secondary outcomes were weight related changes in lifestyle and quality of life. Results. At week 69, 52% of the patients with and 44% of those without maintenance program had lost weight ≥5%, P=0.40, and, at week 121, 33% and 34%, P=0.77, respectively. At week 121 secondary outcomes did not differ between the groups among those successfully followed up. Conclusions. This one-year maintenance program was not effective in preventing weight regain in severely obese patients. Trial Registration. This trial is registered under clinicaltrials.gov Identifier: NCT00590655.

  1. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

    Science.gov (United States)

    Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

    2014-01-01

    Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

  2. Optimal use of MRI in clinical trials, clinical care and clinical registries of patients with rheumatoid arthritis

    DEFF Research Database (Denmark)

    Østergaard, Mikkel; Møller-Bisgaard, Signe

    2014-01-01

    the benefits of including MRI in treat-to-target strategies. The benefits of incorporating MRI into clinical registries are not yet known, but may include improved knowledge about the real-life advantages of MRI, as well as opportunities to develop better clinical and laboratory composite measures to monitor......Magnetic resonance imaging (MRI) clearly is more sensitive than clinical examination and conventional radiography (x-ray) for detection of inflammation (synovitis, bone marrow oedema (osteitis) and tenosynovitis) and damage (bone erosion and cartilage loss/joint space narrowing) in patients...... with rheumatoid arthritis (RA). The question is when and how MRI should be used. The present article reviews our knowledge about, and provides suggestions for, the use of MRI in clinical trials, clinical care and clinical registries. In clinical trials, the OMERACT RA MRI scoring system (RAMRIS) is a thoroughly...

  3. The effect of prophylactic intravenous tranexamic acid on blood loss after vaginal delivery in women at low risk of postpartum haemorrhage: a double-blind randomised controlled trial.

    Science.gov (United States)

    Mirghafourvand, Mojgan; Mohammad-Alizadeh, Sakineh; Abbasalizadeh, Fatemeh; Shirdel, Mina

    2015-02-01

    To determine the effect of prophylactic tranexamic acid (TA) on calculated and measured blood loss after vaginal delivery in women at low risk of postpartum haemorrhage. In this double-blind randomised controlled trial, 120 women with a singleton pregnancy were randomly allocated to receive either one gram intravenous TA or placebo in addition to 10 IU oxytocin after delivery of the fetus. Calculated blood loss was determined based on haematocrit before delivery and 12-24 h postdelivery. The quantity of blood loss was measured during two time periods: from delivery of the fetus to placental expulsion and from placental expulsion to the end of the second hour after childbirth. The mean (SD) calculated total blood loss (519 (320) vs 659 (402) mL, P = 0.036) and measured blood loss from placental delivery to 2 h postpartum (69 (39) vs 108 (53) mL, P  1000 mL was lower in the TA group (7% vs 18%, P = 0.048). Prophylactic TA reduces blood loss after vaginal delivery in women with a low risk of postpartum haemorrhage. The prophylactic use of TA may reduce blood loss complications and enhance maternal health. © 2015 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  4. Influence of Weight Loss, Body Composition, and Lifestyle Behaviors on Plasma Adipokines: A Randomized Weight Loss Trial in Older Men and Women with Symptomatic Knee Osteoarthritis

    Directory of Open Access Journals (Sweden)

    Gary D. Miller

    2012-01-01

    Full Text Available Objective. To investigate effects of weight loss on adipokines and health measures in obese older adults with symptomatic knee osteoarthritis. Methods. Participants were randomly assigned to either weight loss (WL (men: 12, women: 14 or weight stable (WS group (men: 12, women: 13. WL intervention included meal replacements and structured exercise training. Measurements of leptin, adiponectin, soluble leptin receptor, lifestyle behaviors, and body composition were collected at baseline and 6 months. Univariate analysis of covariance was performed on 6 month variables, and Spearman and partial correlations were made between variables. Results. Weight loss was 13.0% and 6.7% in WL for men and women, respectively. Women in WL had lower whole body and trunk fat than WS. The leptin : adiponectin ratio was lower for women in WL than WS at 6 months, with no group differences in adipokines for men. Leptin and free leptin index correlated with body fat in both genders at baseline. Interestingly, only women showed reductions in leptin (P<0.100 and correlations between the percentage change leptin and trunk fat and the percentage changes in free leptin index with total fat and trunk fat. Partial correlations between 6 month adipokines after adjustments for covariates and group/time period show potential multivariate influences. Conclusions. In the presence of an effective weight loss intervention in older obese adults, there are significant relationships between weight and fat loss and leptin in women, but not men, suggesting gender-specific features of adipokine metabolism in this age group.

  5. Reduced reward-driven eating accounts for the impact of a mindfulness-based diet and exercise intervention on weight loss: Data from the SHINE randomized controlled trial.

    Science.gov (United States)

    Mason, Ashley E; Epel, Elissa S; Aschbacher, Kirstin; Lustig, Robert H; Acree, Michael; Kristeller, Jean; Cohn, Michael; Dallman, Mary; Moran, Patricia J; Bacchetti, Peter; Laraia, Barbara; Hecht, Frederick M; Daubenmier, Jennifer

    2016-05-01

    Many individuals with obesity report over eating despite intentions to maintain or lose weight. Two barriers to long-term weight loss are reward-driven eating, which is characterized by a lack of control over eating, a preoccupation with food, and a lack of satiety; and psychological stress. Mindfulness training may address these barriers by promoting awareness of hunger and satiety cues, self-regulatory control, and stress reduction. We examined these two barriers as potential mediators of weight loss in the Supporting Health by Integrating Nutrition and Exercise (SHINE) randomized controlled trial, which compared the effects of a 5.5-month diet and exercise intervention with or without mindfulness training on weight loss among adults with obesity. Intention-to-treat multiple mediation models tested whether post-intervention reward-driven eating and psychological stress mediated the impact of intervention arm on weight loss at 12- and 18-months post-baseline among 194 adults with obesity (BMI: 30-45). Mindfulness (relative to control) participants had significant reductions in reward-driven eating at 6 months (post-intervention), which, in turn, predicted weight loss at 12 months. Post-intervention reward-driven eating mediated 47.1% of the total intervention arm effect on weight loss at 12 months [β = -0.06, SE(β) = 0.03, p = .030, 95% CI (-0.12, -0.01)]. This mediated effect was reduced when predicting weight loss at 18 months (p = .396), accounting for 23.0% of the total intervention effect, despite similar weight loss at 12 months. Psychological stress did not mediate the effect of intervention arm on weight loss at 12 or 18 months. In conclusion, reducing reward-driven eating, which can be achieved using a diet and exercise intervention that includes mindfulness training, may promote weight loss (clinicaltrials.gov registration: NCT00960414). Published by Elsevier Ltd.

  6. Long-term effects of a weight loss intervention with or without exercise component in postmenopausal women: A randomized trial

    Directory of Open Access Journals (Sweden)

    Martijn de Roon

    2017-03-01

    This study shows largely sustained weight loss one year after completing a weight loss program with and without exercise in overweight postmenopausal women. Although the mainly exercise group maintained more physically active compared to the diet group, maintenance of weight loss did not differ between groups.

  7. Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial.

    Science.gov (United States)

    Timpel, Patrick; Cesena, Fernando Henpin Yue; da Silva Costa, Christiane; Soldatelli, Matheus Dorigatti; Gois, Emanuel; Castrillon, Eduardo; Díaz, Lina Johana Jaime; Repetto, Gabriela M; Hagos, Fanah; Castillo Yermenos, Raul E; Pacheco-Barrios, Kevin; Musallam, Wafaa; Braid, Zilda; Khidir, Nesreen; Romo Guardado, Marcela; Roepke, Roberta Muriel Longo

    2018-06-01

    Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months. The intervention consists of a smartphone application that provides both tracking and gamification elements, while the control arm consists of an identically designed application solely with tracking features of health information. The proposed trial will be conducted in an urban primary care clinic of an academic centre in the United States of America, with expertise in the management of overweight and obese adolescents. Eligible adolescents will be followed for 6 months. Changes in body mass index z score from baseline to 6 months will be the primary outcome. Secondary objectives will explore the effects of the gamification-based application on adherence, as well as anthropometric, metabolic and behavioural changes. A required sample size of 108 participants (54 participants per group) was calculated. The benefits of the proposed study include mid-term effects in weight reduction for overweight and obese adolescents. The current proposal will contribute to fill a gap in the literature on the mid-term effects of gamification-based interventions to control weight in adolescents. This trial is a well-designed RCT that is in

  8. Protocol and Recruitment Results from a Randomized Controlled Trial Comparing Group Phone-Based versus Newsletter Interventions for Weight Loss Maintenance among Rural Breast Cancer Survivors

    OpenAIRE

    Befort, Christie A.; Klemp, Jennifer R.; Fabian, Carol; Perri, Michael G.; Sullivan, Debra K.; Schmitz, Kathryn H.; Diaz, Francisco J.; Shireman, Theresa

    2014-01-01

    Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than indivi...

  9. Genetic variation of fasting glucose and changes in glycemia in response to 2-year weight-loss diet intervention: the POUNDS Lost trial

    Science.gov (United States)

    Wang, Tiange; Huang, Tao; Zheng, Yan; Rood, Jennifer; Bray, George A.; Sacks, Frank M.; Qi, Lu

    2016-01-01

    Objective Weight loss intervention through diet modification has been widely used to improve obesity-related hyperglycemia; however, little is known about whether genetic variation modifies the intervention effect. We examined the interaction between weight-loss diets and genetic variation of fasting glucose on changes in glycemic traits in a dietary intervention trial. Research Design and Methods The Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) trial is a randomized, controlled 2-year weight-loss trial. We assessed overall genetic variation of fasting glucose by calculating a genetic risk score (GRS) based on 14 fasting glucose-associated single nucleotide polymorphisms, and examined the progression in fasting glucose and insulin levels, and insulin resistance and insulin sensitivity in 733 adults from this trial. Results The GRS was associated with 6-month changes in fasting glucose (Pfasting insulin (P=0.042), homeostasis model assessment of insulin resistance (HOMA-IR, P=0.009) and insulin sensitivity (HOMA-S, P=0.043). We observed significant interaction between the GRS and dietary fat on 6-month changes in fasting glucose, HOMA-IR and HOMA-S after multivariable adjustment (P-interaction=0.007, 0.045, and 0.028, respectively). After further adjustment for weight loss, the interaction remained significant on change in fasting glucose (P=0.015). In the high-fat diet group, participants in the highest GRS tertile showed increased fasting glucose, whereas participants in the lowest tertile showed decreased fasting glucose (P-trend<0.001); in contrast, the genetic association was not significant in the low-fat diet group (P-trend=0.087). Conclusions Our data suggest that participants with a higher genetic risk may benefit more by eating a low-fat diet to improve glucose metabolism. PMID:27113490

  10. Application of Hybrid HS and Tabu Search Algorithm for Optimal Location of FACTS Devices to Reduce Power Losses in Power Systems

    Directory of Open Access Journals (Sweden)

    Z. Masomi Zohrabad

    2016-12-01

    Full Text Available Power networks continue to grow following the annual growth of energy demand. As constructing new energy generation facilities bears a high cost, minimizing power grid losses becomes essential to permit low cost energy transmission in larger distances and additional areas. This study aims to model an optimization problem for an IEEE 30-bus power grid using a Tabu search algorithm based on an improved hybrid Harmony Search (HS method to reduce overall grid losses. The proposed algorithm is applied to find the best location for the installation of a Unified Power Flow Controller (UPFC. The results obtained from installation of the UPFC in the grid are presented by displaying outputs.

  11. Optimizing Gestational Weight Gain With the Eating4Two Smartphone App: Protocol for a Randomized Controlled Trial.

    Science.gov (United States)

    Davis, Deborah; Davey, Rachel; Williams, Lauren T; Foureur, Maralyn; Nohr, Ellen; Knight-Agarwal, Catherine; Lawlis, Tanya; Oats, Jeremy; Skouteris, Helen; Fuller-Tyszkiewicz, Matthew

    2018-05-30

    Approximately 50% of women gain excessive weight in pregnancy. Optimizing gestational weight gain is important for the short- and long-term health of the childbearing woman and her baby. Despite this, there is no recommendation for routine weighing in pregnancy, and weight is a topic that many maternity care providers avoid. Resource-intensive interventions have mainly targeted overweight and obese women with variable results. Few studies have examined the way that socioeconomic status might influence the effectiveness or acceptability of an intervention to participants. Given the scale of the problem of maternal weight gain, maternity services will be unlikely to sustain resource intensive interventions; therefore, innovative strategies are required to assist women to manage weight gain in pregnancy. The primary aim of the trial was to examine the effectiveness of the Eating4Two smartphone app in assisting women of all body mass index categories to optimize gestational weight gain. Secondary aims include comparing childbirth outcomes and satisfaction with antenatal care and examining the way that relative advantage and disadvantage might influence engagement with and acceptability of the intervention. This randomized controlled trial will randomize 1330 women to control or intervention groups in 3 regions of different socioeconomic status. Women will be recruited from clinical and social media sites. The intervention group will be provided with access to the Eating4Two mobile phone app which provides nutrition and dietary information specifically tailored for pregnancy, advice on food serving sizes, and a graph that illustrates women's weight change in relation to the range recommended by the Institute of Medicine. Women will be encouraged to use the app to prompt conversations with their maternity care providers about weight gain in pregnancy. The control group will receive routine antenatal care. Recruitment has commenced though the recruitment rate is slower

  12. Optimizing imbalance and loss in 2 x 2 3dB multimode interference couplers via access waveguide width

    NARCIS (Netherlands)

    Hill, M.T.; Leijtens, X.J.M.; Khoe, G.D.; Smit, M.K.

    2003-01-01

    The imbalance and excess loss in multimode interference couplers with fabrication errors are examined. Remarkably, there exists a number of optimum access waveguide widths which give a minimum imbalance. Furthermore, quite low excess loss can be simultaneously achieved by choosing one particular

  13. A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial.

    Science.gov (United States)

    Hunt, Kate; Wyke, Sally; Gray, Cindy M; Anderson, Annie S; Brady, Adrian; Bunn, Christopher; Donnan, Peter T; Fenwick, Elisabeth; Grieve, Eleanor; Leishman, Jim; Miller, Euan; Mutrie, Nanette; Rauchhaus, Petra; White, Alan; Treweek, Shaun

    2014-04-05

    The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35-65 years with a body-mass index (BMI) of 28 kg/m(2) or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2-9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95-5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64-5·08), both in favour of the intervention (pScottish Government and The UK Football Pools funded delivery of the programme through a grant to the Scottish Premier League Trust. The National Institute for Health Research Public Health Research Programme funded the assessment (09/3010/06). Copyright © 2014 Hunt et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd. All rights reserved.

  14. A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered by Scottish Premier League football clubs (FFIT): a pragmatic randomised controlled trial

    Science.gov (United States)

    Hunt, Kate; Wyke, Sally; Gray, Cindy M; Anderson, Annie S; Brady, Adrian; Bunn, Christopher; Donnan, Peter T; Fenwick, Elisabeth; Grieve, Eleanor; Leishman, Jim; Miller, Euan; Mutrie, Nanette; Rauchhaus, Petra; White, Alan; Treweek, Shaun

    2015-01-01

    Summary Background The prevalence of male obesity is increasing but few men take part in weight loss programmes. We assessed the effect of a weight loss and healthy living programme on weight loss in football (soccer) fans. Methods We did a two-group, pragmatic, randomised controlled trial of 747 male football fans aged 35–65 years with a body-mass index (BMI) of 28 kg/m2 or higher from 13 Scottish professional football clubs. Participants were randomly assigned with SAS (version 9·2, block size 2–9) in a 1:1 ratio, stratified by club, to a weight loss programme delivered by community coaching staff in 12 sessions held every week. The intervention group started a weight loss programme within 3 weeks, and the comparison group were put on a 12 month waiting list. All participants received a weight management booklet. Primary outcome was mean difference in weight loss between groups at 12 months, expressed as absolute weight and a percentage of their baseline weight. Primary outcome assessment was masked. Analyses were based on intention to treat. The trial is registered with Current Controlled Trials, number ISRCTN32677491. Findings 374 men were allocated to the intervention group and 374 to the comparison group. 333 (89%) of the intervention group and 355 (95%) of the comparison group completed 12 month assessments. At 12 months the mean difference in weight loss between groups, adjusted for baseline weight and club, was 4·94 kg (95% CI 3·95–5·94) and percentage weight loss, similarly adjusted, was 4·36% (3·64–5·08), both in favour of the intervention (p<0·0001). Eight serious adverse events were reported, five in the intervention group (lost consciousness due to drugs for pre-existing angina, gallbladder removal, hospital admission with suspected heart attack, ruptured gut, and ruptured Achilles tendon) and three in the comparison group (transient ischaemic attack, and two deaths). Of these, two adverse events were reported as related to

  15. Effects of low-carbohydrate vs low-fat diets on weight loss and cardiovascular risk factors: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Nordmann, Alain J; Nordmann, Abigail; Briel, Matthias; Keller, Ulrich; Yancy, William S; Brehm, Bonnie J; Bucher, Heiner C

    2006-02-13

    Low-carbohydrate diets have become increasingly popular for weight loss. However, evidence from individual trials about benefits and risks of these diets to achieve weight loss and modify cardiovascular risk factors is preliminary. We used the Cochrane Collaboration search strategy to identify trials comparing the effects of low-carbohydrate diets without restriction of energy intake vs low-fat diets in individuals with a body mass index (calculated as weight in kilograms divided by the square of height in meters) of at least 25. Included trials had to report changes in body weight in intention-to-treat analysis and to have a follow-up of at least 6 months. Two reviewers independently assessed trial eligibility and quality of randomized controlled trials. Five trials including a total of 447 individuals fulfilled our inclusion criteria. After 6 months, individuals assigned to low-carbohydrate diets had lost more weight than individuals randomized to low-fat diets (weighted mean difference, -3.3 kg; 95% confidence interval [CI], -5.3 to -1.4 kg). This difference was no longer obvious after 12 months (weighted mean difference, -1.0 kg; 95% CI, -3.5 to 1.5 kg). There were no differences in blood pressure. Triglyceride and high-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-carbohydrate diets (after 6 months, for triglycerides, weighted mean difference, -22.1 mg/dL [-0.25 mmol/L]; 95% CI, -38.1 to -5.3 mg/dL [-0.43 to -0.06 mmol/L]; and for high-density lipoprotein cholesterol, weighted mean difference, 4.6 mg/dL [0.12 mmol/L]; 95% CI, 1.5-8.1 mg/dL [0.04-0.21 mmol/L]), but total cholesterol and low-density lipoprotein cholesterol values changed more favorably in individuals assigned to low-fat diets (weighted mean difference in low-density lipoprotein cholesterol after 6 months, 5.4 mg/dL [0.14 mmol/L]; 95% CI, 1.2-10.1 mg/dL [0.03-0.26 mmol/L]). Low-carbohydrate, non-energy-restricted diets appear to be at least as

  16. Optimal Siting and Sizing of Multiple DG Units for the Enhancement of Voltage Profile and Loss Minimization in Transmission Systems Using Nature Inspired Algorithms

    Directory of Open Access Journals (Sweden)

    Ambika Ramamoorthy

    2016-01-01

    Full Text Available Power grid becomes smarter nowadays along with technological development. The benefits of smart grid can be enhanced through the integration of renewable energy sources. In this paper, several studies have been made to reconfigure a conventional network into a smart grid. Amongst all the renewable sources, solar power takes the prominent position due to its availability in abundance. Proposed methodology presented in this paper is aimed at minimizing network power losses and at improving the voltage stability within the frame work of system operation and security constraints in a transmission system. Locations and capacities of DGs have a significant impact on the system losses in a transmission system. In this paper, combined nature inspired algorithms are presented for optimal location and sizing of DGs. This paper proposes a two-step optimization technique in order to integrate DG. In a first step, the best size of DG is determined through PSO metaheuristics and the results obtained through PSO is tested for reverse power flow by negative load approach to find possible bus locations. Then, optimal location is found by Loss Sensitivity Factor (LSF and weak (WK bus methods and the results are compared. In a second step, optimal sizing of DGs is determined by PSO, GSA, and hybrid PSOGSA algorithms. Apart from optimal sizing and siting of DGs, different scenarios with number of DGs (3, 4, and 5 and PQ capacities of DGs (P alone, Q alone, and  P and Q both are also analyzed and the results are analyzed in this paper. A detailed performance analysis is carried out on IEEE 30-bus system to demonstrate the effectiveness of the proposed methodology.

  17. Optimal Siting and Sizing of Multiple DG Units for the Enhancement of Voltage Profile and Loss Minimization in Transmission Systems Using Nature Inspired Algorithms.

    Science.gov (United States)

    Ramamoorthy, Ambika; Ramachandran, Rajeswari

    2016-01-01

    Power grid becomes smarter nowadays along with technological development. The benefits of smart grid can be enhanced through the integration of renewable energy sources. In this paper, several studies have been made to reconfigure a conventional network into a smart grid. Amongst all the renewable sources, solar power takes the prominent position due to its availability in abundance. Proposed methodology presented in this paper is aimed at minimizing network power losses and at improving the voltage stability within the frame work of system operation and security constraints in a transmission system. Locations and capacities of DGs have a significant impact on the system losses in a transmission system. In this paper, combined nature inspired algorithms are presented for optimal location and sizing of DGs. This paper proposes a two-step optimization technique in order to integrate DG. In a first step, the best size of DG is determined through PSO metaheuristics and the results obtained through PSO is tested for reverse power flow by negative load approach to find possible bus locations. Then, optimal location is found by Loss Sensitivity Factor (LSF) and weak (WK) bus methods and the results are compared. In a second step, optimal sizing of DGs is determined by PSO, GSA, and hybrid PSOGSA algorithms. Apart from optimal sizing and siting of DGs, different scenarios with number of DGs (3, 4, and 5) and PQ capacities of DGs (P alone, Q alone, and P and Q both) are also analyzed and the results are analyzed in this paper. A detailed performance analysis is carried out on IEEE 30-bus system to demonstrate the effectiveness of the proposed methodology.

  18. Features Predicting Weight Loss in Overweight or Obese Participants in a Web-Based Intervention: Randomized Trial

    OpenAIRE

    Brindal, Emily; Freyne, Jill; Saunders, Ian; Berkovsky, Shlomo; Smith, Greg; Noakes, Manny

    2012-01-01

    Background Obesity remains a serious issue in many countries. Web-based programs offer good potential for delivery of weight loss programs. Yet, many Internet-delivered weight loss studies include support from medical or nutritional experts, and relatively little is known about purely web-based weight loss programs. Objective To determine whether supportive features and personalization in a 12-week web-based lifestyle intervention with no in-person professional contact affect retention and we...

  19. Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial

    OpenAIRE

    Dalcin, A. T.; Jerome, G. J.; Fitzpatrick, S. L.; Louis, T. A.; Wang, N?Y.; Bennett, W. L.; Durkin, N.; Clark, J. M.; Daumit, G. L.; Appel, L. J.; Coughlin, J. W.

    2015-01-01

    Summary Background Behavioural weight loss programs are effective first?line treatments for obesity and are recommended by the US Preventive Services Task Force. Gaining an understanding of intervention components that are found helpful by different demographic groups can improve tailoring of weight loss programs. This paper examined the perceived helpfulness of different weight loss program components. Methods Participants (n?=?236) from the active intervention conditions of the Practice?bas...

  20. Improving hypertension management through pharmacist prescribing; the rural alberta clinical trial in optimizing hypertension (Rural RxACTION: trial design and methods

    Directory of Open Access Journals (Sweden)

    Campbell Norman RC

    2011-08-01

    Full Text Available Abstract Background Patients with hypertension continue to have less than optimal blood pressure control, with nearly one in five Canadian adults having hypertension. Pharmacist prescribing is gaining favor as a potential clinically efficacious and cost-effective means to improve both access and quality of care. With Alberta being the first province in Canada to have independent prescribing by pharmacists, it offers a unique opportunity to evaluate outcomes in patients who are prescribed antihypertensive therapy by pharmacists. Methods The study is a randomized controlled trial of enhanced pharmacist care, with the unit of randomization being the patient. Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up, and prescribing/titration of antihypertensive medications or usual care. Participants are patients in rural Alberta with undiagnosed/uncontrolled blood pressure, as defined by the Canadian Hypertension Education Program. The primary outcome is the change in systolic blood pressure between baseline and 24 weeks in the enhanced-care versus usual-care arms. There are also three substudies running in conjunction with the project examining different remuneration models, investigating patient knowledge, and assessing health-resource utilization amongst patients in each group. Discussion To date, one-third of the required sample size has been recruited. There are 15 communities and 17 pharmacists actively screening, recruiting, and following patients. This study will provide high-level evidence regarding pharmacist prescribing. Trial Registration Clinicaltrials.gov NCT00878566.

  1. Optimizing Radiation Therapy Quality Assurance in Clinical Trials: A TROG 08.03 RAVES Substudy

    Energy Technology Data Exchange (ETDEWEB)

    Trada, Yuvnik, E-mail: yuvnik@gmail.com [Calvary Mater Newcastle, Waratah, New South Wales (Australia); Kneebone, Andrew [Royal North Shore Hospital, St Lenoards, New South Wales (Australia); Paneghel, Andrea [Peter MacCallum Cancer Centre, Melbourne, Victoria (Australia); Pearse, Maria [Auckland Hospital, Auckland (New Zealand); Sidhom, Mark [Liverpool Hospital, Liverpool, New South Wales (Australia); Tang, Colin [Sir Charles Gairdner Hospital, Nedlands, Western Australia (Australia); Wiltshire, Kirsty; Haworth, Annette [Peter MacCallum Cancer Centre, Melbourne, Victoria (Australia); Fraser-Browne, Carol [Auckland Hospital, Auckland (New Zealand); Martin, Jarad [Calvary Mater Newcastle, Waratah, New South Wales (Australia)

    2015-12-01

    Purpose: To explore site- and clinician-level factors associated with protocol violations requiring real-time-review (RTR) resubmission in a multicenter clinical trial to help tailor future quality assurance (QA) protocols. Methods and Materials: RAVES (Radiation Therapy–Adjuvant vs Early Salvage) (Trans-Tasman Radiation Oncology Group 08.03) is a randomized trial comparing adjuvant with early salvage radiation therapy in men with positive surgical margins or pT3 disease after prostatectomy. Quality assurance in RAVES required each clinician and site to submit a credentialing dummy run (DR) and for each patient's radiation therapy plan to undergo external RTR before treatment. Prospectively defined major violations from trial protocol required remedy and resubmission. Site and clinician factors associated with RTR resubmission were examined using hierarchical modeling. Results: Data were collected from 171 consecutive patients, treated by 46 clinicians at 32 hospitals. There were 47 RTR resubmissions (27%) due to 65 major violations. The relative rate of resubmission decreased by 29% per year as the study progressed (odds ratio OR. 0.71, P=.02). The majority of resubmissions were due to contouring violations (39 of 65) and dosimetric violations (22 of 65). For each additional patient accrued, significant decreases in RTR resubmission were seen at both clinician level (OR 0.75, P=.02) and site level (OR 0.72, P=.01). The rate of resubmission due to dosimetric violations was only 1.6% after the first 5 patients. Use of IMRT was associated with lower rates of resubmission compared with 3-dimensional conformal radiation therapy (OR 0.38, P=.05). Conclusion: Several low- and high-risk factors that may assist with tailoring future clinical trial QA were identified. Because the real-time resubmission rate was largely independent of the credentialing exercise, some form of RTR QA is recommended. The greatest benefit from QA was derived early in trial activation

  2. Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial.

    Science.gov (United States)

    Ahmed Ali, Usama; Issa, Yama; Bruno, Marco J; van Goor, Harry; van Santvoort, Hjalmar; Busch, Olivier R C; Dejong, Cornelis H C; Nieuwenhuijs, Vincent B; van Eijck, Casper H; van Dullemen, Hendrik M; Fockens, Paul; Siersema, Peter D; Gouma, Dirk J; van Hooft, Jeanin E; Keulemans, Yolande; Poley, Jan W; Timmer, Robin; Besselink, Marc G; Vleggaar, Frank P; Wilder-Smith, Oliver H; Gooszen, Hein G; Dijkgraaf, Marcel G W; Boermeester, Marja A

    2013-03-18

    In current practice, patients with chronic pancreatitis undergo surgical intervention in a late stage of the disease, when conservative treatment and endoscopic interventions have failed. Recent evidence suggests that surgical intervention early on in the disease benefits patients in terms of better pain control and preservation of pancreatic function. Therefore, we designed a randomized controlled trial to evaluate the benefits, risks and costs of early surgical intervention compared to the current stepwise practice for chronic pancreatitis. The ESCAPE trial is a randomized controlled, parallel, superiority multicenter trial. Patients with chronic pancreatitis, a dilated pancreatic duct (≥5 mm) and moderate pain and/or frequent flare-ups will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (i.e. need for opioid analgesics) the patient will be randomized to either early surgical intervention (group A) or optimal current step-up practice (group B). An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible. Patients in group A will undergo pancreaticojejunostomy or a Frey-procedure in case of an enlarged pancreatic head (≥4 cm). Patients in group B will undergo a step-up practice of optimal medical treatment, if needed followed by endoscopic interventions, and if needed followed by surgery, according to predefined criteria. Primary outcome is pain assessed with the Izbicki pain score during a follow-up of 18 months. Secondary outcomes include complications, mortality, total direct and indirect costs, quality of life, pancreatic insufficiency, alternative pain scales, length of hospital admission, number of interventions and pancreatitis flare-ups. For the sample size calculation we defined a minimal clinically relevant difference in the primary endpoint as a difference of at least

  3. Efficacy of a meal replacement diet plan compared to a food-based diet plan after a period of weight loss and weight maintenance: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hutchisen Tammy

    2010-03-01

    Full Text Available Abstract Background Obesity has reached epidemic proportions in the United States. It is implicated in the development of a variety of chronic disease states and is associated with increased levels of inflammation and oxidative stress. The objective of this study is to examine the effect of Medifast's meal replacement program (MD on body weight, body composition, and biomarkers of inflammation and oxidative stress among obese individuals following a period of weight loss and weight maintenance compared to a an isocaloric, food-based diet (FB. Methods This 40-week randomized, controlled clinical trial included 90 obese adults with a body mass index (BMI between 30 and 50 kg/m2, randomly assigned to one of two weight loss programs for 16 weeks and then followed for a 24-week period of weight maintenance. The dietary interventions consisted of Medifast's meal replacement program for weight loss and weight maintenance, or a self-selected, isocaloric, food-based meal plan. Results Weight loss at 16 weeks was significantly better in the Medifast group (MD versus the food-based group (FB (12.3% vs. 6.9%, and while significantly more weight was regained during weight maintenance on MD versus FB, overall greater weight loss was achieved on MD versus FB. Significantly more of the MD participants lost ≥ 5% of their initial weight at week 16 (93% vs. 55% and week 40 (62% vs. 30%. There was no difference in satiety observed between the two groups during the weight loss phase. Significant improvements in body composition were also observed in MD participants compared to FB at week 16 and week 40. At week 40, both groups experienced improvements in biochemical outcomes and other clinical indicators. Conclusions Our data suggest that the meal replacement diet plan evaluated was an effective strategy for producing robust initial weight loss and for achieving improvements in a number of health-related parameters during weight maintenance, including inflammation

  4. Leisure-time activity is an important determinant of long-term weight maintenance after weight loss in the Sibutramine Trial on Obesity Reduction and Maintenance (STORM trial)

    DEFF Research Database (Denmark)

    van Baak, M. A.; van Mil, E.; Astrup, A.

    2003-01-01

    The success rate of long-term maintenance of weight loss in obese patients is usually low. To improve the success rate, determinants of long-term weight maintenance must be identified.......The success rate of long-term maintenance of weight loss in obese patients is usually low. To improve the success rate, determinants of long-term weight maintenance must be identified....

  5. Randomized Controlled Trial on the Effects of CCTV Training on Quality of Life, Depression, and Adaptation to Vision Loss

    NARCIS (Netherlands)

    Burggraaff, M.C.; van Nispen, R.M.A.; Knol, D.L.; Ringens, P.J.; van Rens, G.H.M.B.

    2012-01-01

    PURPOSE. In addition to performance-based measures, visionrelated quality of life (QOL) and other subjective measures of psychosocial functioning are considered important outcomes of training in the visually impaired. In a multicenter, masked, randomized controlled trial, subjective effects of

  6. The relationship between pretreatment dietary composition and weight loss during a randomised trial of different diet approaches.

    Science.gov (United States)

    McVay, M A; Jeffreys, A S; King, H A; Olsen, M K; Voils, C I; Yancy, W S

    2015-02-01

    Identifying pretreatment dietary habits that are associated with weight-loss intervention outcomes could help guide individuals' selection of weight-loss approach among competing options. A pretreatment factor that may influence weight-loss outcomes is macronutrient intake. Overweight and obese Durham Veterans Affairs outpatients were randomised to a weight-loss intervention with a low-carbohydrate diet (n = 71) or orlistat medication therapy plus a low-fat diet (n = 73). Percentage fat, carbohydrate and protein intake prior to treatment were measured using 4-day food records. Linear mixed-effects models were used to determine whether pretreatment percentage macronutrient intake influenced weight trajectories and weight loss in each weight-loss condition. Participant's mean age was 53 years, baseline body mass index was 39.3 kg m(-2) and 72% were male. A higher pretreatment percentage carbohydrate intake was associated with less rapid initial weight loss (P = 0.02) and less rapid weight regain (P = 0.03) in the low-carbohydrate diet condition but was not associated with weight trajectories in the orlistat plus low-fat diet condition. In both conditions, a higher pretreatment percentage fat intake was associated with more rapid weight regain (P loss on study completion in either condition. Selection of a weight-loss approach on the basis of pretreatment macronutrient intake is unlikely to improve weight outcomes at the end of a 1-year treatment. However, pretreatment macronutrient intake may have implications for tailoring of interventions to slow weight regain after weight loss. © 2013 The British Dietetic Association Ltd.

  7. Living well after breast cancer randomized controlled trial protocol: evaluating a telephone-delivered weight loss intervention versus usual care in women following treatment for breast cancer.

    Science.gov (United States)

    Reeves, Marina M; Terranova, Caroline O; Erickson, Jane M; Job, Jennifer R; Brookes, Denise S K; McCarthy, Nicole; Hickman, Ingrid J; Lawler, Sheleigh P; Fjeldsoe, Brianna S; Healy, Genevieve N; Winkler, Elisabeth A H; Janda, Monika; Veerman, J Lennert; Ware, Robert S; Prins, Johannes B; Vos, Theo; Demark-Wahnefried, Wendy; Eakin, Elizabeth G

    2016-10-28

    Obesity, physical inactivity and poor diet quality have been associated with increased risk of breast cancer-specific and all-cause mortality as well as treatment-related side-effects in breast cancer survivors. Weight loss intervention trials in breast cancer survivors have shown that weight loss is safe and achievable; however, few studies have examined the benefits of such interventions on a broad range of outcomes and few have examined factors important to translation (e.g. feasible delivery method for scaling up, assessment of sustained changes, cost-effectiveness). The Living Well after Breast Cancer randomized controlled trial aims to evaluate a 12-month telephone-delivered weight loss intervention (versus usual care) on weight change and a range of secondary outcomes including cost-effectiveness. Women (18-75 years; body mass index 25-45 kg/m 2 ) diagnosed with stage I-III breast cancer in the previous 2 years are recruited from public and private hospitals and through the state-based cancer registry (target n = 156). Following baseline assessment, participants are randomized 1:1 to either a 12-month telephone-delivered weight loss intervention (targeting diet and physical activity) or usual care. Data are collected at baseline, 6-months (mid-intervention), 12-months (end-of-intervention) and 18-months (maintenance). The primary outcome is change in weight at 12-months. Secondary outcomes are changes in body composition, bone mineral density, cardio-metabolic and cancer-related biomarkers, metabolic health and chronic disease risk, physical function, patient-reported outcomes (quality of life, fatigue, menopausal symptoms, body image, fear of cancer recurrence) and behaviors (dietary intake, physical activity, sitting time). Data collected at 18-months will be used to assess whether outcomes achieved at end-of-intervention are sustained six months after intervention completion. Cost-effectiveness will be assessed, as will mediators and moderators of

  8. Efficacy of cognitive behavioral internet-based therapy in parents after the loss of a child during pregnancy: pilot data from a randomized controlled trial.

    Science.gov (United States)

    Kersting, Anette; Kroker, Kristin; Schlicht, Sarah; Baust, Katja; Wagner, Birgit

    2011-12-01

    The loss of a child during pregnancy can be a traumatic event associated with long-lasting grief and psychological distress. This study examined the efficacy of an internet-based cognitive behavioral therapy program for mothers after pregnancy loss. In a randomized controlled trial with a waiting list control group, 83 participants who had lost a child during pregnancy were randomly allocated either to 5 weeks of internet therapy or to a 5-week waiting condition. Within a manualized cognitive behavioral treatment program, participants wrote ten essays on loss-specific topics. Posttraumatic stress, grief, and general psychopathology, especially depression, were assessed pretreatment, posttreatment, and at 3-month follow-up. Intention-to-treat analyses and completer analyses were performed. Relative to controls, participants in the treatment group showed significant improvements in posttraumatic stress, grief, depression, and overall mental health, but not in anxiety or somatization. Medium to large effect sizes were observed, and the improvement was maintained at 3-month follow-up. This internet-based cognitive behavioral therapy program represents an effective treatment approach with stable effects for women after pregnancy loss. Implementation of the program can thus help to improve the health care provision for mothers in this traumatic loss situation.

  9. Dietary self-monitoring, but not dietary quality, improves with use of smartphone app technology in an 8-week weight loss trial.

