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Sample records for 12-week randomized intervention

  1. It's Time to Start Changing the Game: A 12-Week Workplace Team Sport Intervention Study.

    Science.gov (United States)

    Brinkley, Andrew; McDermott, Hilary; Grenfell-Essam, Rachel; Munir, Fehmidah

    2017-08-23

    A 12-week multi-team sport programme was provided to employees of a large services organisation and conducted in workplaces. This programme was used to investigate the short-term effect of regular sports team participation on individual employee and organisational health. A large services organisation participated in this study. Two regional worksites of office workers were assigned as the team sport (intervention) (n = 28 participants) or control (n = 20 participants) groups. The team sport sessions were underpinned by psychological behaviour change theory and consisted of weekly 1-h team sport sessions for 12 weeks. Measures of aerobic fitness, physical activity behaviour, group cohesion, interaction and communication, psychological wellbeing, health, anthropometrics and workplace experiences were recorded pre- and post-intervention. Data were analysed using a series of mixed ANOVAs. After 12 weeks significant improvements were observed in VO2 max (+ 4.5 ± 5.8 ml/min kg, P organisation. The extent of which these findings are replicable across a scope of organisations should be examined objectively over the long term.

  2. Changes in physical activity levels following 12-week family intervention in Hispanic girls: Bounce study

    Science.gov (United States)

    Pediatric obesity is a major health problem among Hispanic girls. Physical activity guidelines recommend that children engage in at least 60 min of moderate to vigorous activity daily. To examine the changes in physical activity level pre- and post-intervention. Hispanic girls in control (CG; N=26, ...

  3. The effects of 12 weeks Pilates-inspired exercise training on functional performance in older women: A randomized clinical trial.

    Science.gov (United States)

    Vieira, Natália Donzeli; Testa, Daniela; Ruas, Paula Cristine; Salvini, Tânia de Fátima; Catai, Aparecida Maria; Melo, Ruth Caldeira

    2017-04-01

    Recent scientific evidence supports the benefits of Pilates exercises on postural balance and muscle strength of older persons. However, their effects on other aspects of physical fitness, which are also important for independent living in older age, are still unknown. To investigate the effects of a 12-week Pilates-inspired exercise program on the functional performance of community-dwelling older women. Forty community-dwelling older women were randomly enrolled in a Pilates-inspired exercise training (2 times/week, 60 min/session) (PG, n = 21, 66.0 ± 1.4yrs) or kept in the control group (CG; n = 19, 63.3 ± 0.9yrs). The Pilates exercises were conducted in small groups and performed on mats (using accessories such as exercise rubber bands, swiss and exercise balls). The functional performance on one-leg stance (OLS), timed up and go (TUG), five-times-sit-to-stand (STS) and 6-min walk (6 MW) tests was evaluated before and after the 12-week Pilates training or control follow-up period. After 12 weeks, time effects were observed for STS (p = 0.03) and 6 MW tests (p Pilates-inspired exercises improved dynamic balance, lower-extremity strength and aerobic resistance in community-dwelling older women. Therefore, it may be a potentially effective exercise regimen to maintain physical fitness in old age. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Effects of Panax ginseng extract in patients with fibromyalgia: a 12-week, randomized, double-blind, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Alessandra S. Braz

    2013-03-01

    Full Text Available The purpose of the study was to evaluate the efficacy of an extract of Panax ginseng in patients with fibromyalgia. A randomized, double-blind, controlled clinical trial was carried out over 12 weeks to compare the effects of P. ginseng (100 mg/d with amitriptyline (25 mg/d and placebo in 38 patients with fibromyalgia: 13 in Group I (amitriptyline, 13 in Group II (placebo, and 12 in Group III (P. ginseng. Ratings on the Visual Analogue Scale (VAS revealed a reduction in pain in the P. ginseng group (p < .0001, an improvement in fatigue (p < .0001 and an improvement in sleep (p < .001, with respect to baseline characteristics, but there were no differences between the three groups. With respect to anxiety, improvements occurred in the P. ginseng group compared to baseline (p < .0001; however, amitriptyline treatment resulted in significantly greater improvements (p < .05. P. ginseng reduced the number of tender points and improved patients' quality of life (using the Fibromyalgia Impact Questionnaire - FIQ; however, there were no differences between groups. The beneficial effects experienced by patients for all parameters suggest a need for further studies to be performed on the tolerability and efficacy of this phytotherapic as a complementary therapy for fibromyalgia.

  5. Effects of a 12-week alpine skiing intervention on endothelial progenitor cells, peripheral arterial tone and endothelial biomarkers in the elderly

    DEFF Research Database (Denmark)

    Niederseer, David; Steidle-Kloc, Eva; Mayr, Matthias

    2016-01-01

    OBJECTIVE: Endothelial dysfunction occurs early during atherogenesis and it can be normalized by exercise training. Unfortunately, patients' compliance with exercise prescription remains low, often because the given choices do not appeal to them. In Alpine regions, skiing is a popular mode...... of exercise, and therefore we set out to assess whether it can induce antiatherogenic effects. METHODS: We randomized 42 subjects into a group of 12weeks of guided skiing (intervention group, IG, n=22; 12 males/10 females; age: 66.6±2.1years) or a control group (CG, n=20; 10 males/10 females; age: 67......, peripheral arterial tone and homocysteine. Our findings suggest that recreational alpine skiing may serve as a further mode of preventive exercise training, which might result in improved compliance with current recommendations....

  6. The outcomes of a 12-week Internet intervention aimed at improving fitness and health-related quality of life in overweight adolescents: the Young & Active controlled trial.

    Directory of Open Access Journals (Sweden)

    Kirsti Riiser

    Full Text Available Overweight and obesity among adolescents may have consequences, with potentially lasting effects on health and health-related quality of life (HRQoL. Excess weight is also associated with decreases in physical activity and cardiorespiratory fitness. The aim of the current study was to investigate the short-term effects of a 12-week Internet intervention in a primary care setting intended to increase cardiorespiratory fitness and HRQoL among overweight and obese adolescents.In this controlled trial, participants (13-15 years were non-randomly allocated to an intervention- or a control group. The intervention group received 12-weeks access to an online program providing tailored physical activity counseling based on principles from Self-determination Theory and Motivational Interviewing. The control group received standard follow-up by the school nurses. The primary outcome measure of cardiorespiratory fitness was determined using a shuttle run test. The secondary outcomes: HRQoL, leisure time exercise, body image and self-determined motivation for physical activity and exercise, were assessed by self-report measures. Age- and gender-adjusted body mass index (BMI was calculated based on measurements of height and weight. To compare pre-to post intervention differences within groups, a paired samples t-test was used while crude differences between groups were analyzed with an independent samples t-test.Of the 120 participants, 108 completed the study, 75 in the intervention group and 33 in the control group. Exposure to the intervention had a small effect on cardiorespiratory fitness (0.14; 95% CI [0.01;0.28]; P = 0.04, and a moderate effect on HRQoL (5.22; 95% CI [0.90; 9.53]; P = 0.02. Moreover, the control group increased significantly in BMI, yielding a moderate preventive effect on BMI (-0.39; 95% CI [-0.74;-0.03]; P = 0.03 for the intervention group.The results suggest that the Internet intervention with tailored physical activity counseling

  7. Postural correction for kyphosis improves the dyspnea index and pulmonary functions in patients with chronic obstructive pulmonary disease: A randomized trial over 12 weeks

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    Gajanan S Gaude

    2014-01-01

    Full Text Available Background: Patients with chronic obstructive pulmonary disease (COPD tend to attain forward shoulder posture and kyphosis and this affects their respiratory functions. Correcting this posture leads to straightening of the spine leading to improvement in the lung functions. The present study was carried out to evaluate the additional effect of correction of kyphosis in COPD patients. Objectives: The objective of the following study is to evaluate the effect of postural correction with respiratory muscle training in patients with COPD. Settings and Study Design: A randomized controlled prospective study in a tertiary care hospital in out-patients for 12 weeks. Materials and Methods: Confirmed cases of COPD were randomly divided into two groups by computer generated randomization: Study and control group. Study group patients received combination of respiratory muscle training and postural correction by a brace, whereas the control group received only respiratory muscle training exercises. The outcome measures evaluated were maximal inspiratory pressure, spirometry values, dyspnea scores and 6-min walk distance (MWD. Statistical Analysis: Statistical analysis was performed using Statistical Package for the Social Sciences version 16. Descriptive statistics are reported as means and standard deviation. Results: A total of 120 patients were included in the study with 60 in each group. Both groups showed a significant improvement in the inspiratory muscle strength, lung functions, dyspnea index and functional capacity at 8 weeks and 12 weeks of intervention. However, the interscapular distance, percentage of kyphotic index (KI and grades of a plumb line (PL measurement reduced significantly in the study group when compared to the control group (P < 0.01. There was also significant improvement in the 6-MWD and reduction of Borg scale of dyspnea when compared to the control group (P < 0.01. The pulmonary functions improvement was better in the study

  8. Aerobic or Resistance Training and Pulse Wave Velocity in Kidney Transplant Recipients: A 12-Week Pilot Randomized Controlled Trial (the Exercise in Renal Transplant [ExeRT] Trial).

    Science.gov (United States)

    Greenwood, Sharlene A; Koufaki, Pelagia; Mercer, Thomas H; Rush, Robert; O'Connor, Ellen; Tuffnell, Rachel; Lindup, Herolin; Haggis, Lynda; Dew, Tracy; Abdulnassir, Lyndsey; Nugent, Eilish; Goldsmith, David; Macdougall, Iain C

    2015-10-01

    Cardiovascular disease remains the leading cause of death in kidney transplant recipients. This pilot study examined the potential effect of aerobic training or resistance training on vascular health and indexes of cardiovascular risk in kidney transplant recipients. Single-blind, randomized, controlled, parallel trial. 60 participants (mean age, 54 years; 34 men) were randomly assigned to aerobic training (n=20), resistance training (n=20), or usual care (n=20). Participants were included if they had a kidney transplant within 12 months prior to baseline assessment. Patients were excluded if they had unstable medical conditions or had recently started regular exercise. Aerobic training and resistance training were delivered 3 days per week for a 12-week period. The usual-care group received standard care. Pulse wave velocity, peak oxygen uptake (Vo2peak), sit-to-stand 60, isometric quadriceps force, and inflammatory biomarkers were assessed at 0 and 12 weeks. The anticipated 60 participants were recruited within 12 months. 46 participants completed the study (aerobic training, n=13; resistance training, n=13; and usual care, n=20), resulting in a 23% attrition rate. Analyses of covariance, adjusted for baseline values, age, and dialysis vintage pretransplantation, revealed significant mean differences between aerobic training and usual care in pulse wave velocity of -2.2±0.4 (95% CI, -3.1 to -1.3) m/s (PPilot study, small sample size, no measure of endothelial function. Both aerobic training and resistance training interventions appear to be feasible and clinically beneficial in this patient population. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  9. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Yu-Mi Lee

    Full Text Available Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D; however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals.Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46 or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47 for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks.The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017. When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%. The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks.Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms.CRiS KCT0001771.