    Science.gov (United States)

    Wharton, Christopher M; Johnston, Carol S; Cunningham, Barbara K; Sterner, Danielle

    2014-01-01

    Dietary self-monitoring is linked to improved weight loss success. Mobile technologies, such as smartphone applications (apps), might allow for improved dietary tracking adherence. The authors assessed the use of a popular smartphone app for dietary self-monitoring and weight loss by comparing it with traditional diet counseling and entry methods. Diet tracking and weight loss were compared across participants during an 8-week weight loss trial. Participants tracked intake using 1 of 3 methods: the mobile app "Lose It!", the memo feature on a smartphone, or a traditional paper-and-pencil method. App users (n = 19) recorded dietary data more consistently compared with the paper-and-pencil group (n = 15; P = .042) but not the memo group (n = 13). All groups lost weight over the course of the study (P = .001), and no difference in weight loss was noted between groups. Smartphone apps could represent a novel and feasible dietary self-monitoring method for individuals. Copyright © 2014 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  10. Genetic Predisposition to Weight Loss and Regain With Lifestyle Intervention: Analyses From the Diabetes Prevention Program and the Look AHEAD Randomized Controlled Trials.

    Science.gov (United States)

    Papandonatos, George D; Pan, Qing; Pajewski, Nicholas M; Delahanty, Linda M; Peter, Inga; Erar, Bahar; Ahmad, Shafqat; Harden, Maegan; Chen, Ling; Fontanillas, Pierre; Wagenknecht, Lynne E; Kahn, Steven E; Wing, Rena R; Jablonski, Kathleen A; Huggins, Gordon S; Knowler, William C; Florez, Jose C; McCaffery, Jeanne M; Franks, Paul W

    2015-12-01

    Clinically relevant weight loss is achievable through lifestyle modification, but unintentional weight regain is common. We investigated whether recently discovered genetic variants affect weight loss and/or weight regain during behavioral intervention. Participants at high-risk of type 2 diabetes (Diabetes Prevention Program [DPP]; N = 917/907 intervention/comparison) or with type 2 diabetes (Look AHEAD [Action for Health in Diabetes]; N = 2,014/1,892 intervention/comparison) were from two parallel arm (lifestyle vs. comparison) randomized controlled trials. The associations of 91 established obesity-predisposing loci with weight loss across 4 years and with weight regain across years 2-4 after a minimum of 3% weight loss were tested. Each copy of the minor G allele of MTIF3 rs1885988 was consistently associated with greater weight loss following lifestyle intervention over 4 years across the DPP and Look AHEAD. No such effect was observed across comparison arms, leading to a nominally significant single nucleotide polymorphism×treatment interaction (P = 4.3 × 10(-3)). However, this effect was not significant at a study-wise significance level (Bonferroni threshold P lifestyle. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  11. Circumferential bone loss around splinted and nonsplinted immediately loaded implants retaining mandibular overdentures: A randomized controlled clinical trial using cone beam computed tomography.

    Science.gov (United States)

    Elsyad, Moustafa Abdou; Khirallah, Ahmed Samir

    2016-11-01

    Circumferential marginal bone around 2 splinted and nonsplinted immediately loaded implants in the edentulous mandible has not been previously investigated. The purpose of this randomized controlled clinical trial was to assess circumferential bone loss around splinted and nonsplinted immediately loaded implants retaining mandibular overdentures, using cone beam computed tomography (CBCT). Thirty participants with complete edentulism were allocated to 2 groups and received 2 implants in the canine region of the mandible. Implants were either left nonsplinted (with ball attachment [BA]) or splinted (with bar attachment [RA]). Mandibular overdentures were connected to the implants 1 week later. CBCT was used to evaluate vertical bone loss (VBL) and horizontal bone loss (HBLo) bone loss at the distal (D), buccal (B), mesial (M), and lingual (L) sites of each implant upon overdenture insertion (baseline, T0), 1 year (T1) and 3 years (T3) after insertion. Repeated measures ANOVA was used for statistical analysis (α=.05). No significant difference in the survival rate (93.3% for BA and 100% for RA) was found between groups (P=.156). VBL and HBLo increased significantly at T3 compared with T1 for both groups (Poverdentures were associated with significantly higher vertical and horizontal circumferential bone loss than those associated with splinted implants after a follow-up of 3 years. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  12. Weight Loss Maintenance for 2 Years after a 6-Month Randomised Controlled Trial Comparing Education-Only and Group-Based Support in Japanese Adults

    Directory of Open Access Journals (Sweden)

    Yoshio Nakata

    2014-11-01

    Full Text Available Objective: Our previous study, a 6-month randomised controlled trial, demonstrated that a group-based support promoted weight loss as compared to an education-only intervention. The purpose of this study was to examine weight loss maintenance for 2 years. Methods: Originally, 188 overweight Japanese adults, aged 40-65 years, were randomly assigned to 3 groups: control, education-only or group-based support. After the 6-month intervention, 125 participants in the education-only and the group-based support groups were followed up for 2 years. The primary outcome was the amount of weight lost. The participants were retrospectively grouped into quartiles of percent weight loss for secondary analyses. Results: At the end of follow-up, the amount of weight lost in the education-only and the group-based support groups was the same (3.3 kg. Secondary analyses using data of those who completed the study (n = 100 revealed that the participants in the highest quartile of percent weight loss significantly increased their step counts and moderate-to-vigorous physical activity compared with the lowest quartile. No significant differences were observed in the energy intake among the four groups. Conclusion: The effects of group-based support disappear within 2 years. Increasing physical activity may be a crucial factor for successful maintenance of weight loss.

  13. Can racial disparities in optimal gout treatment be reduced? evidence from a randomized trial

    Directory of Open Access Journals (Sweden)

    Singh Jasvinder A

    2012-02-01

    Full Text Available Abstract There is a disproportionate burden of gout in African-Americans in the U.S. due to a higher disease prevalence and lower likelihood of receiving urate-lowering therapy (ULT, compared to Caucasians. There is an absence of strong data as to whether the response to ULT differs by race/ethnicity. BMC Musculoskeletal Disorders recently published a secondary analyses of the CONFIRMS trial, a large randomized controlled, double-blind trial of 2,269 gout patients. The authors reported that the likelihood of achieving the primary study efficacy end-point of achieving serum urate Please see related article: http://www.biomedcentral.com/1471-2474/13/15

  14. Optimizing ADAS-Cog Worksheets: A Survey of Clinical Trial Rater s' Perceptions.

    Science.gov (United States)

    Meyer, Stephen M; Bertzos, Kristina A; Perez, Magdalena; Connor, Donald J; Schafer, Kimberly; Walter, Sarah

    2017-01-01

    The Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog) remains the most widely used test of longitudinal cognitive functioning in Alzheimer's disease (AD) clinical trials. Unlike most neuropsychological tests, the ADAS-Cog source documentation worksheets are not uniform across clinical trials, and vary by document layout, inclusion of administration and/or scoring instructions, and documentation of subtest scoring (e.g., recording correct versus incorrect scores), among other differences. Many ADAS-Cog test administrators (raters) participate in multiple AD trials and switching between different ADAS-Cog worksheets may increase the likelihood of administration and/or scoring mistakes that lessen the reliability of the instrument. An anonymous online survey sought raters' experiences with ADAS-Cog worksheets and their opinions on the design and content of the worksheets. Results of the survey indicated preference for structure and standardization of the ADASCog worksheets, which has been considered in the development of a standard ADAS-Cog source document by the Alzheimer's Disease Cooperative Study (ADCS) Working Group. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  15. Long-Term Effect of Interactive Online Dietician Weight Loss Advice in General Practice (LIVA) Protocol for a Randomized Controlled Trial

    DEFF Research Database (Denmark)

    Brandt, Carl J; Brandt, Vibeke; Pedersen, Mathilde

    2014-01-01

    Background. Internet-based complex interventions aiming to promote weight loss and optimize healthy behaviors have attracted much attention. However, evidence for effect is lacking. Obesity is a growing problem, resulting in an increasing demand for cost efficient weight loss programs suitable...... for use on a large scale, for example, as part of standard primary care. In a previous pilot project by Brandt et al. (2011) without a control group, we examined the effects of online dietician counseling and found an average weight loss of 7.0 kg (95% CI: 4.6 to 9.3 kg) after 20 months. Aims and Methods....... To analyze the effects of a complex intervention using trained dieticians in a general practice setting combined with internet-based interactive and personalized weight management support compared with conventional advice with a noninteractive internet support as placebo treatment in 340 overweight patients...

  16. Long-term Impact of Weight Loss Intervention on Changes in Cognitive Function: Exploratory Analyses from the Action for Health in Diabetes Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Espeland, Mark A; Carmichael, Owen; Hayden, Kathleen; Neiberg, Rebecca H; Newman, Anne B; Keller, Jeffery N; Wadden, Thomas A; Rapp, Stephen R; Hill, James O; Horton, Edward S; Johnson, Karen C; Wagenknecht, Lynne; Wing, Rena R

    2018-03-14

    Diabetes adversely impacts cognition. Lifestyle change can improve diabetes control and potentially improve cognition. We examined whether weight loss through reduced caloric intake and increased physical activity was associated with slower cognitive aging in older adults with type 2 diabetes mellitus. The Look AHEAD randomized controlled clinical trial delivered 10 years of intensive lifestyle intervention (ILI) that yielded long-term weight losses. During 5 years spanning the end of intervention and postintervention follow-up, repeated cognitive assessments were obtained in 1,091 individuals who had been assigned to ILI or a control condition of diabetes support and education (DSE). We compared the means and slopes of scores on cognitive testing over these repeated assessments. Compared with DSE, assignment to ILI was associated with a -0.082 SD deficit in mean global cognitive function across repeated assessments (p = .010). However, overweight (body mass index [BMI] memory. The behavioral weight loss intervention was associated with small relative deficits in cognitive function among individuals who were obese and marginally greater cognitive decline overall compared to control. ClinicalTrials.gov Identifier: NCT00017953.

  17. Adding evidence-based behavioral weight loss strategies to a statewide wellness campaign: a randomized clinical trial.

    Science.gov (United States)

    Leahey, Tricia M; Thomas, Graham; Fava, Joseph L; Subak, Leslee L; Schembri, Michael; Krupel, Katie; Kumar, Rajiv; Weinberg, Brad; Wing, Rena R

    2014-07-01

    We determined the efficacy and cost-effectiveness of adding an evidence-based Internet behavioral weight loss intervention alone or combined with optional group sessions to ShapeUp Rhode Island 2011 (SURI), a 3-month statewide wellness campaign. We randomized participants (n = 230; body mass index = 34.3 ±6.8 kg/m(2); 84% female) to the standard SURI program (S) or to 1 of 2 enhanced programs: SURI plus Internet behavioral program (SI) or SI plus optional group sessions (SIG). The primary outcome was weight loss at the end of the 3-month program. Weight losses differed among all 3 conditions (S: 1.1% ±0.9%; SI: 4.2% ±0.6%; SIG: 6.1% ±0.6%; Ps ≤ .04). Both SI and SIG increased the percentage of individuals who achieved a 5% weight loss (SI: 42%; SIG: 54%; S: 7%; Ps < .001). Cost per kilogram of weight loss was similar for S ($39) and SI ($35); both were lower than SIG ($114). Although weight losses were greatest at the end of SURI with optional group sessions, the addition of an Internet behavioral program was the most cost-effective method to enhance weight losses.

  18. Project TEAMS (Talking about Eating, Activity, and Mutual Support: a randomized controlled trial of a theory-based weight loss program for couples

    Directory of Open Access Journals (Sweden)

    Amy A. Gorin

    2017-09-01

    Full Text Available Abstract Background Obesity risk is shared between spouses, yet existing weight loss programs focus on individuals and not the marital dyad. Given the interdependence of weight in couples, weight management outcomes might be improved by targeting joint weight loss and the creation of an interpersonal milieu that supports long-term behavior change. According to Self-Determination Theory (SDT, greater autonomous self-regulation of behaviors, and subsequently better treatment outcomes, are observed in needs supportive environments in which personally meaningful choice is supported and criticism and control are minimized. Correlational analyses confirm these pathways in weight management, with needs support from one’s spouse or partner emerging as a distinct predictor of weight loss success. Research is now needed to establish causal links and to develop and test weight loss interventions designed to facilitate the needs supportive behavior of spouses. Methods Project TEAMS (Talking about Eating, Activity, and Mutual Support is a randomized controlled trial testing a couples-based intervention, grounded in SDT, designed to change the social context of weight loss by training spouses to provide needs support for each other’s eating and physical activity behavior. Sixty-four couples will be randomized to either 6 months of behavioral weight loss treatment informed by SDT (SDT-WL or to 6 months of standard behavioral weight loss treatment (BWL. Couples will attend weekly sessions for 6 months and will be assessed at 0, 3, 6, and 12 months. By bolstering needs support, SDT-WL is predicted to increase autonomous self-regulation and perceived competence and produce greater weight loss and maintenance than standard behavioral treatment. Exploratory analyses will examine the SDT process model prediction that the influence of needs support on treatment outcomes will be mediated by autonomous self-regulation and perceived competence. Discussion This

  19. Inpatient weight loss as a precursor to bariatric surgery for adolescents with extreme obesity: optimizing bariatric surgery.

    Science.gov (United States)

    Koeck, Emily; Davenport, Katherine; Barefoot, Leah C; Qureshi, Faisal G; Davidow, Daniel; Nadler, Evan P

    2013-07-01

    As the obesity epidemic takes its toll on patients stricken with the disease and our health care system, debate continues regarding the use of weight loss surgery and its long-term consequences, especially for adolescents. One subset of patients regarding whom there is increased controversy is adolescents with extreme obesity (BMI > 60 kg/m(2)) because the risk of complications in this weight category is higher than for others undergoing bariatric surgery. Several strategies have been suggested for this patient group, including staged operations, combined operations, intragastric balloon use, and endoluminal sleeve placement. However, the device options are often not available to adolescents, and there are no data regarding staged or combined procedures in this age group. All adolescents with BMI >60 kg/m(2) referred to our program were evaluated for inpatient medical weight loss prior to laparoscopic sleeve gastrectomy. The program utilizes a multidisciplinary approach with a protein-sparing modified fast diet, exercise, and behavioral modification. Three patients completed the program, and each achieved significant preoperative weight loss through the inpatient program and successfully underwent bariatric surgery. Presurgical weight loss via an inpatient program for adolescents with a BMI >60 kg/m(2) results in total weight loss comparable to a primary surgical procedure alone, with the benefit of decreasing the perioperative risk.

  20. Future long-term trials of postmenopausal hormone replacement therapy - what is possible and what is the optimal protocol and regimen?

    Science.gov (United States)

    Purbrick, B; Stranks, K; Sum, C; MacLennan, A H

    2012-06-01

    The ideal long-term, randomized, placebo-controlled trial of hormone replacement therapy (HRT) from near menopause for up to 30 years to assess major morbidity and mortality is impractical because of high cost, participant retention, therapy compliance, and continuity of research staff and funding. Also the trial regimen may become outdated. It is nihilistic to demand such a long-term trial before endorsing HRT. However, medium-term trials using surrogate measures for long-term morbidity and mortality are possible and two are near completion. If these studies have been able to maintain reasonable participant retention, therapy compliance and minimal breach of protocol, they will set standards for trials of new HRT regimens. This paper discusses lessons learnt from past attempts at long-term trials and suggests the currently optimal protocol and cost of assessing new HRT regimens to optimize potential benefits and minimize adverse effects. A 5-7-year randomized, placebo-controlled trial of a flexible transdermal estrogen regimen ± either a selective estrogen receptor modulator, e.g. bazedoxifene, or micronized progesterone is discussed. Mild to moderately symptomatic women, 1-4 years post menopause, can be recruited via general practice and group meetings. Future trials should be funded by independent agencies and are high priority in women's health.

  1. Operative blood loss and the frequency of haemorrhage associated with adenotonsillectomy in children: a double-blind trial of ethamsylate.

    Science.gov (United States)

    Arora, Y R; Manford, M L

    1979-06-01

    One hundred children were allocated randomly to receive either ethamsylate (Dicynene) or a placebo before undergoing adenotonsillectomy. Blood loss at operation was estimated from the haemoglobin content of swabs and aspirated fluid. Mean blood loss in the ethamsylate-treated group was not significantly less than in the controls. The frequency of secondary haemorrhage was significantly less in children treated with ethamsylate (P less than 0.01). No side-effects were reported in either group.

  2. Motivation for Participating in a Weight Loss Program and Financial Incentives: An Analysis from a Randomized Trial

    Science.gov (United States)

    Crane, Melissa M.; Tate, Deborah F.; Finkelstein, Eric A.; Linnan, Laura A.

    2012-01-01

    This analysis investigated if changes in autonomous or controlled motivation for participation in a weight loss program differed between individuals offered a financial incentive for weight loss compared to individuals not offered an incentive. Additionally, the same relationships were tested among those who lost weight and either received or did not receive an incentive. This analysis used data from a year-long randomized worksite weight loss program that randomly assigned employees in each worksite to either a low-intensity weight loss program or the same program plus small financial incentives for weight loss ($5.00 per percentage of initial weight lost). There were no differences in changes between groups on motivation during the study, however, increases in autonomous motivation were consistently associated with greater weight losses. This suggests that the small incentives used in this program did not lead to increases in controlled motivation nor did they undermine autonomous motivation. Future studies are needed to evaluate the magnitude and timing of incentives to more fully understand the relationship between incentives and motivation. PMID:22577524

  3. Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

    Science.gov (United States)

    Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

    2018-01-01

    Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0

  4. Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial.

    Science.gov (United States)

    Okonkwo, David O; Shutter, Lori A; Moore, Carol; Temkin, Nancy R; Puccio, Ava M; Madden, Christopher J; Andaluz, Norberto; Chesnut, Randall M; Bullock, M Ross; Grant, Gerald A; McGregor, John; Weaver, Michael; Jallo, Jack; LeRoux, Peter D; Moberg, Dick; Barber, Jason; Lazaridis, Christos; Diaz-Arrastia, Ramon R

    2017-11-01

    A relationship between reduced brain tissue oxygenation and poor outcome following severe traumatic brain injury has been reported in observational studies. We designed a Phase II trial to assess whether a neurocritical care management protocol could improve brain tissue oxygenation levels in patients with severe traumatic brain injury and the feasibility of a Phase III efficacy study. Randomized prospective clinical trial. Ten ICUs in the United States. One hundred nineteen severe traumatic brain injury patients. Patients were randomized to treatment protocol based on intracranial pressure plus brain tissue oxygenation monitoring versus intracranial pressure monitoring alone. Brain tissue oxygenation data were recorded in the intracranial pressure -only group in blinded fashion. Tiered interventions in each arm were specified and impact on intracranial pressure and brain tissue oxygenation measured. Monitors were removed if values were normal for 48 hours consecutively, or after 5 days. Outcome was measured at 6 months using the Glasgow Outcome Scale-Extended. A management protocol based on brain tissue oxygenation and intracranial pressure monitoring reduced the proportion of time with brain tissue hypoxia after severe traumatic brain injury (0.45 in intracranial pressure-only group and 0.16 in intracranial pressure plus brain tissue oxygenation group; p injury after severe traumatic brain injury based on brain tissue oxygenation and intracranial pressure values was consistent with reduced mortality and increased proportions of patients with good recovery compared with intracranial pressure-only management; however, the study was not powered for clinical efficacy. Management of severe traumatic brain injury informed by multimodal intracranial pressure and brain tissue oxygenation monitoring reduced brain tissue hypoxia with a trend toward lower mortality and more favorable outcomes than intracranial pressure-only treatment. A Phase III randomized trial to assess

  5. [Benefits of spironolactone as the optimal treatment for drug resistant hypertension. Pathway-2 trial review].

    Science.gov (United States)

    Prado, J C; Ruilope, L M; Segura, J

    Pathway-2 is the first randomised, double-blind and crossover trial that compares spironolactone as a fourth drug with alfa-blocker, beta-blocker and placebo. This study shows that spironolactone is the drug with more possibilities of success for the management of patients with difficult-to-treat hypertension in patients with a combination of three drugs and poor control. The results validate the widespread treatment with mineralocorticoid receptor antagonists in resistant hypertension. Copyright © 2016 SEH-LELHA. Publicado por Elsevier España, S.L.U. All rights reserved.

  6. Effect of weight loss with or without exercise on inflammatory markers and adipokines in postmenopausal women : The SHAPE-2 Trial, a randomized controlled trial

    NARCIS (Netherlands)

    Van Gemert, Willemijn A.; May, Anne M.; Schuit, Albertine J.; Oosterhof, Blanche Y M; Peeters, Petra H.; Monninkhof, Evelyn M.

    2016-01-01

    Background: We investigated the effect of equivalent weight loss, by a hypocaloric diet or mainly exercise, on inflammatory markers and adipokines in overweight postmenopausal women. Methods: Women were randomized to a diet (n = 97), mainly exercise (n = 98), or control group (n = 48). Goal of both

  7. Effect of Weight Loss with or without Exercise on Inflammatory Markers and Adipokines in Postmenopausal Women : The SHAPE-2 Trial, A Randomized Controlled Trial

    NARCIS (Netherlands)

    van Gemert, Willemijn A; May, Anne M; Schuit, Albertine J; Oosterhof, Blanche Y M; Peeters, Petra H M; Monninkhof, Evelyn M.

    BACKGROUND: We investigated the effect of equivalent weight loss, by a hypocaloric diet or mainly exercise, on inflammatory markers and adipokines in overweight postmenopausal women. METHODS: Women were randomized to a diet (n = 97), mainly exercise (n = 98), or control group (n = 48). Goal of both

  8. Fabrication of topology optimized photonic crystal waveguide Z-bend displaying large bandwidth with very low bend loss

    DEFF Research Database (Denmark)

    Harpøth, Anders; Frandsen, Lars Hagedorn; Kristensen, Martin

    2004-01-01

    We have designed, simulated and fabricated a photonic crystal waveguide Z-bend, which displays a total bend loss of ~1dB per bend in a wavelength range of more than 200nm. The fabricated component performs in excellent agreement with 3D finite-difference time-domain calculations....

  9. Risk factors for non-adherence and loss to follow-up in a three-year clinical trial in Botswana.

    Directory of Open Access Journals (Sweden)

    Deborah A Gust

    Full Text Available BACKGROUND: Participant non-adherence and loss to follow-up can compromise the validity of clinical trial results. An assessment of these issues was made in a 3-year tuberculosis prevention trial among HIV-infected adults in Botswana. METHODS AND FINDINGS: Between 11/2004-07/2006, 1995 participants were enrolled at eight public health clinics. They returned monthly to receive bottles of medication and were expected to take daily tablets of isoniazid or placebo for three years. Non-adherence was defined as refusing tablet ingestion but agreeing to quarterly physical examinations. Loss to follow-up was defined as not having returned for appointments in ≥60 days. Between 10/2008-04/2009, survey interviews were conducted with 83 participants identified as lost to follow-up and 127 identified as non-adherent. As a comparison, 252 randomly selected adherent participants were also surveyed. Multivariate logistic regression analysis was used to identify associations with selected risk factors. Men had higher odds of being non-adherent (adjusted odds ratio (AOR, 2.24; 95% confidence interval [95%CI] 1.24-4.04 and lost to follow-up (AOR 3.08; 95%CI 1.50-6.33. Non-adherent participants had higher odds of reporting difficulties taking the regimen or not knowing if they had difficulties (AOR 3.40; 95%CI 1.75-6.60 and lower odds associated with each year of age (AOR 0.95; 95%CI 0.91-0.98, but other variables such as employment, distance from clinic, alcohol use, and understanding study requirements were not significantly different than controls. Among participants who were non-adherent or lost to follow-up, 40/210 (19.0% reported that they stopped the medication because of work commitments and 33/210 (15.7% said they thought they had completed the study. CONCLUSIONS: Men had higher odds of non-adherence and loss to follow-up than women. Potential interventions that might improve adherence in trial participants may include:targeting health education for men

  10. Optimizing the Use of Aripiprazole Augmentation in the Treatment of Major Depressive Disorder: From Clinical Trials to Clinical Practice

    Science.gov (United States)

    Han, Changsu; Wang, Sheng-Min; Lee, Soo-Jung; Jun, Tae-Youn

    2015-01-01

    Major depressive disorder (MDD) is a recurrent, chronic, and devastating disorder leading to serious impairment in functional capacity as well as increasing public health care costs. In the previous decade, switching therapy and dose adjustment of ongoing antidepressants was the most frequently chosen subsequent treatment option for MDD. However, such recommendations were not based on firmly proven efficacy data from well-designed, placebo-controlled, randomized clinical trials (RCTs) but on practical grounds and clinical reasoning. Aripiprazole augmentation has been dramatically increasing in clinical practice owing to its unique action mechanisms as well as proven efficacy and safety from adequately powered and well-controlled RCTs. Despite the increased use of aripiprazole in depression, limited clinical information and knowledge interfere with proper and efficient use of aripiprazole augmentation for MDD. The objective of the present review was to enhance clinicians' current understanding of aripiprazole augmentation and how to optimize the use of this therapy in the treatment of MDD. PMID:26306301

  11. Topology optimization of photonic crystal structures: a high-bandwidth low-loss T-junction waveguide

    DEFF Research Database (Denmark)

    Jensen, Jakob Søndergaard; Sigmund, Ole

    2005-01-01

    in a large frequency range, we use an active-set strategy by using a number of target frequencies that are updated repeatedly in the optimization procedure. We apply a continuation method based on artificial damping to avoid undesired local maxima and also introduce artificial damping in a penalization...

  12. Recovery of insulin sensitivity and optimal body composition after rapid weight loss in obese dogs fed a high-protein medium-carbohydrate diet.

    Science.gov (United States)

    André, A; Leriche, I; Chaix, G; Thorin, C; Burger, M; Nguyen, P

    2017-06-01

    This study investigated the effects of an experimental high-protein medium-carbohydrate diet (protein level, 46% metabolizable energy, ME). First, postprandial plasma glucose and insulin kinetics were determined in steady-state overweight/obese Beagle dogs (28%-41% excess body weight) for an experimental high-protein medium-carbohydrate diet (protein level, 46% ME) and a commercial high-carbohydrate medium-protein diet (protein level, 24%ME) in obese dogs. Secondly, all the dogs were included in a weight loss programme. They were fed the high-protein medium-carbohydrate diet, and the energy allocation was gradually reduced until they reached their optimal body weight. Insulin sensitivity and body composition were evaluated before and after weight loss using a euglycaemic-hyperinsulinaemic clamp and the deuterium oxide dilution technique respectively. For statistical analysis, linear mixed effect models were used with a significance level of 5%. Postprandial plasma glucose and insulin concentrations were substantially lower with the high-protein medium-carbohydrate diet than the high-carbohydrate medium-protein diet. These differences can be explained mainly by the difference in carbohydrate content between the two diets. Energy restriction (35% lower energy intake than in the obese state) resulted in a 2.23 ± 0.05% loss in body weight/week, and the dogs reached their optimal body weight in 12-16 weeks. Weight loss was associated with a significant increase in insulin sensitivity. The high-protein medium-carbohydrate diet allowed fat-free mass preservation despite a relatively high rate of weekly weight loss. The increase in insulin sensitivity indicated improved control of carbohydrate metabolism, possible due to weight loss and to the nature of the diet. Thus, a high-protein medium-carbohydrate diet is a good nutritional solution for managing the weight of overweight dogs. This diet may improve glycaemic control, which could be beneficial for preventing or

  13. A randomized controlled trial to determine the efficacy of a high carbohydrate and high protein ready-to-eat food product for weight loss.

    Science.gov (United States)

    Fuller, N R; Fong, M; Gerofi, J; Leung, L; Leung, C; Denyer, G; Caterson, I D

    2016-04-01

    Incorporating meal replacements has been shown to produce a significantly greater weight loss than a conventional reduced calorie diet. Ready-to-eat conventional foods may also be effective in this role and provide additional benefit because of their palatability, acceptance and enjoyment and thus increase dietary compliance. This trial investigated the efficacy of a ready-to-eat food product (Vita-Weat biscuit) that is both high in carbohydrate and high in protein as part of a diet prescription for weight loss in an overweight and obese population group. A total of 76 participants were randomized to a 6-week weight loss intervention including the ready-to-eat food product (intervention group) or advice on the 'Australian Guide to Healthy Eating' (control group). Both groups lost approximately 2 kg weight which equated to a reduction in body mass index of 0.70 kg m(-2) . There was no significant difference in percentage weight loss from screening to 6 weeks between the two groups; mean difference for the intervention vs. -0.20% (95% confidence interval: -0.96, 1.36); P = 0.73. Both diets were nutritionally matched and well-accepted over the 6-week period. This study shows that the inclusion of a ready-to-eat food product can be included as part of a dietary programme to achieve a clinically significant weight loss over a short period. This may have benefit when incorporated into an individual's meal plan intermittently to assist weight control. It also provides support for current public health nutritional guidelines as the participants in this study following such advice were also successful in achieving a clinically meaningful weight loss. © 2016 World Obesity.

  14. Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity.

    Science.gov (United States)

    Voils, Corrine I; Levine, Erica; Gierisch, Jennifer M; Pendergast, Jane; Hale, Sarah L; McVay, Megan A; Reed, Shelby D; Yancy, William S; Bennett, Gary; Strawbridge, Elizabeth M; White, Allison C; Shaw, Ryan J

    2018-02-01

    The obesity epidemic has negative physical, psychological, and financial consequences. Despite the existence of effective behavioral weight loss interventions, many individuals do not achieve adequate weight loss, and most regain lost weight in the year following intervention. We report the rationale and design for a 2×2 factorial study that involves financial incentives for dietary self-monitoring (yes vs. no) and/or interim weight loss (yes vs. no). Outpatients with obesity participate in a 24-week, group-based weight loss intervention. All participants are asked to record their daily dietary and liquid intake on a smartphone application (app) and to weigh themselves daily at home on a study-provided cellular scale. An innovative information technology (IT) solution collates dietary data from the app and weight from the scale. Using these data, an algorithm classifies participants weekly according to whether they met their group's criteria to receive a cash reward ranging from $0 to $30 for dietary self-monitoring and/or interim weight loss. Notice of the reward is provided via text message, and credit is uploaded to a gift card. This pilot study will provide information on the feasibility of using this novel IT solution to provide variable-ratio financial incentives in real time via its effects on recruitment, intervention adherence, retention, and cost. This study will provide the foundation for a comprehensive, adequately-powered, randomized controlled trial to promote short-term weight loss and long-term weight maintenance. If efficacious, this approach could reduce the prevalence, adverse outcomes, and costs of obesity for millions of Americans. Clinicaltrials.gov registration: NCT02691260. Published by Elsevier Inc.

  15. Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology.

    Science.gov (United States)

    Svetkey, Laura P; Batch, Bryan C; Lin, Pao-Hwa; Intille, Stephen S; Corsino, Leonor; Tyson, Crystal C; Bosworth, Hayden B; Grambow, Steven C; Voils, Corrine; Loria, Catherine; Gallis, John A; Schwager, Jenifer; Bennett, Gary G; Bennett, Gary B

    2015-11-01

    To determine the effect on weight of two mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Randomized, controlled comparative effectiveness trial in 18- to 35-year-olds with BMI ≥ 25 kg/m(2) (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. The 365 randomized participants had mean baseline BMI of 35 kg/m(2) . Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect -1.92 kg [CI -3.17, -0.67], P = 0.003), but not at 12 and 24 months. Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss, and PC did not lead to sustained weight loss relative to Control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. © 2015 The Obesity Society.

  16. Do intermittent diets provide physiological benefits over continuous diets for weight loss? A systematic review of clinical trials.

    Science.gov (United States)

    Seimon, Radhika V; Roekenes, Jessica A; Zibellini, Jessica; Zhu, Benjamin; Gibson, Alice A; Hills, Andrew P; Wood, Rachel E; King, Neil A; Byrne, Nuala M; Sainsbury, Amanda

    2015-12-15

    Energy restriction induces physiological effects that hinder further weight loss. Thus, deliberate periods of energy balance during weight loss interventions may attenuate these adaptive responses to energy restriction and thereby increase the efficiency of weight loss (i.e. the amount of weight or fat lost per unit of energy deficit). To address this possibility, we systematically searched MEDLINE, PreMEDLINE, PubMed and Cinahl and reviewed adaptive responses to energy restriction in 40 publications involving humans of any age or body mass index that had undergone a diet involving intermittent energy restriction, 12 with direct comparison to continuous energy restriction. Included publications needed to measure one or more of body weight, body mass index, or body composition before and at the end of energy restriction. 31 of the 40 publications involved 'intermittent fasting' of 1-7-day periods of severe energy restriction. While intermittent fasting appears to produce similar effects to continuous energy restriction to reduce body weight, fat mass, fat-free mass and improve glucose homeostasis, and may reduce appetite, it does not appear to attenuate other adaptive responses to energy restriction or improve weight loss efficiency, albeit most of the reviewed publications were not powered to assess these outcomes. Intermittent fasting thus represents a valid--albeit apparently not superior--option to continuous energy restriction for weight loss. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  17. Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH: A randomized controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Tsai Midi

    2011-06-01

    Full Text Available Abstract Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33% do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family oriented intervention to reduce sedentary screen time on children's body composition, sedentary behavior, physical activity, and diet. Methods/Design The study design is a pragmatic two-arm parallel randomized controlled trial. Two hundred and seventy overweight children aged 9-12 years and primary caregivers are being recruited. Participants are randomized to intervention (family-based screen time intervention or control (no change. At the end of the study, the control group is offered the intervention content. Data collection is undertaken at baseline and 24 weeks. The primary trial outcome is child body mass index (BMI and standardized body mass index (zBMI. Secondary outcomes are change from baseline to 24 weeks in child percentage body fat; waist circumference; self-reported average daily time spent in physical and sedentary activities; dietary intake; and enjoyment of physical activity and sedentary behavior. Secondary outcomes for the primary caregiver include change in BMI and self-reported physical activity. Discussion This study provides an excellent example of a theory-based, pragmatic, community-based trial targeting sedentary behavior in overweight children. The study has been specifically designed to allow for estimation of the consistency of effects on body composition for Māori (indigenous, Pacific and non-Māori/non-Pacific ethnic groups. If effective, this intervention is imminently scalable and could be integrated within existing weight

  18. Structure Optimization of a Grain Impact Piezoelectric Sensor and Its Application for Monitoring Separation Losses on Tangential-Axial Combine Harvesters

    Science.gov (United States)

    Liang, Zhenwei; Li, Yaoming; Zhao, Zhan; Xu, Lizhang

    2015-01-01

    Grain separation losses is a key parameter to weigh the performance of combine harvesters, and also a dominant factor for automatically adjusting their major working parameters. The traditional separation losses monitoring method mainly rely on manual efforts, which require a high labor intensity. With recent advancements in sensor technology, electronics and computational processing power, this paper presents an indirect method for monitoring grain separation losses in tangential-axial combine harvesters in real-time. Firstly, we developed a mathematical monitoring model based on detailed comparative data analysis of different feeding quantities. Then, we developed a grain impact piezoelectric sensor utilizing a YT-5 piezoelectric ceramic as the sensing element, and a signal process circuit designed according to differences in voltage amplitude and rise time of collision signals. To improve the sensor performance, theoretical analysis was performed from a structural vibration point of view, and the optimal sensor structural has been selected. Grain collide experiments have shown that the sensor performance was greatly improved. Finally, we installed the sensor on a tangential-longitudinal axial combine harvester, and grain separation losses monitoring experiments were carried out in North China, which results have shown that the monitoring method was feasible, and the biggest measurement relative error was 4.63% when harvesting rice. PMID:25594592

  19. Structure optimization of a grain impact piezoelectric sensor and its application for monitoring separation losses on tangential-axial combine harvesters.

    Science.gov (United States)

    Liang, Zhenwei; Li, Yaoming; Zhao, Zhan; Xu, Lizhang

    2015-01-14

    Grain separation losses is a key parameter to weigh the performance of combine harvesters, and also a dominant factor for automatically adjusting their major working parameters. The traditional separation losses monitoring method mainly rely on manual efforts, which require a high labor intensity. With recent advancements in sensor technology, electronics and computational processing power, this paper presents an indirect method for monitoring grain separation losses in tangential-axial combine harvesters in real-time. Firstly, we developed a mathematical monitoring model based on detailed comparative data analysis of different feeding quantities. Then, we developed a grain impact piezoelectric sensor utilizing a YT-5 piezoelectric ceramic as the sensing element, and a signal process circuit designed according to differences in voltage amplitude and rise time of collision signals. To improve the sensor performance, theoretical analysis was performed from a structural vibration point of view, and the optimal sensor structural has been selected. Grain collide experiments have shown that the sensor performance was greatly improved. Finally, we installed the sensor on a tangential-longitudinal axial combine harvester, and grain separation losses monitoring experiments were carried out in North China, which results have shown that the monitoring method was feasible, and the biggest measurement relative error was 4.63% when harvesting rice.

  20. Optimizing delivery of a behavioral pain intervention in cancer patients using a sequential multiple assignment randomized trial SMART.