  10. Effect of a Brown Rice Based Vegan Diet and Conventional Diabetic Diet on Glycemic Control of Patients with Type 2 Diabetes: A 12-Week Randomized Clinical Trial.

    Science.gov (United States)

    Lee, Yu-Mi; Kim, Se-A; Lee, In-Kyu; Kim, Jung-Guk; Park, Keun-Gyu; Jeong, Ji-Yun; Jeon, Jae-Han; Shin, Ji-Yeon; Lee, Duk-Hee

    2016-01-01

    Several intervention studies have suggested that vegetarian or vegan diets have clinical benefits, particularly in terms of glycemic control, in patients with type 2 diabetes (T2D); however, no randomized controlled trial has been conducted in Asians who more commonly depend on plant-based foods, as compared to Western populations. Here, we aimed to compare the effect of a vegan diet and conventional diabetic diet on glycemic control among Korean individuals. Participants diagnosed with T2D were randomly assigned to follow either a vegan diet (excluding animal-based food including fish; n = 46) or a conventional diet recommended by the Korean Diabetes Association 2011 (n = 47) for 12 weeks. HbA1c levels were measured at weeks 0, 4, and 12, and the primary study endpoint was the change in HbA1c levels over 12 weeks. The mean HbA1c levels at weeks 0, 4, and 12 were 7.7%, 7.2%, and 7.1% in the vegan group, and 7.4%, 7.2%, and 7.2% in the conventional group, respectively. Although both groups showed significant reductions in HbA1C levels, the reductions were larger in the vegan group than in the conventional group (-0.5% vs. -0.2%; p-for-interaction = 0.017). When only considering participants with high compliance, the difference in HbA1c level reduction between the groups was found to be larger (-0.9% vs. -0.3%). The beneficial effect of vegan diets was noted even after adjusting for changes in total energy intake or waist circumference over the 12 weeks. Both diets led to reductions in HbA1c levels; however, glycemic control was better with the vegan diet than with the conventional diet. Thus, the dietary guidelines for patients with T2D should include a vegan diet for the better management and treatment. However, further studies are needed to evaluate the long-term effects of a vegan diet, and to identify potential explanations of the underlying mechanisms. CRiS KCT0001771.

  11. 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.

  12. Behavioural pattern of training-adherence in a 12 weeks home-based IMT intervention for individuals with COPD

    DEFF Research Database (Denmark)

    Sørensen, Dorthe; Christensen, Marie Ernst

    2016-01-01

    . Data were collected by semi-structured face-to-face and telephone interviews with participants after completion of the 12 weeks IMT program. Maintaining self-esteem resulted from the participants' behavioural patterns, through which they resolved their main concern: avoiding to disappoint themselves...... of Maintaining Self-esteem provides knowledge of participant's variation in their need for professional support, and should be targeted specifically at participants in the Misgiving Mode....

  13. Effects of a 12-Week Hatha Yoga Intervention on Metabolic Risk and Quality of Life in Hong Kong Chinese Adults with and without Metabolic Syndrome.

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    Caren Lau

    Full Text Available To determine the efficacy of a 12-week Hatha yoga intervention to improve metabolic risk profiles and health-related quality of life (HRQoL in Chinese adults with and without metabolic syndrome (MetS.We conducted a controlled trial within an university-affiliated hospital. 173 Chinese men and women aged 18 or above were assigned to either the yoga intervention group (n = 87 or the control group (n = 86. Primary outcomes included 12-week change in metabolic risk factors and MetS z score. Secondary outcome was HRQoL (Medical Outcomes Short Form Survey at 12 weeks.The mean age of participants was 52.0 (SD 7.4, range 31-71 years. Analysis involving the entire study population revealed that the yoga group achieved greater decline in waist circumference (p0.05. There were no significant differences in the intervention effects on waist circumference and MetS z score between the MetS subgroups (both p>0.05.A 12-week Hatha yoga intervention improves metabolic risk profiles and HRQoL in Chinese adults with and without MetS.Australian New Zealand Clinical Trials Registry ACTRN12613000816752.

  14. A 12-week double-blind randomized clinical trial of vitamin D3 supplementation on body fat mass in healthy overweight and obese women

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    Salehpour Amin

    2012-09-01

    Full Text Available Abstract Background Vitamin D concentrations are linked to body composition indices, particularly body fat mass. Relationships between hypovitaminosis D and obesity, described by both BMI and waist circumference, have been mentioned. We have investigated the effect of a 12-week vitamin D3 supplementation on anthropometric indices in healthy overweight and obese women. Methods In a double-blind, randomized, placebo-controlled, parallel-group trial, seventy-seven participants (age 38±8.1 years, BMI 29.8±4.1 kg/m2 were randomly allocated into two groups: vitamin D (25 μg per day as cholecalciferol and placebo (25 μg per day as lactose for 12 weeks. Body weight, height, waist, hip, fat mass, 25(OH D, iPTH, and dietary intakes were measured before and after the intervention. Results Serum 25(OHD significantly increased in the vitamin D group compared to the placebo group (38.2±32.7 nmol/L vs. 4.6±14.8 nmol/L; P Conclusion Among healthy overweight and obese women, increasing 25(OH D concentrations by vitamin D3 supplementation led to body fat mass reduction. This trial is registered at clinicaltrials.gov as NCT01344161.

  15. Comparison of 2 dosages of intraarticular triamcinolone for the treatment of knee arthritis: results of a 12-week randomized controlled clinical trial

    NARCIS (Netherlands)

    Popma, J.W.; Snel, Frank W.; Haagsma, Cees J.; Brummelhuis-Visser, Petra; Oldenhof, Hans G.J.; van der Palen, Jacobus Adrianus Maria; van de Laar, Mart A F J

    2015-01-01

    Objective. To determine whether a double dose of intraarticular triamcinolone acetonide is more effective for knee arthritis than a 40-mg dose. Methods. In this 12-week randomized controlled clinical trial, 40 mg and 80 mg of intraarticular triamcinolone acetonide were compared in patients with knee

  16. Improved metabolic control after 12-week dietary intervention with low glycaemic isomalt in patients with type 2 diabetes mellitus.

    Science.gov (United States)

    Holub, I; Gostner, A; Hessdörfer, S; Theis, S; Bender, G; Willinger, B; Schauber, J; Melcher, R; Allolio, B; Scheppach, W

    2009-12-01

    The polyol isomalt (Palatinit) is a very low glycaemic sugar replacer. The effect of food supplemented with isomalt instead of higher glycaemic ingredients like sucrose and/or starch hydrolysates on metabolic control in patients with type 2 diabetes was examined in this open study. Thirty-three patients with type 2 diabetes received a diet with foods containing 30 g/d isomalt instead of higher-glycaemic carbohydrates for 12 weeks. Metformin and/or thiazolidindiones were the only concomitant oral antidiabetics allowed during the study. Otherwise, the participants maintained their usual diet during the test phase, but were instructed to refrain from additional sweetened foods. Before start, after 6 weeks and 12 weeks (completion of the study), blood samples were taken and analysed for clinical routine parameters, metabolic, and risk markers. Thirty-one patients completed the study. The test diet was well accepted and tolerated. After 12 weeks, significant reductions were observed for: glycosylated haemoglobin, fructosamine, fasting blood glucose, insulin, proinsulin, C-peptide, insulin resistance (HOMA-IR), and oxidised LDL (an atherosclerosis risk factor). In addition, significant lower nonesterified fatty acid concentrations were found in female participants. Routine blood measurements and blood lipids remained unchanged. The substitution of glycaemic ingredients by isomalt and the consequent on reduction of the glycaemic load within otherwise unchanged diet was accompanied by significant improvement in the metabolic control of diabetes. The present study is in agreement with findings of previous reported studies in human subjects demonstrating beneficial effects of low glycaemic diets on glucose metabolism in patients with diabetes mellitus type 2.

  17. Prospective randomized clinical trial of hydrophilic tapered implant placement at maxillary posterior area: 6 weeks and 12 weeks loading

    Science.gov (United States)

    2016-01-01

    PURPOSE Early loading of implant can be determined by excellent primary stability and characteristic of implant surface. The implant system with recently improved surface can have load application 4-6 weeks after installing in maxilla and mandible. This study evaluated the effect of healing period to the stability of hydrophilic tapered-type implant at maxillary posterior area. MATERIALS AND METHODS This study included 30 patients treated by hydrophilic tapered-type implants (total 41 implants at maxilla) and classified by two groups depending on healing period. Group 1 (11 patients, 15 implants) was a control group and the healing period was 12 weeks, and Group 2 (19 patients, 26 implants) was test group and the healing period was 6 weeks. Immediately after implant placement, at the first impression taking, implant stability was measured using Osstell Mentor. The patients also took periapical radiographs after restoration delivery, 12 months after restoration and final followup period. The marginal bone loss around the implants was measured using the periapical radiographs. RESULTS All implants were survived and success rate was 97.56%. The marginal bone loss was less than 1mm after 1 year postoperatively except the one implant. The stabilities of the implants were not correlated with age, healing period until loading, insertion torque (IT), the diameter of fixture and the location of implant. Only the quality of bone in group 2 (6 week) was correlated with the stability of implant. CONCLUSION Healing period of 6 weeks can make the similar clinical prognosis of implants to that of healing period of 12 weeks if bone quality is carefully considered in case of early loading. PMID:27826390

  18. Effects of a 12-week aerobic exercise intervention on eating behaviour, food cravings, and 7-day energy intake and energy expenditure in inactive men.

    Science.gov (United States)

    Rocha, Joel; Paxman, Jenny; Dalton, Caroline; Winter, Edward; Broom, David R

    2016-11-01

    This study examined effects of 12 weeks of moderate-intensity aerobic exercise on eating behaviour, food cravings, and weekly energy intake and expenditure in inactive men. Eleven healthy men (mean ± SD: age, 26 ± 5 years; body mass index, 24.6 ± 3.8 kg·m(-2); maximum oxygen uptake, 43.1 ± 7.4 mL·kg(-1)·min(-1)) completed the 12-week supervised exercise programme. Body composition, health markers (e.g., blood pressure), eating behaviour, food cravings, and weekly energy intake and expenditure were assessed before and after the exercise intervention. There were no intervention effects on weekly free-living energy intake (p = 0.326, d = -0.12) and expenditure (p = 0.799, d = 0.04) or uncontrolled eating and emotional eating scores (p > 0.05). However, there was a trend with a medium effect size (p = 0.058, d = 0.68) for cognitive restraint to be greater after the exercise intervention. Total food cravings (p = 0.009, d = -1.19) and specific cravings of high-fat foods (p = 0.023, d = -0.90), fast-food fats (p = 0.009, d = -0.71), and carbohydrates/starches (p = 0.009, d = -0.56) decreased from baseline to 12 weeks. Moreover, there was a trend with a large effect size for cravings of sweets (p = 0.052, d = -0.86) to be lower after the exercise intervention. In summary, 12 weeks of moderate-intensity aerobic exercise reduced food cravings and increased cognitive restraint, but these changes were not accompanied by changes in other eating behaviours or weekly energy intake and expenditure. The results indicate the importance of exercising for health improvements even when reductions in body mass are modest.

  19. 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)

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

    2012-01-01

    Background 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. Objective 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. Methods 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. Results We enrolled 309 adults (129/309, 41.8% male, BMI mean 32.3, SD 4 kg/m2) 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/m2, enhanced: –1.0, SD 1.4, control: 0.15, SD 0.82; P < .001) and lost significant weight (basic: –2.1, SD 3.3 kg, enhanced: –3.0, SD 4.1, control: 0.4, SD 2.3; P < .001) with changes in waist circumference (basic: –2.0, SD 3.5 cm, enhanced: –3.2, SD 4.7, control: 0.5, SD 3.0; P < .001) and waist-to-height ratio (basic: –0.01, SD 0.02, enhanced: –0.02, SD 0.03, control: 0.0, SD 0.02; P < .001), but no differences were observed between the basic and enhanced groups. The addition of personalized e-feedback and contact provided limited additional benefits compared with the basic program. Conclusions A commercial Web-based weight-loss program can be efficacious across a range of weight-related outcomes and lifestyle behaviors and achieve

  20. Clinical efficacy and safety of telmisartan versus losartan and their effect on lipid profile in stage 1 hypertension: A randomized, double blind, 12 week trial

    Directory of Open Access Journals (Sweden)

    Anoop Madhukar Salve

    2015-04-01

    Full Text Available The aim of this study was to compare the efficacy and safety of telmisartan and losartan and also to examine their effect on lipid profile in patients of stage 1 hypertension.Method: Sixty three stage 1 hypertensive patients were divided randomly into telmisartan  and losartan  group of 32 and 31 patients respectively. At baseline and 12 weeks, systolic (SBP and diastolic blood pressure (DBP, blood sugar level (BSL, total cholesterol (TC, triglycerides (TG, low density lipoprotein (LDL, very low density lipoprotein (VLDL and high density lipoprotein (HDL were measured. Result: The primary finding of the present study was that telmisartan and losartan significantly decreased SBP and DBP at 12 weeks compared to baseline but there was no significant difference in reduction of blood pressure in between both groups. It was also observed that fasting blood sugar level, serum total cholesterol, triglyceride, VLDL, and LDL decreased significantly and HDL increased significantly (p <0.001 after 12 weeks of treatment in telmisartan group only. No serious adverse effects were reported during the study. Conclusion: It was observed that only telmisartan and not losartan significantly improved lipid profile at 12 weeks.

  1. Comparative effects of 12 weeks of equipment based and mat Pilates in patients with Chronic Low Back Pain on pain, function and transversus abdominis activation. A randomized controlled trial.

    Science.gov (United States)

    Cruz-Díaz, David; Bergamin, M; Gobbo, S; Martínez-Amat, Antonio; Hita-Contreras, Fidel

    2017-08-01

    Pilates method has been recommended for patients with chronic low back pain (CLBP) and the activation of transversus abdominis has been deemed to play an important role in the improvement of these patients. Nevertheless, the evidence of the activation of TrA in Pilates practitioners remains unclear. To assess the effectiveness of 12 weeks of Pilates practice in disability, pain, kinesiophobia and transversus abdominis activation in patients with chronic nonspecific Low Back Pain. A randomized controlled trial was carried out. A single-blind randomized controlled trial with repeated measures at 6 and 12 weeks was carried out. A total of ninety eight patients with low back pain were included and randomly allocated to a Pilates Mat group (PMG) equipment based with apparatus Pilates (PAG) or control group (CG). Roland Morris Disability Questionnaire (RMDQ), visual analog scale (VAS) Tampa Scale of Kinesiophobia (TSK), and transversus abdominis (TrA) activation assessed by real time ultrasound measurement (US) were assessed as outcome measures. Improvement were observed in both intervention groups in all the included variables at 6 and 12 weeks (pPilates group (p=0.007). Equipment based and mat Pilates modalities are both effective in the improvement of TaA activation in patients with CLBP with associate improvement on pain, function and kinesiophobia. Significant differences were observed after 12 weeks of intervention in PMG and PAG with faster improvement in PAG suggesting that, feedback provided by equipment could help in the interiorization of Pilates principles. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Fructose intervention for 12 weeks does not impair glycemic control or incretin hormone responses during oral glucose or mixed meal tests in obese men

    DEFF Research Database (Denmark)

    Matikainen, N; Söderlund, S; Björnson, E

    2017-01-01

    BACKGROUND AND AIMS: Incretin hormones glucagon-like peptide (GLP)-1 and glucose-dependent insulinotropic polypeptide (GIP) are affected early on in the pathogenesis of metabolic syndrome and type 2 diabetes. Epidemiologic studies consistently link high fructose consumption to insulin resistance...... not worsen their glucose, insulin, GLP-1 or PYY responses. A minor increase in GIP response during OGTT occurred in subjects who gained liver fat (p = 0.049). CONCLUSION: In obese males with features of metabolic syndrome, 12 weeks fructose intervention 75 g/day did not change glucose, insulin, GLP-1 or GIP...

  3. Effects of a 12-Week Hatha Yoga Intervention on Cardiorespiratory Endurance, Muscular Strength and Endurance, and Flexibility in Hong Kong Chinese Adults: A Controlled Clinical Trial.

    Science.gov (United States)

    Lau, Caren; Yu, Ruby; Woo, Jean

    2015-01-01

    Objective. To examine the effects of a 12-week Hatha yoga intervention on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults. Methods. 173 adults (aged 52.0 ± 7.5 years) were assigned to either the yoga intervention group (n = 87) or the waitlist control group (n = 86). 19 dropped out from the study. Primary outcomes were changes in cardiorespiratory endurance (resting heart rate (HR) and maximal oxygen uptake (VO2max)), muscular strength and endurance (curl-up and push-up tests), and lower back and hamstring flexibility (the modified back-saver sit-and-reach (MBS) test). Results. Compared to controls, the yoga group achieved significant improvements in VO2max (P yoga group failed to improve resting HR or the curl-up test versus control. Adherence (89%) and attendance (94%) were high. No serious adverse events occurred. Conclusion. A 12-week Hatha yoga intervention has favorable effects on cardiorespiratory endurance, muscular strength and endurance, and flexibility in Chinese adults.

  4. Efficacy and Safety of Baricitinib in Japanese Patients with Active Rheumatoid Arthritis Receiving Background Methotrexate Therapy: A 12-week, Double-blind, Randomized Placebo-controlled Study.

    Science.gov (United States)

    Tanaka, Yoshiya; Emoto, Kahaku; Cai, Zhihong; Aoki, Takehiro; Schlichting, Douglas; Rooney, Terence; Macias, William

    2016-03-01

    To evaluate efficacy and safety, baricitinib [Janus kinase (JAK) 1/JAK2 inhibitor] was compared with placebo in Japanese patients with active rheumatoid arthritis (RA) despite background treatment with methotrexate (MTX). This was a phase IIB, double-blind, randomized, placebo-controlled study (clinicaltrials.gov: NCT01469013). Patients had moderate to severe active adult-onset RA despite stable treatment with MTX. Patients (n = 145) were randomized in a 2:1:1:1:1 ratio to placebo or 1 mg, 2 mg, 4 mg, or 8 mg oral baricitinib daily for 12 weeks. The primary analysis compared the combined 4/8-mg dose groups with placebo for the American College of Rheumatology (ACR) 20 response rate at 12 weeks. Other outcomes included additional measures of disease activity, physical function, laboratory abnormalities, and adverse events. A significantly higher proportion of patients in the combined 4/8-mg baricitinib group (37/48, 77%) compared with the placebo group (15/49, 31%) had at least an ACR20 response after 12 weeks of treatment (p physical function were observed as early as Week 2 of treatment with baricitinib, particularly with daily doses of ≥ 4 mg. Only 1 patient receiving baricitinib discontinued because of an adverse event. Adverse event rates with baricitinib doses ≤ 4 mg daily were similar to placebo, but there was a higher incidence of adverse events and laboratory abnormalities in the 8-mg group. In this phase II study, baricitinib was well tolerated and rapidly improved the signs, symptoms, and physical function of Japanese patients with active RA, supporting continued development of baricitinib (clinicaltrials.gov NCT01469013).

  5. Early Viral Kinetics of Telbivudine and Entecavir: Results of a 12-Week Randomized Exploratory Study with Patients with HBeAg-Positive Chronic Hepatitis B▿

    Science.gov (United States)

    Suh, Dong Jin; Um, Soon Ho; Herrmann, Eva; Kim, Ju-Hyun; Lee, Young Sok; Lee, Heon Ju; Lee, Myung Seok; Lee, Youn-Jae; Bao, Weibin; Lopez, Patricia; Lee, Han Chu; Avila, Claudio; Zeuzem, Stefan

    2010-01-01

    We characterized the early viral kinetic profiles of telbivudine and entecavir and the effects of these potent nucleoside analogs on hepatitis B virus (HBV) DNA and alanine aminotransferase levels in adults with hepatitis B e antigen-positive compensated chronic hepatitis B. Forty-four patients were enrolled in this open-label, parallel-group, multicenter study and randomized to receive telbivudine or entecavir for 12 weeks. Reductions in hepatitis B virus DNA and alanine aminotransferase levels from baseline to weeks 2, 4, 8, and 12 were assessed. Viral kinetic parameters, including viral clearance per day, loss of infected cells per day, and efficiency of inhibition of viral production, were estimated by using a biphasic mathematical model. Statistical analyses were limited to descriptive analyses. The 2 treatment groups achieved similar reductions in HBV DNA and alanine aminotransferase levels. Mean reductions in levels of hepatitis B virus DNA at week 12 were 6.6 ± 1.6 and 6.5 ± 1.5 log10 copies/ml for the telbivudine- and entecavir-treated patients, respectively. There were no significant differences between groups in values for mean viral clearance per day, mean loss of infected cells per day, or efficiency of blocking viral production. The safety profiles for both medications were favorable. During the first 12 weeks of treatment, telbivudine and entecavir demonstrated similar antiviral potencies, resulting in a rapid and profound suppression of serum hepatitis B virus DNA and reduction of alanine aminotransferase levels. No differences in the effects of these 2 agents on early viral kinetics were observed. Both medications were well tolerated. PMID:20028815

  6. Desvenlafaxine compared with placebo for treatment of menopausal vasomotor symptoms: a 12-week, multicenter, parallel-group, randomized, double-blind, placebo-controlled efficacy trial.