    Science.gov (United States)

    Kelleher, Sarah A; Dorfman, Caroline S; Plumb Vilardaga, Jen C; Majestic, Catherine; Winger, Joseph; Gandhi, Vicky; Nunez, Christine; Van Denburg, Alyssa; Shelby, Rebecca A; Reed, Shelby D; Murphy, Susan; Davidian, Marie; Laber, Eric B; Kimmick, Gretchen G; Westbrook, Kelly W; Abernethy, Amy P; Somers, Tamara J

    2017-06-01

    Pain is common in cancer patients and results in lower quality of life, depression, poor physical functioning, financial difficulty, and decreased survival time. Behavioral pain interventions are effective and nonpharmacologic. Traditional randomized controlled trials (RCT) test interventions of fixed time and dose, which poorly represent successive treatment decisions in clinical practice. We utilize a novel approach to conduct a RCT, the sequential multiple assignment randomized trial (SMART) design, to provide comparative evidence of: 1) response to differing initial doses of a pain coping skills training (PCST) intervention and 2) intervention dose sequences adjusted based on patient response. We also examine: 3) participant characteristics moderating intervention responses and 4) cost-effectiveness and practicality. Breast cancer patients (N=327) having pain (ratings≥5) are recruited and randomly assigned to: 1) PCST-Full or 2) PCST-Brief. PCST-Full consists of 5 PCST sessions. PCST-Brief consists of one 60-min PCST session. Five weeks post-randomization, participants re-rate their pain and are re-randomized, based on intervention response, to receive additional PCST sessions, maintenance calls, or no further intervention. Participants complete measures of pain intensity, interference and catastrophizing. Novel RCT designs may provide information that can be used to optimize behavioral pain interventions to be adaptive, better meet patients' needs, reduce barriers, and match with clinical practice. This is one of the first trials to use a novel design to evaluate symptom management in cancer patients and in chronic illness; if successful, it could serve as a model for future work with a wide range of chronic illnesses. Copyright © 2016. Published by Elsevier Inc.

  1. Allelic variants of melanocortin 3 receptor gene (MC3R and weight loss in obesity: a randomised trial of hypo-energetic high- versus low-fat diets.

    Directory of Open Access Journals (Sweden)

    José L Santos

    Full Text Available INTRODUCTION: The melanocortin system plays an important role in energy homeostasis. Mice genetically deficient in the melanocortin-3 receptor gene have a normal body weight with increased body fat, mild hypophagia compared to wild-type mice. In humans, Thr6Lys and Val81Ile variants of the melanocortin-3 receptor gene (MC3R have been associated with childhood obesity, higher BMI Z-score and elevated body fat percentage compared to non-carriers. The aim of this study is to assess the association in adults between allelic variants of MC3R with weight loss induced by energy-restricted diets. SUBJECTS AND METHODS: This research is based on the NUGENOB study, a trial conducted to assess weight loss during a 10-week dietary intervention involving two different hypo-energetic (high-fat and low-fat diets. A total of 760 obese patients were genotyped for 10 single nucleotide polymorphisms covering the single exon of MC3R gene and its flanking regions, including the missense variants Thr6Lys and Val81Ile. Linear mixed models and haplotype-based analysis were carried out to assess the potential association between genetic polymorphisms and differential weight loss, fat mass loss, waist change and resting energy expenditure changes. RESULTS: No differences in drop-out rate were found by MC3R genotypes. The rs6014646 polymorphism was significantly associated with weight loss using co-dominant (p = 0.04 and dominant models (p = 0.03. These p-values were not statistically significant after strict control for multiple testing. Haplotype-based multivariate analysis using permutations showed that rs3827103-rs1543873 (p = 0.06, rs6014646-rs6024730 (p = 0.05 and rs3746619-rs3827103 (p = 0.10 displayed near-statistical significant results in relation to weight loss. No other significant associations or gene*diet interactions were detected for weight loss, fat mass loss, waist change and resting energy expenditure changes. CONCLUSION: The study

  2. Low-order model of the Loss-of-Fluid Test (LOFT) reactor plant for use in Kalman filter-based optimal estimators

    International Nuclear Information System (INIS)

    Tylee, J.L.

    1980-01-01

    A low-order, nonlinear model of the Loss-of-Fluid Test (LOFT) reactor plant, for use in Kalman filter estimators, is developed, described, and evaluated. This model consists of 31 differential equations and represents all major subsystems of both the primary and secondary sides of the LOFT plant. Comparisons between model calculations and available LOFT power range testing transients demonstrate the accuracy of the low-order model. The nonlinear model is numerically linearized for future implementation in Kalman filter and optimal control algorithms. The linearized model is shown to be an adequate representation of the nonlinear plant dynamics

  3. [Examination of the optimal midazolam dose required for loss of puncture memory at the time of spinal anesthesia].

    Science.gov (United States)

    Boku, Aiji; Koyama, Shinichi; Kishimoto, Naotaka; Nakatani, Keiji; Kurita, Satoshi; Nagata, Noboru; Niwa, Hitoshi

    2011-08-01

    We examined midazolam ED50 according to age that was necessary for loss of puncture memory at the time of spinal anesthesia and determined whether we could estimate the presence of puncture memory from the degree of sedation after midazolam administration. We enrolled patients with ASA PS 1 or 2 and patients from 50 to 80 years of age who had been planned for surgery with spinal anesthesia. We divided the patients into groups according to their age--50s, 60s, and 70s as L, M, and H groups, respectively. We evaluated the degree of sedation with six phases of scores after intravenous administration of midazolam and spinal anesthesia was performed. The midazolam dose was based on the ups and downs method. The midazolam ED50s required for the loss of puncture memory in groups L, M, and H were 0.043, 0.035, and 0.026 mg x kg(-1), respectively. We estimated the association between the sedation degree score after midazolam administration and the puncture memory from ROC curve, but AUC was 0.56 for all cases. The midazolam ED50 required for the loss of puncture memory decreased with age but it was difficult to estimate puncture memory from the degree of sedation.

  4. Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-04-15

    The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  5. Features predicting weight loss in overweight or obese participants in a web-based intervention: randomized trial.

    Science.gov (United States)

    Brindal, Emily; Freyne, Jill; Saunders, Ian; Berkovsky, Shlomo; Smith, Greg; Noakes, Manny

    2012-12-12

    Obesity remains a serious issue in many countries. Web-based programs offer good potential for delivery of weight loss programs. Yet, many Internet-delivered weight loss studies include support from medical or nutritional experts, and relatively little is known about purely web-based weight loss programs. To determine whether supportive features and personalization in a 12-week web-based lifestyle intervention with no in-person professional contact affect retention and weight loss. We assessed the effect of different features of a web-based weight loss intervention using a 12-week repeated-measures randomized parallel design. We developed 7 sites representing 3 functional groups. A national mass media promotion was used to attract overweight/obese Australian adults (based on body mass index [BMI] calculated from self-reported heights and weights). Eligible respondents (n = 8112) were randomly allocated to one of 3 functional groups: information-based (n = 183), supportive (n = 3994), or personalized-supportive (n = 3935). Both supportive sites included tools, such as a weight tracker, meal planner, and social networking platform. The personalized-supportive site included a meal planner that offered recommendations that were personalized using an algorithm based on a user's preferences for certain foods. Dietary and activity information were constant across sites, based on an existing and tested 12-week weight loss program (the Total Wellbeing Diet). Before and/or after the intervention, participants completed demographic (including self-reported weight), behavioral, and evaluation questionnaires online. Usage of the website and features was objectively recorded. All screening and data collection procedures were performed online with no face-to-face contact. Across all 3 groups, attrition was high at around 40% in the first week and 20% of the remaining participants each week. Retention was higher for the supportive sites compared to the information-based site only

  6. Nutrient Intake During Diet-Induced Weight Loss and Exercise Interventions in a Randomized Trial in Older Overweight and Obese Adults.

    Science.gov (United States)

    Miller, G D; Beavers, D P; Hamm, D; Mihalko, S L; Messier, S P

    2017-01-01

    Dietary restriction in obese older adults undergoing weight loss may exacerbate nutrient deficiencies common in this group; the nutritional health of older adults is a factor in their quality of life, disability, and mortality. This study examined the effect of an 18-month weight loss program based in social cognitive theory incorporating partial meal replacements, on nutrient intake in older overweight and obese adults. The following analysis is from the Intensive Diet and Exercise for Arthritis (IDEA) trial, a single-blind, randomized controlled trial. Individuals were randomized into one of three 18-month interventions: exercise (E); intensive diet-induced weight loss (D); or intensive diet-induced weight loss plus exercise (D+E). The study setting was at a university research facility. Overweight and obese older adults (n=388; BMI=33.7±3.8 kg/m2; 65.8±6.1 years) were recruited. The D and D+E interventions (group mean goal of ≥10% loss by 18-months) utilized partial meal replacements (2 meal replacement shakes/day for 6-months). Exercise training for E and D+E was 3 days/week, 60 minutes/day. Three day food records were collected at baseline, 6-months, and 18-months and analyzed for total energy and macro- and micronutrient intake. Comparisons of dietary intake among treatment groups were performed at 6 and 18 months using mixed linear models. Weight loss at 18-months was 11.3±8.3% (D), 10.3±6.8% (D+E), and 1.2±4.2% (E). Meal replacements were used by more than 60% (6-months) and 50% (18-months) of D and D+E participants, compared to ≤15% for E. Both D and D+E consumed less energy and fat, and more carbohydrates and selected micronutrients than E during follow-up. More than 50% of all participants consumed less than the recommended intake of particular vitamins and minerals. The diet intervention improved intakes of several nutrients. However, inadequate intake of several vitamins and minerals of concern for older adults suggests they need further

  7. A three-component cognitive behavioural lifestyle program for preconceptional weight-loss in women with polycystic ovary syndrome (PCOS): a protocol for a randomized controlled trial.

    Science.gov (United States)

    Jiskoot, G; Benneheij, S H; Beerthuizen, A; de Niet, J E; de Klerk, C; Timman, R; Busschbach, J J; Laven, J S E

    2017-03-06

    Obesity in women with polycystic ovary syndrome (PCOS) negatively affects all clinical features, and a 5 to 10% weight loss has shown promising results on reproductive, metabolic and psychological level. Incorporating a healthy diet, increasing physical activity and changing dysfunctional thought patterns in women with PCOS are key points in losing weight. The biggest challenge in weight management programs is to achieve a reasonable and sustainable weight loss. The aim of this study is to explore whether Cognitive Behavioural Therapy (CBT) by a mental health professional, working in a multidisciplinary team with a dietician and a physical therapist (a three-component intervention), is more effective for weight loss in the long term, within 12 months. We will also explore whether mobile phone applications are effective in supporting behavioural change and sustainable weight loss. The present study is a longitudinal randomized controlled trial (RCT) to study the effectiveness of a three-component 1-year cognitive-behavioural lifestyle intervention in overweight/obese women with PCOS. A total of 210 participants are randomly assigned to three groups: 1) CBT provided by the multidisciplinary team or; 2) CBT provided by the multidisciplinary team and Short Message Service (SMS) or; 3) usual care: encourage weight loss through publicly available services (control group). The primary aim of the 12-month intervention is to explore whether a three-component 1-year cognitive-behavioural lifestyle intervention is effective to decrease weight, when compared to usual care. Secondary outcomes include: the effect of the intervention on the PCOS phenotype, waist circumference, waist to hip ratio, ovulation rates, total testosterone, SHBG, free androgen index (FAI), AMH, hirsutism, acne, fasting glucose, blood pressure and all psychological parameters. Additionally, we assessed time to pregnancy, ongoing pregnancies, clinical pregnancies, miscarriages and birth weight. All

  8. Does the incorporation of portion-control strategies in a behavioral program improve weight loss in a 1-year randomized controlled trial?

    Science.gov (United States)

    Rolls, B J; Roe, L S; James, B L; Sanchez, C E

    2017-03-01

    Controlling food portion sizes can help reduce energy intake, but the effect of different portion-control methods on weight management is not known. In a 1-year randomized trial, we tested whether the efficacy of a behavioral weight-loss program was improved by incorporating either of the two portion-control strategies instead of standard advice about eating less. The Portion-Control Strategies Trial included 186 women with obesity (81%) or overweight (19%). Participants were randomly assigned to one of three equally intensive behavioral programs, consisting of 19 individual sessions over 12 months. The Standard Advice Group was instructed to eat less food while making healthy choices, the Portion Selection Group was instructed to choose portions based on the energy density using tools such as food scales and the Pre-portioned Foods Group was instructed to structure meals around pre-portioned foods such as single-serving main dishes, for which some vouchers were provided. In an intention-to-treat analysis, a mixed-effects model compared weight loss trajectories across 23 measurements; at month 12, weight was measured for 151 participants (81%). The trajectories showed that the Pre-portioned Foods Group initially lost weight at a greater rate than the other two groups (P=0.021), but subsequently regained weight at a greater rate (P=0.0005). As a result, weight loss did not differ significantly across groups at month 6 (mean±s.e. 5.2±0.4 kg) or month 12 (4.5±0.5 kg). After 1 year, measured weight loss averaged 6% of baseline weight. The frequency of using portion-control strategies initially differed across groups, then declined over time and converged at months 6 and 12. Incorporating instruction on portion-control strategies within a 1-year behavioral program did not lead to a greater weight loss than standard advice. Using pre-portioned foods enhanced early weight loss, but this was not sustained over time. Long-term maintenance of behavioral strategies to

  9. Effect of a High-Protein Diet versus Standard-Protein Diet on Weight Loss and Biomarkers of Metabolic Syndrome: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Ismael Campos-Nonato

    2017-06-01

    Full Text Available Background: Some studies have shown that protein-enriched diets can lead to greater weight loss and improvements in biomarkers of metabolic syndrome (MeS than standard protein diets. Therefore, the aim of this study was to determine the effect of increased protein intake on weight loss in Mexican adults with MeS. Methods: Randomized controlled trial in 118 adults aged 47.4 ± 11.5 years and meeting the established criteria for MeS were randomized to prescribed hypocaloric diets (500 kcal less than resting metabolic rate providing either 0.8 g/kg body weight (standard protein diet (SPD or 1.34 g/kg body weight (higher protein diet (HPD for 6 months. Body weight, waist circumference, percent body fat by bioimpedance analysis, fasting blood glucose, fasting insulin, hemoglobin A1c, total cholesterol, high-density lipoprotein (HDL cholesterol, very-low-density lipoprotein (VLDL cholesterol, triglycerides, C-reactive protein, creatinine, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase were measured at baseline, 3 months and at 6 months. Results: There were 105 subjects (51 for SPD and 54 for HPD who completed the trial. Overall weight loss was 5.1 ± 3.6 kg in the SPD group compared to 7.0 ± 3.7 kg in the in HPD group. Both groups lost a significant percent of centimeters of waist circumference (SPD -6.5 ± 2.6 cm and HPD -8.8 ± 2.6 cm. There was no statistical difference Except for the varying weight losses the two groups did not show any further differences overall. However in the subgroup judged to be adherent more than 75% of the time with the prescribed diets, there was a significant difference in mean weight loss (SPD -5.8% vs. HPD -9.5% after adjusting for baseline BMI. Both groups demonstrated significant decreases in waist circumference, glucose, insulin, triglycerides, and VLDL cholesterol, but there were no differences between the groups. There were no changes in blood tests for

  10. Effects on weight loss in adults of replacing diet beverages with water during a hypoenergetic diet: a randomized, 24-wk clinical trial.

    Science.gov (United States)

    Madjd, Ameneh; Taylor, Moira A; Delavari, Alireza; Malekzadeh, Reza; Macdonald, Ian A; Farshchi, Hamid R

    2015-12-01

    Obese people believe that drinking diet beverages (DBs) may be a simple strategy to achieve weight loss. However, nutritionists advise drinking water when attempting to lose weight. It is unclear how important drinking water instead of DBs is during a weight-loss program. In this study, we compared the effect on weight loss of either replacing DBs with water or continuing to consume DBs in adults during a 24-wk weight-loss program. Overweight and obese women [n = 89; body mass index (BMI; in kg/m(2)): 27-40; age: 18-50 y] who usually consumed DBs in their diet were asked to either substitute water for DBs (water group) or continue drinking DBs 5 times/wk after their lunch for 24 wk (DB group) while on a weight-loss program. Sixty-two participants (71%) completed the trial (32 in the DB group, 30 in the water group). Baseline variables were not statistically significantly different between groups. A statistically significant reduction in anthropometric measurements and statistically significant improvements in cardiometabolic risk characteristics were observed over 24 wk in both groups. Compared with the DB group, the water group had a greater decrease in weight (mean ± SD: water: -8.8 ± 1.9 kg; DBs: -7.6 ± 2.1 kg; P = 0.015, time × group), fasting insulin (mean ± SD: water: -2.84 ± 0.77 mU/L; DBs: -1.78 ± 1.25 mU/L, P water: -0.097 ± 0.049; DBs: -0.057 ± 0.042, P water: -1.02 ± 0.25 mmol/L; DBs: -0.72 ± 0.27 mmol/L; P fasting plasma glucose, and lipid profiles within both groups over 24 wk. Replacement of DBs with water after the main meal may lead to greater weight reduction during a weight-loss program. It may also offer clinical benefits to improve insulin resistance. This trial was registered at www.irct.ir/ as IRCT201402177754N5. © 2015 American Society for Nutrition.

  11. Effect of a High-Protein Diet versus Standard-Protein Diet on Weight Loss and Biomarkers of Metabolic Syndrome: A Randomized Clinical Trial.

    Science.gov (United States)

    Campos-Nonato, Ismael; Hernandez, Lucia; Barquera, Simon

    2017-01-01

    Some studies have shown that protein-enriched diets can lead to greater weight loss and improvements in biomarkers of metabolic syndrome (MeS) than standard protein diets. Therefore, the aim of this study was to determine the effect of increased protein intake on weight loss in Mexican adults with MeS. Randomized controlled trial in 118 adults aged 47.4 ± 11.5 years and meeting the established criteria for MeS were randomized to prescribed hypocaloric diets (500 kcal less than resting metabolic rate) providing either 0.8 g/kg body weight (standard protein diet (SPD)) or 1.34 g/kg body weight (higher protein diet (HPD)) for 6 months. Body weight, waist circumference, percent body fat by bioimpedance analysis, fasting blood glucose, fasting insulin, hemoglobin A1c, total cholesterol, high-density lipoprotein (HDL) cholesterol, very-low-density lipoprotein (VLDL) cholesterol, triglycerides, C-reactive protein, creatinine, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase were measured at baseline, 3 months and at 6 months. There were 105 subjects (51 for SPD and 54 for HPD) who completed the trial. Overall weight loss was 5.1 ± 3.6 kg in the SPD group compared to 7.0 ± 3.7 kg in the in HPD group. Both groups lost a significant percent of centimeters of waist circumference (SPD -6.5 ± 2.6 cm and HPD -8.8 ± 2.6 cm). There was no statistical difference Except for the varying weight losses the two groups did not show any further differences overall. However in the subgroup judged to be adherent more than 75% of the time with the prescribed diets, there was a significant difference in mean weight loss (SPD -5.8% vs. HPD -9.5%) after adjusting for baseline BMI. Both groups demonstrated significant decreases in waist circumference, glucose, insulin, triglycerides, and VLDL cholesterol, but there were no differences between the groups. There were no changes in blood tests for liver or renal function. There were no

  12. International Study to Predict Optimized Treatment for Depression (iSPOT-D, a randomized clinical trial: rationale and protocol

    Directory of Open Access Journals (Sweden)

    Cooper Nicholas J

    2011-01-01

    Full Text Available Abstract Background Clinically useful treatment moderators of Major Depressive Disorder (MDD have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators. Methods/Design The International Study to Predict Optimized Treatment - in Depression (iSPOT-D is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65 from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls. Study-eligible patients are antidepressant medication (ADM naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary. Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm. Discussion First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide. Trial registration International Study to Predict Optimised Treatment - in Depression (iSPOT-D ClinicalTrials.gov Identifier

  13. Prevention of bone loss by vitamin D supplementation in elderly women : A randomized double-blind trial

    NARCIS (Netherlands)

    Ooms, Marcel E.; Roos, Jan C.; Bezemer, P. Dick; van der Vijgh, Wim J F; Bouter, Lex M.; Lips, Paul

    1995-01-01

    The purpose of the study was to determine the effect of vitamin D supplementation on bone turnover and bone loss in elderly women. Three hundred forty-eight women, ages 70 yr and older, were randomized to receive 400 IU vitamin D3 per day (n = 177) or placebo (n = 171), double-blind, for a period of

  14. Long-term effects of a weight loss intervention with or without exercise component in postmenopausal women : A randomized trial

    NARCIS (Netherlands)

    de Roon, Martijn; van Gemert, Willemijn A; Peeters, Petra H; Schuit, A.J.; Monninkhof, Evelyn M

    2017-01-01

    The aim of this study was to determine the long-term effects of a weight loss intervention with or without an exercise component on body weight and physical activity. Women were randomized to diet (n = 97) or exercise (N = 98) for 16 weeks. During the intervention, both groups had achieved the set

  15. Weight-loss diets and 2-y changes in circulating amino acids in 2 randomized intervention trials123

    OpenAIRE

    Zheng, Yan; Ceglarek, Uta; Huang, Tao; Li, Lerong; Rood, Jennifer; Ryan, Donna H; Bray, George A; Sacks, Frank M; Schwarzfuchs, Dan; Thiery, Joachim; Shai, Iris; Qi, Lu

    2016-01-01

    Background: Circulating amino acids, such as branched-chain amino acids (BCAAs) and aromatic amino acids (AAAs), have been associated with diabetes risk; however, little is known about how a long-term dietary intervention for weight loss affects circulating amino acids.

  16. A two-year randomized weight loss trial comparing a vegan diet to a more moderate low-fat diet.

    Science.gov (United States)

    Turner-McGrievy, Gabrielle M; Barnard, Neal D; Scialli, Anthony R

    2007-09-01

    The objective was to assess the effect of a low-fat, vegan diet compared with the National Cholesterol Education Program (NCEP) diet on weight loss maintenance at 1 and 2 years. Sixty-four overweight, postmenopausal women were randomly assigned to a vegan or NCEP diet for 14 weeks, and 62 women began the study. The study was done in two replications. Participants in the first replication (N = 28) received no follow-up support after the 14 weeks, and those in the second replication (N = 34) were offered group support meetings for 1 year. Weight and diet adherence were measured at 1 and 2 years for all participants. Weight loss is reported as median (interquartile range) and is the difference from baseline weight at years 1 and 2. Individuals in the vegan group lost more weight than those in the NCEP group at 1 year [-4.9 (-0.5, -8.0) kg vs. -1.8 (0.8, -4.3); p vegan diet was associated with significantly greater weight loss than the NCEP diet at 1 and 2 years. Both group support and meeting attendance were associated with significant weight loss at follow-up.

  17. Center-size as a predictor of weight-loss outcome in multicenter trials including a low-calorie diet

    DEFF Research Database (Denmark)

    Gasteyger, Christoph Rolf; Christensen, Robin; Larsen, Thomas Meinert

    2010-01-01

    weight loss. This is a post hoc analysis of an existing database: 701 obese subjects (77% women, 23% men, mean BMI: 38.9 kg/m(2)) were enrolled at 22 sites (4-85 subjects/site) in five countries to follow a LCD providing 800-1,000 kcal/day during 8 weeks. The main outcome measure was the percentage...

  18. A Controlled Pharmacogenetic Trial of Sibutramine on Weight Loss and Body Composition in Obese or Overweight Adults

    Science.gov (United States)

    Grudell, April B.M.; Sweetser, Seth; Camilleri, Michael; Eckert, Deborah J.; Vazquez-Roque, Maria I.; Carlson, Paula J.; Burton, Duane D.; Braddock, Autumn E.; Clark, Matthew M.; Graszer, Karen M.; Kalsy, Sarah A.; Zinsmeister, Alan R.

    2008-01-01

    Background/ Aim Weight loss in response to sibutramine is highly variable. We assessed the association of specific markers of polymorphisms of candidate a2A adrenoreceptor, 5-HT transporter and GNβ3 genes and weight loss with sibutramine. Methods We conducted a randomized, double-blind, pharmacogenetic study of behavioral therapy and sibutramine (10 or 15 mg daily) or placebo for 12 weeks in 181 overweight or obese participants. We measured body weight, BMI, body composition, gastric emptying and genetic variation (α2A C1291G, 5-HTTLPR, and GNβ3 C825T genotypes). ANCOVA was used to assess treatment effects on, and associations of the specific markers of candidate genes with weight loss and body composition. Results Sibutramine, 10 and 15 mg, caused significant weight loss (p = 0.009); there was a statistically significant gene by dose interaction for GNβ3 genotype. For each candidate gene, significant treatment effects at 12 weeks were observed (psibutramine doses versus placebo): α2A CC genotype ( Δ ~5kg), GNβ3 TC/TT genotype (Δ ~6kg), and 5-HTTLPR LS/SS (Δ ~4.5kg). Gene pairs resulted in significantly greater sibutramine treatment effects on weight (both psibutramine also resulted in significantly greater reduction of body fat for specific α2A CC and GNβ3 TC/TT genotype variants individually (both psibutramine and behavioral therapy. PMID:18725220

  19. Screen-time Weight-loss Intervention Targeting Children at Home (SWITCH): A randomized controlled trial study protocol

    OpenAIRE

    Tsai Midi; Jiang Yannan; Epstein Leonard; Foley Louise; Mhurchu Cliona; Maddison Ralph; Dewes Ofa; Heke Ihirangi

    2011-01-01

    Abstract Background Approximately one third of New Zealand children and young people are overweight or obese. A similar proportion (33%) do not meet recommendations for physical activity, and 70% do not meet recommendations for screen time. Increased time being sedentary is positively associated with being overweight. There are few family-based interventions aimed at reducing sedentary behavior in children. The aim of this trial is to determine the effects of a 24 week home-based, family orie...

  20. Risk factors for non-adherence and loss to follow-up in a three-year clinical trial in Botswana.

    Science.gov (United States)

    Gust, Deborah A; Mosimaneotsile, Barudi; Mathebula, Unami; Chingapane, Balladiah; Gaul, Zaneta; Pals, Sherri L; Samandari, Taraz

    2011-04-25

    Participant non-adherence and loss to follow-up can compromise the validity of clinical trial results. An assessment of these issues was made in a 3-year tuberculosis prevention trial among HIV-infected adults in Botswana. Between 11/2004-07/2006, 1995 participants were enrolled at eight public health clinics. They returned monthly to receive bottles of medication and were expected to take daily tablets of isoniazid or placebo for three years. Non-adherence was defined as refusing tablet ingestion but agreeing to quarterly physical examinations. Loss to follow-up was defined as not having returned for appointments in ≥60 days. Between 10/2008-04/2009, survey interviews were conducted with 83 participants identified as lost to follow-up and 127 identified as non-adherent. As a comparison, 252 randomly selected adherent participants were also surveyed. Multivariate logistic regression analysis was used to identify associations with selected risk factors. Men had higher odds of being non-adherent (adjusted odds ratio (AOR), 2.24; 95% confidence interval [95%CI] 1.24-4.04) and lost to follow-up (AOR 3.08; 95%CI 1.50-6.33). Non-adherent participants had higher odds of reporting difficulties taking the regimen or not knowing if they had difficulties (AOR 3.40; 95%CI 1.75-6.60) and lower odds associated with each year of age (AOR 0.95; 95%CI 0.91-0.98), but other variables such as employment, distance from clinic, alcohol use, and understanding study requirements were not significantly different than controls. Among participants who were non-adherent or lost to follow-up, 40/210 (19.0%) reported that they stopped the medication because of work commitments and 33/210 (15.7%) said they thought they had completed the study. Men had higher odds of non-adherence and loss to follow-up than women. Potential interventions that might improve adherence in trial participants may include:targeting health education for men, reducing barriers, clarifying study expectations, educating

  1. Enhancement of Self-Monitoring in a Web-Based Weight Loss Program by Extra Individualized Feedback and Reminders: Randomized Trial.

    Science.gov (United States)

    Hutchesson, Melinda Jane; Tan, Chor Yin; Morgan, Philip; Callister, Robin; Collins, Clare

    2016-04-12

    Self-monitoring is an essential behavioral strategy for effective weight loss programs. Traditionally, self-monitoring has been achieved using paper-based records. However, technology is now more frequently used to deliver treatment programs to overweight and obese adults. Information technologies, such as the Internet and mobile phones, allow innovative intervention features to be incorporated into treatment that may facilitate greater adherence to self-monitoring processes, provide motivation for behavior change, and ultimately lead to greater weight loss success. The objective of our study was to determine whether the consistency of self-monitoring differed between participants randomly assigned to a basic or an enhanced 12-week commercial Web-based weight loss program. We randomly assigned a sample of 301 adults (mean age 42.3 years; body mass index 31.3 kg/m2; female 176/301, 58.5%) to the basic or enhanced group. The basic program included tools for self-monitoring (online food and exercise diary, and a weekly weigh-in log) with some feedback and reminders to weigh in (by text or email). The enhanced program included the basic components, as well as extra individualized feedback on self-monitoring entries and reminders (by text, email, or telephone) to engage with self-monitoring tools. We evaluated the level of self-monitoring by examining the consistency of self-monitoring of food, exercise, and weight during the 12 weeks. Consistency was defined as the number of weeks during which participants completed a criterion number of entries (ie, ≥3 days of online food or exercise diary records per week and ≥1 weigh-in per week). The enhanced group's consistency of use of self-monitoring tools was significantly greater than that of the basic group throughout the 12 weeks (median consistency for food 8 vs 3 weeks, respectively, Pself-monitoring behaviors in a Web-based weight loss program. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN

  2. Fresh Start, a postpartum weight loss intervention for diverse low-income women: design and methods for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Milagros C. Rosal

    2016-09-01

    Full Text Available Abstract Background Overweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women’s weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and methods of a randomized clinical trial of Fresh Start, an innovative narrative-based group intervention aimed at promoting postpartum weight loss among low-income, diverse women. Methods/design Study participants were recruited from the five sites of the Women, Infants and Children (WIC program in central Massachusetts. Participants were English-speaking, age ≥ 18 years, 6 weeks to 6 months postpartum, with a body mass index (BMI ≥ 27 kg/m2. The Fresh Start postpartum weight loss intervention, adapted from the Diabetes Prevention Program (DPP in collaboration with WIC staff and clients, consisted of an 8-week group-based curriculum followed by nine monthly telephone calls. It included a narrative component (i.e., storytelling, group discussions, print materials and access to exercise facilities. The study is a two-arm randomized controlled trial. The control condition included print materials and access to exercise facilities. In-person assessments were conducted at baseline and at 6 and 12 months following the eight-week intervention phase. Discussion The Fresh Start intervention translated key elements of an evidence-based weight loss protocol into a format that is hypothesized to be relevant, acceptable and effective for the target audience of low-SES postpartum women. This novel intervention was developed in collaboration with WIC to be sustainable within the context of its clinics, which reach approximately 9 million individuals

  3. Project TEAMS (Talking about Eating, Activity, and Mutual Support): a randomized controlled trial of a theory-based weight loss program for couples.

    Science.gov (United States)

    Gorin, Amy A; Powers, Theodore A; Gettens, Katelyn; Cornelius, Talea; Koestner, Richard; Mobley, Amy R; Pescatello, Linda; Medina, Tania Huedo

    2017-09-29

    Obesity risk is shared between spouses, yet existing weight loss programs focus on individuals and not the marital dyad. Given the interdependence of weight in couples, weight management outcomes might be improved by targeting joint weight loss and the creation of an interpersonal milieu that supports long-term behavior change. According to Self-Determination Theory (SDT), greater autonomous self-regulation of behaviors, and subsequently better treatment outcomes, are observed in needs supportive environments in which personally meaningful choice is supported and criticism and control are minimized. Correlational analyses confirm these pathways in weight management, with needs support from one's spouse or partner emerging as a distinct predictor of weight loss success. Research is now needed to establish causal links and to develop and test weight loss interventions designed to facilitate the needs supportive behavior of spouses. Project TEAMS (Talking about Eating, Activity, and Mutual Support) is a randomized controlled trial testing a couples-based intervention, grounded in SDT, designed to change the social context of weight loss by training spouses to provide needs support for each other's eating and physical activity behavior. Sixty-four couples will be randomized to either 6 months of behavioral weight loss treatment informed by SDT (SDT-WL) or to 6 months of standard behavioral weight loss treatment (BWL). Couples will attend weekly sessions for 6 months and will be assessed at 0, 3, 6, and 12 months. By bolstering needs support, SDT-WL is predicted to increase autonomous self-regulation and perceived competence and produce greater weight loss and maintenance than standard behavioral treatment. Exploratory analyses will examine the SDT process model prediction that the influence of needs support on treatment outcomes will be mediated by autonomous self-regulation and perceived competence. This study addresses the fundamental importance of interpersonal

  4. Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial

    Directory of Open Access Journals (Sweden)

    Caterson Ian D

    2009-10-01

    Full Text Available Abstract Background and aims Elevated levels of serum uric acid are associated with an increased risk of cardiovascular morbidity and mortality. The response of uric acid to weight loss therapy (lifestyle plus sibutramine in an overweight and obese cardiovascular high risk population was studied. Methods and results Data from a four week single-blind lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT study were analyzed. 2584 patients (24% had diabetes mellitus (DM only, 1748 (16% had cardiovascular disease (CVD only and 6397 (60% had both DM + CVD. Uric acid concentrations (mean ± standard deviation at screening were significantly higher among patients with CVD compared to patients without CVD (p Conclusion A four week daily intake of sibutramine and life style changes was associated with significant reductions in mean uric acid levels. Changes in renal glucose load in diabetes seem to counteract a potential uricosuric effect of sibutramine. Trial Registration The trial is registered at ClinicalTrial.gov number: NCT00234832.

  5. Combat, prevention and optimization of commercial losses of power energy; Combate, prevencao e otimizacao das perdas comerciais da energia eletrica

    Energy Technology Data Exchange (ETDEWEB)

    Penin, Carlos Alexandre de Sousa

    2008-07-01

    The objective of this work is to study the problem of NTL using a wide approach, analyze the experience of dealerships in Brazil and abroad, discuss the best practices for mitigation of those losses and propose improvements in the combat and prevention processes, and the legal procedures for recovery of incomes, leaning on a careful regulatory context. This study draws attention to Brazil's socioeconomic diversity, comparing it to various international examples, and intends to identify the most relevant aspects that must be considered on the theme, discussing procedures and methodologies for the equation of the amount of resources to be applied by distributing companies to achieve the appropriate reduction of NTL. (author)

  6. Using social media to deliver weight loss programming to young adults: Design and rationale for the Healthy Body Healthy U (HBHU) trial.

    Science.gov (United States)

    Napolitano, Melissa A; Whiteley, Jessica A; Mavredes, Meghan N; Faro, Jamie; DiPietro, Loretta; Hayman, Laura L; Neighbors, Charles J; Simmens, Samuel

    2017-09-01

    The transitional period from late adolescence to early adulthood is a vulnerable period for weight gain, with a twofold increase in overweight/obesity during this life transition. In the United States, approximately one-third of young adults have obesity and are at a high risk for weight gain. To describe the design and rationale of a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) sponsored randomized, controlled clinical trial, the Healthy Body Healthy U (HBHU) study, which compares the differential efficacy of three interventions on weight loss among young adults aged 18-35years. The intervention is delivered via Facebook and SMS Text Messaging (text messaging) and includes: 1) targeted content (Targeted); 2) tailored or personalized feedback (Tailored); or 3) contact control (Control). Recruitment is on-going at two campus sites, with the intervention delivery conducted by the parent site. A total of 450 students will be randomly-assigned to receive one of three programs for 18months. We hypothesize that: a) the Tailored group will lose significantly more weight at the 6, 12, 18month follow-ups compared with the Targeted group; and that b) both the Tailored and Targeted groups will have greater weight loss at the 6, 12, 18month follow-ups than the Control group. We also hypothesize that participants who achieve a 5% weight loss at 6 and 18months will have greater improvements in their cardiometabolic risk factors than those who do not achieve this target. We will examine intervention costs to inform implementation and sustainability other universities. Expected study completion date is 2019. This project has significant public health impact, as the successful translation could reach as many as 20 million university students each year, and change the current standard of practice for promoting weight management within university campus communities. ClinicalTrial.gov: NCT02342912. Copyright © 2017. Published by Elsevier Inc.

  7. Does diet intervention in line with nutrition recommendations affect dietary carbon footprint? Results from a weight loss trial among lactating women.

    Science.gov (United States)

    Huseinovic, E; Ohlin, M; Winkvist, A; Bertz, F; Sonesson, U; Brekke, H K

    2017-10-01

    Results from studies evaluating the sustainability of diets combining environmental and nutritional aspects have been diverse; thus, greenhouse gas emissions (that is, carbon footprint (CF)) of diets in line with dietary recommendations in free-living individuals warrants further examination. Here, changes in dietary CF related to changes in food choice during a weight loss trial among lactating women who received a 12-week diet intervention based on the Nordic Nutrition Recommendations (NNR) 2004 were analyzed. The objective of this study was to examine if a diet intervention based on NNR 2004 results in reduced dietary CF. Changes in dietary CF were analyzed among 61 lactating women participating in a weight loss trial. Food intake data from 4-day weighed diet records and results from life cycle analyses were used to examine changes in dietary CF across eight food groups during the intervention, specified in the unit carbon dioxide equivalent (CO 2 eq/day). Differences in changes in dietary CF between women receiving diet treatment (D-group) and women not receiving it (ND-group) were compared. There was no difference in change in dietary CF of the overall diet between D- and ND-group (P>0.05). As for the eight food groups, D-group increased their dietary CF from fruit and vegetables (+0.06±0.13 kg CO 2 eq/day) compared with a decrease in ND-group (-0.01±0.01 kg CO 2 eq/day) during the intervention, P=0.01. A diet intervention in line with NNR 2004 produced clinically relevant weight loss, but did not reduce dietary CF among lactating women with overweight and obesity. Dietary interventions especially designed to decrease dietary CF and their coherence with dietary recommendations need further exploration.

  8. Tranexamic Acid Safely Reduced Blood Loss in Hemi- and Total Hip Arthroplasty for Acute Femoral Neck Fracture: A Randomized Clinical Trial.