    Science.gov (United States)

    Pinkerton, JoAnn V; Constantine, Ginger; Hwang, Eunhee; Cheng, Ru-Fong J

    2013-01-01

    The aim of this study was to assess the 12-week efficacy of desvenlafaxine in treating moderate to severe vasomotor symptoms and the clinical relevance of improvements in postmenopausal women experiencing 50 or more moderate to severe hot flashes per week. Participants were randomized to placebo or desvenlafaxine 100 mg/day in the 12-week efficacy substudy of a year-long, multicenter, parallel-group, double-blind study. Coprimary outcomes were changes from baseline in the daily number and severity of hot flashes on weeks 4 and 12. The percentage of women achieving the minimal clinically important difference (MCID) in the number of hot flashes on week 12 was determined. The efficacy substudy modified intent-to-treat population included 365 women (desvenlafaxine, n = 184; placebo, n = 181). Desvenlafaxine 100 mg/day significantly reduced the number and severity of hot flashes versus placebo on week 4 (P desvenlafaxine reduced the number of moderate and severe hot flashes by 7.3 (62%) per day (placebo, -4.5 [38%] per day) and the severity score by 0.59 (25%) per day (placebo, -0.28 [12%] per day). MCID-a reduction of 5.35 moderate and severe hot flashes per day-was achieved by 64% of desvenlafaxine-treated women (placebo, 41%; P desvenlafaxine and 3.7% (7/190) of participants taking placebo discontinued because of adverse events (P = 0.016), and 2.5% (5/200) of participants taking desvenlafaxine and 8.4% (16/190) of participants taking placebo discontinued because of lack of efficacy (P = 0.012). Postmenopausal women with moderate to severe hot flashes who are treated with desvenlafaxine achieve rapid symptom reduction that is clinically relevant based on MCID.

  7. GLP-1-Based Therapies Have No Microvascular Effects in Type 2 Diabetes Mellitus: An Acute and 12-Week Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, Trynke; Kramer, Mark H H; Diamant, Michaela; Serné, Erik H; van Raalte, Daniël H

    2016-10-01

    To assess the effects of glucagon-like peptide (GLP)-1-based therapies (ie, GLP-1 receptor agonists and dipeptidyl peptidase-4 inhibitors) on microvascular function in patients with type 2 diabetes mellitus. We studied 57 patients with type 2 diabetes mellitus (mean±SD age: 62.8±6.9 years; body mass index: 31.8±4.1 kg/m(2); HbA1c [glycated hemoglobin] 7.3±0.6%) in an acute and 12-week randomized, placebo-controlled, double-blind trial conducted at the Diabetes Center of the VU University Medical Center. In the acute study, the GLP-1 receptor agonist exenatide (therapeutic concentrations) or placebo (saline 0.9%) was administered intravenously. During the 12-week study, patients received the GLP-1 receptor agonist liraglutide (1.8 mg daily), the dipeptidyl peptidase-4 inhibitor sitagliptin (100 mg daily), or matching placebos. Capillary perfusion was assessed by nailfold skin capillary videomicroscopy and vasomotion by laser Doppler fluxmetry, in the fasting state and after a high-fat mixed meal. In neither study, treatment affected fasting or postprandial capillary perfusion compared with placebo (P>0.05). In the fasting state, acute exenatide infusion increased neurogenic vasomotion domain power, while reducing myogenic domain power (both Pdiabetes mellitus. Twelve-week treatment with liraglutide or sitagliptin has no effect on capillary perfusion or vasomotion in these patients. Our data suggest that the effects of GLP-1-based therapies on glucose are not mediated through microvascular responses. © 2016 American Heart Association, Inc.

  8. Effectiveness and tissue compatibility of a 12-week treatment of chronic venous leg ulcers with an octenidine based antiseptic--a randomized, double-blind controlled study.

    Science.gov (United States)

    Vanscheidt, Wolfgang; Harding, Keith; Téot, Luc; Siebert, Jörg

    2012-06-01

    The aim of this study was to evaluate the cytotoxic effect of octenidine dihydrochloride/phenoxyethanol (OHP) found in vitro by conducting a randomized, double-blind controlled clinical study focusing on its safe and effective use in chronic venous leg ulcers. In total, 126 male and female patients were treated with either OHP (n = 60) or Ringer solution (n = 66). The treatment lasted over a period of maximum 12 weeks. For the assessment of the wound-healing process, clinical outcome parameters were employed, that is, time span until 100% epithelization, wound status and the wound surface area were analysed. Side effects were recorded during the study period. The median time to complete ulcer healing was comparable between the OHP and Ringer solution groups (92 versus 87 days; P = 0·952), without being influenced by wound size or duration of the target ulcer (P-values: 0·947/0·978). In patients treated with OHP, fewer adverse events (AEs) were observed compared with the Ringer group (17% versus 29% of patients reported 20 versus 38 AEs). OHP is well suitable for the treatment of chronic wounds without cytotoxic effects. Furthermore, OHP does not impair the wound healing in chronic venous ulcers. © 2011 The Authors. © 2011 Blackwell Publishing Ltd and Medicalhelplines.com Inc.

  9. The effect of 12 weeks Anethum graveolens (dill on metabolic markers in patients with metabolic syndrome; a randomized double blind controlled trial

    Directory of Open Access Journals (Sweden)

    Mansouri Masoume

    2012-10-01

    Full Text Available Abstract Background The clustering of metabolic abnormalities defined as metabolic syndrome is now both a public health and a clinical problem .While interest in herbal medicine has greatly increased, lack of human evidence to support efficacies shown in animals does exist. This clinical trial study designed to investigate whether herbal medicine, Anethum graveolens (dill extract, could improve metabolic components in patients with metabolic syndrome. Methods A double-blind, randomized, placebo-controlled trial using a parallel design was conducted. 24 subjects who had metabolic syndrome diagnostic criteria (update of ATP III were randomly assigned to either dill extract (n = 12 or placebo (n = 12 for 3 months. Results Across lipid component of metabolic syndrome, no significant differences in triglyceride (TG concentration and high density lipoprotein cholesterol were seen between the two groups. However TG improved significantly from baseline (257.0 vs. 201.5p = 0.01 with dill treatment but such a significant effect was not observed in placebo group. Moreover, no significant differences in waist circumference, blood pressure and fasting blood sugar were seen between two groups after 3 months follow up period. Conclusion In this small clinical trial in patients with metabolic syndrome, 12 weeks of dill extract treatment had a beneficial effect in terms of reducing TG from baseline. However dill treatment was not associated with a significant improvement in metabolic syndrome related markers compared to control group. Larger studies might be required to prove the efficacy and safety of long-term administration of dill to resolve metabolic syndrome components.

  10. The effect of 12 weeks Anethum graveolens (dill on metabolic markers in patients with metabolic syndrome; a randomized double blind controlled trial

    Directory of Open Access Journals (Sweden)

    Bagher Larijani

    2012-10-01

    Full Text Available The clustering of metabolic abnormalities defined as metabolic syndrome is now both a public health and a clinical problem .While interest in herbal medicine has greatly increased, lack of human evidence to support efficacies shown in animals does exist. This clinical trial study designed to investigate whether herbal medicine, Anethum graveolens (dill extract, could improve metabolic components in patients with metabolic syndrome.MethodsA double-blind, randomized, placebo-controlled trial using a parallel design was conducted. 24 subjects who had metabolic syndrome diagnostic criteria (update of ATP III were randomly assigned to either dill extract (n = 12 or placebo (n = 12 for 3 months.ResultsAcross lipid component of metabolic syndrome, no significant differences in triglyceride (TG concentration and high density lipoprotein cholesterol were seen between the two groups. However TG improved significantly from baseline (257.0 vs. 201.5p = 0.01 with dill treatment but such a significant effect was not observed in placebo group. Moreover, no significant differences in waist circumference, blood pressure and fasting blood sugar were seen between two groups after 3 months follow up period.ConclusionIn this small clinical trial in patients with metabolic syndrome, 12 weeks of dill extract treatment had a beneficial effect in terms of reducing TG from baseline. However dill treatment was not associated with a significant improvement in metabolic syndrome related markers compared to control group. Larger studies might be required to prove the efficacy and safety of long-term administration of dill to resolve metabolic syndrome components.

  11. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials

    Directory of Open Access Journals (Sweden)

    Myers JS

    2014-03-01

    Full Text Available Jonathan S Myers,1 Steven Vold,2 Fiaz Zaman,3 Julia M Williams,4 David A Hollander41Wills Eye Hospital, Philadelphia, PA, USA; 2Vold Vision, PLLC, Bentonville, AR, USA; 3Houston Eye Associates, Houston, TX, USA; 4Allergan, Inc., Irvine, CA, USABackground: The purpose of this study was to evaluate the intraocular pressure (IOP-lowering efficacy and safety of bimatoprost 0.01% or 0.03% as monotherapy in patients treated with latanoprost 0.005% monotherapy who require additional IOP lowering for their ocular hypertension or open-angle glaucoma.Methods: Two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolled patients with baseline IOP ≥20 mmHg after ≥30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily. Patient evaluations at weeks 4 and 12 included IOP at 8 am, 10 am, and 4 pm and safety assessments. Results in the monotherapy study arms (bimatoprost 0.01% or 0.03% are presented.Results: Latanoprost-treated baseline mean diurnal IOP (± standard error of the mean was 22.2±0.3 mmHg and 22.1±0.4 mmHg in the bimatoprost 0.01% and bimatoprost 0.03% treatment arms, respectively (P=0.957. In both treatment arms, mean (± standard error of the mean reduction in IOP from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001, ranging from 3.7±0.4 (17.0% mmHg to 4.4±0.4 (19.9% mmHg with bimatoprost 0.01% and from 2.8±0.5 (12.8% mmHg to 3.9±0.5 (16.7% mmHg with bimatoprost 0.03%. Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The incidence of conjunctival

  12. Randomised controlled trial of a 12 week yoga intervention on negative affective states, cardiovascular and cognitive function in post-cardiac rehabilitation patients.

    Science.gov (United States)

    Yeung, Alan; Kiat, Hosen; Denniss, A Robert; Cheema, Birinder S; Bensoussan, Alan; Machliss, Bianca; Colagiuri, Ben; Chang, Dennis

    2014-10-24

    Negative affective states such as anxiety, depression and stress are significant risk factors for cardiovascular disease, particularly in cardiac and post-cardiac rehabilitation populations.Yoga is a balanced practice of physical exercise, breathing control and meditation that can reduce psychosocial symptoms as well as improve cardiovascular and cognitive function. It has the potential to positively affect multiple disease pathways and may prove to be a practical adjunct to cardiac rehabilitation in further reducing cardiac risk factors as well as improving self-efficacy and post-cardiac rehabilitation adherence to healthy lifestyle behaviours. This is a parallel arm, multi-centre, randomised controlled trial that will assess the outcomes of post- phase 2 cardiac rehabilitation patients assigned to a yoga intervention in comparison to a no-treatment wait-list control group. Participants randomised to the yoga group will engage in a 12 week yoga program comprising of two group based sessions and one self-administered home session each week. Group based sessions will be led by an experienced yoga instructor. This will involve teaching beginner students a hatha yoga sequence that incorporates asana (poses and postures), pranayama (breathing control) and meditation. The primary outcomes of this study are negative affective states of anxiety, depression and stress assessed using the Depression Anxiety Stress Scale. Secondary outcomes include measures of quality of life, and cardiovascular and cognitive function. The cardiovascular outcomes will include blood pressure, heart rate, heart rate variability, pulse wave velocity, carotid intima media thickness measurements, lipid/glucose profiles and C-reactive protein assays. Assessments will be conducted prior to (week 0), mid-way through (week 6) and following the intervention period (week 12) as well as at a four week follow-up (week 16). This study will determine the effect of yoga practice on negative affective states

  13. Differences between men and women in dietary intakes and metabolic profile in response to a 12-week nutritional intervention promoting the Mediterranean diet.

    Science.gov (United States)

    Leblanc, Vicky; Hudon, Anne-Marie; Royer, Marie-Michelle; Corneau, Louise; Dodin, Sylvie; Bégin, Catherine; Lemieux, Simone

    2015-01-01

    Few studies have compared men and women in response to nutritional interventions but none has assessed differences between men and women in the response to a nutritional intervention programme based on the self-determination theory (SDT) and using the Mediterranean diet (MedDiet) as a model of healthy eating, in a context of CVD prevention and within a non-Mediterranean population. The present study aimed to document differences between men and women in changes in dietary, anthropometric and metabolic variables, in response to a nutritional intervention programme promoting the adoption of the MedDiet and based on the SDT. A total of sixty-four men and fifty-nine premenopausal women presenting risk factors for CVD were recruited through different media advertisements in the Québec City Metropolitan area (Canada). The 12-week nutritional programme used a motivational interviewing approach and included individual and group sessions. A validated FFQ was administered to evaluate dietary intakes from which a Mediterranean score (Medscore) was derived. Both men and women significantly increased their Medscore in response to the intervention (P < 0·0001). Men showed a significantly greater decrease in red and processed meat (-0·4 (95 % CI -0·7, -0·1) portions per d) and a greater increase in fruit (0·9 (95 % CI 0·2, 1·6) portions per d) intakes than women. Significant decreases were observed for BMI and waist circumference in both men and women (P ≤ 0·04). Significant greater decreases were found for total cholesterol (total-C):HDL-cholesterol (HDL-C) (-0·2; 95 % CI -0·4, -0·03) and TAG:HDL-C (-0·2; 95 % CI -0·4, -0·04) ratios in men than in women. When adjusting for the baseline value of the response variable, differences between men and women became non-significant for red and processed meat and fruit intakes whereas significant differences between men and women (i.e. larger increases in men than women) were observed for legumes, nuts and seeds (0·6

  14. Aloe sterol supplementation improves skin elasticity in Japanese men with sunlight-exposed skin: a 12-week double-blind, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Tanaka M

    2016-11-01

    Full Text Available Miyuki Tanaka,1 Yuki Yamamoto,2 Eriko Misawa,1 Kazumi Nabeshima,1 Marie Saito,1 Koji Yamauchi,1 Fumiaki Abe,1 Fukumi Furukawa2 1Functional Food Ingredients Department, Food Ingredients & Technology Institute, Morinaga Milk Industry Co., Ltd., Zama, Kanagawa, 2Department of Dermatology, Wakayama Medical University, Kimiidera, Wakayama, Japan Background/objective: Recently, it was confirmed that the daily oral intake of plant sterols of Aloe vera gel (Aloe sterol significantly increases the skin barrier function, moisture, and elasticity in photoprotected skin. This study aimed to investigate whether Aloe sterol intake affected skin conditions following sunlight exposure in Japanese men. Methods: We performed a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects of oral Aloe sterol supplementation on skin conditions in 48 apparently healthy men (age range: 30–59 years; average: 45 years. The subjects were instructed to expose the measurement position of the arms to the sunlight outdoors every day for 12 weeks. The skin parameters were measured at 0 (baseline, 4, 8, and 12 weeks. Results: Depending on the time for the revelation of the sunlight, the b* value and melanin index increased and the skin moisture decreased. After taking an Aloe sterol tablet daily for 12 weeks, the skin elasticity index (R2, R5, and R7 levels were significantly higher than the baseline value. There were no differences between the groups in these skin elasticity values. In the subgroup analysis of subjects aged <46 years, the change in the R5 and R7 was significantly higher in the Aloe group than in the placebo group at 8 weeks (P=0.0412 and P=0.0410, respectively. There was a difference in the quantity of sun exposure between each subject, and an additional clinical study that standardizes the amount of ultraviolet rays is warranted. No Aloe sterol intake-dependent harmful phenomenon was observed during the intake period

  15. Whole Grain Compared with Refined Wheat Decreases the Percentage of Body Fat Following a 12-Week, Energy-Restricted Dietary Intervention in Postmenopausal Women

    DEFF Research Database (Denmark)

    Kristensen, Mette; Toubro, Søren; Jensen, Morten Georg;

    2012-01-01

    ) with whole-grain wheat (WW) for 12 wk on body weight and composition after a 2-wk run-in period of consumption of RW-containing food intake. In this open-label randomized trial, 79 overweight or obese postmenopausal women were randomized to an energy-restricted diet (deficit of approximately 1250 k......Observational studies show inverse associations between intake of whole grain and adiposity and cardiovascular risk; however, only a few dietary intervention trials have investigated the effect of whole-grain consumption on health outcomes. We studied the effect of replacing refined wheat (RW......J/d) with RW or WW foods providing 2 MJ/d. Body weight and composition, blood pressure, and concentration of circulating risk markers were measured at wk 0, 6, and 12. Fecal output and energy excretion were assessed during run-in and wk 12. Plasma alkylresorcinol analysis indicated good compliance...

  16. Effects and prevalence of nonresponders after 12 weeks of high-intensity interval or resistance training in women with insulin resistance: a randomized trial.

    Science.gov (United States)

    Álvarez, Cristian; Ramírez-Campillo, Rodrigo; Ramírez-Vélez, Robinson; Izquierdo, Mikel

    2017-04-01

    Our aim was to investigate the effects and prevalence of nonresponders (NR) to high-intensity interval training (HIIT) and resistance training (RT) in women with insulin resistance on cardiometabolic health parameters. Sedentary overweight/obese insulin-resistant women (age = 33.5 ± 6.5 yr; body mass index = 29.9 ± 3.7 kg/m(2)) were randomly assigned to a triweekly HIIT program (HIIT; n = 18) or resistance training (RT; n = 17). Anthropometry (body mass, fat mass, muscle mass, waist circumference, and skinfold thickness), cardiovascular (blood pressure), metabolic [fasting glucose, fasting insulin, and homeostatic model of insulin resistance (HOMA-IR)], as well as muscle strength, and endurance performance covariables were measured before and after 12 wk in both intervention groups. The interindividual variability to exercise training of the subjects was categorized as responders and NR using as cut points two times the typical error of measurement in mean outcomes. After intervention, significant reduction in waist circumference, skinfold thicknesses, fat mass, blood pressure, fasting glucose, insulin, and HOMA-IR (P training. A uniqueness of the present study was to examine the NR prevalence in women with insulin resistance after high-intensity interval (HIIT) and resistance training (RT). This study demonstrates that 12 wk of HIIT and RT have similar effects and NR prevalence to improve glucose control variables. However, significantly different NR prevalence were observed in other anthropometric, cardiovascular, strength, and endurance performance measurements. Copyright © 2017 the American Physiological Society.

  17. 12 Weeks of Combined Endurance and Resistance Training Reduces Innate Markers of Inflammation in a Randomized Controlled Clinical Trial in Patients with Multiple Sclerosis

    Directory of Open Access Journals (Sweden)

    Nathalie Deckx

    2016-01-01

    Full Text Available Previously, we reported that patients with multiple sclerosis (MS demonstrate improved muscle strength, exercise tolerance, and lean tissue mass following a combined endurance and resistance exercise program. However, the effect of exercise on the underlying disease pathogenesis remains elusive. Since recent evidence supports a crucial role of dendritic cells (DC in the pathogenesis of MS, we investigated the effect of a 12-week combined exercise program in MS patients on the number and function of DC. We demonstrate an increased number of plasmacytoid DC (pDC following the exercise program. These pDC display an activated phenotype, as evidenced by increased numbers of circulating CD62L+ and CD80+ pDC. Interestingly, the number of CD80+ pDC positively correlates with the presence of IL-10-producing regulatory type 1 cells (Tr1, an important cell type for maintaining peripheral tolerance to self-antigens. In addition, decreased production of the inflammatory mediators, TNF-α and MMP-9, upon Toll-like receptor (TLR stimulation was found at the end of the exercise program. Overall, our findings suggest that the 12-week exercise program reduces the secretion of inflammatory mediators upon TLR stimulation and promotes the immunoregulatory function of circulating pDC, suggestive for a favorable impact of exercise on the underlying immunopathogenesis of MS.

  18. Effects of a 12-week, short-interval, intermittent, low-intensity, slow-jogging program on skeletal muscle, fat infiltration, and fitness in older adults: randomized controlled trial.

    Science.gov (United States)

    Ikenaga, Masahiro; Yamada, Yosuke; Kose, Yujiro; Morimura, Kazuhiro; Higaki, Yasuki; Kiyonaga, Akira; Tanaka, Hiroaki

    2017-01-01

    We developed a short-interval, low-intensity, slow-jogging (SJ) program consisting of sets of 1 min of SJ at walking speed and 1 min of walking. We aimed to examine the effects of an easily performed SJ program on skeletal muscle, fat infiltration, and fitness in older adults. A total of 81 community-dwelling, independent, older adults (70.8 ± 4.0 years) were randomly assigned to the SJ or control group. The SJ group participants were encouraged to perform 90 min of SJ at their anaerobic threshold (AT) intensity and 90 min of walking intermittently per week. Aerobic capacity at the AT and sit-to-stand (STS) scores were measured. Intracellular water (ICW) in the legs was assessed by segmental multi-frequency bioelectrical impedance analysis. Subcutaneous (SAT) and intermuscular (IMAT) adipose tissue and muscle cross-sectional area (CSA) were measured at the mid-thigh using computed tomography. A total of 75 participants (37 SJ group, 38 controls) completed the 12-week intervention. The AT and STS improved in the SJ group compared with the controls (AT 15.7 vs. 4.9 %, p increased only in the SJ group (9.7 %, p decreased only in the SJ group (p muscle mass, improved aerobic capacity, muscle function, and muscle composition in older adults.

  19. Psychomotor symptoms and treatment outcomes of ziprasidone monotherapy in patients with major depressive disorder: a 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial.