    Science.gov (United States)

    Watts, Chad D; Houdek, Matthew T; Sems, S Andrew; Cross, William W; Pagnano, Mark W

    2017-07-01

    We aimed to determine whether (1) tranexamic acid (TXA) reduces the incidence of transfusion (2) TXA reduces the calculated blood loss, and (3) there are any observable differences in 30- and 90-day complications with TXA administration during arthroplasty for femoral neck fracture (FNF). Prospective, double-blinded, randomized controlled trial. Level 1 Academic Trauma Center. One hundred thirty-eight patients who presented with a low-energy, isolated, FNF (AO 31B) treated with either hemi- or total hip arthroplasty within 72 hours of injury were randomized to either the TXA group (69 patients) or placebo group (69 patients). In the TXA group, patients received 2 doses of 15 mg/kg intravenous TXA dissolved in 100 mL of saline, each administered over 10 minutes; 1 dose just before incision, and the second at wound closure. In the placebo group, 100 mL of saline solution was administered in a similar fashion. Perioperative care was otherwise standardized including conservative transfusion criteria. Our primary outcome was to determine the proportion of patients who underwent blood transfusion during hospitalization. Secondary outcomes were calculated blood loss, number of units transfused during hospitalization, and incidence of adverse events at 30 and 90 days including thromboembolic event, wound complications, reoperation, hospital readmission, and all-cause mortality. TXA reduced mean incidence of transfusion by 305 mL (P = 0.0005). There was a trend toward decreased transfusion rate in the TXA group (17% vs. 26%, P = 0.22). TXA was safe with no differences in adverse events at 30 and 90 days. This randomized clinical trial found that TXA administration safely reduced blood loss with a tendency for decreased transfusion rate and total blood product consumption for patients undergoing hip arthroplasty for acute FNF. More studies are needed to further ascertain the role of TXA in the management of patients with FNF. Therapeutic Level I. See Instructions for Authors

  9. A randomised trial comparing the effect of exercise training and weight loss on microvascular function in coronary artery disease

    DEFF Research Database (Denmark)

    Olsen, Rasmus Huan; Pedersen, Lene Rørholm; Jürs, Anders

    2015-01-01

    BACKGROUND: Coronary microvascular function is associated with outcome and is reduced in coronary artery disease (CAD) and obesity. We compared the effect of aerobic interval training (AIT) and weight loss on coronary flow reserve (CFR) and peripheral vascular function in revascularised obese CAD...... patients. METHODS AND RESULTS: Seventy non-diabetic patients (BMI 28-40 kg × m(-2), age 45-75 years) were randomised to 12 weeks' AIT (three weekly sessions lasting 38 min with ≈ 16 min at 85-90% of VO2peak) or low energy diet (LED, 800-1000 kcal/day). Per protocol adherence was defined by training......-attendance ≥ 60% and weight loss ≥ 5%, respectively. CFR was assessed by Doppler echocardiography of the LAD. Peripheral vascular function was assessed by arterial tonometry as reactive hyperaemia index (RHI) and augmentation index. Most participants had impaired CFR with a mean CFR of 2.38 (SD 0.59). Twenty...

  10. Can local application of Tranexamic acid reduce post-coronary bypass surgery blood loss? A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Latter David

    2009-06-01

    Full Text Available Abstract Background Diffuse microvascular bleeding remains a common problem after cardiac procedures. Systemic use of antifibrinolytic reduces the postoperative blood loss. The purpose of this study was to examine the effectiveness of local application of tranexamic acid to reduce blood loss after coronary artery bypass grafting (CABG. Methods Thirty eight patients scheduled for primary isolated coronary artery bypass grafting were included in this double blind, prospective, randomized, placebo controlled study. Tranexamic acid (TA group (19 patients received 1 gram of TA diluted in 100 ml normal saline. Placebo group (19 patients received 100 ml of normal saline only. The solution was purred in the pericardial and mediastinal cavities. Results Both groups were comparable in their baseline demographic and surgical characteristics. During the first 24 hours post-operatively, cumulative blood loss was significantly less in TA group (median of 626 ml compared to Placebo group (median of 1040 ml (P = 0.04. There was no significant difference in the post-op Packed RBCs transfusion between both groups (median of one unit in each (P = 0.82. Significant less platelets transfusion required in TA group (median zero unit than in placebo group (median 2 units (P = 0.03. Apart from re-exploration for excessive surgical bleeding in one patient in TA group, no difference was found in morbidity or mortality between both groups. Conclusion Topical application of tranexamic acid in patients undergoing primary coronary artery bypass grafting led to a significant reduction in postoperative blood loss without adding extra risk to the patient.

  11. Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial.

    Science.gov (United States)

    Peterli, Ralph; Wölnerhanssen, Bettina Karin; Peters, Thomas; Vetter, Diana; Kröll, Dino; Borbély, Yves; Schultes, Bernd; Beglinger, Christoph; Drewe, Jürgen; Schiesser, Marc; Nett, Philipp; Bueter, Marco

    2018-01-16

    Sleeve gastrectomy is increasingly used in the treatment of morbid obesity, but its long-term outcome vs the standard Roux-en-Y gastric bypass procedure is unknown. To determine whether there are differences between sleeve gastrectomy and Roux-en-Y gastric bypass in terms of weight loss, changes in comorbidities, increase in quality of life, and adverse events. The Swiss Multicenter Bypass or Sleeve Study (SM-BOSS), a 2-group randomized trial, was conducted from January 2007 until November 2011 (last follow-up in March 2017). Of 3971 morbidly obese patients evaluated for bariatric surgery at 4 Swiss bariatric centers, 217 patients were enrolled and randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass with a 5-year follow-up period. Patients were randomly assigned to undergo laparoscopic sleeve gastrectomy (n = 107) or laparoscopic Roux-en-Y gastric bypass (n = 110). The primary end point was weight loss, expressed as percentage excess body mass index (BMI) loss. Exploratory end points were changes in comorbidities and adverse events. Among the 217 patients (mean age, 45.5 years; 72% women; mean BMI, 43.9) 205 (94.5%) completed the trial. Excess BMI loss was not significantly different at 5 years: for sleeve gastrectomy, 61.1%, vs Roux-en-Y gastric bypass, 68.3% (absolute difference, -7.18%; 95% CI, -14.30% to -0.06%; P = .22 after adjustment for multiple comparisons). Gastric reflux remission was observed more frequently after Roux-en-Y gastric bypass (60.4%) than after sleeve gastrectomy (25.0%). Gastric reflux worsened (more symptoms or increase in therapy) more often after sleeve gastrectomy (31.8%) than after Roux-en-Y gastric bypass (6.3%). The number of patients with reoperations or interventions was 16/101 (15.8%) after sleeve gastrectomy and 23/104 (22.1%) after Roux-en-Y gastric bypass. Among patients with morbid obesity, there was no significant difference in excess BMI loss between laparoscopic sleeve gastrectomy and laparoscopic Roux

  12. Weight loss among female health care workers- a 1-year workplace based randomized controlled trial in the FINALE-health study

    Directory of Open Access Journals (Sweden)

    Christensen Jeanette R

    2012-08-01

    Full Text Available Abstract Background Weight management constitutes a substantial problem particularly among groups of low socio-economic status. Interventions at work places may be a solution, but high quality worksite interventions documenting prolonged weight loss are lacking. This paper presents results of an intervention aimed to achieve a 12 months weight loss among overweight health care workers. Methods Ninety-eight overweight female health care workers were randomized into an intervention or a reference group. The intervention consisted of diet, physical exercise and cognitive behavioral training during working hours 1 hour/week. The reference group was offered monthly oral presentations. Several anthropometric measures, blood pressure, cardiorespiratory fitness, maximal muscle strength, and musculoskeletal pain were measured before and after the 12-months intervention period. Data were analyzed by intention-to-treat analysis. Results The intervention group significantly reduced body weight by 6 kg (p  Conclusions The intervention generated substantial reductions in body weight, BMI and body fat percentage among overweight female health care workers over 12 months. The positive results support the workplace as an efficient arena for weight loss among overweight females. Trial registration NCT01015716.

  13. [A comparative study on efficacy of glucocorticoids, mineralocorticoids and vasoactive drugs on reversing hearing loss in patients suffering idiopathic sensorineural cochlear hypoacusis. A preliminary clinical trial].

    Science.gov (United States)

    Campos-Bañales, Eugenia María; López-Campos, Daniel; de Serdio-Arias, José Luis; Esteban-Rodriguez, J; García-Sáinz, Mar; Muñoz-Cortés, Álvaro; López-Aguado, Daniel

    2015-01-01

    Sensory neural hearing loss (SNHL) is a disorder characterised by an important deterioration of the auditory function. Re-establishing normal ion homeostasis of the endolymph could be related to hearing recovery and it might be mediated by mineralocorticoids. The main purpose of this preliminary, randomized controlled clinical trial was assessing the recovery of idiopathic sensory neural cochlear hearing loss (SNHL) by comparing the efficacy of 2 types of steroids versus vasodilators. The 3-month intervention involved 70 patients, allocated into 4 different groups: a control with no medication, consisting of 14 patients (8 men and 6 women); a vasodilator group of 21 patients (11 men and 10 women); a glucocorticoid group with 16 patients (10 men and 6 women); and a mineralocorticoid therapy group, consisting of 19 patients (11 men and 8 women). The level of hearing loss and its topography were estimated using Liminal Tone Audiometry (LTA) and Auditory Brainstem Response (ABR). Our research found overall greater efficacy of mineralocorticoids versus glucocorticoids and vasodilators. There was better response in women than in men and it was higher from the left ear, regardless of patient gender. The hearing gain was significantly superior in the mineralocorticoid group, followed by the glucocorticoid group. However, the responses to vasodilators were lesser and of low statistical significance. Copyright © 2014 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

  14. Renal Function Following Three Distinct Weight Loss Dietary Strategies During 2 Years of a Randomized Controlled Trial

    OpenAIRE

    Tirosh, Amir; Golan, Rachel; Harman-Boehm, Ilana; Henkin, Yaakov; Schwarzfuchs, Dan; Rudich, Assaf; Kovsan, Julia; Fiedler, Georg M.; Blüher, Matthias; Stumvoll, Michael; Thiery, Joachim; Stampfer, Meir J.; Shai, Iris

    2013-01-01

    OBJECTIVE This study addressed the long-term effect of various diets, particularly low-carbohydrate high-protein, on renal function on participants with or without type 2 diabetes. RESEARCH DESIGN AND METHODS In the 2-year Dietary Intervention Randomized Controlled Trial (DIRECT), 318 participants (age, 51 years; 86% men; BMI, 31 kg/m2; mean estimated glomerular filtration rate [eGFR], 70.5 mL/min/1.73 m2; mean urine microalbumin-to-creatinine ratio, 12:12) with serum creatinine 0.05) across...

  15. Missing data in randomized clinical trials for weight loss: scope of the problem, state of the field, and performance of statistical methods.

    Directory of Open Access Journals (Sweden)

    Mai A Elobeid

    2009-08-01

    Full Text Available Dropouts and missing data are nearly-ubiquitous in obesity randomized controlled trails, threatening validity and generalizability of conclusions. Herein, we meta-analytically evaluate the extent of missing data, the frequency with which various analytic methods are employed to accommodate dropouts, and the performance of multiple statistical methods.We searched PubMed and Cochrane databases (2000-2006 for articles published in English and manually searched bibliographic references. Articles of pharmaceutical randomized controlled trials with weight loss or weight gain prevention as major endpoints were included. Two authors independently reviewed each publication for inclusion. 121 articles met the inclusion criteria. Two authors independently extracted treatment, sample size, drop-out rates, study duration, and statistical method used to handle missing data from all articles and resolved disagreements by consensus. In the meta-analysis, drop-out rates were substantial with the survival (non-dropout rates being approximated by an exponential decay curve (e(-lambdat where lambda was estimated to be .0088 (95% bootstrap confidence interval: .0076 to .0100 and t represents time in weeks. The estimated drop-out rate at 1 year was 37%. Most studies used last observation carried forward as the primary analytic method to handle missing data. We also obtained 12 raw obesity randomized controlled trial datasets for empirical analyses. Analyses of raw randomized controlled trial data suggested that both mixed models and multiple imputation performed well, but that multiple imputation may be more robust when missing data are extensive.Our analysis offers an equation for predictions of dropout rates useful for future study planning. Our raw data analyses suggests that multiple imputation is better than other methods for handling missing data in obesity randomized controlled trials, followed closely by mixed models. We suggest these methods supplant last

  16. Optimized enzyme-linked immunosorbent assay for detecting cytomegalovirus infections during clinical trials of recombinant vaccines.

    Science.gov (United States)

    Pagnon, Anke; Piras, Fabienne; Gimenez-Fourage, Sophie; Dubayle, Joseline; Arnaud-Barbe, Nadège; Hessler, Catherine; Caillet, Catherine

    2017-11-01

    In clinical trials of cytomegalovirus (CMV) glycoprotein B (gB) vaccines, CMV infection is detected by first depleting serum of anti-gB antibodies and then measuring anti-CMV antibodies with a commercially available enzyme-linked immunosorbent assay (ELISA) kit, with confirmation of positive findings by immunoblot. Identification of CMV immunoantigens for the development of an ELISA that detects specifically CMV infection in clinical samples from individuals immunized with gB vaccines. Sensitivity and specificity of ELISAs using antigenic regions of CMV proteins UL83/pp65, UL99/pp28, UL44/pp52, UL80a/pp38, UL57, and UL32/pp150 were measured. An IgG ELISA using a UL32/pp150 [862-1048] capture peptide was the most specific (93.7%) and sensitive (96.4%) for detecting CMV-specific antibodies in sera. The ELISA successfully detected CMV-specific antibodies in 22 of 22 sera of subjects who had been vaccinated with a gB vaccine but who had later been infected with CMV. The ELISA was linear over a wide range of CMV concentrations (57-16,814 ELISA units/mL) and was reproducible as indicated by a 5% intra-day and 7% inter-day coefficients of variation. The signal was specifically competed by UL32/pp150 [862-1048] peptide but not by CMV-gB or herpes simplex virus 2 glycoprotein D. Lipid and hemoglobin matrix did not interfere with the assay. The UL32/pp150 [862-1048] IgG ELISA can be used for the sensitive and specific detection of CMV infection in gB-vaccinated individuals. Copyright © 2017 Elsevier B.V. All rights reserved.

  17. Effect of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk: A randomized 1-year trial.

    Science.gov (United States)

    Sundfør, T M; Svendsen, M; Tonstad, S

    2018-07-01

    Long-term adherence to conventional weight-loss diets is limited while intermittent fasting has risen in popularity. We compared the effects of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk factors in adults with abdominal obesity and ≥1 additional component of metabolic syndrome. In total 112 participants (men [50%] and women [50%]) aged 21-70 years with BMI 30-45 kg/m 2 (mean 35.2 [SD 3.7]) were randomized to intermittent or continuous energy restriction. A 6-month weight-loss phase including 10 visits with dieticians was followed by a 6-month maintenance phase without additional face-to-face counselling. The intermittent energy restriction group was advised to consume 400/600 kcal (female/male) on two non-consecutive days. Based on dietary records both groups reduced energy intake by ∼26-28%. Weight loss was similar among participants in the intermittent and continuous energy restriction groups (8.0 kg [SD 6.5] versus 9.0 kg [SD 7.1]; p = 0.6). There were favorable improvements in waist circumference, blood pressure, triglycerides and HDL-cholesterol with no difference between groups. Weight regain was minimal and similar between the intermittent and continuous energy restriction groups (1.1 kg [SD 3.8] versus 0.4 kg [SD 4.0]; p = 0.6). Intermittent restriction participants reported higher hunger scores than continuous restriction participants on a subjective numeric rating scale (4.7 [SD 2.2] vs 3.6 [SD 2.2]; p = 0.002). Both intermittent and continuous energy restriction resulted in similar weight loss, maintenance and improvements in cardiovascular risk factors after one year. However, feelings of hunger may be more pronounced during intermittent energy restriction. www.clinicaltrials.govNCT02480504. Copyright © 2018 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine

  18. Effects of a weight loss plus exercise program on physical function in overweight, older women: a randomized controlled trial.

    Science.gov (United States)

    Anton, Stephen D; Manini, Todd M; Milsom, Vanessa A; Dubyak, Pamela; Cesari, Matteo; Cheng, Jing; Daniels, Michael J; Marsiske, Michael; Pahor, Marco; Leeuwenburgh, Christiaan; Perri, Michael G

    2011-01-01

    Obesity and a sedentary lifestyle are associated with physical impairments and biologic changes in older adults. Weight loss combined with exercise may reduce inflammation and improve physical functioning in overweight, sedentary, older adults. This study tested whether a weight loss program combined with moderate exercise could improve physical function in obese, older adult women. Participants (N = 34) were generally healthy, obese, older adult women (age range 55-79 years) with mild to moderate physical impairments (ie, functional limitations). Participants were randomly assigned to one of two groups for 24 weeks: (i) weight loss plus exercise (WL+E; n = 17; mean age = 63.7 years [4.5]) or (ii) educational control (n = 17; mean age = 63.7 [6.7]). In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions within their community each week. During exercise sessions, participants engaged in brisk walking and lower-body resistance training of moderate intensity. Participants in the educational control group attended monthly health education lectures on topics relevant to older adults. Outcomes were: (i) body weight, (ii) walking speed (assessed by 400-meter walk test), (iii) the Short Physical Performance Battery (SPPB), and (iv) knee extension isokinetic strength. Participants randomized to the WL+E group lost significantly more weight than participants in the educational control group (5.95 [0.992] vs 0.23 [0.99] kg; P meter walk test = 44 seconds; P < 0.05). Scores on the SPPB improved in both the intervention and educational control groups from pre- to post-test (P < 0.05), with significant differences between groups (P = 0.02). Knee extension strength was maintained in both groups. Our findings suggest that a lifestyle-based weight loss program consisting of moderate caloric restriction plus moderate exercise can produce significant weight loss and improve physical function while maintaining muscle

  19. Combat, prevention and optimization of commercial losses of power energy; Combate, prevencao e otimizacao das perdas comerciais da energia eletrica

    Energy Technology Data Exchange (ETDEWEB)

    Penin, Carlos Alexandre de Sousa

    2008-07-01

    The objective of this work is to study the problem of NTL using a wide approach, analyze the experience of dealerships in Brazil and abroad, discuss the best practices for mitigation of those losses and propose improvements in the combat and prevention processes, and the legal procedures for recovery of incomes, leaning on a careful regulatory context. This study draws attention to Brazil's socioeconomic diversity, comparing it to various international examples, and intends to identify the most relevant aspects that must be considered on the theme, discussing procedures and methodologies for the equation of the amount of resources to be applied by distributing companies to achieve the appropriate reduction of NTL. (author)

  20. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial.

    Science.gov (United States)

    Kil, Jonathan; Lobarinas, Edward; Spankovich, Christopher; Griffiths, Scott K; Antonelli, Patrick J; Lynch, Eric D; Le Prell, Colleen G

    2017-09-02

    Noise-induced hearing loss is a leading cause of occupational and recreational injury and disease, and a major determinant of age-related hearing loss. No therapeutic agent has been approved for the prevention or treatment of this disorder. In animal models, glutathione peroxidase 1 (GPx1) activity is reduced after acute noise exposure. Ebselen, a novel GPx1 mimic, has been shown to reduce both temporary and permanent noise-induced hearing loss in preclinical studies. We assessed the safety and efficacy of ebselen for the prevention of noise-induced hearing loss in young adults in a phase 2 clinical trial. In this single-centre, randomised, double-blind, placebo-controlled phase 2 trial, healthy adults aged 18-31 years were randomly assigned (1:1:1:1) at the University of Florida (Gainsville, FL, USA) to receive ebselen 200 mg, 400 mg, or 600 mg, or placebo orally twice daily for 4 days, beginning 2 days before a calibrated sound challenge (4 h of pre-recorded music delivered by insert earphones). Randomisation was done with an allocation sequence generated by an independent third party. The primary outcome was mean temporary threshold shift (TTS) at 4 kHz measured 15 min after the calibrated sound challenge by pure tone audiometry; a reduction of 50% in an ebselen dose group compared with the placebo group was judged to be clinically relevant. All participants who received the calibrated sound challenge and at least one dose of study drug were included in the efficacy analysis. All randomly assigned patients were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT01444846. Between Jan 11, 2013, and March 24, 2014, 83 participants were enrolled and randomly assigned to receive ebselen 200 mg (n=22), 400 mg (n=20), or 600 mg (n=21), or placebo (n=20). Two participants in the 200 mg ebselen group were discontinued from the study before the calibrated sound challenge because they no longer met the inclusion criteria; these

  1. Optimizing treatment with tumour necrosis factor inhibitors in rheumatoid arthritis—a proof of principle and exploratory trial: is dose tapering practical in good responders?

    Science.gov (United States)

    Lorente-Cánovas, Beatriz; Doré, Caroline J; Bosworth, Ailsa; Ma, Margaret H; Galloway, James B; Cope, Andrew P; Pande, Ira; Walker, David; Scott, David L

    2017-01-01

    Abstract Objectives RA patients receiving TNF inhibitors (TNFi) usually maintain their initial doses. The aim of the Optimizing Treatment with Tumour Necrosis Factor Inhibitors in Rheumatoid Arthritis trial was to evaluate whether tapering TNFi doses causes loss of clinical response. Methods We enrolled RA patients receiving etanercept or adalimumab and a DMARD with DAS28 under 3.2 for over 3 months. Initially (months 0–6) patients were randomized to control (constant TNFi) or two experimental groups (tapering TNFi by 33 or 66%). Subsequently (months 6–12) control subjects were randomized to taper TNFi by 33 or 66%. Disease flares (DAS28 increasing ⩾0.6 with at least one additional swollen joint) were the primary outcome. Results Two hundred and forty-four patients were screened, 103 randomized and 97 treated. In months 0–6 there were 8/50 (16%) flares in controls, 3/26 (12%) with 33% tapering and 6/21 (29%) with 66% tapering. Multivariate Cox analysis showed time to flare was unchanged with 33% tapering but was reduced with 66% tapering compared with controls (adjusted hazard ratio 2.81, 95% CI: 0.99, 7.94; P = 0.051). Analysing all tapered patients after controls were re-randomized (months 6–12) showed differences between groups: there were 6/48 (13%) flares with 33% tapering and 14/39 (36%) with 66% tapering. Multivariate Cox analysis showed 66% tapering reduced time to flare (adjusted hazard ratio 3.47, 95% CI: 1.26, 9.58; P = 0.016). Conclusion Tapering TNFi by 33% has no impact on disease flares and appears practical in patients in sustained remission and low disease activity states. Trail registration EudraCT, https://www.clinicaltrialsregister.eu, 2010-020738-24; ISRCTN registry, https://www.isrctn.com, 28955701 PMID:28968858

  2. Optimizing treatment with tumour necrosis factor inhibitors in rheumatoid arthritis-a proof of principle and exploratory trial: is dose tapering practical in good responders?

    Science.gov (United States)

    Ibrahim, Fowzia; Lorente-Cánovas, Beatriz; Doré, Caroline J; Bosworth, Ailsa; Ma, Margaret H; Galloway, James B; Cope, Andrew P; Pande, Ira; Walker, David; Scott, David L

    2017-11-01

    RA patients receiving TNF inhibitors (TNFi) usually maintain their initial doses. The aim of the Optimizing Treatment with Tumour Necrosis Factor Inhibitors in Rheumatoid Arthritis trial was to evaluate whether tapering TNFi doses causes loss of clinical response. We enrolled RA patients receiving etanercept or adalimumab and a DMARD with DAS28 under 3.2 for over 3 months. Initially (months 0-6) patients were randomized to control (constant TNFi) or two experimental groups (tapering TNFi by 33 or 66%). Subsequently (months 6-12) control subjects were randomized to taper TNFi by 33 or 66%. Disease flares (DAS28 increasing ⩾0.6 with at least one additional swollen joint) were the primary outcome. Two hundred and forty-four patients were screened, 103 randomized and 97 treated. In months 0-6 there were 8/50 (16%) flares in controls, 3/26 (12%) with 33% tapering and 6/21 (29%) with 66% tapering. Multivariate Cox analysis showed time to flare was unchanged with 33% tapering but was reduced with 66% tapering compared with controls (adjusted hazard ratio 2.81, 95% CI: 0.99, 7.94; P = 0.051). Analysing all tapered patients after controls were re-randomized (months 6-12) showed differences between groups: there were 6/48 (13%) flares with 33% tapering and 14/39 (36%) with 66% tapering. Multivariate Cox analysis showed 66% tapering reduced time to flare (adjusted hazard ratio 3.47, 95% CI: 1.26, 9.58; P = 0.016). Tapering TNFi by 33% has no impact on disease flares and appears practical in patients in sustained remission and low disease activity states. EudraCT, https://www.clinicaltrialsregister.eu, 2010-020738-24; ISRCTN registry, https://www.isrctn.com, 28955701. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

  3. Optimal Order of Successive Office Hysteroscopy and Endometrial Biopsy for the Evaluation of Abnormal Uterine Bleeding: A Randomized Controlled Trial.

    Science.gov (United States)

    Sarkar, Papri; Mikhail, Emad; Schickler, Robyn; Plosker, Shayne; Imudia, Anthony N

    2017-09-01

    To estimate the optimal order of office hysteroscopy and endometrial biopsy when performed successively for evaluation of abnormal uterine bleeding. Patients undergoing successive office hysteroscopy and endometrial biopsy were included in a single-blind, prospective, randomized trial. The primary outcome was to evaluate the effect of order of procedures on patients' pain score. Prespecified secondary outcomes include procedure duration, hysteroscopic visualization of the uterine cavity, endometrial sample adequacy, and number of attempts at biopsy. Pain scores were assessed using a visual analog scale from 0 to 10 and endometrial sample adequacy was determined from the histopathology report. Hysteroscopy images were recorded. Sample size of 34 per group (n=68) was determined to be adequate to detect a difference of 20% in visual analog scale score between hysteroscopy first (group A) and biopsy first (group B) at α of 0.05 and 80% power. Between October 2015 and January 2017, 78 women were randomized to group A (n=40) and group B (n=38). There was no difference in global pain perception [7 (0-10) vs 7 (0-10); P=.57, 95% CI 5.8-7.1]. Procedure duration [3 (1-9) vs 3 (2-10), P=.32, 95% CI 3.3-4.1] and endometrial sample adequacy (78.9% vs 75.7%, P=.74) were similar in both groups. Group A patients had better endometrial visualization (Pabnormal uterine bleeding, the global pain perception, and time required are independent of the order in which procedures are performed. Performing hysteroscopy first ensures better image, whereas biopsy first yields adequate tissue sample with fewer attempts. ClinicalTrials.gov, NCT02472184.

  4. Trials to optimize dosimetry for 153Sm-EDTMP therapy to improve therapeutic effects

    International Nuclear Information System (INIS)

    Riccabona, G.; Moncayo-Naveda, R.; Oberlandstaetter, M.; Donnemiller, E.; Kendler, D.

    2001-01-01

    In a trial to improve results of therapy with 153 Sm-EDTMP for pain control in patients with disseminated bone metastases dosimetric studies were performed. Out of 30 treated patients 8 were selected for the study at random (5 breast Ca., 3 prostate Ca.). Whole body retention (WBR) of 99m Tc-DPD and 99m Tc-EDTMP was compared with WBR of 153 Sm-EDTMP. Volume of metastases and regional 99 m Tc-phosphonate uptake were assessed by SPECT and conjugated whole body scan data after phantom studies. Effective half-life was estimated also. Clinically results of pain control, side effects and changes of in vitro parameters were followed after therapy for up to 8 months. Therapy was performed in these patients with 55,5 MBq/kg body weight. Results showed an identical pattern of radioactivity distribution on 99 Tc-phosphonate and 153 Sm-EDTMP posttherapy scans, WBR of tracers and therapeutic agent was similar. Tumour volumes were 151-652 mL, count ratios metastases/normal bone 1,72-2,41, so that 6-50% of applied 153 Sm-EDTMP were concentrated in bone lesions. This gave dose estimates of 2,8-13,7 Gy in metastases. Evaluation of clinical results showed that the majority of very good results were observed in patients receiving > 10 Gy (n=3) while with lower doses only 1/4 responded very well. 1 patient was lost to follow-up due to death in the first month after therapy. Moderate and transient myelodepression (platelets) was seen in 3/7 patients without relation to Gy applied. As obviously 153 Sm concentration is not homogenous in bone metastases it can be assumed, that in border zones between tumour and bone 30-40 Gy can be delivered when 10 Gy are calculated for the whole lesion, which would explain the satisfactory therapeutic effect in our study. The dosimetric approach to 153 Sm-EDTMP therapy could necessitate the application of higher amounts of 153 Sm-EDTMP to reach adequate radiation doses in lesions without necessarily increasing risk of myelodepression and with even

  5. The Erlangen Dose Optimization Trial for radiotherapy of benign painful shoulder syndrome. Long-term results

    International Nuclear Information System (INIS)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R.

    2014-01-01

    To evaluate the long-term efficacy of pain reduction by two dose-fractionation schedules for radiotherapy of painful shoulder syndrome. Between February 2006 and February 2010, 312 evaluable patients were recruited for this prospective trial. All patients received low-dose orthovoltage radiotherapy. One course consisted of 6 fractions in 3 weeks. In the case of insufficient pain remission after 6 weeks, a second course was administered. Patients were randomly assigned to one of two groups to receive single doses of either 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before radiotherapy, as well as immediately after (early response), 6 weeks after (delayed response) and approximately 3 years after (long-term response) completion of radiotherapy using a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS). Median follow-up was 35 months (range 11-57). The overall early, delayed and long-term response rates for all patients were 83, 85 and 82%, respectively. The mean VAS scores before treatment and those for early, delayed and long-term response in the 0.5- and 1.0-Gy groups were 56.8±23.7 and 53.2±21.8 (p=0.16); 38.2±36.1 and 34.0±24.5 (p=0.19); 33.0±27.2 and 23.7±22.7 (p=0.04) and 27.9±25.8 and 32.1±26.9 (p=0.25), respectively. The mean CPS values before treatment and those for early, delayed and long-term response were 9.7±3.0 and 9.5±2.7 (p=0.31); 6.1±3.6 and 5.4±3.6 (p=0.10); 5.3±3.7 and 4.1±3.7 (p=0.05) and 4.0±3.9 and 5.3±4.4 (p=0.05), respectively. No significant differences in the quality of the long-term response were found between the 0.5- and 1.0-Gy arms (p=0.28). Radiotherapy is an effective treatment for the management of benign painful shoulder syndrome. For radiation protection reasons, the dose for a radiotherapy series should not exceed 3.0 Gy. (orig.)

  6. Effects of a weight loss plus exercise program on physical function in overweight, older women: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Anton SD

    2011-06-01

    Full Text Available Stephen D Anton1,2, Todd M Manini1, Vanessa A Milsom2, Pamela Dubyak2, Matteo Cesari3, Jing Cheng4, Michael J Daniels5, Michael Marsiske2, Marco Pahor1, Christiaan Leeuwenburgh1, Michael G Perri21Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA; 2Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA; 3Area di Geriatria, Università Campus Bio-Medico, Rome, Italy; 4Division of Oral Epidemiology and Dental Public Health, San Francisco, CA, USA; 5Department of Statistics, University of Florida, Gainesville, FL, USABackground: Obesity and a sedentary lifestyle are associated with physical impairments and biologic changes in older adults. Weight loss combined with exercise may reduce inflammation and improve physical functioning in overweight, sedentary, older adults. This study tested whether a weight loss program combined with moderate exercise could improve physical function in obese, older adult women.Methods: Participants (n = 34 were generally healthy, obese, older adult women (age range 55–79 years with mild to moderate physical impairments (ie, functional limitations. Participants were randomly assigned to one of two groups for 24 weeks: (i weight loss plus exercise (WL+E; n = 17; mean age = 63.7 years [4.5] or (ii educational control (n = 17; mean age = 63.7 [6.7]. In the WL+E group, participants attended a group-based weight management session plus three supervised exercise sessions within their community each week. During exercise sessions, participants engaged in brisk walking and lower-body resistance training of moderate intensity. Participants in the educational control group attended monthly health education lectures on topics relevant to older adults. Outcomes were: (i body weight, (ii walking speed (assessed by 400-meter walk test, (iii the Short Physical Performance Battery (SPPB, and (iv knee extension isokinetic strength.Results: Participants randomized

  7. The prevention and reduction of weight loss in an acute tertiary care setting: protocol for a pragmatic stepped wedge randomised cluster trial (the PRoWL project)

    Science.gov (United States)

    2013-01-01

    Background Malnutrition, with accompanying weight loss, is an unnecessary risk in hospitalised persons and often remains poorly recognised and managed. The study aims to evaluate a hospital-wide multifaceted intervention co-facilitated by clinical nurses and dietitians addressing the nutritional care of patients, particularly those at risk of malnutrition. Using the best available evidence on reducing and preventing unplanned weight loss, the intervention (introducing universal nutritional screening; the provision of oral nutritional supplements; and providing red trays and additional support for patients in need of feeding) will be introduced by local ward teams in a phased way in a large tertiary acute care hospital. Methods/Design A pragmatic stepped wedge randomised cluster trial with repeated cross section design will be conducted. The unit of randomisation is the ward, with allocation by a random numbers table. Four groups of wards (n = 6 for three groups, n = 7 for one group) will be randomly allocated to each intervention time point over the trial. Two trained local facilitators (a nurse and dietitian for each group) will introduce the intervention. The primary outcome measure is change in patient’s body weight, secondary patient outcomes are: length of stay, all-cause mortality, discharge destinations, readmission rates and ED presentations. Patient outcomes will be measured on one ward per group, with 20 patients measured per ward per time period by an unblinded researcher. Including baseline, measurements will be conducted at five time periods. Staff perspectives on the context of care will be measured with the Alberta Context Tool. Discussion Unplanned and unwanted weight loss in hospital is common. Despite the evidence and growing concern about hospital nutrition there are very few evaluations of system-wide nutritional implementation programs. This project will test the implementation of a nutritional intervention across one hospital system using a

  8. Optimal Dose of Calcium for Treatment of Nutritional Rickets: A Randomized Controlled Trial.

    Science.gov (United States)

    Thacher, Tom D; Smith, Lauren; Fischer, Philip R; Isichei, Christian O; Cha, Stephen S; Pettifor, John M

    2016-11-01

    Calcium supplementation is indicated for the treatment of nutritional rickets. Our aim was to determine the optimal dose of calcium for treatment of children with rickets. Sixty-five Nigerian children with radiographically confirmed rickets were randomized to daily supplemental calcium intake of 500 mg (n = 21), 1000 mg (n = 23), or 2000 mg (n = 21). Venous blood, radiographs, and forearm areal bone density (aBMD) were obtained at baseline and at 8, 16, and 24 weeks after enrollment. The primary outcome was radiographic healing, using a 10-point radiographic severity score. The radiographic severity scores improved in all three groups, but the rate of radiographic healing (points per month) was significantly more rapid in the 1000-mg (-0.29; 95% confidence interval [CI] -0.13 to -0.45) and 2000-mg (-0.36; 95% CI -0.19 to -0.53) supplementation groups relative to the 500-mg group. The 2000-mg group did not heal more rapidly than the 1000-mg group. Of those who completed treatment for 24 weeks, 12 (67%), 20 (87%), and 14 (67%) in the 2000-mg, 1000-mg, and 500-mg groups, respectively, had achieved a radiographic score of 1.5 or less (p = 0.21). Serum alkaline phosphatase decreased and calcium increased similarly in all groups. Forearm diaphyseal aBMD improved significantly more rapidly in the 2000-mg group than in the 500-mg and 1000-mg groups (p rickets than 500 mg, but 2000 mg did not have greater benefit than 1000 mg. Some children require longer than 24 weeks for complete healing of nutritional rickets. © 2016 American Society for Bone and Mineral Research. © 2016 American Society for Bone and Mineral Research.

  9. Single-trial log transformation is optimal in frequency analysis of resting EEG alpha.

    Science.gov (United States)

    Smulders, Fren T Y; Ten Oever, Sanne; Donkers, Franc C L; Quaedflieg, Conny W E M; van de Ven, Vincent

    2018-02-01

    The appropriate definition and scaling of the magnitude of electroencephalogram (EEG) oscillations is an underdeveloped area. The aim of this study was to optimize the analysis of resting EEG alpha magnitude, focusing on alpha peak frequency and nonlinear transformation of alpha power. A family of nonlinear transforms, Box-Cox transforms, were applied to find the transform that (a) maximized a non-disputed effect: the increase in alpha magnitude when the eyes are closed (Berger effect), and (b) made the distribution of alpha magnitude closest to normal across epochs within each participant, or across participants. The transformations were performed either at the single epoch level or at the epoch-average level. Alpha peak frequency showed large individual differences, yet good correspondence between various ways to estimate it in 2 min of eyes-closed and 2 min of eyes-open resting EEG data. Both alpha magnitude and the Berger effect were larger for individual alpha than for a generic (8-12 Hz) alpha band. The log-transform on single epochs (a) maximized the t-value of the contrast between the eyes-open and eyes-closed conditions when tested within each participant, and (b) rendered near-normally distributed alpha power across epochs and participants, thereby making further transformation of epoch averages superfluous. The results suggest that the log-normal distribution is a fundamental property of variations in alpha power across time in the order of seconds. Moreover, effects on alpha power appear to be multiplicative rather than additive. These findings support the use of the log-transform on single epochs to achieve appropriate scaling of alpha magnitude. © 2018 The Authors. European Journal of Neuroscience published by Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

  10. Ascending dose-controlled trial of beloranib, a novel obesity treatment for safety, tolerability, and weight loss in obese women.