    Science.gov (United States)

    Jeon, Hong Jin; Fava, Maurizio; Mischoulon, David; Baer, Lee; Clain, Alisabet; Doorley, James; DiPierro, Moneika; Cardoos, Amber; Papakostas, George I

    2014-11-01

    The aim of this study was to evaluate efficacy of ziprasidone monotherapy for major depressive disorder (MDD) with and without psychomotor symptoms. In accordance with the sequential parallel comparison design, 106 MDD patients (age 44.0±10.7 years; female, 43.4%) were recruited and a post-hoc analysis was carried out on 12-week double-blind treatment with either ziprasidone (40-160 mg/day) or placebo, divided into two phases of 6 weeks each to the assigned treatment sequences, drug/drug, placebo/placebo, and placebo/drug. Psychomotor symptoms were evaluated on the basis of the Mini-International Neuropsychiatric Interview at baseline. Efficacy assessments, on the basis of the 17-item Hamilton Depression Rating Scale (HDRS-17) and the Quick Inventory of Depressive Symptomatology Scale, Self-Rated (QIDS-SR), were performed every week throughout the trial. In phase I, ziprasidone monotherapy produced significant improvement in patients with psychomotor symptoms compared with placebo on the basis of HDRS-17 (F=5.95, P=0.017) and QIDS-SR (F=5.26, P=0.025) scores, whereas no significant changes were found in HDRS-17 (F=2.32, P=0.15) and QIDS-SR (F=3.70, P=0.074) scores in patients without psychomotor symptoms. In phase II, ziprasidone monotherapy produced no significant differences compared with placebo. In the pooled analysis, ziprasidone monotherapy showed significance according to QIDS-SR (Z=2.00, P=0.046) and a trend toward statistical significance according to the HDRS-17 (Z=1.66, P=0.10) in patients with psychomotor symptoms. Ziprasidone monotherapy may produce significant improvement compared with placebo in MDD patients with psychomotor symptoms.

  20. Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial

    OpenAIRE

    2013-01-01

    Background Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave® Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chro...

  1. Efficacy and safety of canagliflozin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, 12-week study†

    Science.gov (United States)

    Inagaki, N; Kondo, K; Yoshinari, T; Maruyama, N; Susuta, Y; Kuki, H

    2013-01-01

    Aims We examined the efficacy, safety and tolerability of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in Japanese patients with type 2 diabetes (T2DM) undergoing diet and exercise therapy. Methods Patients aged 20–80 years with T2DM diagnosed ≥3 months previously, and HbA1c of 6.9–9.9% were randomized to 50, 100, 200 or 300 mg canagliflozin or placebo once daily for 12 weeks. The primary and secondary endpoints were changes in HbA1c, fasting plasma glucose (FPG), urinary glucose/creatinine and postprandial glycaemic parameters following a meal test. The safety assessments included adverse events (AEs) and clinical laboratory tests. Results Overall, 383 patients were randomized to receive either placebo (n = 75), or 50 mg (n = 82), 100 mg (n = 74), 200 mg (n = 77) or 300 mg canagliflozin (n = 75). At week 12, significant reductions in HbA1c were observed in all canagliflozin groups relative to placebo (−0.61, –0.80, –0.79 and −0.88% for 50, 100, 200 and 300 mg, respectively, versus +0.11% for placebo; all, p canagliflozin groups. Body weight was significantly decreased by canagliflozin. No deaths or drug-related serious AEs were reported. There was no dose-dependent increase in the incidence of AEs in the canagliflozin groups. The incidence of hypoglycaemia was low; episodes were not severe or dose dependent. Canagliflozin did not affect serum creatinine levels or the urinary albumin/creatinine ratio. Conclusions Treatment with canagliflozin for 12 weeks significantly improved glycaemic control and reduced body weight in Japanese patients with T2DM. Canagliflozin was well tolerated. PMID:23782594

  2. Dairy food consumption and meal-induced cortisol response interacted to influence weight loss in overweight women undergoing a 12-week, meal-controlled, weight loss intervention.

    Science.gov (United States)

    Witbracht, Megan G; Van Loan, Marta; Adams, Sean H; Keim, Nancy L; Laugero, Kevin D

    2013-01-01

    Dairy food enhances weight loss in animal models, possibly by modifying the metabolic effects of cortisol. This study determined in overweight women (ages 20.0-45.9 y; n = 51) whether including dairy food in an energy-restricted diet affects cortisol concentrations and whether differences in provoked cortisol explain the magnitude of weight loss. Women received either an adequate amount of dairy food (AD), the equivalent of ≥711 mL/d milk, or a low amount of dairy food (LD), the equivalent to ≤238 mL/d milk, in a 12-wk, energy-restricted dietary intervention. Participants were tested in a 12-h laboratory visit, which included 2 standard meals and a dinner buffet that was consumed ad libitum. Salivary cortisol was measured from waking to bedtime. Energy restriction increased (P ≤ 0.04) the minimum and decreased (P ≤ 0.02) the diurnal amplitude in the salivary cortisol concentration from baseline to postintervention. Energy restriction enhanced the dinner meal-stimulated salivary cortisol response (DMR) (P ≤ 0.02) but only in the LD group. Compared with the LD treatment, the AD treatment induced (P ≤ 0.04) greater reductions in body weight and fat, but only in women characterized as having a baseline DMR (responders) (n = 26); weight and fat lost in the AD and LD groups were similar in nonresponders (n = 25). Overall, energy restriction dampened diurnal salivary cortisol fluctuations [symptomatic of hypothalamic-pituitary-adrenal (HPA) axis dysfunction] and enhanced dinner meal-stimulated salivary cortisol concentrations. The AD treatment prevented the latter. Furthermore, certain phenotypic markers of HPA axis function may help to expose the weight-reducing effects of consuming dairy food.

  3. Umeclidinium/vilanterol as step-up therapy from tiotropium in patients with moderate COPD: a randomized, parallel-group, 12-week study

    Directory of Open Access Journals (Sweden)

    Kerwin EM

    2017-02-01

    Full Text Available Edward M Kerwin,1 Chris J Kalberg,2 Dmitry V Galkin,2 Chang-Qing Zhu,3 Alison Church,2 John H Riley,4 William A Fahy4 1Clinical Research Institute of Southern Oregon, Medford, OR, 2Respiratory Department, GlaxoSmithKline, Research Triangle Park, NC, USA; 3Clinical Statistics, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, 4Respiratory Department, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, UK Introduction: Patients with COPD who remain symptomatic on long-acting bronchodilator monotherapy may benefit from step-up therapy to a long-acting bronchodilator combination. This study evaluated the efficacy and safety of umeclidinium (UMEC/vilanterol (VI in patients with moderate COPD who remained symptomatic on tiotropium (TIO. Methods: In this randomized, blinded, double-dummy, parallel-group study (NCT01899742, patients (N=494 who were prescribed TIO for ≥3 months at screening (forced expiratory volume in 1 s [FEV1]: 50%–70% of predicted; modified Medical Research Council [mMRC] score ≥1 and completed a 4-week run-in with TIO were randomized to UMEC/VI 62.5/25 µg or TIO 18 µg for 12 weeks. Efficacy assessments included trough FEV1 at Day 85 (primary end point, 0–3 h serial FEV1, rescue medication use, Transition Dyspnea Index (TDI, St George’s Respiratory Questionnaire (SGRQ, and COPD Assessment Test (CAT. Safety evaluations included adverse events (AEs. Results: Compared with TIO, UMEC/VI produced greater improvements in trough FEV1 (least squares [LS] mean difference: 88 mL at Day 85 [95% confidence interval {CI}: 45–131]; P<0.001 and FEV1 after 5 min on Day 1 (50 mL [95% CI: 27–72]; P<0.001. Reductions in rescue medication use over 12 weeks were greater with UMEC/VI versus TIO (LS mean change: -0.1 puffs/d [95% CI: -0.2–0.0]; P≤0.05. More patients achieved clinically meaningful improvements in TDI score (≥1 unit with UMEC/VI (63% versus TIO (49%; odds ratio at Day 84=1.78 [95% CI: 1.21–2.64]; P≤0

  4. Implementation of a 12-week disease management program improved clinical outcomes and quality of life in adults with asthma in a rural district hospital: pre- and post-intervention study.

    Science.gov (United States)

    Chamnan, Parinya; Boonlert, Kittipa; Pasi, Wanit; Yodsiri, Songkran; Pong-on, Sirinya; Khansa, Bhoonsab; Yongkulwanitchanan, Pichapat

    2010-03-01

    Despite the availability of effective medical treatment and disease management guidelines, asthma remains a poorly controlled disease in developing countries. There is little evidence of the effectiveness of disease management guidelines in rural clinical practice. The effect of disease management guidelines on clinical outcomes and quality of life in asthmatic patients in a rural community hospital was examined. Fifty-seven patients aged > or = 16 years with physician-diagnosed asthma from a hospital outpatient clinic in Ubon-ratchathani, Thailand, were recruited. Asthma diagnosis was confirmed by reviewing clinical records. We implemented a 12-week disease management program, including the use of written asthma treatment plan and asthma action plan tailored to individual patients. Using one-group pre- and post-intervention design, we compared the average number of emergency visits and hospitalizations from acute asthmatic attacks before and after the implementation of interventions using the Wilcoxon matched-pairs signed-rank test. We also compared patient's asthma quality of life (AQL) scores, measured using the 7-point scaled Mini Asthma Quality of Life Questionnaire. It was found that among the 57 patients, 38 (67%) were women, and the mean age (SD) of the patients was 47.6 (17.0) years. Sixteen patients (28%) had a family history of asthma. Emergency visits decreased from 0.48 (SD = 0.83) per patient before implementation of interventions to 0.11 (0.37) per patient after implementation of interventions (p = 0.003). Hospitalizations with acute asthma attacks reduced from 0.14 (0.35) per patient to 0.04 (0.27) per patient (p = 0.034). Overall AQL scores increased significantly from 3.7 to 5.4 (p management program could reduce emergency visits and hospitalizations, and improve patients' quality of life in a rural practice setting.

  5. The effect of whole-grain compared to refined wheat on the gut microbial composition and integrity in a colonic epithelial cell model following a 12-week energy-restricted dietary intervention in postmenopausal women

    DEFF Research Database (Denmark)

    Christensen, Ellen Gerd; Licht, Tine Rask; Kristensen, M.;

    Intake of whole-grain products are considered to decrease the risk of cardiovascular disease (CVD). This effect could potentially be linked to a prebiotic effect, hence positive modulation of the gut microbial composition or activity. Kristensen and coworkers recently conducted a study in postmen......Intake of whole-grain products are considered to decrease the risk of cardiovascular disease (CVD). This effect could potentially be linked to a prebiotic effect, hence positive modulation of the gut microbial composition or activity. Kristensen and coworkers recently conducted a study...... in postmenopausal women who were randomized to either whole-grain wheat (WW) (n=38) or refined wheat (RW) (n=34) consumption as part of an energy-restricted diet for 12-weeks following a 2-week run-in period with RW. Percentage fat mass as well as serum total and LDL cholesterol were found to differ between the two...... groups (Kristensen, et al, 2012). We used fecal samples from the same study to examine effects of WW and RW on the bacterial composition by quantitative PCR targeting the phylums Bacteroidetes and Firmicutes, and the genera Bifidobacteria, Lactobacillus, Bacteroides, and Prevotella, as well...

  6. A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome® gel (IDEA-033 compared with the ketoprofen-free vehicle (TDT 064, in patients with osteoarthritis of the knee

    Directory of Open Access Journals (Sweden)

    Kneer W

    2013-10-01

    Full Text Available Werner Kneer,1 Matthias Rother,2 Stefan Mazgareanu,3 Egbert J Seidel4 On behalf of the European IDEA-033 study group 1Orthopaedic Outpatient Centre, Stockach, Germany; 2IMR Partner GmbH, Graefelfing, Germany; 3Cardiorentis Ltd, Zug, Switzerland; 4Sophien- und Hufeland-Clinic, Weimar, Germany Objective: To evaluate the safety and efficacy of ketoprofen in Transfersome® gel (IDEA-033 in comparison with a ketoprofen-free vehicle (TDT 064 for the treatment of osteoarthritis (OA of the knee. Methods: Patients with knee OA (N = 866 were randomly assigned to receive topical IDEA-033 containing 100, 50, or 25 mg ketoprofen, or TDT 064 twice daily for 12 weeks, in a double-blind trial. The primary efficacy endpoint was the change in the Western Ontario and McMaster Universities (WOMAC® Osteoarthritis Index pain subscale score. The coprimary efficacy endpoints were the WOMAC function subscale score and the patient global assessment of response to therapy. The secondary endpoints included the numeric pain rating for the first 14 days of treatment and the Outcome Measures in Rheumatology (OMERACT-Osteoarthritis Research Society International (OARSI responder rates. Results: The WOMAC pain scores were reduced by approximately 50% or more in all four groups. The 100 and 50 mg ketoprofen groups, but not the 25 mg group, showed a superior reduction in the WOMAC pain score versus the TDT 064 group (100 mg: −57.4% [P = 0.0383]; 50 mg: −57.1% [P = 0.0204]; and 25 mg: −53.4% [P = 0.3616] versus TDT 064: −49.5%. The superiority of the ketoprofen-containing formulations was not demonstrated for the WOMAC function subscale score, whereas the patient global assessment of 50 mg ketoprofen group, but not the 100 or 25 mg group, was superior to that of the TDT 064 group (P = 0.0283. Responder rates were significantly higher for all the IDEA-033 groups versus the TDT 064 group, but were high in all groups (100 mg: 88.6%; 50 mg: 86.8%; 25 mg: 88.6%; and TDT 064

  7. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial

    DEFF Research Database (Denmark)

    Madsbad, Sten; Schmitz, Ole; Ranstam, Jonas;

    2004-01-01

    OBJECTIVE: Liraglutide is a long-acting glucagon-like peptide 1 analog designed for once daily injection. This study assessed the efficacy and safety of liraglutide after 12 weeks of treatment in type 2 diabetic patients. RESEARCH DESIGN AND METHODS: A double-blind, randomized, parallel...

  8. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial

    DEFF Research Database (Denmark)

    Madsbad, Sten; Schmitz, Ole; Ranstam, Jonas

    2004-01-01

    OBJECTIVE: Liraglutide is a long-acting glucagon-like peptide 1 analog designed for once daily injection. This study assessed the efficacy and safety of liraglutide after 12 weeks of treatment in type 2 diabetic patients. RESEARCH DESIGN AND METHODS: A double-blind, randomized, parallel...

  9. Change in perceived psychosocial status following a 12-week Tai Chi exercise programme.

    Science.gov (United States)

    Taylor-Piliae, Ruth E; Haskell, William L; Waters, Catherine M; Froelicher, Erika Sivarajan

    2006-05-01

    This paper reports a study to examine change in psychosocial status following a 12-week Tai Chi exercise intervention among ethnic Chinese people with cardiovascular disease risk factors living in the United States of America. Regular participation in physical activity is associated with protection against cardioavascular disease, and improvements in physical and psychological health. Increasing amounts of scientific evidence suggests that mind-body exercise, such as Tai Chi, are related to improvements in mental health, emotional well-being, and stress reduction. No prior study has examined the effect of a Tai Chi exercise intervention on psychosocial status among people with cardiovascular disease risk factors. This was a quasi-experimental study. Participants attended a 60-minute Tai Chi exercise class three times per week for 12 weeks. Data were collected at baseline, 6 and 12 weeks following the intervention. Psychosocial status was assessed using Chinese versions of Cohen's Perceived Stress Scale, Profile of Mood States, Multidimensional Scale of Perceived Social Support, and Tai Chi exercise self-efficacy. A total of 39 participants, on average 66-year-old (+/-8.3), married (85%), Cantonese-speaking (97%), immigrants participated. The majority were women (69%), with stress (eta2 = 0.13) were found. In addition, Tai Chi exercise statistically significantly increased self-efficacy to overcome barriers to Tai Chi (eta2 = 0.19), confidence to perform Tai Chi (eta2 = 0.27), and perceived social support (eta2 = 0.12). Tai Chi was a culturally appropriate mind-body exercise for these older adults, with statistically significant psychosocial benefits observed over 12-weeks. Further research examining Tai Chi exercise using a randomized clinical trial design with an attention-control group may reduce potential confounding effects, while exploring potential mechanisms underlying the relaxation response associated with mind-body exercise. In addition, future studies

  10. Effect of 12-Week Pilates Trainning on EDSS in Women Suffering fromMultiple Sclerosis

    Directory of Open Access Journals (Sweden)

    Z Shanazari

    2013-04-01

    Full Text Available Abstract Background & aim: Multiple sclerosis is a debilitating disease that strikes the immune system. Multiple sclerosis is a chronic disease which debilitates the nervous system. The study was evaluated the effects of Pilates exercise on women with physical disabilities suffering from multiple sclerosis for 12 weeks .The aim of this study was to investigating the effects of Pilates trainning on EDSS of women suffering from Multiple Sclerosis (MS for 12 weeks. Methods: In the present clinical trial study, 38 patients age 20-40 years (mean disease duration of 8±2 years with multiple sclerosis grade 0-4.5 were selected. The Patients were randomly divided into two groups: experimental and control groups. The training program for pilates, 12 weeks, three sessions a week, with each session consisting of 60 minutes. Patients' physical disability was measured using Krutzke Expanded Disability Status Scale, before and after exercise. Data were analyzed by ANCOVA test. Results: Physical disability scores before and after the exercise in intervention was 47.1 and 37 and in the control group, was 93.1 and 43.1 respectively, which was significantly different in the intervention group before and after training (p<0.05. Conclusion: Pilates training improves the physical disability of MS patients. Therefore, this exercise can be used as a complementary treatment alongside drug treatments. Key Words: Multiple Sclerosis, Women, Pilates, EDSS

  11. Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

    Science.gov (United States)

    Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

    2014-06-01

    Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items.

  12. Moderate Walking Enhances the Effects of an Energy-Restricted Diet on Fat Mass Loss and Serum Insulin in Overweight and Obese Adults in a 12-Week Randomized Controlled Trial.

    Science.gov (United States)

    Kleist, Bernadette; Wahrburg, Ursel; Stehle, Peter; Schomaker, Ralph; Greiwing, Andreas; Stoffel-Wagner, Birgit; Egert, Sarah

    2017-08-09

    Background: Increased physical activity may be advantageous for weight loss.Objective: We investigated the effects of an energy-restricted diet with and without moderate walking on body weight, body composition, resting energy expenditure (REE), and endocrine and cardiometabolic risk variables in overweight and obese participants.Methods: A 12-wk, randomized, 2-arm, parallel, controlled, energy-restricted (500-800 kcal/d) dietary intervention study was conducted in 82 men and women [mean baseline characteristics: age, 39.4 y; weight, 99.3 kg; body mass index (in kg/m(2)), 31.9]. Participants were divided into 2 groups. One group received a hypoenergetic diet (DI) only (n = 44). The second group received the same DI and participated in a regular walking program of 2.5 h/wk (DI + walking; n = 38).Results: After the 12-wk intervention, body weight was significantly decreased in the DI + walking group and the DI group (-8.8 compared with -7.0 kg, P = 0.064 for intergroup differences). The decrease in body weight was accompanied by a significant reduction in total fat mass, which was significantly more pronounced in the DI + walking group than in the DI group (-6.4 ± 3.1 compared with -4.8 ± 3.0 kg; P = 0.020). REE after 12 wk was not significantly different compared with the baseline REE. Diastolic blood pressure, mean arterial pressure, LDL cholesterol, and non-HDL cholesterol were similarly significantly improved by both interventions. In the DI + walking group, insulin and the homeostasis model assessment of insulin resistance index were also significantly reduced. Serum free triiodothyronine was significantly decreased and serum cortisol was significantly increased in both groups.Conclusions: Participation in a 12-wk weight-loss study resulted in significant reductions in body weight and fat mass and was associated with significant improvements in biomarkers for cardiovascular disease risk. Moderate weight loss was not accompanied by a reduction in REE

  13. mHealth Physical Activity Intervention: A Randomized Pilot Study in Physically Inactive Pregnant Women.

    Science.gov (United States)

    Choi, JiWon; Lee, Ji Hyeon; Vittinghoff, Eric; Fukuoka, Yoshimi

    2016-05-01

    Physical inactivity is prevalent in pregnant women, and innovative strategies to promote physical activity are strongly needed. The purpose of the study was to test a 12-week mobile health (mHealth) physical activity intervention for feasibility and potential efficacy. Participants were recruited between December 2012 and February 2014 using diverse recruitment methods. Thirty pregnant women between 10 and 20 weeks of gestation were randomized to an intervention (mobile phone app plus Fitbit) or a control (Fitbit) group. Both conditions targeted gradual increases in physical activity. The mHealth intervention included daily messages and a mobile phone activity diary with automated feedback and self-monitoring systems. On monthly average, 4 women were screened for initial eligibility by telephone and 2.5 were randomized. Intervention participants had a 1096 ± 1898 step increase in daily steps compared to an increase of 259 ± 1604 steps in control participants at 12 weeks. The change between groups in weekly mean steps per day during the 12-week study period was not statistically significant (p = 0.38). The intervention group reported lower perceived barrier to being active, lack of energy, than the control group at 12-week visit (p = 0.02). The rates of responding to daily messages and using the daily diary through the mobile app declined during the 12 week study period. It was difficult to recruit and randomize inactive women who wanted to increase physical activity during pregnancy. Pregnant women who were motivated to increase physical activity might find using mobile technologies in assessing and promoting PA acceptable. Possible reasons for the non-significant treatment effect of the mHealth intervention on physical activity are discussed. Public awareness of safety and benefits of physical activity during pregnancy should be promoted. Clinicaltrials.Gov Identifier NCT01461707.

  14. History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release

    NARCIS (Netherlands)

    Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.

    2009-01-01

    Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind,

  15. History of early abuse as a predictor of treatment response in patients with fibromyalgia : A post-hoc analysis of a 12-week, randomized, double-blind, placebo-controlled trial of paroxetine controlled release

    NARCIS (Netherlands)

    Pae, Chi-Un; Masand, Prakash S.; Marks, David M.; Krulewicz, Stan; Han, Changsu; Peindl, Kathleen; Mannelli, Paolo; Patkar, Ashwin A.