    Science.gov (United States)

    Hughes, T E; Kim, D D; Marjason, J; Proietto, J; Whitehead, J P; Vath, J E

    2013-09-01

    Evaluate the safety and tolerability of beloranib, a fumagillin-class methionine aminopetidase-2 (MetAP2) inhibitor, in obese women over 4 weeks. Thirty-one obese (mean BMI 38 kg/m2) women were randomized to intravenous 0.1, 0.3, or 0.9 mg/m2 beloranib or placebo twice weekly for 4 weeks (N = 7, 6, 9, and 9). The most frequent AEs were headache, infusion site injury, nausea, and diarrhea. Nausea and infusion site injury occurred more with beloranib than placebo. The most common reason for discontinuation was loss of venous access. There were no clinically significant abnormal laboratory findings. In subjects completing 4 weeks, median weight loss with 0.9 mg/m2 beloranib was -3.8 kg (95% CI -5.1, -0.9; N = 8) versus -0.6 kg with placebo (-4.5, -0.1; N = 6). Weight change for 0.1 and 0.3 mg/m2 beloranib was similar to placebo. Beloranib (0.9 mg/m2) was associated with a significant 42 and 18% reduction in triglycerides and LDL-cholesterol, as well as improvement in C-reactive protein and reduced sense of hunger. Changes in β-hydroxybutyrate, adiponectin, leptin, and fibroblast growth factor-21 were consistent with the putative mechanism of MetAP2 inhibition. Glucose and blood pressure were unchanged. Beloranib treatment was well tolerated and associated with rapid weight loss and improvements in lipids, C-reactive protein, and adiponectin. Copyright © 2013 The Obesity Society.

  11. Effects of a mindfulness‐based weight loss intervention in adults with obesity: A randomized clinical trial

    Science.gov (United States)

    Moran, Patricia J.; Kristeller, Jean; Acree, Michael; Bacchetti, Peter; Kemeny, Margaret E.; Dallman, Mary; Lustig, Robert H.; Grunfeld, Carl; Nixon, Douglas F.; Milush, Jeffrey M.; Goldman, Veronica; Laraia, Barbara; Laugero, Kevin D.; Woodhouse, Leslie; Epel, Elissa S.

    2016-01-01

    Objective To determine whether adding mindfulness‐based eating and stress management practices to a diet‐exercise program improves weight loss and metabolic syndrome components. Methods In this study 194 adults with obesity were randomized to a 5.5‐month program with or without mindfulness training and identical diet‐exercise guidelines. Intention‐to‐treat analyses with multiple imputation were used for missing data. The primary outcome was 18‐month weight change. Results Estimated effects comparing the mindfulness to control arm favored the mindfulness arm in (a) weight loss at 12 months, −1.9 kg (95% CI: −4.5, 0.8; P = 0.17), and 18 months, −1.7 kg (95% CI: −4.7, 1.2; P = 0.24), though not statistically significant; (b) changes in fasting glucose at 12 months, −3.1 mg/dl (95% CI: −6.3, 0.1; P = 0.06), and 18 months, −4.1 mg/dl (95% CI: −7.3, −0.9; P = 0.01); and (c) changes in triglyceride/HDL ratio at 12 months, −0.57 (95% CI: −0.95, −0.18; P = 0.004), and 18 months, −0.36 (95% CI: −0.74, 0.03; P = 0.07). Estimates for other metabolic risk factors were not statistically significant, including waist circumference, blood pressure, and C‐reactive protein. Conclusions Mindfulness enhancements to a diet‐exercise program did not show substantial weight loss benefit but may promote long‐term improvement in some aspects of metabolic health in obesity that requires further study. PMID:26955895

  12. Effects of a mindfulness-based weight loss intervention in adults with obesity: A randomized clinical trial.

    Science.gov (United States)

    Daubenmier, Jennifer; Moran, Patricia J; Kristeller, Jean; Acree, Michael; Bacchetti, Peter; Kemeny, Margaret E; Dallman, Mary; Lustig, Robert H; Grunfeld, Carl; Nixon, Douglas F; Milush, Jeffrey M; Goldman, Veronica; Laraia, Barbara; Laugero, Kevin D; Woodhouse, Leslie; Epel, Elissa S; Hecht, Frederick M

    2016-04-01

    To determine whether adding mindfulness-based eating and stress management practices to a diet-exercise program improves weight loss and metabolic syndrome components. In this study 194 adults with obesity were randomized to a 5.5-month program with or without mindfulness training and identical diet-exercise guidelines. Intention-to-treat analyses with multiple imputation were used for missing data. The primary outcome was 18-month weight change. Estimated effects comparing the mindfulness to control arm favored the mindfulness arm in (a) weight loss at 12 months, -1.9 kg (95% CI: -4.5, 0.8; P = 0.17), and 18 months, -1.7 kg (95% CI: -4.7, 1.2; P = 0.24), though not statistically significant; (b) changes in fasting glucose at 12 months, -3.1 mg/dl (95% CI: -6.3, 0.1; P = 0.06), and 18 months, -4.1 mg/dl (95% CI: -7.3, -0.9; P = 0.01); and (c) changes in triglyceride/HDL ratio at 12 months, -0.57 (95% CI: -0.95, -0.18; P = 0.004), and 18 months, -0.36 (95% CI: -0.74, 0.03; P = 0.07). Estimates for other metabolic risk factors were not statistically significant, including waist circumference, blood pressure, and C-reactive protein. Mindfulness enhancements to a diet-exercise program did not show substantial weight loss benefit but may promote long-term improvement in some aspects of metabolic health in obesity that requires further study. © 2016 The Authors. Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).

  13. Blocking carbohydrate absorption and weight loss: a clinical trial using Phase 2 brand proprietary fractionated white bean extract.

    Science.gov (United States)

    Udani, Jay; Hardy, Mary; Madsen, Damian C

    2004-03-01

    Phase 2' starch neutralizer brand bean extract product ("Phase 2") is a water-extract of a common white bean (Phaseolus vulgaris) that has been shown in vitro to inhibit the digestive enzyme alpha-amylase. Inhibiting this enzyme may prevent the digestion of complex carbohydrates, thus decreasing the number of carbohydrate calories absorbed and potentially promoting weight loss. Fifty obese adults were screened to participate in a randomized, double-blind, placebo-controlled study evaluating the effects of treatment with Phase 2 versus placebo on weight loss. Participants were randomized to receive either 1500 mg Phase 2 or an identical placebo twice daily with meals. The active study period was eight weeks. Thirty-nine subjects completed the initial screening process and 27 subjects completed the study. The results after eight weeks demonstrated the Phase 2 group lost an average of 3.79 lbs (average of 0.47 lb per week) compared with the placebo group, which lost an average of 1.65 lbs (average of 0.21 lb per week), representing a difference of 129 percent (p=0.35). Triglyceride levels in the Phase 2 group were reduced an average of 26.3 mg/dL, more than three times greater a reduction than observed in the placebo group (8.2 mg/dL) (p=0.07). No adverse events during the study were attributed to the study medication. Clinical trends were identified for weight loss and a decrease in triglycerides, although statistical significance was not reached. Phase 2 shows potential promise as an adjunct therapy in the treatment of obesity and hypertriglyceridemia and further studies with larger numbers of subjects are warranted to conclusively demonstrate effectiveness.

  14. Efficacy of a randomized trial examining commercial weight loss programs and exercise on metabolic syndrome in overweight and obese women.

    Science.gov (United States)

    Baetge, Claire; Earnest, Conrad P; Lockard, Brittanie; Coletta, Adriana M; Galvan, Elfego; Rasmussen, Christopher; Levers, Kyle; Simbo, Sunday Y; Jung, Y Peter; Koozehchian, Majid; Oliver, Jonathan; Dalton, Ryan; Sanchez, Brittany; Byrd, Michael J; Khanna, Deepesh; Jagim, Andrew; Kresta, Julie; Greenwood, Mike; Kreider, Richard B

    2017-02-01

    While commercial dietary weight-loss programs typically advise exercise, few provide actual programing. The goal of this study was to compare the Curves Complete 90-day Challenge (CC, n = 29), which incorporates exercising and diet, to programs advocating exercise (Weight Watchers Points Plus (WW, n = 29), Jenny Craig At Home (JC, n = 27), and Nutrisystem Advance Select (NS, n = 28)) or control (n = 20) on metabolic syndrome (MetS) and weight loss. We randomized 133 sedentary, overweight women (age, 47 ± 11 years; body mass, 86 ± 14 kg; body mass index, 35 ± 6 kg/m 2 ) into respective treatment groups for 12 weeks. Data were analyzed using chi square and general linear models adjusted for age and respective baseline measures. Data are means ± SD or mean change ± 95% confidence intervals (CIs). We observed a significant trend for a reduction in energy intake for all treatment groups and significant weight loss for all groups except control: CC (-4.32 kg; 95% CI, -5.75, -2.88), WW (-4.31 kg; 95% CI, -5.82, -2.96), JC (-5.34 kg; 95% CI, -6.86, -3.90), NS (-5.03 kg; 95% CI, -6.49, -3.56), and control (0.16 kg, 95% CI, -1.56, 1.89). Reduced MetS prevalence was observed at follow-up for CC (35% vs. 14%, adjusted standardized residuals (adjres.) = 3.1), but not WW (31% vs. 28% adjres. = 0.5), JC (37% vs. 42%, adjres. = -0.7), NS (39% vs. 50% adjres. = -1.5), or control (45% vs. 55% adjres. = -1.7). While all groups improved relative fitness (mL·kg -1 ·min -1 ) because of weight loss, only the CC group improved absolute fitness (L/min). In conclusion, commercial programs offering concurrent diet and exercise programming appear to offer greater improvements in MetS prevalence and cardiovascular function after 12 weeks of intervention.

  15. Weight loss as treatment for knee osteoarthritis symptoms in obese patients: 1-year results from a randomised controlled trial

    DEFF Research Database (Denmark)

    Bliddal, Henning; Leeds, Anthony R; Stigsgaard, Lise

    2011-01-01

    OBJECTIVE: To evaluate 1-year symptomatic improvement in obese patients with knee osteoarthritis (OA) on an intensive low-energy diet (LED) maintained by frequent consultations with a dietician compared to minimal attention. METHODS: The LED programme consisted of group therapy with dietary......) was assessed as the mean group difference during and after 1 year. RESULTS: The study population consisted of 89 patients, 89% women, average age 63 years. After 1 year, mean weight loss in the LED group was -10.9 kg (11%) versus -3.6 kg (4%) in the control group (p...

  16. Protocol and recruitment results from a randomized controlled trial comparing group phone-based versus newsletter interventions for weight loss maintenance among rural breast cancer survivors.

    Science.gov (United States)

    Befort, Christie A; Klemp, Jennifer R; Fabian, Carol; Perri, Michael G; Sullivan, Debra K; Schmitz, Kathryn H; Diaz, Francisco J; Shireman, Theresa

    2014-03-01

    Obesity is a risk factor for breast cancer recurrence and death. Women who reside in rural areas have higher obesity prevalence and suffer from breast cancer treatment-related disparities compared to urban women. The objective of this 5-year randomized controlled trial is to compare methods for delivering extended care for weight loss maintenance among rural breast cancer survivors. Group phone-based counseling via conference calls addresses access barriers, is more cost-effective than individual phone counseling, and provides group support which may be ideal for rural breast cancer survivors who are more likely to have unmet support needs. Women (n=210) diagnosed with Stage 0 to III breast cancer in the past 10 years who are ≥ 3 months out from initial cancer treatments, have a BMI 27-45 kg/m(2), and have physician clearance were enrolled from multiple cancer centers. During Phase I (months 0 to 6), all women receive a behavioral weight loss intervention delivered through group phone sessions. Women who successfully lose 5% of weight enter Phase II (months 6 to 18) and are randomized to one of two extended care arms: continued group phone-based treatment or a mail-based newsletter. During Phase III, no contact is made (months 18 to 24). The primary outcome is weight loss maintenance from 6 to 18 months. Secondary outcomes include quality of life, serum biomarkers, and cost-effectiveness. This study will provide essential information on how to reach rural survivors in future efforts to establish weight loss support for breast cancer survivors as a standard of care. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. A randomized controlled trial on the efficacy of carbohydrate-reduced or fat-reduced diets in patients attending a telemedically guided weight loss program

    Directory of Open Access Journals (Sweden)

    Stehle Peter

    2009-07-01

    Full Text Available Abstract Background We investigated whether macronutrient composition of energy-restricted diets influences the efficacy of a telemedically guided weight loss program. Methods Two hundred overweight subjects were randomly assigned to a conventional low-fat diet and a low-carbohydrate diet group (target carbohydrate content: >55% energy and ® technology by mobile phone. Various fatness and fat distribution parameters, energy and macronutrient intake, and various biochemical risk markers were measured at baseline and after 6, and 12 months. Results In both groups, energy intake decreased by 400 kcal/d compared to baseline values within the first 6 months and slightly increased again within the second 6 months. Macronutrient composition differed significantly between the groups from the beginning to month 12. At study termination, weight loss was 5.8 kg (SD: 6.1 kg in the low-carbohydrate group and 4.3 kg (SD: 5.1 kg in the low-fat group (p = 0.065. In the low-carbohydrate group, triglyceride and HDL-cholesterol levels were lower at month 6 and waist circumference and systolic blood pressure were lower at month 12 compared with the low-fat group (P = 0.005–0.037. Other risk markers improved to a similar extent in both groups. Conclusion Despite favourable effects of both diets on weight loss, the carbohydrate-reduced diet was more beneficial with respect to cardiovascular risk factors compared to the fat-reduced diet. Nevertheless, compliance with a weight loss program appears to be even a more important factor for success in prevention and treatment of obesity than the composition of the diet. Trial registration Clinicaltrials.gov as NCT00868387

  18. Novel devices for individualized controlled inhalation can optimize aerosol therapy in efficacy, patient care and power of clinical trials

    Directory of Open Access Journals (Sweden)

    Fischer A

    2009-12-01

    Full Text Available Abstract In the treatment of pulmonary diseases the inhalation of aerosols plays a key role - it is the preferred route of drug delivery in asthma, chronic obstructive pulmonary disease (COPD and cystic fibrosis. But, in contrast to oral and intravenous administration drug delivery to the lungs is controlled by additional parameters. Beside its pharmacology the active agent is furthermore determined by its aerosol characteristics as particle diameter, particle density, hygroscopicity and electrical charge. The patient related factors like age and stage of pulmonary disease will be additionally affected by the individual breathing pattern and morphometry of the lower airways. A number of these parameters with essential impact on the pulmonary drug deposition can be influenced by the performance of the inhalation system. Therefore, the optimization of nebulisation technology was a major part of aerosol science in the last decade. At this time the control of inspiration volume and air flow as well as the administration of a defined aerosol bolus was in the main focus. Up to date a more efficient and a more targeted pulmonary drug deposition - e.g., in the alveoli - will be provided by novel devices which also allow shorter treatment times and a better reproducibility of the administered lung doses. By such means of precise dosing and drug targeting the efficacy of inhalation therapy can be upgraded, e.g., the continuous inhalation of budesonide in asthma. From a patients' perspective an optimized inhalation manoeuvre means less side effects, e.g., in cystic fibrosis therapy the reduced oropharyngeal tobramycin exposure causes fewer bronchial irritations. Respecting to shorter treatment times also, this result in an improved quality of life and compliance. For clinical trials the scaling down of dose variability in combination with enhanced pulmonary deposition reduces the number of patients to be included and the requirement of pharmaceutical

  19. The optimal frequency of aquatic physiotherapy for individuals with chronic musculoskeletal pain: a randomised controlled trial.

    Science.gov (United States)

    Cuesta-Vargas, Antonio I; White, Melanie; González-Sánchez, Manuel; Kuisma, Raija

    2015-01-01

    To establish whether there was a difference in health-related quality of life (HRQoL) in people with chronic musculoskeletal disorders (PwCMSKD) after participating in a multimodal physiotherapy program (MPP) either two or three sessions a week. Total of 114 PwCMSKD participated in this prospective randomised controlled trial. An individualised MPP, consisting of exercises for mobility, motor-control, muscle strengthening, cardiovascular training, and health education, was implemented either twice a week (G2: n = 58) or three times a week) (G3: n = 56) for 1 year. HRQoL physical and mental health state (PHS/MHS), Roland Morris disability Questionnaire (RMQ), Neck-Disability-Index (NDI) and Western Ontario and McMaster Universities' Arthritis Index (WOMAC) were used to measure outcomes of MPP for people with chronic low back pain, chronic neck pain and osteoarthritis, respectively. Measures were taken at baseline, 8 weeks (8 w), 6 months (6 m), and 1 year (1 y) after starting the programme. No statistically significant differences were found between the two groups (G2 and G3), except in NDI at 8 w (-3.34, (CI 95%: -6.94/0.84, p = 0.025 (scale 0-50)). All variables showed improvement reaching the following values (from baseline to 1 y) G2: PHS: 57.72 (baseline: 41.17; (improvement: 16.55%), MHS: 74.51 (baseline: 47.46, 27.05%), HRQoL 0.90 (baseline: 0.72, 18%)), HRQoL-VAS 84.29 (baseline: 58.04, 26.25%), RMQ 4.15 (baseline: 7.85, 15.42%), NDI 3.96 (baseline: 21.87, 35.82%), WOMAC 7.17 (baseline: 25.51, 19.10%). G3: PHS: 58.64 (baseline: 39.75, 18.89%), MHS: 75.50 (baseline: 45.45, (30.05%), HRQoL 0.67 (baseline: 0.88, 21%), HRQoL-VAS 86.91 (baseline: 52.64, 34.27%), RMQ 4.83 (baseline: 8.93, 17.08%), NDI 4.91 (baseline: 23.82, 37.82%), WOMAC 6.35 (baseline: 15.30, 9.32%). No significant differences between the two groups were found in the outcomes of a MPP except in the NDI at 8 weeks, but both groups improved in all variables during the course of 1

  20. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  1. Body fat loss and compensatory mechanisms in response to different doses of aerobic exercise - a randomized controlled trial in overweight sedentary males

    DEFF Research Database (Denmark)

    Larsen, Mads Rosenkilde; Auerbach, Pernille Landrock; Reichkendler, Michala Holm

    2012-01-01

    The amount of weight loss induced by exercise is often disappointing. A diet-induced negative energy balance triggers compensatory mechanisms, e.g. lower metabolic rate and increased appetite. However, knowledge about potential compensatory mechanisms triggered by increased aerobic exercise...... is limited. A randomized controlled trial was performed in healthy sedentary moderately overweight young men to examine the effects of increasing doses of aerobic exercise on body composition, accumulated energy balance, and the degree of compensation. Eighteen participants were randomized to a continuous...... sedentary control group, 21 to a moderate (MOD; 300 kcal/day) and 22 to a high dose (HIGH; 600 kcal/day) exercise group for 13 weeks, corresponding to approximately 30 and 60 minutes of daily aerobic exercise, respectively. Body weight (MOD: -3.6kg, P...

  2. Radiotherapy for benign achillodynia. Long-term results of the Erlangen Dose Optimization Trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, Oliver J.; Jeremias, Carolin; Gaipl, Udo S.; Frey, Benjamin; Schmidt, Manfred; Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany)

    2015-12-15

    The aim of this study was to evaluate the long-term efficacy of two dose-fractionation schedules for radiotherapy of achillodynia. Between February 2006 and February 2010, 112 evaluable patients were recruited for this prospective trial. All patients received orthovoltage radiotherapy. One course consisted of 6 fractions/3 weeks. In the case of insufficient remission of pain after 6 weeks, a second series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after (early response), 6 weeks after (delayed response), and approximately 2 years after radiotherapy (long-term response) with a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS). The median follow-up was 24 months (range, 11-56). The overall early, delayed, and long-term response rates for all patients were 84 %, 88 %, and 95 %, respectively. The mean VAS values before treatment for early, delayed, and long-term responses for the 0.5-Gy and 1.0-Gy groups were 55.7 ± 21.0 and 58.2 ± 23.5 (p = 0.53), 38.0 ± 23.2 and 30.4 ± 22.6 (p = 0.08), 35.5 ± 25.9 and 30.9 ± 25.4 (p = 0.52), and 11.2 ± 16.4 and 15.3 ± 18.9 (p = 0.16), respectively. The mean CPS values before treatment for early, delayed, and long-term responses were 8.2 ± 3.0 and 8.9 ± 3.3 (p = 0.24), 5.6 ± 3.1 and 5.4 ± 3.3 (p = 0.76), 4.4 ± 2.6 and 5.3 ± 3.8 (p = 0.58), and 2.2 ± 2.9 and 2.8 ± 3.3 (p = 0.51), respectively. No significant differences in long-term response quality between the two arms was found (p = 0.73). Radiotherapy is a very effective treatment for the management of benign achillodynia. For radiation protection, the dose for a radiotherapy series should not exceed 3.0 Gy. (orig.) [German] Ziel war die Untersuchung der Langzeiteffektivitaet zweier Dosisfraktionierungskonzepte bei der Strahlentherapie von Patienten mit Achillodynie. Zwischen 2006 und 2010 wurden 112 auswertbare

  3. Study Protocol. ECSSIT – Elective Caesarean Section Syntocinon® Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon® 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section

    Directory of Open Access Journals (Sweden)

    Montgomery Alan A

    2009-08-01

    Full Text Available Abstract Background Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4–10 minutes therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. Methods and design A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml. A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. Discussion It is both important and timely that we evaluate the optimal approach to the management

  4. Study Protocol. ECSSIT – Elective Caesarean Section Syntocinon® Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon®) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section

    Science.gov (United States)

    Murphy, Deirdre J; Carey, Michael; Montgomery, Alan A; Sheehan, Sharon R

    2009-01-01

    Background Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4–10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. Methods and design A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. Discussion It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  5. Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

    BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  6. Study protocol. ECSSIT - Elective Caesarean Section Syntocinon Infusion Trial. A multi-centre randomised controlled trial of oxytocin (Syntocinon) 5 IU bolus and placebo infusion versus oxytocin 5 IU bolus and 40 IU infusion for the control of blood loss at elective caesarean section.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2009-01-01

    BACKGROUND: Caesarean section is one of the most commonly performed major operations in women throughout the world. Rates are escalating, with studies from the United States of America, the United Kingdom, China and the Republic of Ireland reporting rates between 20% and 25%. Operative morbidity includes haemorrhage, anaemia, blood transfusion and in severe cases, maternal death. The value of routine oxytocics in the third stage of vaginal birth has been well established and it has been assumed that these benefits apply to caesarean delivery as well. A slow bolus dose of oxytocin is recommended following delivery of the baby at caesarean section. Some clinicians use an additional infusion of oxytocin for a further period following the procedure. Intravenous oxytocin has a very short half-life (4-10 minutes) therefore the potential advantage of an oxytocin infusion is that it maintains uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhages occur. The few trials to date addressing the optimal approach to preventing haemorrhage at caesarean section have been under-powered to evaluate clinically important outcomes. There has been no trial to date comparing the use of an intravenous slow bolus of oxytocin versus an oxytocin bolus and infusion. METHODS AND DESIGN: A multi-centre randomised controlled trial is proposed. The study will take place in five large maternity units in Ireland with collaboration between academics and clinicians in the disciplines of obstetrics and anaesthetics. It will involve 2000 women undergoing elective caesarean section after 36 weeks gestation. The main outcome measure will be major haemorrhage (blood loss >1000 ml). A study involving 2000 women will have 80% power to detect a 36% relative change in the risk of major haemorrhage with two-sided 5% alpha. DISCUSSION: It is both important and timely that we evaluate the optimal approach to the management of the third stage at

  7. A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss.

    Science.gov (United States)

    Yancy, William S; Westman, Eric C; McDuffie, Jennifer R; Grambow, Steven C; Jeffreys, Amy S; Bolton, Jamiyla; Chalecki, Allison; Oddone, Eugene Z

    2010-01-25

    Two potent weight loss therapies, a low-carbohydrate, ketogenic diet (LCKD) and orlistat therapy combined with a low-fat diet (O + LFD), are available to the public but, to our knowledge, have never been compared. Overweight or obese outpatients (n = 146) from the Department of Veterans Affairs primary care clinics in Durham, North Carolina, were randomized to either LCKD instruction (initially, carbohydrate daily) or orlistat therapy, 120 mg orally 3 times daily, plus low-fat diet instruction (fat, 500-1000 kcal/d deficit) delivered at group meetings over 48 weeks. Main outcome measures were body weight, blood pressure, fasting serum lipid, and glycemic parameters. The mean age was 52 years and mean body mass index was 39.3 (calculated as weight in kilograms divided by height in meters squared); 72% were men, 55% were black, and 32% had type 2 diabetes mellitus. Of the study participants, 57 of the LCKD group (79%) and 65 of the O + LFD group (88%) completed measurements at 48 weeks. Weight loss was similar for the LCKD (expected mean change, -9.5%) and the O + LFD (-8.5%) (P = .60 for comparison) groups. The LCKD had a more beneficial impact than O + LFD on systolic (-5.9 vs 1.5 mm Hg) and diastolic (-4.5 vs 0.4 mm Hg) blood pressures (P Low-density lipoprotein cholesterol levels improved within the O + LFD group only, whereas glucose, insulin, and hemoglobin A(1c) levels improved within the LCKD group only; comparisons between groups, however, were not statistically significant. In a sample of medical outpatients, an LCKD led to similar improvements as O + LFD for weight, serum lipid, and glycemic parameters and was more effective for lowering blood pressure. clinicaltrials.gov Identifier: NCT00108524.

  8. Preventing Excessive Blood Loss During Percutaneous Nephrolithotomy by Using Tranexamic Acid: A Double Blinded Prospective Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Adnan Siddiq

    2017-12-01

    Full Text Available Objective: Percutaneous nephrolithotomy (PCNL is most frequently performed procedure for renal stones 2 cm and larger. Perioperative hemorrhage being most common complication, warrants as important predicting factor of adverse outcomes. Prevention with inexpensive and safe drug like tranexamic acid (TA would ultimately turn out to be cornerstone for establishing future guidelines. Aim of this study is to evaluate whether TA is efficacious in preventing blood loss during PCNL. Materials and Methods: Ethical review board approval taken. Sample size calculation yielded 240 patients, comprising 120 in each group. Group A receiving TA and group B receiving placebo. Age, gender, body mass index (BMI, stone size, volume and location, preoperative blood count, creatinine, urine analysis, coagulation profile and necessary radiological investigations done. Randomization through lottery method. Both patient and investigator were blinded. Hemoglobin (Hb and hematocrit (Hct levels done at 24 hours postoperatively and fall in values recorded. Results: Both groups were equal in characteristics like age, gender, BMI, stone size, volume and location (p>0.05. Operative variables like calyx punctured, position of puncture and operative time were also found to be similar in both groups. Median change in Hb in placebo group was 1.6 interquartile range (IQR 4, while in TA group was 1.3 (IQR 7.8 (p=0.001. Similarly, median change in Hct level in placebo group was 3.6 (IQR 11.8 and in TA group was 2.4 (IQR 13 (p<0.001. Sixteen patients were transfused after surgery; 12 (75% belonged to placebo group while 4 (25% belonged to TA group (p=0.038. Hospital stay was not significantly different in both groups (p=0.177 with median of 4.0 and IQR of 0 in both groups. Conclusion: TA during PCNL reduces blood loss and minimizes blood transfusion rate.

  9. Bariatric Surgery Promising in Migraine Control: a Controlled Trial on Weight Loss and Its Effect on Migraine Headache.

    Science.gov (United States)

    Razeghi Jahromi, Soodeh; Abolhasani, Maryam; Ghorbani, Zeinab; Sadre-Jahani, Solmaz; Alizadeh, Zahra; Talebpour, Mohammad; Meysamie, Alipasha; Togha, Mansoureh

    2018-01-01

    There is evidence that substantial weight loss through bariatric surgery (BS) may result in short-term improvement of migraine severity. However, it still remains to be seen whether smaller amounts of weight loss have a similar effect on migraine headache. This study has been designed to compare the effects of weight reduction through BS and non-surgical modifications. Migraine characteristics were assessed at 1 month before (T0), 1 month (T1), and 6 months (T2) after BS (vertical sleeve gastrectomy (VSG) (n = 25) or behavioral therapy (BT) (n = 26) in obese women (aged 18-60 years) with migraine headache. Migraine was diagnosed using the International Classification of Headache Disorders (ICHDIIβ) criteria. There was significant reduction in the visual analog scale (VAS) from the baseline to T1 and T2 in both groups. The number of migraine-free days showed a significant increase within each group (p migraine characteristics, age, changes in weight, BMI, body fat, and fat-free mass from T0 to T2, the BS group showed statistically significant lower VAS and duration of migraine attacks and a significantly higher number of migraine-free days than the BT group at T1 and T2 (p ≤ 0.028). Our results indicated that far before significant weight reduction after BS (VSG), there was marked alleviation in the severity and duration of migraine and a significant increase in the number of migraine-free days in obese female migraineurs. However, the effects in the BT group were not comparable with the effects in the BS group.

  10. A within-trial cost-effectiveness analysis of primary care referral to a commercial provider for weight loss treatment, relative to standard care—an international randomised controlled trial

    Science.gov (United States)

    Fuller, N R; Colagiuri, S; Schofield, D; Olson, A D; Shrestha, R; Holzapfel, C; Wolfenstetter, S B; Holle, R; Ahern, A L; Hauner, H; Jebb, S A; Caterson, I D

    2013-01-01

    Background: Due to the high prevalence of overweight and obesity there is a need to identify cost-effective approaches for weight loss in primary care and community settings. Objective: We evaluated the cost effectiveness of two weight loss programmes of 1-year duration, either standard care (SC) as defined by national guidelines, or a commercial provider (Weight Watchers) (CP). Design: This analysis was based on a randomised controlled trial of 772 adults (87% female; age 47.4±12.9 years; body mass index 31.4±2.6 kg m−2) recruited by health professionals in primary care in Australia, United Kingdom and Germany. Both a health sector and societal perspective were adopted to calculate the cost per kilogram of weight loss and the ICER, expressed as the cost per quality adjusted life year (QALY). Results: The cost per kilogram of weight loss was USD122, 90 and 180 for the CP in Australia, the United Kingdom and Germany, respectively. For SC the cost was USD138, 151 and 133, respectively. From a health-sector perspective, the ICER for the CP relative to SC was USD18 266, 12 100 and 40 933 for Australia, the United Kingdom and Germany, respectively. Corresponding societal ICER figures were USD31 663, 24 996 and 51 571. Conclusion: The CP was a cost-effective approach from a health funder and societal perspective. Despite participants in the CP group attending two to three times more meetings than the SC group, the CP was still cost effective even including these added patient travel costs. This study indicates that it is cost effective for general practitioners (GPs) to refer overweight and obese patients to a CP, which may be better value than expending public funds on GP visits to manage this problem. PMID:22929209

  11. Low-fat versus low-carbohydrate weight reduction diets: effects on weight loss, insulin resistance, and cardiovascular risk: a randomized control trial.

    Science.gov (United States)

    Bradley, Una; Spence, Michelle; Courtney, C Hamish; McKinley, Michelle C; Ennis, Cieran N; McCance, David R; McEneny, Jane; Bell, Patrick M; Young, Ian S; Hunter, Steven J

    2009-12-01

    Low-fat hypocaloric diets reduce insulin resistance and prevent type 2 diabetes in those at risk. Low-carbohydrate, high-fat diets are advocated as an alternative, but reciprocal increases in dietary fat may have detrimental effects on insulin resistance and offset the benefits of weight reduction. We investigated a low-fat (20% fat, 60% carbohydrate) versus a low-carbohydrate (60% fat, 20% carbohydrate) weight reduction diet in 24 overweight/obese subjects ([mean +/- SD] BMI 33.6 +/- 3.7 kg/m(2), aged 39 +/- 10 years) in an 8-week randomized controlled trial. All food was weighed and distributed, and intake was calculated to produce a 500 kcal/day energy deficit. Insulin action was assessed by the euglycemic clamp and insulin secretion by meal tolerance test. Body composition, adipokine levels, and vascular compliance by pulse-wave analysis were also measured. Significant weight loss occurred in both groups (P loss with no difference between groups (P = 0.71). The change in overall systemic arterial stiffness was, however, significantly different between diets (P = 0.04); this reflected a significant decrease in augmentation index following the low-fat diet, compared with a nonsignificant increase within the low-carbohydrate group. This study demonstrates comparable effects on insulin resistance of low-fat and low-carbohydrate diets independent of macronutrient content. The difference in augmentation index may imply a negative effect of low-carbohydrate diets on vascular risk.

  12. A comparison of lower canine retraction and loss of anchorage between conventional and self-ligating brackets: a single-center randomized split-mouth controlled trial.

    Science.gov (United States)

    da Costa Monini, André; Júnior, Luiz Gonzaga Gandini; Vianna, Alexandre Protásio; Martins, Renato Parsekian

    2017-05-01

    To evaluate the rate of lower canine retraction, anchorage loss, and changes on lower canines and first molars axial inclination using self-ligating and conventional brackets. Twenty-five adult patients with a treatment plan involving extractions of four first premolars were selected for this split-mouth trial and had either conventional or self-ligating brackets bonded to lower canines in a block randomization. Retraction was accomplished using 100-g nickel titanium closed-coil springs, which were reactivated each 4 weeks. Oblique radiographs were taken before and after total canine retraction and the cephalograms were superimposed on stable structures of the mandible. Cephalometric points were digitized twice by a single-blinded operator for error control and the average of the points were used to determine the following variables: canine cusp horizontal changes, molar cusp horizontal changes, and angulation changes in canines and molars. Paired t tests were used to analyze the blinded data for group differences. All patients reached final phase without bracket debonds. No differences were found between the two groups for all variables tested. No serious harm was observed. Both brackets showed the same rate of canine retraction and loss of anteroposterior anchorage of the molars. No changes were found between brackets regarding the inclination of canines and first molars. Using self-ligating brackets to retract lower canines will not increase the velocity of tooth movement, does not increase anchorage, and does not decrease tipping.

  13. Randomized trial of a phone- and web-based weight loss program for women at elevated breast cancer risk: the HELP study.

    Science.gov (United States)

    Cadmus-Bertram, Lisa; Nelson, Sandahl H; Hartman, Sheri; Patterson, Ruth E; Parker, Barbara A; Pierce, John P

    2016-08-01

    Excess weight and physical inactivity are modifiable risk factors for breast cancer. Behavioral intervention is particularly important among women with an elevated risk profile. This trial tested an intervention that trained women to use a self-monitoring website to increase activity and lose weight. Women with BMI ≥27.5 kg/m(2) at elevated breast cancer risk were randomized to the intervention (N = 71) or usual care (N = 34). The intervention group received telephone-based coaching and used web-based self-monitoring tools. At 6 months, significant weight loss was observed in the intervention group (4.7 % loss from starting weight; SD = 4.7 %) relative to usual care (0.4 % gain; SD = 3.0 %) (p web- and phone-based approach produced modest but significant improvements in weight and physical activity for women at elevated breast cancer risk.

  14. Moderate carbohydrate, moderate protein weight loss diet reduces cardiovascular disease risk compared to high carbohydrate, low protein diet in obese adults: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Evans Ellen M

    2008-11-01

    Full Text Available Abstract Background To evaluate the metabolic effects of two weight loss diets differing in macronutrient composition on features of dyslipidemia and post-prandial insulin (INS response to a meal challenge in overweight/obese individuals. Methods This study was a parallel-arm randomized 4 mo weight loss trial. Adults (n = 50, 47 ± 7 y matched on BMI (33.6 ± 0.6 kg/m2, P = 0.79 consumed energy restricted diets (deficit ~500 kcal/d: PRO (1.6 g.kg-1.d-1 protein and -1.d-1 protein and > 220 g/d carbohydrate for 4 mos. Meal challenges of respective diets were utilized for determination of blood lipids and post-prandial INS and glucose response at the beginning and end of the study. Results There was a trend for PRO to lose more weight (-9.1% vs. -7.3%, P = 0.07 with a significant reduction in percent fat mass compared to CHO (-8.7% vs. -5.7%; P = 0.03. PRO also favored reductions in triacylglycerol (-34% vs. -14%; P P = 0.05; however, CHO favored reduction in LDL-C (-7% vs. +2.5%; P P P Conclusion A weight loss diet with moderate carbohydrate, moderate protein results in more favorable changes in body composition, dyslipidemia, and post-prandial INS response compared to a high carbohydrate, low protein diet suggesting an additional benefit beyond weight management to include augmented risk reduction for metabolic disease.

  15. Weight loss strategies associated with BMI in overweight adults with type 2 diabetes at entry into the Look AHEAD (Action for Health in Diabetes) trial.

    Science.gov (United States)

    Raynor, Hollie A; Jeffery, Robert W; Ruggiero, Andrea M; Clark, Jeanne M; Delahanty, Linda M

    2008-07-01

    Intentional weight loss is recommended for those with type 2 diabetes, but the strategies patients attempt and their effectiveness for weight management are unknown. In this investigation we describe intentional weight loss strategies used and those related to BMI in a diverse sample of overweight participants with type 2 diabetes at enrollment in the Look AHEAD (Action for Health in Diabetes) clinical trial. This was a cross-sectional study of baseline weight loss strategies, including self-weighing frequency, eating patterns, and weight control practices, reported in 3,063 women and 2,082 men aged 45-74 years with BMI > or =25 kg/m(2). Less than half (41.4%) of participants self-weighed > or =1/week. Participants ate breakfast 6.0 +/- 1.8 days/week, ate 5.0 +/- 3.1 meals/snacks per day, and ate 1.9 +/- 2.7 fast food meals/week. The three most common weight control practices (increasing fruits and vegetables, cutting out sweets, and eating less high-carbohydrate foods) were reported by approximately 60% of participants for > or =20 weeks over the previous year. Adjusted models showed that self-weighing less than once per week (B = 0.83), more fast food meals consumed per week (B = 0.14), and fewer breakfast meals consumed per week (B = -0.19) were associated (P < 0.05) with a higher BMI (R(2) = 0.24). Regular self-weighing and breakfast consumption, along with infrequent consumption of fast food, were related to lower BMI in the Look AHEAD study population.

  16. Effect of Alternate-Day Fasting on Weight Loss, Weight Maintenance, and Cardioprotection Among Metabolically Healthy Obese Adults: A Randomized Clinical Trial.

    Science.gov (United States)

    Trepanowski, John F; Kroeger, Cynthia M; Barnosky, Adrienne; Klempel, Monica C; Bhutani, Surabhi; Hoddy, Kristin K; Gabel, Kelsey; Freels, Sally; Rigdon, Joseph; Rood, Jennifer; Ravussin, Eric; Varady, Krista A

    2017-07-01

    Alternate-day fasting has become increasingly popular, yet, to date, no long-term randomized clinical trials have evaluated its efficacy. To compare the effects of alternate-day fasting vs daily calorie restriction on weight loss, weight maintenance, and risk indicators for cardiovascular disease. A single-center randomized clinical trial of obese adults (18 to 64 years of age; mean body mass index, 34) was conducted between October 1, 2011, and January 15, 2015, at an academic institution in Chicago, Illinois. Participants were randomized to 1 of 3 groups for 1 year: alternate-day fasting (25% of energy needs on fast days; 125% of energy needs on alternating "feast days"), calorie restriction (75% of energy needs every day), or a no-intervention control. The trial involved a 6-month weight-loss phase followed by a 6-month weight-maintenance phase. The primary outcome was change in body weight. Secondary outcomes were adherence to the dietary intervention and risk indicators for cardiovascular disease. Among the 100 participants (86 women and 14 men; mean [SD] age, 44 [11] years), the dropout rate was highest in the alternate-day fasting group (13 of 34 [38%]), vs the daily calorie restriction group (10 of 35 [29%]) and control group (8 of 31 [26%]). Mean weight loss was similar for participants in the alternate-day fasting group and those in the daily calorie restriction group at month 6 (-6.8% [95% CI, -9.1% to -4.5%] vs -6.8% [95% CI, -9.1% to -4.6%]) and month 12 (-6.0% [95% CI, -8.5% to -3.6%] vs -5.3% [95% CI, -7.6% to -3.0%]) relative to those in the control group. Participants in the alternate-day fasting group ate more than prescribed on fast days, and less than prescribed on feast days, while those in the daily calorie restriction group generally met their prescribed energy goals. There were no significant differences between the intervention groups in blood pressure, heart rate, triglycerides, fasting glucose, fasting insulin, insulin resistance, C

  17. Perioperative warming with a thermal gown prevents maternal temperature loss during elective cesarean section. A randomized clinical trial.

    Science.gov (United States)

    de Bernardis, Ricardo Caio Gracco; Siaulys, Monica Maria; Vieira, Joaquim Edson; Mathias, Lígia Andrade Silva Telles

    2016-01-01

    Decrease in body temperature is common during general and regional anesthesia. Forced-air warming intraoperative during cesarean section under spinal anesthesia seems not able to prevent it. The hypothesis considers that active warming before the intraoperative period avoids temperature loss during cesarean. Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia received active warming from a thermal gown in the preoperative care unit 30min before spinal anesthesia and during surgery (Go, n=20), or no active warming at any time (Ct, n=20). After induction of spinal anesthesia, the thermal gown was replaced over the chest and upper limbs and maintained throughout study. Room temperature, hemoglobin saturation, heart rate, arterial pressure, and tympanic body temperature were registered 30min before (baseline) spinal anesthesia, right after it (time zero) and every 15min thereafter. There was no difference for temperature at baseline, but they were significant throughout the study (p<0.0001; repeated measure ANCOVA). Tympanic temperature baseline was 36.6±0.3°C, measured 36.5±0.3°C at time zero and reached 36.1±0.2°C for gown group, while control group had baseline temperature of 36.4±0.4°C, measured 36.3±0.3°C at time zero and reached 35.4±0.4°C (F=32.53; 95% CI 0.45-0.86; p<0.001). Hemodynamics did not differ throughout the study for both groups of patients. Active warming 30min before spinal anesthesia and during surgery prevented a fall in body temperature in full-term pregnant women during elective cesarean delivery. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  18. [Perioperative warming with a thermal gown prevents maternal temperature loss during elective cesarean section. A randomized clinical trial].

    Science.gov (United States)

    Bernardis, Ricardo Caio Gracco de; Siaulys, Monica Maria; Vieira, Joaquim Edson; Mathias, Lígia Andrade Silva Telles

    2016-01-01

    Decrease in body temperature is common during general and regional anesthesia. Forced-air warming intraoperative during cesarean section under spinal anesthesia seems not able to prevent it. The hypothesis considers that active warming before the intraoperative period avoids temperature loss during cesarean. Forty healthy pregnant patients undergoing elective cesarean section with spinal anesthesia received active warming from a thermal gown in the preoperative care unit 30min before spinal anesthesia and during surgery (Go, n=20), or no active warming at any time (Ct, n=20). After induction of spinal anesthesia, the thermal gown was replaced over the chest and upper limbs and maintained throughout study. Room temperature, hemoglobin saturation, heart rate, arterial pressure, and tympanic body temperature were registered 30min before (baseline) spinal anesthesia, right after it (time zero) and every 15min thereafter. There was no difference for temperature at baseline, but they were significant throughout the study (p<0.0001; repeated measure ANCOVA). Tympanic temperature baseline was 36.6±0.3°C, measured 36.5±0.3°C at time zero and reached 36.1±0.2°C for gown group, while control group had baseline temperature of 36.4±0.4°C, measured 36.3±0.3°C at time zero and reached 35.4±0.4°C (F=32.53; 95% CI 0.45-0.86; p<0.001). Hemodynamics did not differ throughout the study for both groups of patients. Active warming 30min before spinal anesthesia and during surgery prevented a fall in body temperature in full-term pregnant women during elective cesarean delivery. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  19. Optimizing Implementation of Obesity Prevention Programs: A Qualitative Investigation Within a Large-Scale Randomized Controlled Trial.

    Science.gov (United States)

    Kozica, Samantha L; Teede, Helena J; Harrison, Cheryce L; Klein, Ruth; Lombard, Catherine B

    2016-01-01

    The prevalence of obesity in rural and remote areas is elevated in comparison to urban populations, highlighting the need for interventions targeting obesity prevention in these settings. Implementing evidence-based obesity prevention programs is challenging. This study aimed to investigate factors influencing the implementation of obesity prevention programs, including adoption, program delivery, community uptake, and continuation, specifically within rural settings. Nested within a large-scale randomized controlled trial, a qualitative exploratory approach was adopted, with purposive sampling techniques utilized, to recruit stakeholders from 41 small rural towns in Australia. In-depth semistructured interviews were conducted with clinical health professionals, health service managers, and local government employees. Open coding was completed independently by 2 investigators and thematic analysis undertaken. In-depth interviews revealed that obesity prevention programs were valued by the rural workforce. Program implementation is influenced by interrelated factors across: (1) contextual factors and (2) organizational capacity. Key recommendations to manage the challenges of implementing evidence-based programs focused on reducing program delivery costs, aided by the provision of a suite of implementation and evaluation resources. Informing the scale-up of future prevention programs, stakeholders highlighted the need to build local rural capacity through developing supportive university partnerships, generating local program ownership and promoting active feedback to all program partners. We demonstrate that the rural workforce places a high value on obesity prevention programs. Our results inform the future scale-up of obesity prevention programs, providing an improved understanding of strategies to optimize implementation of evidence-based prevention programs. © 2015 National Rural Health Association.

  20. Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial.

    Science.gov (United States)

    France, Christopher R; Thomas, James S

    2018-06-01

    The virtual immersive gaming to optimize recovery (VIGOR) study is a randomized controlled trial of the effects of virtual reality games to encourage lumbar spine flexion among individuals with chronic low back pain and fear of movement. Whereas traditional graded activity or graded exposure therapies for chronic low back pain have high attrition and poor long-term efficacy, we believe that virtual reality games have distinct advantages that can enhance adherence and clinical outcomes. First, they are engaging and enjoyable activities that can distract from pain and fear of harm. In addition, because they gradually reinforce increases in lumbar spine flexion to achieve game objectives, continued engagement over time is expected to promote recovery through restoration of normal spinal motion. The study design includes two treatment groups which differ in the amount of lumbar flexion required to achieve the game objectives. All participants will play the games for nine weeks, and pre-treatment to 1-week post-treatment changes in pain and disability will serve as the co-primary clinical outcomes. In addition, changes in lumbar flexion and expectations of pain/harm will be examined as potential treatment outcome mediators. Maintenance of treatment outcomes will also be assessed for up to 48-weeks post-treatment. In brief, we hypothesize that the virtual reality games will reduce pain and disability by promoting spinal motion and allowing participants to develop an implicit understanding that they are capable of engaging in significant lumbar spine motion in their daily lives without a risk of injury to their back. Copyright © 2018 Elsevier Inc. All rights reserved.

  1. Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

    Science.gov (United States)

    Matthews, Lynsay; Pugmire, Juliana; Moore, Laurence; Kelson, Mark; McConnachie, Alex; McIntosh, Emma; Morgan-Trimmer, Sarah; Murphy, Simon; Hughes, Kathryn; Coulman, Elinor; Utkina-Macaskill, Olga; Simpson, Sharon Anne

    2017-10-25

    HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s). To test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals. 12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI) > 30 kg/m 2 and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual

  2. A Commercially Available Portion-Controlled Diet Program Is More Effective for Weight Loss than a Self-Directed Diet: Results from a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Chad M. Cook

    2017-11-01

    Full Text Available ObjectiveTo examine changes in weight and related outcomes in response to a commercial weight loss program compared to a self-directed diet in adults with overweight or obesity.DesignParticipants were randomly assigned [stratified by body mass index (BMI and age] to a commercial weight loss program (n = 38 or to a self-directed Dietary Approaches to Stop Hypertension (DASH diet (n = 40 for a 16-week period. Daily energy intake goals were 1,500 kcal/d for men and 1,200 kcal/d for women, except for the first week of the commercial program (1,000 kcal/d. This study was registered at http://ClinicalTrials.gov (NCT03017443.ParticipantsPrimarily Caucasian (71% women (n = 61 and men (n = 17 from the greater metropolitan area of the city of Chicago, IL, USA. with a mean baseline BMI of 34.4 kg/m2, body weight of 95.7 kg, and age of 50.4 years.ResultsData = mean (95% CI. At week 16, the commercial program group lost significantly more body weight [−5.9 (−7.5, −4.3 kg vs. −1.8 (−2.9, −0.8 kg; or −6.4 vs. −1.8% of initial body weight, respectively], fat mass [−4.4 (−5.7, −3.1 kg vs. −1.2 (−2.1, −0.4 kg] and total body circumference (chest + waist + hip + upper arm + thigh [−16.9 (−21.5, −12.3 cm vs. −5.8 (−9.0, −2.6 cm] (p < 0.01 for all. Additionally, more participants in the commercial program group lost a clinically meaningful amount of weight, defined as ≥5% of initial body weight, at week 16 (58% vs. 13%, p < 0.001.ConclusionThe commercial program resulted in greater weight loss and improvements in body composition/anthropometric parameters compared to a self-directed DASH diet over a 16-week period. Some important limitations were that no objective measurements of dietary intake or physical activity were collected to potentially ascertain the independent or combined effects of these components on weight loss (or lack thereof. Additionally, future

  3. A Randomized Controlled Trial of Two Different Macronutrient Profiles on Weight, Body Composition and Metabolic Parameters in Obese Adolescents Seeking Weight Loss.

    Directory of Open Access Journals (Sweden)

    Helen Truby

    Full Text Available Adolescent obesity is difficult to treat and the optimal dietary pattern, particularly in relation to macronutrient composition, remains controversial. This study tested the effect of two structured diets with differing macronutrient composition versus control, on weight, body composition and metabolic parameters in obese adolescents.A randomized controlled trial conducted in a children's hospital.Eighty seven obese youth (means: age 13.6 years, BMI z-score 2.2, waist: height ratio 0.65, 69% female completed a psychological preparedness program and were then randomized to a short term 'structured modified carbohydrate' (SMC, 35% carbohydrate; 30% protein; 35% fat, n = 37 or a 'structured low fat' (SLF, 55% carbohydrate; 20% protein; 25% fat, n = 36 or a wait listed control group (n = 14. Anthropometric, body composition and biochemical parameters were measured at randomization and after 12 weeks, and analyzed under the intention to treat principle using analysis of variance models.After 12 weeks, data was collected from 79 (91% participants. BMI z-scores were significantly lower in both intervention groups compared to control after adjusting for baseline values, SLF vs. control, mean difference = -0.13 (95%CI = -0.18, -0.07, P<0.001; SMC vs. control, -0.14 (-0.19, -0.09, P<0.001, but there was no difference between the two intervention diet groups: SLF vs. SMC, 0.00 (-0.05, 0.04, P = 0.83.Both dietary patterns resulted in similar changes in weight, body composition and metabolic improvements compared to control. The use of a structured eating system which allows flexibility but limited choices can assist in weight change and the rigid application of a low fat eating pattern is not exclusive in its efficacy.International Clinical Trials Registry ISRCTN49438757.

  4. A Targeted and Tailored eHealth Weight Loss Program for Young Women: The Be Positive Be Healthe Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Melinda J. Hutchesson

    2018-05-01

    Full Text Available Young women are gaining weight rapidly. Evidence for effective weight loss interventions targeting young women is lacking. This randomized controlled trial assessed the efficacy and acceptability of a six-month targeted and tailored eHealth weight loss program for young women (Be Positive Be Healthe (BPBH. Women aged 18–35 years were randomized to BPBH (n = 29 or control (n = 28. BPBH supported participants to modify diet and physical activity behaviours using evidenced-based strategies (e.g., self-monitoring tailored for young women and delivered using e-health (website, social media, smartphone application, email, text messages. The primary outcome was a change in weight (kg at six months. Acceptability was assessed via a process evaluation survey and usage of intervention components. No significant between-group differences were observed for weight, with significant mean differences favouring the intervention group observed for body fat (kg (−3.10 (−5.69, 0.52, p = 0.019 and intakes of alcohol (g (−0.69 (−1.33, 0.04, p = 0.037, vegetables (% energy/day (4.71 (−2.20, 7.22, p < 0.001 and energy-dense, nutrient-poor foods (% energy/day (−9.23 (−16.94, 1.52, p = 0.018. Retention, intervention usage and satisfaction were moderate. BPBH facilitated positive improvements in body fat and dietary intake, but not weight. Intervention acceptability findings support the use of some intervention components (e.g., Facebook, Smartphone app with young women.

  5. Dietary weight loss and exercise interventions effects on quality of life in overweight/obese postmenopausal women: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wang Ching-Yun

    2011-10-01

    Full Text Available Abstract Background Although lifestyle interventions targeting multiple lifestyle behaviors are more effective in preventing unhealthy weight gain and chronic diseases than intervening on a single behavior, few studies have compared individual and combined effects of diet and/or exercise interventions on health-related quality of life (HRQOL. In addition, the mechanisms of how these lifestyle interventions affect HRQOL are unknown. The primary aim of this study was to examine the individual and combined effects of dietary weight loss and/or exercise interventions on HRQOL and psychosocial factors (depression, anxiety, stress, social support. The secondary aim was to investigate predictors of changes in HRQOL. Methods This study was a randomized controlled trial. Overweight/obese postmenopausal women were randomly assigned to 12 months of dietary weight loss (n = 118, moderate-to-vigorous aerobic exercise (225 minutes/week, n = 117, combined diet and exercise (n = 117, or control (n = 87. Demographic, health and anthropometric information, aerobic fitness, HRQOL (SF-36, stress (Perceived Stress Scale, depression [Brief Symptom Inventory (BSI-18], anxiety (BSI-18 and social support (Medical Outcome Study Social Support Survey were assessed at baseline and 12 months. The 12-month changes in HRQOL and psychosocial factors were compared using analysis of covariance, adjusting for baseline scores. Multiple regression was used to assess predictors of changes in HRQOL. Results Twelve-month changes in HRQOL and psychosocial factors differed by intervention group. The combined diet + exercise group improved 4 aspects of HRQOL (physical functioning, role-physical, vitality, and mental health, and stress (p ≤ 0.01 vs. controls. The diet group increased vitality score (p Conclusions A combined diet and exercise intervention has positive effects on HRQOL and psychological health, which may be greater than that from exercise or diet alone. Improvements in

  6. A randomized controlled trial to prevent excessive gestational weight gain and promote postpartum weight loss in overweight and obese women: Health In Pregnancy and Postpartum (HIPP).

    Science.gov (United States)

    Wilcox, Sara; Liu, Jihong; Addy, Cheryl L; Turner-McGrievy, Gabrielle; Burgis, Judith T; Wingard, Ellen; Dahl, Alicia A; Whitaker, Kara M; Schneider, Lara; Boutté, Alycia K

    2018-03-01

    Interventions to prevent excessive gestational weight gain and promote postpartum weight loss have yielded modest results, particularly in overweight and obese women. To examine the impact of a theory-based lifestyle intervention on gestational weight gain, postpartum weight loss, and related maternal and child outcomes and to examine race differences in these outcomes. A randomized controlled trial (target N=400; 200 intervention, 200 standard care; 200 African American, 200 white). Overweight and obese African American and white women ≤16weeks gestation are recruited from obstetrics and gynecology clinics in South Carolina. Intervention participants receive two in-depth counseling sessions (early pregnancy and postpartum), telephone counseling, behavioral podcasts, and social media support that target weight self-monitoring and increasing physical activity and healthy dietary behavior practices, guided by Social Cognitive Theory. Standard care participants receive monthly mailings and a matched number of podcasts on non-weight related topics. All intervention activities last from ≤18weeks gestation to 6months after delivery. Gestational weight gain is the primary outcome. Secondary outcomes are meeting gestational weight gain guidelines (inadequate, adequate, excessive), weekly rate of gestational weight gain, postpartum weight retention, physical activity and dietary behaviors, health-related quality of life, and offspring adiposity. Participants are assessed at baseline (≤16weeks gestation), 32weeks gestation, and 6 and 12months postpartum, and offspring are assessed at 6 and 12months. HIPP is an innovative study that addresses significant gaps in the literature. Primary outcome results are expected in 2019. Copyright © 2018 Elsevier Inc. All rights reserved.

  7. Robust sampling-sourced numerical retrieval algorithm for optical energy loss function based on log–log mesh optimization and local monotonicity preserving Steffen spline

    Energy Technology Data Exchange (ETDEWEB)

    Maglevanny, I.I., E-mail: sianko@list.ru [Volgograd State Social Pedagogical University, 27 Lenin Avenue, Volgograd 400131 (Russian Federation); Smolar, V.A. [Volgograd State Technical University, 28 Lenin Avenue, Volgograd 400131 (Russian Federation)

    2016-01-15

    We introduce a new technique of interpolation of the energy-loss function (ELF) in solids sampled by empirical optical spectra. Finding appropriate interpolation methods for ELFs poses several challenges. The sampled ELFs are usually very heterogeneous, can originate from various sources thus so called “data gaps” can appear, and significant discontinuities and multiple high outliers can be present. As a result an interpolation based on those data may not perform well at predicting reasonable physical results. Reliable interpolation tools, suitable for ELF applications, should therefore satisfy several important demands: accuracy and predictive power, robustness and computational efficiency, and ease of use. We examined the effect on the fitting quality due to different interpolation schemes with emphasis on ELF mesh optimization procedures and we argue that the optimal fitting should be based on preliminary log–log scaling data transforms by which the non-uniformity of sampled data distribution may be considerably reduced. The transformed data are then interpolated by local monotonicity preserving Steffen spline. The result is a piece-wise smooth fitting curve with continuous first-order derivatives that passes through all data points without spurious oscillations. Local extrema can occur only at grid points where they are given by the data, but not in between two adjacent grid points. It is found that proposed technique gives the most accurate results and also that its computational time is short. Thus, it is feasible using this simple method to address practical problems associated with interaction between a bulk material and a moving electron. A compact C++ implementation of our algorithm is also presented.

  8. Robust sampling-sourced numerical retrieval algorithm for optical energy loss function based on log–log mesh optimization and local monotonicity preserving Steffen spline

    International Nuclear Information System (INIS)

    Maglevanny, I.I.; Smolar, V.A.

    2016-01-01

    We introduce a new technique of interpolation of the energy-loss function (ELF) in solids sampled by empirical optical spectra. Finding appropriate interpolation methods for ELFs poses several challenges. The sampled ELFs are usually very heterogeneous, can originate from various sources thus so called “data gaps” can appear, and significant discontinuities and multiple high outliers can be present. As a result an interpolation based on those data may not perform well at predicting reasonable physical results. Reliable interpolation tools, suitable for ELF applications, should therefore satisfy several important demands: accuracy and predictive power, robustness and computational efficiency, and ease of use. We examined the effect on the fitting quality due to different interpolation schemes with emphasis on ELF mesh optimization procedures and we argue that the optimal fitting should be based on preliminary log–log scaling data transforms by which the non-uniformity of sampled data distribution may be considerably reduced. The transformed data are then interpolated by local monotonicity preserving Steffen spline. The result is a piece-wise smooth fitting curve with continuous first-order derivatives that passes through all data points without spurious oscillations. Local extrema can occur only at grid points where they are given by the data, but not in between two adjacent grid points. It is found that proposed technique gives the most accurate results and also that its computational time is short. Thus, it is feasible using this simple method to address practical problems associated with interaction between a bulk material and a moving electron. A compact C++ implementation of our algorithm is also presented.

  9. Weight loss in individuals with metabolic syndrome given DASH diet counseling when provided a low sodium vegetable juice: a randomized controlled trial.

    Science.gov (United States)

    Shenoy, Sonia F; Poston, Walker Sc; Reeves, Rebecca S; Kazaks, Alexandra G; Holt, Roberta R; Keen, Carl L; Chen, Hsin Ju; Haddock, C Keith; Winters, Barbara L; Khoo, Chor San H; Foreyt, John P

    2010-02-23

    Metabolic syndrome, a constellation of metabolic risk factors for type 2 diabetes and cardiovascular disease, is one of the fastest growing disease entities in the world. Weight loss is thought to be a key to improving all aspects of metabolic syndrome. Research studies have suggested benefits from diets rich in vegetables and fruits in helping individuals reach and achieve healthy weights. To evaluate the effects of a ready to serve vegetable juice as part of a calorie-appropriate Dietary Approaches to Stop Hypertension (DASH) diet in an ethnically diverse population of people with Metabolic Syndrome on weight loss and their ability to meet vegetable intake recommendations, and on their clinical characteristics of metabolic syndrome (waist circumference, triglycerides, HDL, fasting blood glucose and blood pressure).A secondary goal was to examine the impact of the vegetable juice on associated parameters, including leptin, vascular adhesion markers, and markers of the oxidative defense system and of oxidative stress. A prospective 12 week, 3 group (0, 8, or 16 fluid ounces of low sodium vegetable juice) parallel arm randomized controlled trial. Participants were requested to limit their calorie intake to 1600 kcals for women and 1800 kcals for men and were educated on the DASH diet. A total of 81 (22 men & 59 women) participants with Metabolic Syndrome were enrolled into the study. Dietary nutrient and vegetable intake, weight, height, leptin, metabolic syndrome clinical characteristics and related markers of endothelial and cardiovascular health were measured at baseline, 6-, and 12-weeks. There were significant group by time interactions when aggregating both groups consuming vegetable juice (8 or 16 fluid ounces daily). Those consuming juice lost more weight, consumed more Vitamin C, potassium, and dietary vegetables than individuals who were in the group that only received diet counseling (p juice into the daily diet can be a simple and effective way to

  10. Weight loss in individuals with metabolic syndrome given DASH diet counseling when provided a low sodium vegetable juice: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Hsin

    2010-02-01

    Full Text Available Abstract Background Metabolic syndrome, a constellation of metabolic risk factors for type 2 diabetes and cardiovascular disease, is one of the fastest growing disease entities in the world. Weight loss is thought to be a key to improving all aspects of metabolic syndrome. Research studies have suggested benefits from diets rich in vegetables and fruits in helping individuals reach and achieve healthy weights. Objective To evaluate the effects of a ready to serve vegetable juice as part of a calorie-appropriate Dietary Approaches to Stop Hypertension (DASH diet in an ethnically diverse population of people with Metabolic Syndrome on weight loss and their ability to meet vegetable intake recommendations, and on their clinical characteristics of metabolic syndrome (waist circumference, triglycerides, HDL, fasting blood glucose and blood pressure. A secondary goal was to examine the impact of the vegetable juice on associated parameters, including leptin, vascular adhesion markers, and markers of the oxidative defense system and of oxidative stress. Methods A prospective 12 week, 3 group (0, 8, or 16 fluid ounces of low sodium vegetable juice parallel arm randomized controlled trial. Participants were requested to limit their calorie intake to 1600 kcals for women and 1800 kcals for men and were educated on the DASH diet. A total of 81 (22 men & 59 women participants with Metabolic Syndrome were enrolled into the study. Dietary nutrient and vegetable intake, weight, height, leptin, metabolic syndrome clinical characteristics and related markers of endothelial and cardiovascular health were measured at baseline, 6-, and 12-weeks. Results There were significant group by time interactions when aggregating both groups consuming vegetable juice (8 or 16 fluid ounces daily. Those consuming juice lost more weight, consumed more Vitamin C, potassium, and dietary vegetables than individuals who were in the group that only received diet counseling (p

  11. Genetic variation of habitual coffee consumption and glycemic changes in response to weight-loss diet intervention: the Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) trial.

    Science.gov (United States)

    Han, Liyuan; Ma, Wenjie; Sun, Dianjianyi; Heianza, Yoriko; Wang, Tiange; Zheng, Yan; Huang, Tao; Duan, Donghui; Bray, J George A; Champagne, Catherine M; Sacks, Frank M; Qi, Lu

    2017-11-01

    Background: Coffee consumption has been associated with glucose metabolism and risk of type 2 diabetes. Objective: We examined whether the genetic variation determining habitual coffee consumption affected glycemic changes in response to weight-loss dietary intervention. Design: A genetic risk score (GRS) was calculated based on 8 habitual coffee consumption-associated single nucleotide polymorphisms. We used general linear models to test changes in glycemic traits in groups randomly assigned to high- and low-fat diets according to tertiles of the GRS. Results: We observed significant interactions between the GRS and low compared with high dietary fat intake on 6-mo changes in fasting insulin and homeostasis model assessment of insulin resistance (HOMA-IR) ( P -interaction = 0.023 and 0.022, respectively), adjusting for age, sex, race, physical activity, smoking, alcohol, seasonal variation, and baseline values of the respective outcomes. Participants with a higher GRS of habitual coffee consumption showed a greater reduction in fasting insulin and a marginally greater decrease in HOMA-IR in the low-fat diet intervention group. Conclusions: Our data suggest that participants with genetically determined high coffee consumption may benefit more by eating a low-fat diet in improving fasting insulin and HOMA-IR in a short term. This trial was registered at clinicaltrials.gov as NCT00072995 and NCT03258203. © 2017 American Society for Nutrition.

  12. Effect of Twice-Yearly Denosumab on Prevention of Bone Mineral Density Loss in De Novo Kidney Transplant Recipients: A Randomized Controlled Trial.

    Science.gov (United States)

    Bonani, M; Frey, D; Brockmann, J; Fehr, T; Mueller, T F; Saleh, L; von Eckardstein, A; Graf, N; Wüthrich, R P

    2016-06-01

    We conducted an open-label, prospective, randomized trial to assess the efficacy and safety of RANKL inhibition with denosumab to prevent the loss of bone mineral density (BMD) in the first year after kidney transplantation. Ninety kidney transplant recipients were randomized 1:1 2 weeks after surgery to receive denosumab (60 mg at baseline and 6 months) or no treatment. After 12 months, total lumbar spine areal BMD (aBMD) increased by 4.6% (95% confidence interval [CI] 3.3-5.9%) in 46 patients in the denosumab group and decreased by -0.5% (95% CI -1.8% to 0.9%) in 44 patients in the control group (between-group difference 5.1% [95% CI 3.1-7.0%], p bone turnover (C-terminal telopeptide of type I collagen, procollagen type I N-terminal propeptide) markedly decreased with denosumab (all p transplantation but was associated with more frequent episodes of urinary tract infection. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

  13. Benefits of incorporating the adaptive dynamic range optimization amplification scheme into an assistive listening device for people with mild or moderate hearing loss.

    Science.gov (United States)

    Chang, Hung-Yue; Luo, Ching-Hsing; Lo, Tun-Shin; Chen, Hsiao-Chuan; Huang, Kuo-You; Liao, Wen-Huei; Su, Mao-Chang; Liu, Shu-Yu; Wang, Nan-Mai

    2017-08-28

    This study investigated whether a self-designed assistive listening device (ALD) that incorporates an adaptive dynamic range optimization (ADRO) amplification strategy can surpass a commercially available monaurally worn linear ALD, SM100. Both subjective and objective measurements were implemented. Mandarin Hearing-In-Noise Test (MHINT) scores were the objective measurement, whereas participant satisfaction was the subjective measurement. The comparison was performed in a mixed design (i.e., subjects' hearing status being mild or moderate, quiet versus noisy, and linear versus ADRO scheme). The participants were two groups of hearing-impaired subjects, nine mild and eight moderate, respectively. The results of the ADRO system revealed a significant difference in the MHINT sentence reception threshold (SRT) in noisy environments between monaurally aided and unaided conditions, whereas the linear system did not. The benchmark results showed that the ADRO scheme is effectively beneficial to people who experience mild or moderate hearing loss in noisy environments. The satisfaction rating regarding overall speech quality indicated that the participants were satisfied with the speech quality of both ADRO and linear schemes in quiet environments, and they were more satisfied with ADRO than they with the linear scheme in noisy environments.

  14. Optical loss analysis and parameter optimization for fan-shaped single-polarization grating coupler at wavelength of 1.3 µm band

    Science.gov (United States)

    Ushida, Jun; Tokushima, Masatoshi; Sobu, Yohei; Shimura, Daisuke; Yashiki, Kenichiro; Takahashi, Shigeki; Kurata, Kazuhiko

    2018-05-01

    Fan-shaped grating couplers (F-GCs) can be smaller than straight ones but are less efficient in general in coupling to single-mode fibers. To find a small F-GC with sufficiently high fiber-coupling characteristics, we numerically compared the dependencies of coupling efficiencies on wavelengths, the starting width of gratings, and misalignment distances among 25, 45, and 60° tapered angles of fan shape by using the three-dimensional finite-difference time domain method. A F-GC with a tapered angle of 25° exhibited the highest performances for all dependencies. The optical loss origins of F-GCs were discussed in terms of the electric field structures in them and scattering at the joint between the fan-shaped slab and channel waveguide. We fabricated an optimized 25° F-GC by using ArF photolithography, which almost exactly reproduced the optical coupling efficiency and radiation angle characteristics that were numerically expected.

  15. A randomized controlled trial on the effect of incomplete milking during early lactation on ketonemia and body condition loss in Holstein dairy cows.

    Science.gov (United States)

    Morin, P-A; Krug, C; Chorfi, Y; Dubuc, J; Lacasse, P; Roy, J-P; Santschi, D E; Dufour, S

    2018-05-01

    Limiting milk production for a short period of time in early lactation could be a relevant strategy to prevent hyperketonemia (HYK). From December 2013 to March 2015, 838 multiparous Holstein cows from 13 herds were enrolled in a randomized controlled trial evaluating the effect of incomplete milking in early lactation on ketonemia and its effect on body condition score (BCS) loss. Cows were randomly assigned 4 wk before expected calving date to 1 of 2 treatment groups, (1) a conventional milking protocol (CON) for which cows were completely milked or (2) an incomplete milking protocol (INC) for which a maximum of 10 to 14 kg of milk/d were withdrawn during the first 5 d in milk (DIM). β-Hydroxybutyrate (BHB) concentrations were measured from blood samples collected on each cow 3 times at weekly intervals. Hyperketonemia was defined as BHB ≥1.4 mmol/L. Body condition score variation in the postcalving period was calculated by subtracting BCS assessed at wk 7 from BCS assessed at first week after calving. Effect of treatment on ketonemia and prevalence of HYK were evaluated for 4 specific time periods: 1 to 3, 4 to 7, 8 to 17, and 18 to 26 DIM. Effect of treatment on ketonemia was investigated using linear mixed models with natural logarithm of BHB measurements as outcome and treatment groups as fixed effect. Generalized linear mixed models with HYK as outcome, using logit link, and treatment groups as fixed effect were used to investigate effect of treatment on odds of HYK. A logistic regression model with BCS loss (effects was used to study effect of INC on odds of having BCS loss ≥0.75. A total of 813 lactations had complete data and were used for statistical analysis of ketonemia and HYK. A total of 709 lactations had complete data and were used for analysis of BCS loss. Geometric means of blood BHB concentrations during the 1 to 3, 4 to 7, 8 to 17, and 18 to 26 DIM periods were, respectively, 0.72 (95% confidence interval = 0.66, 0.80), 0.66 (0.60, 0

  16. Power loss analysis in altered tooth-sum spur gearing

    Directory of Open Access Journals (Sweden)

    Sachidananda H. K.

    2018-01-01

    Full Text Available The main cause of power loss or dissipation of heat in case of meshed gears is due to friction existing between gear tooth mesh and is a major concern in low rotational speed gears, whereas in case of high operating speed the power loss taking place due to compression of air-lubricant mixture (churning losses and windage losses due to aerodynamic trial of air lubricant mixture which controls the total efficiency needs to be considered. Therefore, in order to improve mechanical efficiency it is necessary for gear designer during gear tooth optimization to consider these energy losses. In this research paper the power loss analysis for a tooth-sum of 100 altered by ±4% operating between a specified center distance is considered. The results show that negative altered tooth-sum gearing performs better as compared to standard and positive altered tooth-sum gearing.

  17. Optimal timing of an invasive strategy in patients with non-ST-elevation acute coronary syndrome: a meta-analysis of randomised trials.

    Science.gov (United States)

    Jobs, Alexander; Mehta, Shamir R; Montalescot, Gilles; Vicaut, Eric; Van't Hof, Arnoud W J; Badings, Erik A; Neumann, Franz-Josef; Kastrati, Adnan; Sciahbasi, Alessandro; Reuter, Paul-Georges; Lapostolle, Frédéric; Milosevic, Aleksandra; Stankovic, Goran; Milasinovic, Dejan; Vonthein, Reinhard; Desch, Steffen; Thiele, Holger

    2017-08-19

    A routine invasive strategy is recommended for patients with non-ST-elevation acute coronary syndromes (NSTE-ACS). However, optimal timing of invasive strategy is less clearly defined. Individual clinical trials were underpowered to detect a mortality benefit; we therefore did a meta-analysis to assess the effect of timing on mortality. We identified randomised controlled trials comparing an early versus a delayed invasive strategy in patients presenting with NSTE-ACS by searching MEDLINE, Cochrane Central Register of Controlled Trials, and Embase. We included trials that reported all-cause mortality at least 30 days after in-hospital randomisation and for which the trial investigators agreed to collaborate (ie, providing individual patient data or standardised tabulated data). We pooled hazard ratios (HRs) using random-effects models. This meta-analysis is registered at PROSPERO (CRD42015018988). We included eight trials (n=5324 patients) with a median follow-up of 180 days (IQR 180-360). Overall, there was no significant mortality reduction in the early invasive group compared with the delayed invasive group HR 0·81, 95% CI 0·64-1·03; p=0·0879). In pre-specified analyses of high-risk patients, we found lower mortality with an early invasive strategy in patients with elevated cardiac biomarkers at baseline (HR 0·761, 95% CI 0·581-0·996), diabetes (0·67, 0·45-0·99), a GRACE risk score more than 140 (0·70, 0·52-0·95), and aged 75 years older (0·65, 0·46-0·93), although tests for interaction were inconclusive. An early invasive strategy does not reduce mortality compared with a delayed invasive strategy in all patients with NSTE-ACS. However, an early invasive strategy might reduce mortality in high-risk patients. None. Copyright © 2017 Elsevier Ltd. All rights reserved.

  18. Clinical Trials

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    Full Text Available ... studies. View funding information for clinical trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn ... and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn ...

  19. Clinical Trials

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    Full Text Available ... trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Get ... and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Connect ...

  20. Very-low-carbohydrate ketogenic diet v. low-fat diet for long-term weight loss: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Bueno, Nassib Bezerra; de Melo, Ingrid Sofia Vieira; de Oliveira, Suzana Lima; da Rocha Ataide, Terezinha

    2013-10-01

    The role of very-low-carbohydrate ketogenic diets (VLCKD) in the long-term management of obesity is not well established. The present meta-analysis aimed to investigate whether individuals assigned to a VLCKD (i.e. a diet with no more than 50 g carbohydrates/d) achieve better long-term body weight and cardiovascular risk factor management when compared with individuals assigned to a conventional low-fat diet (LFD; i.e. a restricted-energy diet with less than 30% of energy from fat). Through August 2012, MEDLINE, CENTRAL, ScienceDirect,Scopus, LILACS, SciELO, ClinicalTrials.gov and grey literature databases were searched, using no date or language restrictions, for randomised controlled trials that assigned adults to a VLCKD or a LFD, with 12 months or more of follow-up. The primary outcome was bodyweight. The secondary outcomes were TAG, HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C), systolic and diastolic blood pressure,glucose, insulin, HbA1c and C-reactive protein levels. A total of thirteen studies met the inclusion/exclusion criteria. In the overall analysis,five outcomes revealed significant results. Individuals assigned to a VLCKD showed decreased body weight (weighted mean difference 20·91 (95% CI 21·65, 20·17) kg, 1415 patients), TAG (weighted mean difference 20·18 (95% CI 20·27, 20·08) mmol/l, 1258 patients)and diastolic blood pressure (weighted mean difference 21·43 (95% CI 22·49, 20·37) mmHg, 1298 patients) while increased HDL-C(weighted mean difference 0·09 (95% CI 0·06, 0·12) mmol/l, 1257 patients) and LDL-C (weighted mean difference 0·12 (95% CI 0·04,0·2) mmol/l, 1255 patients). Individuals assigned to a VLCKD achieve a greater weight loss than those assigned to a LFD in the longterm; hence, a VLCKD may be an alternative tool against obesity.

  1. A Phase III, Multicenter, Parallel-Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam Versus Vehicle in Women With Female Pattern Hair Loss.

    Science.gov (United States)

    Bergfeld, Wilma; Washenik, Ken; Callender, Valerie; Zhang, Paul; Quiza, Carlos; Doshi, Uday; Blume-Peytavi, Ulrike

    2016-07-01

    BACKGROUND Female pattern hair loss (FPHL) is a common hair disorder that affects millions of women. A new 5% minoxidil topical foam (MTF) formulation, which does not contain propylene glycol, has been developed. To compare the efficacy and safety of once-daily 5% MTF with vehicle foam for the treatment of FPHL. This was a Phase III, randomized, double-blind, vehicle-controlled, parallel-group, international multicenter trial (17 sites) in women aged at least 18 years with FPHL (grade D3 to D6 on the Savin Density Scale), treated once daily with 5% MTF or vehicle foam for 24 weeks. The co-primary efficacy endpoints were the change from baseline at week 24 in target area hair count (TAHC) and subject assessment of scalp coverage. Also evaluated were TAHC at week 12, expert panel review of hair regrowth at week 24, and change from baseline in total unit area density (TUAD, sum of hair diameters/cm2) at weeks 12 and 24. A total of 404 women were enrolled. At 12 and 24 weeks, 5% MTF treatment resulted in regrowth of 10.9 hairs/cm2 and 9.1 hairs/cm2 more than vehicle foam, respectively (both P<.0001). Improved scalp coverage at week 24 was observed by both subject self-assessment (0.69-point improvement over vehicle foam; P<.0001) and expert panel review (0.36-point improvement over the vehicle foam; P<.0001). TUAD increased by 658 μm/cm2 and 644 μm/cm2 more with 5% MTF than with vehicle foam at weeks 12 and 24, respectively (both P<.0001). MTF was well tolerated. A low incidence of scalp irritation and facial hypertrichosis was observed, with no clinically significant differences between groups. Five percent MTF once daily for 24 weeks was well tolerated and promoted hair regrowth in women with FPHL, resulting in improved scalp coverage and increased hair density compared with vehicle foam. ClinicalTrials.gov identifier: nCT01226459J Drugs Dermatol. 2016;15(7):874-881.

  2. Training Needs of Clinical and Research Professionals to Optimize Minority Recruitment and Retention in Cancer Clinical Trials.

    Science.gov (United States)

    Niranjan, Soumya J; Durant, Raegan W; Wenzel, Jennifer A; Cook, Elise D; Fouad, Mona N; Vickers, Selwyn M; Konety, Badrinath R; Rutland, Sarah B; Simoni, Zachary R; Martin, Michelle Y

    2017-08-03

    The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority patient populations. However, clinical trial recruitment is complex and requires a broader appreciation of the multiple factors that influence minority participation. One area that has received little attention is minority recruitment training for professionals who assume various roles in the clinical trial recruitment process. Therefore, we assessed the perspectives of cancer center clinical and research personnel on their training and education needs toward minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five U.S. cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Interviews were recorded and transcribed. Qualitative analyses focused on response data related to training for minority recruitment for cancer clinical trials. Four prominent themes were identified: (1) Research personnel are not currently being trained to focus on recruitment and retention of minority populations; (2) Training for minority recruitment and retention provides for a specific focus on factors influencing minority research participation; (3) Training on cultural awareness may help to bridge cultural gaps between potential minority participants and research professionals; (4) Views differ regarding the importance of research personnel training designed to focus on recruitment of minority populations. There is a lack of systematic training for minority recruitment. Many stakeholders acknowledged the benefits of minority recruitment training and welcomed training that focuses on increasing cultural awareness to increase the participation of minorities in cancer clinical trials.

  3. Comparison of 3 ad libitum diets for weight-loss maintenance, risk of cardiovascular disease, and diabetes: A 6-mo randomized, controlled trial

    DEFF Research Database (Denmark)

    Due, Anette; Larsen, Thomas M; Mu, Huiling

    2008-01-01

    BACKGROUND: The optimal dietary content and type of fat and carbohydrate for weight management has been debated for decades. OBJECTIVE: The objective was to compare the effects of 3 ad libitum diets on the maintenance of an initial weight loss of >or=8% and risk factors for CVD and diabetes during...... a 6-mo controlled dietary intervention. DESIGN: Nondiabetic overweight or obese [mean +/- SD body mass index (in kg/m(2)): 31.5 +/- 2.6] men (n = 55) and women (n = 76) aged 28.2 +/- 4.8 y were randomly assigned to a diet providing a moderate amount of fat (35-45% of energy) and >20% of fat...... as monounsaturated fatty acids (MUFA diet; n = 54), to a low-fat (20-30% of energy) diet (LF diet; n = 51), or to a control diet (35% of energy as fat; n = 26). Protein constituted 10-20% of energy in all 3 diets. All foods were provided free of charge from a purpose-built supermarket. RESULTS: More subjects dropped...

  4. A gain-loss framework based on ensemble flow forecasts to switch the urban drainage-wastewater system management towards energy optimization during dry periods

    Science.gov (United States)

    Courdent, Vianney; Grum, Morten; Munk-Nielsen, Thomas; Mikkelsen, Peter S.

    2017-05-01

    Precipitation is the cause of major perturbation to the flow in urban drainage and wastewater systems. Flow forecasts, generated by coupling rainfall predictions with a hydrologic runoff model, can potentially be used to optimize the operation of integrated urban drainage-wastewater systems (IUDWSs) during both wet and dry weather periods. Numerical weather prediction (NWP) models have significantly improved in recent years, having increased their spatial and temporal resolution. Finer resolution NWP are suitable for urban-catchment-scale applications, providing longer lead time than radar extrapolation. However, forecasts are inevitably uncertain, and fine resolution is especially challenging for NWP. This uncertainty is commonly addressed in meteorology with ensemble prediction systems (EPSs). Handling uncertainty is challenging for decision makers and hence tools are necessary to provide insight on ensemble forecast usage and to support the rationality of decisions (i.e. forecasts are uncertain and therefore errors will be made; decision makers need tools to justify their choices, demonstrating that these choices are beneficial in the long run). This study presents an economic framework to support the decision-making process by providing information on when acting on the forecast is beneficial and how to handle the EPS. The relative economic value (REV) approach associates economic values with the potential outcomes and determines the preferential use of the EPS forecast. The envelope curve of the REV diagram combines the results from each probability forecast to provide the highest relative economic value for a given gain-loss ratio. This approach is traditionally used at larger scales to assess mitigation measures for adverse events (i.e. the actions are taken when events are forecast). The specificity of this study is to optimize the energy consumption in IUDWS during low-flow periods by exploiting the electrical smart grid market (i.e. the actions are taken

  5. Benefits of phoneme discrimination training in a randomized controlled trial of 50- to 74-year-olds with mild hearing loss.

    Science.gov (United States)

    Ferguson, Melanie A; Henshaw, Helen; Clark, Daniel P A; Moore, David R

    2014-01-01

    The aims of this study were to (i) evaluate the efficacy of phoneme discrimination training for hearing and cognitive abilities of adults aged 50 to 74 years with mild sensorineural hearing loss who were not users of hearing aids, and to (ii) determine participant compliance with a self-administered, computer-delivered, home- and game-based auditory training program. This study was a randomized controlled trial with repeated measures and crossover design. Participants were trained and tested over an 8- to 12-week period. One group (Immediate Training) trained during weeks 1 and 4. A second waitlist group (Delayed Training) did no training during weeks 1 and 4, but then trained during weeks 5 and 8. On-task (phoneme discrimination) and transferable outcome measures (speech perception, cognition, self-report of hearing disability) for both groups were obtained during weeks 0, 4, and 8, and for the Delayed Training group only at week 12. Robust phoneme discrimination learning was found for both groups, with the largest improvements in threshold shown for those with the poorest initial thresholds. Between weeks 1 and 4, the Immediate Training group showed moderate, significant improvements on self-report of hearing disability, divided attention, and working memory, specifically for conditions or situations that were more complex and therefore more challenging. Training did not result in consistent improvements in speech perception in noise. There was no evidence of any test-retest effects between weeks 1 and 4 for the Delayed Training group. Retention of benefit at 4 weeks post-training was shown for phoneme discrimination, divided attention, working memory, and self-report of hearing disability. Improved divided attention and reduced self-reported hearing difficulties were highly correlated. It was observed that phoneme discrimination training benefits some but not all people with mild hearing loss. Evidence presented here, together with that of other studies that

  6. Effectiveness of conventional versus virtual reality-based balance exercises in vestibular rehabilitation for unilateral peripheral vestibular loss: results of a randomized controlled trial.

    Science.gov (United States)

    Meldrum, Dara; Herdman, Susan; Vance, Roisin; Murray, Deirdre; Malone, Kareena; Duffy, Douglas; Glennon, Aine; McConn-Walsh, Rory

    2015-07-01

    To compare the effectiveness of virtual reality-based balance exercises to conventional balance exercises during vestibular rehabilitation in patients with unilateral peripheral vestibular loss (UVL). Assessor-blind, randomized controlled trial. Two acute care university teaching hospitals. Patients with UVL (N=71) who had dizziness/vertigo, and gait and balance impairment. Patients with UVL were randomly assigned to receive 6 weeks of either conventional (n=36) or virtual reality-based (n=35) balance exercises during vestibular rehabilitation. The virtual reality-based group received an off-the-shelf virtual reality gaming system for home exercise, and the conventional group received a foam balance mat. Treatment comprised weekly visits to a physiotherapist and a daily home exercise program. The primary outcome was self-preferred gait speed. Secondary outcomes included other gait parameters and tasks, Sensory Organization Test (SOT), dynamic visual acuity, Hospital Anxiety and Depression Scale, Vestibular Rehabilitation Benefits Questionnaire, and Activities Balance Confidence Questionnaire. The subjective experience of vestibular rehabilitation was measured with a questionnaire. Both groups improved, but there were no significant differences in gait speed between the groups postintervention (mean difference, -.03m/s; 95% confidence interval [CI], -.09 to .02m/s). There were also no significant differences between the groups in SOT scores (mean difference, .82%; 95% CI, -5.00% to 6.63%) or on any of the other secondary outcomes (P>.05). In both groups, adherence to exercise was high (∼77%), but the virtual reality-based group reported significantly more enjoyment (P=.001), less difficulty with (P=.009) and less tiredness after (P=.03) balance exercises. At 6 months, there were no significant between-group differences in physical outcomes. Virtual reality-based balance exercises performed during vestibular rehabilitation were not superior to conventional balance

  7. Orange juice allied to a reduced-calorie diet results in weight loss and ameliorates obesity-related biomarkers: A randomized controlled trial.

    Science.gov (United States)

    Ribeiro, Carolina; Dourado, Grace; Cesar, Thais

    2017-06-01

    Assumptions have linked orange juice (OJ) consumption with weight gain and adverse effects on health due to its sugar content; however, epidemiologic studies have not shown increased risk for overweight or obesity with the consumption of 100% OJ. The aim of this study was to verify whether the combination of a reduced-calorie diet (RCD) and 100% OJ contribute to weight loss, promote changes in glucose and lipid metabolism, and improve diet quality in obese individuals. A randomized controlled trial with 78 obese patients (age 36 ± 1 y, body mass index [BMI] 33 ± 3 kg/m 2 ) were enrolled in two groups: Individuals in the OJ group submitted to an RCD that included OJ (500 mL/d), and individuals in the control group submitted to an RCD without OJ. Body composition, biochemical biomarkers, and dietary intake were analyzed over a 12-wk period. Both treatments had similar outcomes regarding body weight (-6.5 kg; P = 0.363), BMI (-2.5 kg/m 2 ; P = 0.34), lean mass (-1 kg; P = 0.29), fat mass (-5 kg; P = 0.58), body fat (-3%; P = 0.15), and waist-to-hip ratio (-0.1; P = 0.79). Insulin levels in the OJ group decreased by 18% (P = 0.05), homeostasis model assessment-insulin resistance by 33% (P = 0.04), total cholesterol by 24% (P = 0.004), low-density lipoprotein cholesterol by 24% (P ≤ 0.001), and high-sensitivity C-reactive protein levels by 33% (P = 0.001) compared with the control group. Consumption of energy and nutrients was similar between the two groups, but vitamin C and folate increased by 62% (P ≤ 0.015) and 39% (P = 0.033), respectively, after OJ intervention. When consumed concomitantly with an RCD, OJ does not inhibit weight loss; ameliorate the insulin sensitivity, lipid profile, or inflammatory status, or contribute nutritionally to the quality of the diet. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  8. Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Ahmadi, Shahnaz; Jamilian, Mehri; Karamali, Maryam; Tajabadi-Ebrahimi, Maryam; Jafari, Parvaneh; Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Asemi, Zatollah

    2017-12-01

    The aim of the current study was to assess the effects of probiotic supplementation on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome (PCOS). In a randomized, double-blind, placebo-controlled trial, 60 women with PCOS were randomized to receive probiotic capsule (n = 30) or placebo (n = 30) for 12 weeks. Consumption of probiotic supplements resulted in a significant reduction in weight (-0.5 ± 0.4 vs. +0.1 ± 1.0 kg, p = 0.004) and BMI (-0.2 ± 0.2 vs. +0.03 ± 0.4 kg/m 2 , p = 0.004) compared with the placebo. In addition, compared with the placebo, probiotic administration was associated with a significant decrease in fasting plasma glucose (-2.4 ± 8.4 vs. +2.1 ± 7.0 mg/dL, p = 0.02), serum insulin concentrations (-2.0 ± 5.8 vs. +1.6 ± 5.0 μIU/mL, p = 0.01), homoeostasis model of assessment-insulin resistance (-0.5 ± 1.4 vs. +0.3 ± 1.1, p = 0.01), homoeostatic model assessment-beta cell function (-7.5 ± 22.3 vs. +6.3 ± 21.7, p = 0.01), serum triglycerides (-13.3 ± 51.3 vs. +13.6 ± 37.1 mg/dL, p= 0.02) and a significant increase in quantitative insulin sensitivity check index (QUICKI) (+0.006 ± 0.01 vs. -0.005 ± 0.02, p = 0.01). When we adjusted the analysis for baseline values of biochemical parameters, age and baseline BMI, except for QUICKI (p = 0.08), other findings did not alter. We found that probiotic supplementation among PCOS women for 12 weeks had favourable effects on weight loss, markers of insulin resistance, triglycerides and VLDL-cholesterol concentrations.

  9. Impact of a Mindfulness-Based Weight-Loss Intervention on Sleep Quality Among Adults with Obesity: Data from the SHINE Randomized Controlled Trial.

    Science.gov (United States)

    Adler, Elizabeth; Dhruva, Anand; Moran, Patricia J; Daubenmier, Jennifer; Acree, Michael; Epel, Elissa S; Bacchetti, Peter; Prather, Aric A; Mason, Ashley; Hecht, Frederick M

    2017-03-01

    Sleep disturbance is a common problem among adults with obesity. Mindfulness interventions have been shown to improve sleep quality in various populations but have not been investigated in adults with obesity. The aim of this study was to compare the effects of a mindfulness-based weight-loss intervention with an active control on self-reported sleep quality among adults with obesity. This study was a secondary analysis of a randomized controlled trial and included 194 adults with a body mass index in the range 30-45 kg/m 2 . The treatment intervention included mindfulness-based eating and stress-management practices, and the active control intervention included training in progressive muscle relaxation (PMR). Both groups received identical diet and exercise guidelines in 17 group sessions conducted over 5.5 months that were matched for time, attention, and social support. The primary outcome of this analysis was between-group change in self-reported sleep quality, which was assessed using the Pittsburgh Sleep Quality Index (PSQI) global score at baseline and at 6, 12, and 18 months. Between-group differences in mean PSQI change scores in the mindfulness group (n = 100) compared to the control group (n = 94) were -0.27 (-0.68, 1.22; p = 0.58) at 6 months, -0.57 (-0.35, 1.50; p = 0.22) at 12 months, and -0.50 (-0.53, 1.53; p = 0.34) at 18 months, all in the direction of more sleep improvement in the mindfulness group but none reaching statistical significance. In the mindfulness group, average weekly minutes of meditation practice time was associated with improved sleep quality from baseline to 6 months. No statistically significant evidence was found that a weight-loss program that incorporates mindfulness improves self-reported sleep quality compared to a control diet/exercise intervention that included PMR. Within the mindfulness group, average weekly minutes of mindfulness practice was associated with improved sleep quality.

  10. Optimizing adherence in HIV prevention product trials: Development and psychometric evaluation of simple tools for screening and adherence counseling.

    Science.gov (United States)

    Tolley, Elizabeth E; Guthrie, Kate Morrow; Zissette, Seth; Fava, Joseph L; Gill, Katherine; Louw, Cheryl E; Kotze, Philip; Reddy, Krishnaveni; MacQueen, Kathleen

    2018-01-01

    Low adherence in recent HIV prevention clinical trials highlights the need to better understand, measure, and support product use within clinical trials. Conventional self-reported adherence instruments within HIV prevention trials, often relying on single-item questions, have proven ineffective. While objective adherence measures are desirable, none currently exist that apply to both active and placebo arms. Scales are composed of multiple items in the form of questions or statements that, when combined, measure a more complex construct that may not be directly observable. When psychometrically validated, such measures may better assess the multiple factors contributing to adherence/non-adherence. This study aimed to develop and psychometrically evaluate tools to screen and monitor trial participants' adherence to HIV prevention products within the context of clinical trial research. Based on an extensive literature review and conceptual framework, we identified and refined 86 items assessing potential predictors of adherence and 48 items assessing adherence experience. A structured survey, including adherence items and other variables, was administered to former ASPIRE and Ring Study participants and similar non-trial participants (n = 709). We conducted exploratory factor analyses (EFA) to identify a reduced set of constructs and items that could be used at screening to predict potential adherence, and at follow-up to monitor and intervene on adherence. We examined associations with other variables to assess content and construct validity. The EFA of screener items resulted in a 6-factor solution with acceptable to very good internal reliability (α: .62-.84). Similar to our conceptual framework, factors represent trial-related commitment (Distrust of Research and Commitment to Research); alignment with trial requirements (Visit Adherence and Trial Incompatibility); Belief in Trial Benefits and Partner Disclosure. The EFA on monitoring items resulted in 4

  11. Durable efficacy of enfuvirtide over 48 weeks in heavily treatment-experienced HIV-1-infected patients in the T-20 versus optimized background regimen only 1 and 2 clinical trials

    NARCIS (Netherlands)

    Nelson, Mark; Arastéh, Keikawus; Clotet, Bonaventura; Cooper, David A.; Henry, Keith; Katlama, Christine; Lalezari, Jacob P.; Lazzarin, Adriano; Montaner, Julio S. G.; O'Hearn, Mary; Piliero, Peter J.; Reynes, Jacques; Trottier, Benoit; Walmsley, Sharon L.; Cohen, Calvin; Eron, Joseph J.; Kuritzkes, Daniel R.; Lange, Joep; Stellbrink, Hans-Jürgen; Delfraissy, Jean-François; Buss, Neil E.; Donatacci, Lucille; Wat, Cynthia; Smiley, Lynn; Wilkinson, Martin; Valentine, Adeline; Guimaraes, Denise; DeMasi, Ralph; Chung, Jain; Salgo, Miklos P.

    2005-01-01

    The T-20 Versus Optimized Background Regimen Only (TORO) 1 and TORO 2 clinical trials are open-label, controlled, parallel-group, phase 3 studies comparing enfuvirtide plus an optimized background (OB) of antiretrovirals (n = 661) with OB alone (n = 334) in treatment-experienced HIV-1-infected

  12. A Sound Therapy-Based Intervention to Expand the Auditory Dynamic Range for Loudness among Persons with Sensorineural Hearing Losses: A Randomized Placebo-Controlled Clinical Trial

    Science.gov (United States)

    Formby, Craig; Hawley, Monica L.; Sherlock, LaGuinn P.; Gold, Susan; Payne, JoAnne; Brooks, Rebecca; Parton, Jason M.; Juneau, Roger; Desporte, Edward J.; Siegle, Gregory R.

    2015-01-01

    The primary aim of this research was to evaluate the validity, efficacy, and generalization of principles underlying a sound therapy–based treatment for promoting expansion of the auditory dynamic range (DR) for loudness. The basic sound therapy principles, originally devised for treatment of hyperacusis among patients with tinnitus, were evaluated in this study in a target sample of unsuccessfully fit and/or problematic prospective hearing aid users with diminished DRs (owing to their elevated audiometric thresholds and reduced sound tolerance). Secondary aims included: (1) delineation of the treatment contributions from the counseling and sound therapy components to the full-treatment protocol and, in turn, the isolated treatment effects from each of these individual components to intervention success; and (2) characterization of the respective dynamics for full, partial, and control treatments. Thirty-six participants with bilateral sensorineural hearing losses and reduced DRs, which affected their actual or perceived ability to use hearing aids, were enrolled in and completed a placebo-controlled (for sound therapy) randomized clinical trial. The 2 × 2 factorial trial design was implemented with or without various assignments of counseling and sound therapy. Specifically, participants were assigned randomly to one of four treatment groups (nine participants per group), including: (1) group 1—full treatment achieved with scripted counseling plus sound therapy implemented with binaural sound generators; (2) group 2—partial treatment achieved with counseling and placebo sound generators (PSGs); (3) group 3—partial treatment achieved with binaural sound generators alone; and (4) group 4—a neutral control treatment implemented with the PSGs alone. Repeated measurements of categorical loudness judgments served as the primary outcome measure. The full-treatment categorical-loudness judgments for group 1, measured at treatment termination, were

  13. Optimizing adaptive design for Phase 2 dose-finding trials incorporating long-term success and financial considerations: A case study for neuropathic pain.

    Science.gov (United States)

    Gao, Jingjing; Nangia, Narinder; Jia, Jia; Bolognese, James; Bhattacharyya, Jaydeep; Patel, Nitin

    2017-06-01

    In this paper, we propose an adaptive randomization design for Phase 2 dose-finding trials to optimize Net Present Value (NPV) for an experimental drug. We replace the traditional fixed sample size design (Patel, et al., 2012) by this new design to see if NPV from the original paper can be improved. Comparison of the proposed design to the previous design is made via simulations using a hypothetical example based on a Diabetic Neuropathic Pain Study. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Recurrent pregnancy loss

    DEFF Research Database (Denmark)

    Egerup, P; Kolte, A M; Larsen, E C

    2016-01-01

    STUDY QUESTION: Is there a different prognostic impact for consecutive and non-consecutive early pregnancy losses in women with secondary recurrent pregnancy loss (RPL)? SUMMARY ANSWER: Only consecutive early pregnancy losses after the last birth have a statistically significant negative prognostic...... impact in women with secondary RPL. WHAT IS KNOWN ALREADY: The risk of a new pregnancy loss increases with the number of previous pregnancy losses in patients with RPL. Second trimester losses seem to exhibit a stronger negative impact than early losses. It is unknown whether the sequence of pregnancy...... losses plays a role for the prognosis in patients with a prior birth. STUDY DESIGN, SIZE, DURATION: This retrospective cohort study of pregnancy outcome in patients with unexplained secondary RPL included in three previously published, Danish double-blinded placebo-controlled trials of intravenous...

  15. Reporting of loss to follow-up information in randomised controlled trials with time-to-event outcomes: a literature survey

    Directory of Open Access Journals (Sweden)

    Bender Ralf

    2011-09-01

    Full Text Available Abstract Background To assess the reporting of loss to follow-up (LTFU information in articles on randomised controlled trials (RCTs with time-to-event outcomes, and to assess whether discrepancies affect the validity of study results. Methods Literature survey of all issues of the BMJ, Lancet, JAMA, and New England Journal of Medicine published between 2003 and 2005. Eligible articles were reports of RCTs including at least one Kaplan-Meier plot. Articles were classified as "assessable" if sufficient information was available to assess LTFU. In these articles, LTFU information was derived from Kaplan-Meier plots, extracted from the text, and compared. Articles were then classified as "consistent" or "not consistent". Sensitivity analyses were performed to assess the validity of study results. Results 319 eligible articles were identified. 187 (59% were classified as "assessable", as they included sufficient information for evaluation; 140 of 319 (44% presented consistent LTFU information between the Kaplan-Meier plot and text. 47 of 319 (15% were classified as "not consistent". These 47 articles were included in sensitivity analyses. When various imputation methods were used, the results of a chi2-test applied to the corresponding 2 × 2 table changed and hence were not robust in about half of the studies. Conclusions Less than half of the articles on RCTs using Kaplan-Meier plots provide assessable and consistent LTFU information, thus questioning the validity of the results and conclusions of many studies presenting survival analyses. Authors should improve the presentation of both Kaplan-Meier plots and LTFU information, and reviewers of study publications and journal editors should critically appraise the validity of the information provided.

  16. A Multi-Component Day-Camp Weight-Loss Program Is Effective in Reducing BMI in Children after One Year: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Kristian Traberg Larsen

    Full Text Available The objective of the present study was to evaluate the effectiveness of a one-year multi-component immersive day-camp weight-loss intervention for children with overweight and obesity. The study design was a parallel-group randomized controlled trial. One hundred fifteen 11-13-year-old children with overweight and obesity were randomized into either: A six-week day-camp intervention arm focusing on increased physical activity, and healthy diet followed by a subsequent one-year family-based intervention, or a standard intervention arm consisting of one weekly exercise session for six weeks. Body mass index (BMI was the primary outcome. BMI z-score, clustered cardiovascular risk z-score, and body composition were secondary outcomes. All outcomes were measured at baseline, six week-, and 52 week follow-up. After six weeks, children from the day-camp intervention arm had improved their BMI (-2.2 kg/m2 (95% CI -2.6 to -1.7, P<0.001 and all secondary outcomes when compared to the children from the standard intervention arm. After 52 weeks, the day-camp intervention arm had a lower BMI (-1.2 kg/m2 (95% CI -1.8 to -0.5, P = 0.001, and BMI z-score (-0.20 (95% CI -0.35 to -0.05, P = 0.008, and clustered cardiovascular risk z-score (-0.23 (95% CI -0.37 to -0.08, P = 0.002 compared to the standard intervention arm. No group differences were detected in body composition after 52 weeks. This study shows that the day-camp intervention arm is effective in reducing BMI and improving the metabolic health of children with overweight and obesity. However, the effects seem to be diminishing over time.

  17. Effect of a low-fat or low-carbohydrate weight-loss diet on markers of cardiovascular risk among premenopausal women: a randomized trial.

    Science.gov (United States)

    Foraker, Randi E; Pennell, Michael; Sprangers, Peter; Vitolins, Mara Z; DeGraffinreid, Cecilia; Paskett, Electra D

    2014-08-01

    Low-fat and low-carbohydrate weight-loss diets can have a beneficial effect on longitudinal measures of blood pressure and blood lipids. We aimed to assess longitudinal changes in blood pressure and blood lipids in a population of premenopausal women. We hypothesized that results may differ by level of adherence to the respective diet protocol and baseline presence of hypertension or hyperlipidemia. Overweight or obese premenopausal women were randomized to a low-fat (n=41) or low-carbohydrate (n=38) diet. As part of the 52-week Lifestyle Eating and Fitness (LEAF) intervention trial, we fit linear mixed models to determine whether a change in outcome differed by treatment arm. Within-group trends in blood pressure and blood lipids did not differ (p>0.30). Across study arms, there was a significant decrease in systolic blood pressure (SBP, 3 mm Hg, p=0.01) over time, but diastolic blood pressure (DBP) did not change significantly over the course of the study. Blood lipids (total cholesterol [TC], low-density lipoproteins [LDL], and high-density lipoproteins [HDL]) all exhibited nonlinear trends over time (p0.20). We observed a decline in SBP among women who were hypertensive at baseline (p0.40). Our results support that dietary interventions may be efficacious for lowering blood pressure and blood lipids among overweight or obese premenopausal women. However, a decrease in SBP was the only favorable change that was sustained in this study population. These changes can be maintained over the course of a 1-year intervention, yet changes in blood lipids may be less sustainable.

  18. Macronutrient Intake-Associated FGF21 Genotype Modifies Effects of Weight-Loss Diets on 2-Year Changes of Central Adiposity and Body Composition: The POUNDS Lost Trial.

    Science.gov (United States)

    Heianza, Yoriko; Ma, Wenjie; Huang, Tao; Wang, Tiange; Zheng, Yan; Smith, Steven R; Bray, George A; Sacks, Frank M; Qi, Lu

    2016-11-01

    Fibroblast growth factor 21 (FGF21) is involved in the regulation of energy balance and adipose metabolism. Our previous genome-wide association study identified genetic variants in the FGF21 region associated with macronutrient intake preference. We investigated whether the FGF21 genotype modified effects of weight-loss diets varying in macronutrient intake on changes in adiposity in a 2-year randomized diet intervention trial. We genotyped FGF21 rs838147 in 715 overweight or obese individuals who were assigned to one of four diets varying in macronutrient contents. A DEXA scan was performed to evaluate body composition. We observed a significant interaction between the FGF21 genotype and carbohydrate/fat intake on 2-year changes in waist circumference (WC), percentage of total fat mass, and percentage of trunk fat (P = 0.049, P = 0.001, and P = 0.003 for interaction, respectively). In response to the low-carbohydrate/high-fat diet, carrying the carbohydrate intake-decreasing C allele of rs838147 was marginally associated with less reduction in WC (P = 0.08) and significantly associated with less reduction of total fat mass (P = 0.01) and trunk fat (P = 0.02). Opposite genetic associations with these outcomes were observed among the high-carbohydrate/low-fat diet group; carrying the C allele was associated with a greater reduction of WC, total body fat mass, and trunk fat. Our data suggest that FGF21 genotypes may interact with dietary carbohydrate/fat intake on changes in central adiposity and body fat composition. A low-calorie, high-carbohydrate/low-fat diet was beneficial for overweight or obese individuals carrying the carbohydrate intake-decreasing allele of the FGF21 variant to improve body composition and abdominal obesity. © 2016 by the American Diabetes Association.

  19. Loss of idealism or realistic optimism? A cross-sectional analysis of dental hygiene students' and registered dental hygienists' professional identity perceptions.

    Science.gov (United States)

    Champine, J M; Inglehart, M R; Furgeson, D; Halaris, J F; Fitzgerald, M; Danciu, T E; Kinney, J S

    2018-02-01

    The dental hygiene profession in the U.S. is in the process of establishing a direct access model of care and contributing to the creation of the profession of a dental therapist. The objectives were to analyse the professional role perceptions of dental hygiene students and registered dental hygienists in these times of change. Specifically, it was explored whether dental hygiene students' current professional identities differ (i) from their expected future identities, and (ii) from dental hygienists' current and (iii) past identities. Survey data were collected from 215 dental hygiene students concerning their present and future role perceptions, and from 352 registered dental hygienists concerning their present and past professional identity perceptions. Students' future professional identity perceptions were even more positive than their very positive current perceptions of their professional role components. Students' current perceptions of professional pride, professional ambition, work ethic and patient relations were more positive than dental hygienists' current perceptions of these professional role components. A comparison of students' current perceptions with dental hygienists' current and retrospective descriptions showed that students were more positive than dental hygienists in each case. The fact that dental hygienists had less positive role perceptions than dental hygiene students might lead to the conclusion that a loss of idealism occurs over the course of a professional lifespan. However, dental hygienists actually improved their role perceptions over time and students' future descriptions were more positive than their current descriptions, supporting the interpretation that realistic optimism dominates professional role perceptions in these times of change. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Lin, Susie; McKenna, Samuel J; Yao, Chuan-Fong; Chen, Yu-Ray; Chen, Chit

    2017-01-01

    The objective of this study was to evaluate the efficacy of hypotensive anesthesia in reducing intraoperative blood loss, decreasing operation time, and improving the quality of the surgical field during orthognathic surgery. A systematic review and meta-analysis of randomized controlled trials addressing these issues were carried out. An electronic database search was performed. The risk of bias was evaluated with the Jadad Scale and Delphi List. The inverse variance statistical method and a random-effects model were used. Ten randomized controlled trials were included for analysis. Our meta-analysis indicated that hypotensive anesthesia reduced intraoperative blood loss by a mean of about 169 mL. Hypotensive anesthesia was not shown to reduce the operation time for orthognathic surgery, but it did improve the quality of the surgical field. Subgroup analysis indicated that for blood loss in double-jaw surgery, the weighted mean difference favored the hypotensive group, with a reduction in blood loss of 175 mL, but no statistically significant reduction in blood loss was found for anterior maxillary osteotomy. If local anesthesia with epinephrine was used in conjunction with hypotensive anesthesia, the reduction in intraoperative blood loss was increased to 254.93 mL. Hypotensive anesthesia was effective in reducing blood loss and improving the quality of the surgical field, but it did not reduce the operation time for orthognathic surgery. The use of local anesthesia in conjunction with hypotensive general anesthesia further reduced the amount of intraoperative blood loss for orthognathic surgery. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  1. Optimal energy distribution of carbohydrate intake for Japanese elderly patients with type 2 diabetes: the Japanese Elderly Intervention Trial.

    Science.gov (United States)

    Kamada, Chiemi; Yoshimura, Hidenori; Okumura, Ryota; Takahashi, Keiko; Iimuro, Satoshi; Ohashi, Yasuo; Araki, Atsushi; Umegaki, Hiroyuki; Sakurai, Takashi; Yoshimura, Yukio; Ito, Hideki

    2012-04-01

    In diet therapy for diabetes, optimal energy intake and the energy distribution of macronutrients (protein : fat : carbohydrate [PFC] energy ratio) are important. We aimed to clarify the correlation between the PFC energy ratio and metabolic parameters including glycated hemoglobin A1c (HbA1c) and triglycerides in Japanese elderly patients with type 2 diabetes mellitus aged 65 years or older. Participants were 1173 diabetic patients aged 65 years or older with serum HbA1c level of >/=7.4% enrolled in the Japanese Elderly Diabetes Intervention Trial (J-EDIT). The participants were divided into four groups by the percentage of total energy intake (%E) of carbohydrate (C1: less than 55%E, C2: 55%E or more and less than 60%E, C3: 60%E or more and less than 65%E, and C4: 65%E or more). Relations of %E of carbohydrate to HbA1c and other metabolic parameters, energy intake and nutritional intake were examined. Furthermore, the subjects were divided into four categories by HbA1c levels by quartile method (Q1: less than 7.90%, Q2: 7.90% or more and less than 8.30%, Q3: 8.30% or more and less than 8.80%, Q4: 8.80% or more). Relations of HbA1c to other metabolic parameters, energy intake and nutritional intake were examined. The mean HbA1c levels in the four groups were C1: 8.40%, C2: 8.50%, C3: 8.41% and C4: 8.36% in men, and C1: 8.51%, C2: 8.47%, C3: 8.35% and C4: 8.52% in women, respectively. There were no significant differences and linear trend in HbA1c levels across groups. The mean triglyceride levels were in the range of 122-128 mg/dL in men from C1 to C3, although it was significantly higher in C4 (177 mg/dL). The mean triglyceride levels were in the range of 128-136 mg/dL in women from C1 to C3, although it was significantly higher in Q4 (150 mg/dL). Amounts of protein and fat intakes decreased with an increase of %E of carbohydrate, although amount of carbohydrate intake did not change significantly. As a result, %E of protein and fat, and energy intake decreased

  2. The OPTIMIZE trial: Rationale and design of a randomized controlled trial of motivational enhancement therapy to improve adherence to statin medication.

    Science.gov (United States)

    Rash, Joshua A; Lavoie, Kim L; Sigal, Ronald J; Campbell, David J T; Manns, Braden J; Tonelli, Marcello; Campbell, Tavis S

    2016-07-01

    Statins are a class of medications that are particularly effective for lowering cholesterol and reducing cardiovascular morbidity and mortality. Despite a range of benefits, non-adherence to statin medication is prevalent with 50% to 75% of patients failing to adhere to treatment within the first 2-years. A previous review on interventions to improve adherence to cholesterol lowering medication concluded that rigorous trials were needed with emphasis on the patient's perspective and shared decision making. Motivational interviewing (MInt) is a promising patient-centered approach for improving adherence in patients with chronic diseases. This manuscript describes the rational and design of a randomized controlled trial (RCT) testing the efficacy of MInt in improving adherence to statin medication. Patients filling their first statin prescription will be recruited to complete a 6-month observation run-in period (phase-1) after which medication possession ratio (MPR) will be assessed. Patients meeting criteria for non-adherence (MPR≤60%) will be invited to participate in the trial. 336 non-adherent new statin users will undergo a fasting lipid panel, complete baseline questionnaires, and be randomly allocated to receive four sessions of adherence education delivered using MInt (EdMInt) or to an education control (EC) delivered at 3-month intervals. Final assessments will occur 12-months after the first EdMInt or EC session. The primary outcome is change in MPR adherence to statin medication from baseline to 12-months. Secondary outcomes include within-patient change in self-reported medication adherence, stage of change and self-efficacy for medication adherence, motivation to adhere to statin medication, and lipid profile. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Association of Behavior With Noise-Induced Hearing Loss Among Attendees of an Outdoor Music Festival: A Secondary Analysis of a Randomized Clinical Trial.

    Science.gov (United States)

    Kraaijenga, Véronique J C; van Munster, J J C M; van Zanten, G A

    2018-06-01

    To date, factors associated with noise-induced hearing loss at music festivals have not yet been analyzed in a single comprehensive data set. In addition, little is known about the hearing loss-associated behavior of music festival attendees. To assess which factors are associated with the occurrence of a temporary threshold shift (TTS) after music exposure and to investigate the behavior of music festival attendees. This prospective post hoc analysis gathered data from a randomized, single-blind clinical trial conducted on September 5, 2015, at an outdoor music festival in Amsterdam, the Netherlands. Adult volunteers with normal hearing were recruited via social media from August 26 through September 3, 2015. Intention to use earplugs was an exclusion criterion. Of 86 volunteers assessed, 51 were included. This post hoc analysis was performed from October 3, 2016, through February 27, 2017. Music festival visit for 4.5 hours. The primary outcome was a TTS on a standard audiogram for the frequencies 3.0- and 4.0-kHz. Multivariable linear regression was performed to determine which factors are associated with a TTS. A questionnaire on behavior, hearing, and tinnitus was distributed to the participants before and after the festival visit. A total of 51 participants were included (18 men [35%] and 33 women [65%]) with a mean (SD) age of 27 (6) years. Mean (SD) threshold change across 3.0 and 4.0 kHz was 5.4 (5.7) dB for the right ear and 4.0 (6.1) dB for the left ear. Earplug use (absolute difference in the left ear, -6.0 dB [95% CI, -8.7 to -3.2 dB]; in the right ear, -6.4 dB [95% CI, -8.8 to -4.1 dB]), quantity of alcohol use (absolute difference per unit in the left ear, 1.1 dB [95% CI, 0.5 to 1.7 dB]; in the right ear, 0.7 dB [95% CI, 0.1 to 1.4 dB]), drug use (absolute difference in the right ear, 6.0 dB [95% CI, 0.9 to 11.1 dB]), and male sex (absolute difference in the right ear, 4.1 dB [95% CI, 0.3 to 5.9 dB]) were independently associated with hearing loss

  4. A comparison of categorization criteria used to define successful weight loss maintainers and regainers in the Look AHEAD and DPP trials

    Science.gov (United States)

    Introduction: While a variety of lifestyle interventions have resulted in successful weight loss, effective strategies to maintain weight loss are lacking, with many interventions reporting high rates of regain. Identifying characteristics of individuals who successfully maintained their weight afte...

  5. Comparing Weight Loss-Maintenance Outcomes of a Worksite-Based Lifestyle Program Delivered via DVD and Face-to-Face: A Randomized Trial.

    Science.gov (United States)

    Ing, Claire Townsend; Miyamoto, Robin E S; Fang, Rui; Antonio, Mapuana; Paloma, Diane; Braun, Kathryn L; Kaholokula, Joseph Keawe'aimoku

    2018-03-01

    Native Hawaiians and other Pacific Islanders have high rates of overweight and obesity compared with other ethnic groups in Hawai'i. Effective weight loss and weight loss-maintenance programs are needed to address obesity and obesity-related health inequities for this group. Compare the effectiveness of a 9-month, worksite-based, weight loss-maintenance intervention delivered via DVD versus face-to-face in continued weight reduction and weight loss maintenance beyond the initial weight loss phase. We tested DVD versus face-to-face delivery of the PILI@Work Program's 9-month, weight loss-maintenance phase in Native Hawaiian-serving organizations. After completing the 3-month weight loss phase, participants ( n = 217) were randomized to receive the weight loss-maintenance phase delivered via trained peer facilitators or DVDs. Participant assessments at randomization and postintervention included weight, height, blood pressure, physical functioning, exercise frequency, and fat intake. Eighty-three face-to-face participants were retained at 12 months (74.1%) compared with 73 DVD participants (69.5%). There was no significant difference between groups in weight loss or weight loss maintenance. The number of lessons attended in Phase 1 of the intervention (β = 0.358, p = .022) and baseline systolic blood pressure (β = -0.038, p = .048) predicted percent weight loss at 12 months. Weight loss maintenance was similar across groups. This suggests that low-cost delivery methods for worksite-based interventions targeting at-risk populations can help address obesity and obesity-related disparities. Additionally, attendance during the weight loss phase and lower baseline systolic blood pressure predicted greater percent weight loss during the weight loss-maintenance phase, suggesting that early engagement and initial physical functioning improve long-term weight loss outcomes.

  6. A randomised controlled trial of oxytocin 5IU and placebo infusion versus oxytocin 5IU and 30IU infusion for the control of blood loss at elective caesarean section--pilot study. ISRCTN 40302163.

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

    OBJECTIVE: To compare the blood loss at elective lower segment caesarean section with administration of oxytocin 5IU bolus versus oxytocin 5IU bolus and oxytocin 30IU infusion and to establish whether a large multi-centre trial is feasible. STUDY DESIGN: Women booked for an elective caesarean section were recruited to a pilot randomised controlled trial and randomised to either oxytocin 5IU bolus and placebo infusion or oxytocin 5IU bolus and oxytocin 30IU infusion. We wished to establish whether the study design was feasible and acceptable and to establish sample size estimates for a definitive multi-centre trial. The outcome measures were total estimated blood loss at caesarean section and in the immediate postpartum period and the need for an additional uterotonic agent. RESULTS: A total of 115 women were randomised and 110 were suitable for analysis (5 protocol violations). Despite strict exclusion criteria 84% of the target population were considered eligible for study participation and of those approached only 15% declined to participate and 11% delivered prior to the planned date. The total mean estimated blood loss was lower in the oxytocin infusion arm compared to placebo (567 ml versus 624 ml) and fewer women had a major haemorrhage (>1000 ml, 14% versus 17%) or required an additional uterotonic agent (5% versus 11%). A sample size of 1500 in each arm would be required to demonstrate a 3% absolute reduction in major haemorrhage (from baseline 10%) with >80% power. CONCLUSION: An additional oxytocin infusion at elective caesarean section may reduce blood loss and warrants evaluation in a large multi-centre trial.

  7. [Optimizing the managment of patients with diabetes mellitus: selected clinical trials from the 2004 Congress of the American Diabetes Association].

    Science.gov (United States)

    Scheen, A J; Radermecker, R P; Philips, J C

    2004-06-01

    The 64th scientific congress of the American Diabetes Association had a special session devoted to the presentation of the results from three clinical trials: 1) the first multicentre international trial of pancreatic islet transplantation according to the so-called Edmonton protocol with the primary endpoint of restoring insulin independence in type 1 diabetic patients; 2) three pivotal studies of 30 weeks testing both the efficacy and safety of exenatide (exendin-4), a new insulin secretagogue that is a long-acting analogue of glucagon-like peptide-1, in patients with type 2 diabetes treated with either metformin, or a sulfonylurea, or a metformin-sulfonylurea combination; and 3) the "Collaborative AtoRvastatin Diabetes Study" (CARDS), a placebo-controlled primary prevention trial of cardiovascular complications using atorvastatin 10 mg in 2 838 at risk patients with type 2 diabetes. The main results and conclusions of these trials are briefly presented as they open new perspectives in the management of patients with type 1 or type 2 diabetes mellitus.

  8. Optimizing cutoff scores for the Barthel Index and the modified Rankin Scale for defining outcome in acute stroke trials

    NARCIS (Netherlands)

    Uyttenboogaart, Maarten; Stewart, Roy E; Vroomen, Patrick C A J; De Keyser, Jacques; Luijckx, Gert-Jan

    Background and Purpose - There is little agreement on how to assess outcome in acute stroke trials. Cutoff scores for the Barthel Index (BI) and modified Rankin Scale (mRS) are frequently arbitrarily chosen to dichotomize favorable and unfavorable outcome. We investigated sensitivity and specificity

  9. Inter-trial coherence as a marker of cortical phase synchrony in children with sensorineural hearing loss and auditory neuropathy spectrum disorder fitted with hearing aids and cochlear implants

    Science.gov (United States)

    Nash-Kille, Amy; Sharma, Anu

    2014-01-01

    Objective Although brainstem dys-synchrony is a hallmark of children with auditory neuropathy spectrum disorder (ANSD), little is known about how the lack of neural synchrony manifests at more central levels. We used time-frequency single-trial EEG analyses (i.e., inter-trial coherence; ITC), to examine cortical phase synchrony in children with normal hearing (NH), sensorineural hearing loss (SNHL) and ANSD. Methods Single trial time-frequency analyses were performed on cortical auditory evoked responses from 41 NH children, 91 children with ANSD and 50 children with SNHL. The latter two groups included children who received intervention via hearing aids and cochlear implants. ITC measures were compared between groups as a function of hearing loss, intervention type, and cortical maturational status. Results In children with SNHL, ITC decreased as severity of hearing loss increased. Children with ANSD revealed lower levels of ITC relative to children with NH or SNHL, regardless of intervention. Children with ANSD who received cochlear implants showed significant improvements in ITC with increasing experience with their implants. Conclusions Cortical phase coherence is significantly reduced as a result of both severe-to-profound SNHL and ANSD. Significance ITC provides a window into the brain oscillations underlying the averaged cortical auditory evoked response. Our results provide a first description of deficits in cortical phase synchrony in children with SNHL and ANSD. PMID:24360131

  10. Hearing loss

    Science.gov (United States)

    Decreased hearing; Deafness; Loss of hearing; Conductive hearing loss; Sensorineural hearing loss; Presbycusis ... Symptoms of hearing loss may include: Certain sounds seeming too loud Difficulty following conversations when two or more people are talking ...

  11. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Kyung

    2012-03-01

    Full Text Available Abstract Background Second-generation drug-eluting stents (DES have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES. In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI. A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES and antiplatelet regimen (TAT vs DDAT. The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734.

  12. Study of Optimal Replacement of Thyroxine in the Elderly (SORTED) - results from the feasibility randomised controlled trial.

    Science.gov (United States)

    Razvi, Salman; Ingoe, Lorna; Ryan, Vicky; Pearce, Simon H S; Wilkes, Scott

    2016-01-01

    Hypothyroidism is a common condition, particularly in the older population. Thyroid hormone requirements change with age and serum TSH levels also alter, especially in older patients. However, in practice laboratory reference ranges for thyroid function are not age-specific and treatment in older patients aims to achieve a similar target thyroid function level as younger age groups. A dual centre, single blind, randomised controlled trial was conducted to determine the feasibility of a future definitive RCT in hypothyroid individuals aged 80 years or older who were treated with levothyroxine. Potential participants were identified from 17 research-active GP practices ( n  = 377), by opportunistic invitations ( n  = 9) or in response to publicity ( n  = 4). Participants were randomly allocated to either usual (0.4-4.0 mU/L) or a higher (4.1-8.0 mU/L) target serum TSH range. Information on participants' willingness to enter the trial, acceptability of study design, length of time to complete recruitment and dose titration strategy was collected. Fifteen percent (57/390) of potentially eligible hypothyroid individuals consented to participate in this trial and 48 were randomised to trial medication for 24 weeks, giving a recruitment rate of 12 %. Recruitment averaged 5.5 participants per month over approximately 9 months. Eight participants withdrew (3/24 and 5/24 in the usual and higher TSH arms, respectively) with the commonest reason cited (5 patients) being tiredness. Interestingly, 3/5 participants withdrew from the site that required a visit to a Research Facility whereas only 5/43 participants withdrew from the site that offered home visits. In the higher TSH arm, of those participants who completed the study, approximately half of participants (10/19) reached target TSH. It is feasible to perform a randomised controlled trial of thyroid hormones in hypothyroid patients aged 80 or older. A definitive trial would require collaboration with a

  13. Efficacy of the Aussie Optimism Program: Promoting Pro-social Behavior and Preventing Suicidality in Primary School Students. A Randomised-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Clare M. Roberts

    2018-02-01

    Full Text Available The efficacy of an enhanced version of the Aussie Optimism Program (AOP was investigated in a cluster randomized controlled trial. Grade 6 students aged 10–11 years of age (N = 2288 from 63 government primary schools in Perth, Western Australia, participated in the pre, post, and follow-up study. Schools were randomly assigned to one of three conditions: Aussie Optimism with teacher training, Aussie Optimism with teacher training plus coaching, or a usual care condition that received the regular Western Australian Health Education Curriculum. Students in the Aussie Optimism conditions received 20, 1-h lessons relating to social and interpersonal skills and optimistic thinking skills over the last 2 years of primary school. Parents in the active conditions received a parent information booklet each year, plus a self-directed program in Grade 7. Students and parents completed the Extended Strengths and Difficulties Questionnaire. Students who scored in the clinical range on the Emotional Symptoms Scale were given The Diagnostic Interview for Children and Adolescents IV, to assess suicidal ideation and behavior, and depressive and anxiety disorders. Results indicated that Aussie Optimism with teacher training plus coaching was associated with the best outcomes: a significant increase in student-reported pro-social behavior from pre-test to post-test 1 (maintained at post-test 2 and significantly lower incidence rates from suicidal ideation at post-test 2 and follow-up. No significant intervention effects on anxiety and depressive disorders, and total difficulties were reported. These findings suggest that the AOP with teacher training along with coaching may have the potential to positively impact on suicidality and pro-social behavior in the pre-adolescent years.

  14. Timing of Surgery and Rehabilitation to Optimize Outcome for Patients with Multiple Ligament Knee Injuries: A Multicenter Clinical Trial

    Science.gov (United States)

    2016-10-01

    contracture. Suboptimal outcomes for treatment of MLKIs include persistent pain , stiffness, residual instability and laxity, loss of motion and...a complete grade III injury of 2 or more ligaments) without a history of prior knee ligament reconstruction that do not have associated poly -trauma

  15. Thermally induced diffraction losses for a Gaussian pump beam and optimization of the mode-to-pump ratio in an end-pumped Nd:GdVO4 laser

    International Nuclear Information System (INIS)

    Wang, Y T; Li, W J; Pan, L L; Yu, J T; Zhang, R H

    2013-01-01

    The analytical model of thermally induced diffraction losses for a Gaussian pump beam are derived as functions of the mode-to-pump ratio and pump power in end-pumped Nd-doped lasers considering the energy transfer upconversion effects. The mode-to-pump ratio is optimized based on it. The results show that the optimum mode-to-pump ratio with the thermally induced diffraction losses is less than 0.65, and it is less than the results in which the thermally induced diffraction losses are neglected. The theoretical model is applied to a diode-end-pumped Nd:GdVO 4 laser operating at 1342 nm, and the theoretical calculations are in good agreement with the experimental results. (paper)

  16. Cognitive-Behavioral Therapy, Behavioral Weight Loss, and Sequential Treatment for Obese Patients with Binge-Eating Disorder: A Randomized Controlled Trial

    Science.gov (United States)

    Grilo, Carlos M.; Masheb, Robin M.; Wilson, G. Terence; Gueorguieva, Ralitza; White, Marney A.

    2011-01-01

    Objective: Cognitive-behavioral therapy (CBT) is the best established treatment for binge-eating disorder (BED) but does not produce weight loss. The efficacy of behavioral weight loss (BWL) in obese patients with BED is uncertain. This study compared CBT, BWL, and a sequential approach in which CBT is delivered first, followed by BWL (CBT + BWL).…

  17. A randomized trial of the effect of low dose epinephrine infusion in addition to tranexamic acid on blood loss during total hip arthroplasty

    DEFF Research Database (Denmark)

    Jans, Ø.; Grevstad, U.; Mandoe, H.

    2016-01-01

    procedure. Intraoperative tranexamic acid (TXA) was administered to all subjects. The primary outcome was intraoperative blood loss directly measured by drains and weighing swabs. Secondary outcome was total blood loss at 24 h postoperatively calculated using the Gross formula. Results: Of 106 subjects...

  18. Effect of tesofensine on bodyweight loss, body composition, and quality of life in obese patients: a randomised, double-blind, placebo-controlled trial

    DEFF Research Database (Denmark)

    Astrup, Arne; Madsbad, Sten; Breum, Leif

    2008-01-01

    BACKGROUND: Weight-loss drugs produce an additional mean weight loss of only 3-5 kg above that of diet and placebo over 6 months, and more effective pharmacotherapy of obesity is needed. We assessed the efficacy and safety of tesofensine-an inhibitor of the presynaptic uptake of noradrenaline...

  19. Primary care management for optimized antithrombotic treatment [PICANT]: study protocol for a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Siebenhofer Andrea

    2012-08-01

    Full Text Available Abstract Background Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management. The aim of this study is to investigate whether a best-practice model that applies major elements of case management and patient education, can improve antithrombotic management in primary healthcare in terms of reducing major thromboembolic and bleeding events. Methods This 24-month cluster-randomized trial will be performed with 690 adult patients from 46 practices. The trial intervention will be a complex intervention involving general practitioners, healthcare assistants, and patients with an indication for oral anticoagulation. To assess adherence to medication and symptoms in patients, as well as to detect complications early, healthcare assistants will be trained in case management and will use the Coagulation-Monitoring List (Co-MoL to regularly monitor patients. Patients will receive information (leaflets and a video, treatment monitoring via the Co-MoL and be motivated to perform self-management. Patients in the control group will continue to receive treatment as usual from their general practitioners. The primary endpoint is the combined endpoint of all thromboembolic events requiring hospitalization and all major bleeding complications. Secondary endpoints are mortality, hospitalization, strokes, major bleeding and thromboembolic complications, severe treatment interactions, the number of adverse events, quality of anticoagulation, health-related quality of life, and costs. Further secondary objectives will be investigated to explain the mechanism by which the intervention is effective: patients’ assessment of chronic illness care, self-reported adherence to medication, general practitioners’ and healthcare assistants’ knowledge, and patients’ knowledge and satisfaction with shared decision making. Practice recruitment is expected to take place between July and December 2012

  20. Using a technology-based intervention to promote weight loss in sedentary overweight or obese adults: a randomized controlled trial study design

    Directory of Open Access Journals (Sweden)

    Vaughn W Barry

    2011-02-01

    Full Text Available Vaughn W Barry1, Amanda C McClain1, Sara Shuger1, Xuemei Sui1, James W Hardin2, Gregory A Hand1, Sara Wilcox1, Steven N Blair1,21Department of Exercise Science; 2Department of Epidemiology and Biostatistics, University of South Carolina, Columbia, SC, USAPurpose: The SenseWear™ Armband is an activity monitor developed to improve lifestyle self-monitoring. Currently, few studies assess electronic self-monitoring and weight loss with a lifestyle intervention program. To our knowledge, only one study has used the SenseWear Armband in combination with a lifestyle intervention to improve weight loss, and no studies have evaluated whether a self-monitoring intervention based solely on the armband can promote weight loss. Consequently, the aims of the study were to assess weight loss from electronic self-monitoring, to compare these values to the lifestyle intervention and standard care groups, and to compare weight loss with lifestyle intervention with and without the armband.Patients and methods: We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 years; BMI, 33.3 ± 5.2 kg/m2 to participate in the 9-month study. Participants were randomized into one of four weight loss groups: 1 the standard care group received a self-directed weight loss program, complete with an evidence-based weight loss manual (standard care, n = 50; 2 a 14-week group-based behavioral weight loss program followed by weekly, biweekly, and monthly telephone counseling calls (GWL, n = 49; 3 the use of the armband to help improve lifestyle self-monitoring (SWA alone, n = 49; or (4 the group-based behavioral weight loss program and follow-up telephone counseling calls plus the armband (GWL + SWA, n = 49. All participants received the evidence-based weight loss manual at baseline. All measures were performed at baseline and months 4 and 9. The primary outcomes were weight loss and waist circumference reduction.Results: This study is a well-designed randomized

  1. EffectS of non-nutritive sWeetened beverages on appetITe during aCtive weigHt loss (SWITCH): Protocol for a randomized, controlled trial assessing the effects of non-nutritive sweetened beverages compared to water during a 12-week weight loss period and a follow up weight maintenance period.

    Science.gov (United States)

    Masic, U; Harrold, J A; Christiansen, P; Cuthbertson, D J; Hardman, C A; Robinson, E; Halford, J C G

    2017-02-01

    Acute and medium-term intervention studies suggest that non-nutritive sweeteners (NNS) are beneficial for weight loss, however there is limited human data on the long-term effects of consuming NNS on weight loss, maintenance, and appetite. Further research is therefore required to elucidate the prolonged impact of NNS consumption on these outcome measures. A randomized parallel groups design will be used to assess whether regular NNS beverage intake is equivalent to a water control in promoting weight loss over 12-weeks (weekly weight loss sessions; Phase I), then supporting weight maintenance over 40-weeks (monthly sessions; Phase II) and subsequently independent weight maintenance over 52-weeks (Phase III) in 432 participants. A subset of these participants (n=116) will complete laboratory-based appetite probe days (15 sessions; 3 sessions each at baseline, at the start of phase I and the end of each phase). A separate subset (n=50) will complete body composition scans (DXA) at baseline and at the end of each phase. All participants will regularly be weighed and will complete questionnaires and cognitive tasks to assess changes in body weight and appetitive behaviours. Measures of physical activity and biochemical markers will also be taken. The trial will assess the efficacy of NNS beverages compared to water during a behavioural weight loss and maintenance programme. We aim to understand whether the impact of NNS on weight, dietary adherence and well-being are beneficial or transient and effects on prolonged successful weight loss and weight maintenance through sustained changes in appetite and eating behaviour. Clinical Trials: NCT02591134; registered: 23.10.2015. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

  2. Enhanced recovery pathways optimize health outcomes and resource utilization: A meta-analysis of randomized controlled trials in colorectal surgery

    DEFF Research Database (Denmark)

    Adamina, Michel; Kehlet, Henrik; Tomlinson, George A

    2011-01-01

    in costs that threatens the stability of health care systems. Enhanced recovery pathways (ERP) have been proposed as a means to reduce morbidity and improve effectiveness of care. We have reviewed the evidence supporting the implementation of ERP in clinical practice. Methods Medline, Embase...... of health care processes. Thus, while accelerating recovery and safely reducing hospital stay, ERPs optimize utilization of health care resources. ERPs can and should be routinely used in care after colorectal and other major gastrointestinal procedures....

  3. Pregnancy Loss

    Science.gov (United States)

    ... To receive Pregnancy email updates Enter email Submit Pregnancy loss Pregnancy loss is a harsh reality faced ... have successful pregnancies. Expand all | Collapse all Why pregnancy loss happens As many as 10 to 15 ...

  4. Impact of weight loss on survival after chemoradiation for locally advanced head and neck Cancer: secondary results of a randomized phase III trial (SAKK 10/94)

    International Nuclear Information System (INIS)

    Ghadjar, Pirus; Hayoz, Stefanie; Zimmermann, Frank; Bodis, Stephan; Kaul, David; Badakhshi, Harun; Bernier, Jacques; Studer, Gabriela; Plasswilm, Ludwig; Budach, Volker; Aebersold, Daniel M

    2015-01-01

    To analyze the impact of weight loss before and during chemoradiation on survival outcomes in patients with locally advanced head and neck cancer. From 07/1994-07/2000 a total of 224 patients with squamous cell carcinoma of the head and neck were randomized to either hyperfractionated radiation therapy alone or the same radiation therapy combined with two cycles of concomitant cisplatin. The primary endpoint was time to any treatment failure (TTF); secondary endpoints were locoregional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS) and overall survival (OS). Patient weight was measured 6 months before treatment, at treatment start and treatment end. The proportion of patients with >5% weight loss was 32% before, and 51% during treatment, and the proportion of patients with >10% weight loss was 12% before, and 17% during treatment. After a median follow-up of 9.5 years (range, 0.1 – 15.4 years) weight loss before treatment was associated with decreased TTF, LRRFS, DMFS, cancer specific survival and OS in a multivariable analysis. However, weight loss during treatment was not associated with survival outcomes. Weight loss before and during chemoradiation was commonly observed. Weight loss before but not during treatment was associated with worse survival

  5. Positioning and number of nutritional levels in dose-response trials to estimate the optimal-level and the adjustment of the models

    Directory of Open Access Journals (Sweden)

    Fernando Augusto de Souza

    2014-07-01

    Full Text Available The aim of this research was to evaluate the influence of the number and position of nutrient levels used in dose-response trials in the estimation of the optimal-level (OL and the goodness of fit on the models: quadratic polynomial (QP, exponential (EXP, linear response plateau (LRP and quadratic response plateau (QRP. It was used data from dose-response trials realized in FCAV-Unesp Jaboticabal considering the homogeneity of variances and normal distribution. The fit of the models were evaluated considered the following statistics: adjusted coefficient of determination (R²adj, coefficient of variation (CV and the sum of the squares of deviations (SSD.It was verified in QP and EXP models that small changes on the placement and distribution of the levels caused great changes in the estimation of the OL. The LRP model was deeply influenced by the absence or presence of the level between the response and stabilization phases (change in the straight to plateau. The QRP needed more levels on the response phase and the last level on stabilization phase to estimate correctly the plateau. It was concluded that the OL and the adjust of the models are dependent on the positioning and the number of the levels and the specific characteristics of each model, but levels defined near to the true requirement and not so spaced are better to estimate the OL.

  6. Does training family physicians in shared decision making promote optimal use of antibiotics for acute respiratory infections? Study protocol of a pilot clustered randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Côté Luc

    2007-11-01

    Full Text Available Abstract Background In North America, although it varies according to the specific type of acute respiratory infections (ARI, use of antibiotics is estimated to be well above the expected prevalence of bacterial infections. The objective of this pilot clustered randomized controlled trial (RCT is to assess the feasibility of a larger clustered RCT aiming at evaluating the impact of DECISION+, a continuing professional development (CPD program in shared decision making, on the optimal use of antibiotics in the context of ARI. Methods/design This pilot study is a cluster RCT conducted with family physicians from Family Medicine Groups (FMG in the Quebec City area, Canada. Participating FMG are randomised to an immediate DECISION+ group, a CPD program in shared decision making, (experimental group, or a delayed DECISION+ group (control group. Data collection involves recruiting five patients consulting for ARI per physician from both study groups before (Phase 1 and after (Phase 2 exposure of the experimental group to the DECISION+ program, and after exposure of the control group to the DECISION+ program (Phase 3. The primary outcome measures to assess the feasibility of a larger RCT include: 1 proportion of contacted FMG that agree to participate; 2 proportion of recruited physicians who participate in the DECISION+ program; 3 level of satisfaction of physicians regarding DECISION+; and 4 proportion of missing data in each data collection phase. Levels of agreement of the patient-physician dyad on the Decisional Conflict Scale and physicians' prescription profile for ARI are performed as secondary outcome measures. Discussion This study protocol is informative for researchers and clinicians interested in designing and/or conducting clustered RCT with FMG regarding training of physicians in shared decision making. Trial Registration ClinicalTrials.gov Identifier: NCT00354315

  7. Design of the BRISC study: a multicentre controlled clinical trial to optimize the communication of breast cancer risks in genetic counselling

    Directory of Open Access Journals (Sweden)

    Menko Fred H

    2008-10-01

    Full Text Available Abstract Background Understanding risks is considered to be crucial for informed decision-making. Inaccurate risk perception is a common finding in women with a family history of breast cancer attending genetic counseling. As yet, it is unclear how risks should best be communicated in clinical practice. This study protocol describes the design and methods of the BRISC (Breast cancer RISk Communication study evaluating the effect of different formats of risk communication on the counsellee's risk perception, psychological well-being and decision-making regarding preventive options for breast cancer. Methods and design The BRISC study is designed as a pre-post-test controlled group intervention trial with repeated measurements using questionnaires. The intervention-an additional risk consultation-consists of one of 5 conditions that differ in the way counsellee's breast cancer risk is communicated: 1 lifetime risk in numerical format (natural frequencies, i.e. X out of 100, 2 lifetime risk in both numerical format and graphical format (population figures, 3 lifetime risk and age-related risk in numerical format, 4 lifetime risk and age-related risk in both numerical format and graphical format, and 5 lifetime risk in percentages. Condition 6 is the control condition in which no intervention is given (usual care. Participants are unaffected women with a family history of breast cancer attending one of three participating clinical genetic centres in the Netherlands. Discussion The BRISC study allows for an evaluation of the effects of different formats of communicating breast cancer risks to counsellees. The results can be used to optimize risk communication in order to improve informed decision-making among women with a family history of breast cancer. They may also be useful for risk communication in other health-related services. Trial registration Current Controlled Trials ISRCTN14566836.

  8. Do Postoperative Psychotherapeutic Interventions and Support Groups Influence Weight Loss Following Bariatric Surgery? A Systematic Review and Meta-analysis of Randomized and Nonrandomized Trials

    DEFF Research Database (Denmark)

    Beck, Nina N.; Johannsen, Maja; Støvring, René K.

    2012-01-01

    Bariatric surgery is currently considered the most effective treatment of severe obesity, but considerable individual variations in weight loss results have been reported. We therefore conducted a systematic review and meta-analysis of studies investigating the effect of psychotherapeutic...

  9. Does Glycine max leaves or Garcinia Cambogia promote weight-loss or lower plasma cholesterol in overweight individuals: a randomized control trial

    OpenAIRE

    Kim, Ji-Eun; Jeon, Seon-Min; Park, Ki Hun; Lee, Woo Song; Jeong, Tae-Sook; McGregor, Robin A; Choi, Myung-Sook

    2011-01-01

    Abstract Background Natural food supplements with high flavonoid content are often claimed to promote weight-loss and lower plasma cholesterol in animal studies, but human studies have been more equivocal. The aim of this study was firstly to determine the effectiveness of natural food supplements containing Glycine max leaves extract (EGML) or Garcinia cambogia extract (GCE) to promote weight-loss and lower plasma cholesterol. Secondly to examine whether these supplements have any beneficial...

  10. Radiographs and low field MRI (0.2T) as predictors of efficacy in a weight loss trial in obese women with knee osteoarthritis

    DEFF Research Database (Denmark)

    Gudbergsen, Henrik; Boesen, Mikael; Christensen, Robin

    2011-01-01

    To study the predictive value of baseline radiographs and low-field (0.2T) MRI scans for the symptomatic outcome of clinically significant weight loss in obese patients with knee osteoarthritis.......To study the predictive value of baseline radiographs and low-field (0.2T) MRI scans for the symptomatic outcome of clinically significant weight loss in obese patients with knee osteoarthritis....

  11. A three-component cognitive behavioural lifestyle program for preconceptional weight-loss in women with polycystic ovary syndrome (PCOS): A protocol for a randomized controlled trial

    OpenAIRE

    Jiskoot, Geranne; Benneheij, Sofie; Beerthuizen, Annemerle; Niet, J.E.; Klerk, Cora; Timman, Reinier; Busschbach, Jan; Laven, Joop

    2017-01-01

    textabstractBackground: Obesity in women with polycystic ovary syndrome (PCOS) negatively affects all clinical features, and a 5 to 10% weight loss has shown promising results on reproductive, metabolic and psychological level. Incorporating a healthy diet, increasing physical activity and changing dysfunctional thought patterns in women with PCOS are key points in losing weight. The biggest challenge in weight management programs is to achieve a reasonable and sustainable weight loss. The ai...

  12. Long-term weight loss observed with olanzapine orally disintegrating tablets in overweight patients with chronic schizophrenia. A 1 year open-label, prospective trial.

    Science.gov (United States)

    Chawla, Bharat; Luxton-Andrew, Heather

    2008-04-01

    To investigate the long-term weight loss outcomes during usual clinical practice after switching from olanzapine standard oral tablet (SOT) to olanzapine orally disintegrating tablets (ODT). In this open-label prospective study, 26 patients with schizophrenia who were clinically stable on olanzapine SOT treatment were switched to olanzapine ODT. All other aspects of treatment remained constant. Weight was recorded at 3, 6, and 12 months. Patients incurred an average weight loss of 2.7 +/- 0.7 kg (p = 0.001) after switching patients from olanzapine SOT to olanzapine ODT at 12 months. Peak weight loss was observed at 6 months; however, significant weight loss was achieved as early as 3 months. The majority (81.9%) of patients lost weight, while 18.1% had no weight change or weight gain. Body mass index (BMI) significantly decreased by 1.0 +/- 0.3 kg/m(2) (p = 0.001). Interestingly, patients treated with higher doses of olanzapine (> or = 20 mg) incurred a greater weight loss of their body weight (5.6%), compared to those treated with lower doses (< 20 mg), who lost 1.9% of their body weight (p = 0.04). This study demonstrated that, in usual clinical practice, switching patients from olanzapine SOT to olanzapine ODT treatment resulted in significant weight loss that was maintained over 12 months. 2008 John Wiley & Sons, Ltd.

  13. A region-based palliative care intervention trial using the mixed-method approach: Japan OPTIM study

    Directory of Open Access Journals (Sweden)

    Morita Tatsuya

    2012-01-01

    Full Text Available Abstract Background Disseminating palliative care is a critical task throughout the world. Several outcome studies explored the effects of regional palliative care programs on a variety of end-points, and some qualitative studies investigated the process of developing community palliative care networks. These studies provide important insights into the potential benefits of regional palliative care programs, but the clinical implications are still limited, because: 1 many interventions included fundamental changes in the structure of the health care system, and, thus, the results would not be applicable for many regions where structural changes are difficult or unfeasible; 2 patient-oriented outcomes were not measured or explored only in a small number of populations, and interpretation of the results from a patient's view is difficult; and 3 no studies adopted a mixed-method approach using both quantitative and qualitative methodologies to interpret the complex phenomenon from multidimensional perspectives. Methods/designs This is a mixed-method regional intervention trial, consisting of a pre-post outcome study and qualitative process studies. The primary aim of the pre-post outcome study is to evaluate the change in the number of home deaths, use of specialized palliative care services, patient-reported quality of palliative care, and family-reported quality of palliative care after regional palliative care intervention. The secondary aim is to explore the changes in a variety of outcomes, including patients' quality of life, pain intensity, family care burden, and physicians' and nurses' knowledge, difficulties, and self-perceived practice. Outcome measurements used in this study include the Care Evaluation Scale, Good Death Inventory, Brief pain Inventory, Caregiving Consequence Inventory, Sense of Security Scale, Palliative Care Knowledge test, Palliative Care Difficulties Scale, and Palliative Care Self-reported Practice Scale. Study

  14. Towards an optimized coupling-loss induced quench protection system (CLIQ) for quadrupole magnets (Proc. 25th ICEC & ICMC2014 conference)

    NARCIS (Netherlands)

    Ravaioli, Emanuele; Datskov, Vladimir I.; Desbiolles, Vincent; Feuvrier, Jerome; Kirby, Glyn; Maciejewski, Michal; Sperin, Kevin A.; ten Kate, Herman H.J.; Verweij, Arjan P.; Willering, G.

    2015-01-01

    The recently developed Coupling-Loss-Induced Quench (CLIQ) protection system is a new method for initiating a fast and voluminous transition to the normal state for protecting high energy density superconducting magnets. Its simple and robust electrical design, its lower failure rate, and its more

  15. Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

    International Nuclear Information System (INIS)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R.

    2012-01-01

    Background and purpose: To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome. Patients and methods: Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 ± 23.7 and 53.2 ± 21.8 (p = 0.158), 38.2 ± 26.1 and 34.0 ± 24.5 (p = 0.189), and 33.0 ± 27.2 and 23.7 ± 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 ± 3.0 and 9.5 ± 2.7 (p = 0.309), 6.1 ± 3.6 and 5.4 ± 3.6 (p = 0.096), 5.3 ± 3.7 and 4.1 ± 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380). Conclusion: Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  16. Weight loss with naltrexone SR/bupropion SR combination therapy as an adjunct to behavior modification: the COR-BMOD trial

    Science.gov (United States)

    This 56-week, randomized, placebo-controlled trial examined the efficacy and safety of naltrexone plus bupropion as an adjunct to intensive behavior modification (BMOD). A total of 793 participants (BMI = 36.5 +/- 4.2 kg/m(2)) was randomly assigned in a 1:3 ratio to: (i) placebo + BMOD (N = 202); or...

  17. An inflammation based score can optimize the selection of patients with advanced cancer considered for early phase clinical trials.

    Directory of Open Access Journals (Sweden)

    David J Pinato

    Full Text Available Adequate organ function and good performance status (PS are common eligibility criteria for phase I trials. As inflammation is pathogenic and prognostic in cancer we investigated the prognostic performance of inflammation-based indices including the neutrophil (NLR and platelet to lymphocyte ratio (PLR.We studied inflammatory scores in 118 unselected referrals. NLR normalization was recalculated at disease reassessment. Each variable was assessed for progression-free (PFS and overall survival (OS on uni- and multivariate analyses and tested for 90 days survival (90DS prediction using receiving operator curves (ROC.We included 118 patients with median OS 4.4 months, 23% PS>1. LDH≥450 and NLR≥5 were multivariate predictors of OS (p<0.001. NLR normalization predicted for longer OS (p<0.001 and PFS (p<0.05. PS and NLR ranked as most accurate predictors of both 90DS with area under ROC values of 0.66 and 0.64, and OS with c-score of 0.69 and 0.60. The combination of NLR+PS increased prognostic accuracy to 0.72. The NLR was externally validated in a cohort of 126 subjects.We identified the NLR as a validated and objective index to improve patient selection for experimental therapies, with its normalization following treatment predicting for a survival benefit of 7 months. Prospective validation of the NLR is warranted.

  18. The role of self-regulatory skills and automaticity on the effectiveness of a brief weight loss habit-based intervention: secondary analysis of the 10 top tips randomised trial.

    Science.gov (United States)

    Kliemann, Nathalie; Vickerstaff, Victoria; Croker, Helen; Johnson, Fiona; Nazareth, Irwin; Beeken, Rebecca J

    2017-09-05

    Habit-interventions are designed to promote the automaticity of healthy behaviours and may also enhance self-regulatory skills during the habit-formation process. A recent trial of habit-based advice for weight loss (10 Top Tips; 10TT), found that patients allocated to 10TT lost significantly more weight over 3 months than those allocated to usual care, and reported greater increases in automaticity for the target behaviours. The current study aimed to test the hypothesis that i) 10TT increased self-regulatory skills more than usual care, and ii) that self-regulatory skills and automaticity changes mediated the effect of 10TT on weight loss. 537 obese patients from 14 primary care practices in the UK were randomized to receive 10TT or usual care. Patients in the 10TT group received a leaflet containing tips for weight loss and healthy habits formation, a self-monitoring log book and a wallet-sized shopping guide on how to read food labels. Patients were weighed and completed validated questionnaires for self-regulation and automaticity at baseline and 3-month follow-up. Within-group and Between-group effects were explored using Paired T-test and ANCOVA, respectively. Mediation was assessed using bootstrapping to estimate indirect effects and the sobel test. Over 3 months patients who were given 10TT reported greater increases in self-regulatory skills (Mean difference: .08; 95% CI .01; .15) than those who received usual care. Chan