    2009-01-01

    Objectives. We conducted a post-hoc analysis to determine whether a history of physical or sexual abuse was associated with response to treatment in a double-blind, randomized, placebo-controlled trial of paroxetine controlled release (CR) in fibromyalgia. Methods. A randomized, double-blind, placeb

  16. Rating of perceived exertion after 12 weeks of high-intensity, intermittent sprinting.

    Science.gov (United States)

    Heydari, Mehrdad; Boutcher, Stephen H

    2013-02-01

    The effect of a 12-week high-intensity intermittent exercise (HIIE) intervention on the rating of perceived exertion (RPE) response of young males was examined. Participants (N = 38; M BMI = 28.7 kg x m(-2), SD = 3.1; M age = 24.9 yr., SD = 4.3) were randomly assigned to either an exercise or control group. The exercise group received HIIE three times per week, 20 min. per session, for 12 weeks. RPE was assessed before and after HIIE training and during pre- and post-maximal oxygen uptake (VO2 max) testing. After HIIE training, RPE was significantly higher in Weeks 11-12 compared to Weeks 1-2. In contrast, heart rate was similar throughout training. Comparing post- to pre-VO2 max test, RPE was significantly lower in the exercise group, whereas for controls, RPE was similar. Aerobic power improved 15% for the exercise group, with no significant change for controls. HIIE resulted in significant increases in RPE, whereas RPE during the VO2 max test was significantly decreased.

  17. The Effects of a Pedometer-Based Intervention on First-Year University Students: A Randomized Control Trial

    Science.gov (United States)

    Sharp, Paul; Caperchione, Cristina

    2016-01-01

    Objectives: To assess the effects of a 12-week pedometer-based intervention on the physical activity behavior, health-related quality of life (HRQOL), and psychological well-being of first-year university students. Participants: First-year university students (N = 184) were recruited during September 2012 and randomly assigned to an intervention…

  18. 积雪苷治疗35例鱼尾纹12周疗效观察%Centella triterpenes cream(R) in the treatment of crow's feet in 35 women: a randomized, double-blind vehicle-controlled 12-week study

    Institute of Scientific and Technical Information of China (English)

    张洁尘; 陈祥生; 侯伟; 田蔚蔚; 陈解春

    2012-01-01

    目的 评估积雪苷治疗鱼尾纹的临床疗效及安全性.方法 采用12周随机、双盲、赋形剂自身对照试验,通过第0、4、8、12周研究者盲法评价皱纹程度、受试者盲法自评、仪器测量3个方面评价试验用药侧与对照侧鱼尾纹的改善情况.结果 完成试验的35名受试者的双侧鱼尾纹程度根据研究者盲法评估,在使用第4周,治疗组与对照组的皱纹变化有统计学意义(P<0.05).在第8、12周试验用药侧的皱纹程度的减轻优于对照侧,皱纹评分具有统计学意义(P<0.05).采用Visioscan VC98定量测量双侧鱼尾纹SEw值结果显示,试验用药侧随时间的变化SEw的值增大,即皱纹程度减轻,与对照侧相比,差异有统计学意义.受试者评估显示,双侧药物在使用过程中刺激性及粗皱纹的改善情况无差异,外眦部位肌肤纹理改善方面治疗侧优于对照侧(P<0.05).结论 积雪苷霜软膏每日3次局部外用改善鱼尾纹有一定疗效,无不良反应.%Objective To evaluate the efficacy and safety of centella triterpenes cream(R) for treating crow's feet.Methods A double-blind,randomized,vehicle-controlled 12-week study was conducted.Centella triterpenes cream(R) was applied to the lateral canthus on one side (treatment side) and vehicle-(c)ontrol cream to the lateral canthus on the other side (control side) 3 times daily.Efficacy was evaluated based on an investigator-blinded assessment,subject self-blinded assessment and a quantitative analysis by Visioscan(R)VC98 at the baseline,4,8,12 weeks after the beginning of treatment.Results Thirty-six volunteers were recruited and 35 subjects completed the 12-week trial.The investigator-blinded assessment showed a significant difference in the changes of wrinkle scores between the treatment side and control side after 4 weeks (P < 0.05),and the improvement of wrinkles was more obvious on the treatment side than on the control side at 8 and 12 weeks with a

  19. Effects of 12 weeks high-intensity & reduced-volume training in elite athletes

    DEFF Research Database (Denmark)

    Kilen, Anders; Larsson, Tanja Hultengren; Jørgensen, Majke;

    2014-01-01

    It was investigated if high-intensity interval training (HIT) at the expense of total training volume improves performance, maximal oxygen uptake and swimming economy. 41 elite swimmers were randomly allocated to a control (CON) or HIT group. For 12 weeks both groups trained ∼12 h per week. HIT c...

  20. The HOPE Social Media Intervention for Global HIV Prevention: A Cluster Randomized Controlled Trial in Peru

    Science.gov (United States)

    Young, Sean D.; Cumberland, William G.; Nianogo, Roch; Menacho, Luis A.; Galea, Jerome T.; Coates, Thomas

    2015-01-01

    Background Social media technologies are newly emerging tools that can be used for HIV prevention and testing in low- and middle-income countries, such as Peru. This study examined the efficacy of using the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. Methods In a cluster randomized controlled trial with concealed allocation, Peruvian MSM from Greater Lima/Callao (N = 556) were randomly assigned to join private intervention or control groups on Facebook for 12 weeks. In the intervention condition, forty-nine Peruvian MSM were trained and randomly assigned to be HIV prevention mentors to participants via Facebook groups over 12 weeks. Control participants received an enhanced standard of care, including standard offline HIV prevention available in Peru as well as participation in Facebook groups (without peer leaders) that provided study updates and HIV testing information. After accepting a request to join the groups, continued participation was voluntary. Participants could request a free HIV test at a local community clinic, and completed questionnaires on HIV risk behaviors and social media use at baseline and 12-week follow-up. Findings Between March 19, 2012, and June 11, 2012, and Sept 26, 2012, and Dec 19, 2012, 556 participants were randomly assigned to intervention groups (N=278) or control groups (N=278); we analyse data for 252 and 246. 43 participants (17%) in the intervention group and 16 (7%) in the control groups got tested for HIV (adjusted odds ratio 2.61, 95% CI 1.55–4.38). No adverse events were reported. Retention at 12-week follow-up was 90%. Across conditions, 7 (87.5%) of the 8 participants who tested positive were linked to care at a local clinic. Interpretation Development of peer-mentored social media communities seemed to be an effective method to increase HIV testing among high-risk populations in Peru.: Results suggest that the HOPE social

  1. Effects of 12 weeks high-intensity & reduced-volume training in elite athletes.

    Directory of Open Access Journals (Sweden)

    Anders Kilen

    Full Text Available It was investigated if high-intensity interval training (HIT at the expense of total training volume improves performance, maximal oxygen uptake and swimming economy. 41 elite swimmers were randomly allocated to a control (CON or HIT group. For 12 weeks both groups trained ∼12 h per week. HIT comprised ∼5 h vs. 1 h and total distance was ∼17 km vs. 35 km per week for HIT and CON, respectively. HIT was performed as 6-10×10-30 s maximal effort interspersed by 2-4 minutes of rest. Performance of 100 m all-out freestyle and 200 m freestyle was similar before and after the intervention in both HIT (60.4±4.0 vs. 60.3±4.0 s; n = 13 and 133.2±6.4 vs. 132.6±7.7 s; n = 14 and CON (60.2±3.7 vs. 60.6±3.8 s; n = 15 and 133.5±7.0 vs. 133.3±7.6 s; n = 15. Maximal oxygen uptake during swimming was similar before and after the intervention in both the HIT (4.0±0.9 vs. 3.8±1.0 l O2×min-1; n = 14 and CON (3.8±0.7 vs. 3.8±0.7 l O2×min-1; n = 11 group. Oxygen uptake determined at fixed submaximal speed was not significantly affected in either group by the intervention. Body fat % tended to increase (P = 0.09 in the HIT group (15.4±1.6% vs. 16.3±1.6%; P = 0.09; n = 16 and increased (P<0.05 in the CON group (13.9±1.5% vs. 14.9±1.5%; n = 17. A distance reduction of 50% and a more than doubled HIT amount for 12 weeks did neither improve nor compromise performance or physiological capacity in elite swimmers.

  2. Effects of 12 weeks high-intensity & reduced-volume training in elite athletes

    DEFF Research Database (Denmark)

    Kilen, Anders; Larsson, Tanja Hultengren; Jørgensen, Majke

    2014-01-01

    It was investigated if high-intensity interval training (HIT) at the expense of total training volume improves performance, maximal oxygen uptake and swimming economy. 41 elite swimmers were randomly allocated to a control (CON) or HIT group. For 12 weeks both groups trained ∼12 h per week. HIT...... (60.4±4.0 vs. 60.3±4.0 s; n = 13 and 133.2±6.4 vs. 132.6±7.7 s; n = 14) and CON (60.2±3.7 vs. 60.6±3.8 s; n = 15 and 133.5±7.0 vs. 133.3±7.6 s; n = 15). Maximal oxygen uptake during swimming was similar before and after the intervention in both the HIT (4.0±0.9 vs. 3.8±1.0 l O2×min-1; n = 14) and CON...

  3. Lifestyle Intervention on Metabolic Syndrome and its Impact on Quality of Life: A Randomized Controlled Trial

    Science.gov (United States)

    Saboya, Patrícia Pozas; Bodanese, Luiz Carlos; Zimmermann, Paulo Roberto; Gustavo, Andreia da Silva; Macagnan, Fabricio Edler; Feoli, Ana Pandolfo; Oliveira, Margareth da Silva

    2017-01-01

    Background Lifestyle intervention programs can reduce the prevalence of metabolic syndrome (MetS) and, therefore, reduce the risk for cardiac disease, one of the main public health problems nowadays. Objective The aim of this study was to compare the effects of three types of approach for lifestyle change programs in the reduction of metabolic parameters, and to identify its impact on the quality of life (QOL) of individuals with MetS. Methods A randomized controlled trial included 72 individuals with MetS aged 30-59 years. Individuals were randomized into three groups of multidisciplinary intervention [Standard Intervention (SI) - control group; Group Intervention (GI); and Individual Intervention (II)] during 12 weeks. The primary outcome was change in the metabolic parameters, and secondarily, the improvement in QOL measures at three moments: baseline, 3 and 9 months. Results Group and individual interventions resulted in a significant reduction in body mass index, waist circumference, systolic blood pressure at 3 months and the improvement of QOL, although it was significantly associated with the physical functioning domain. However, these changes did not remain 6 months after the end of intervention. Depression and anxiety were significantly associated with worse QOL, although they showed no effect on the response to intervention. Conclusion Multidisciplinary intervention, especially in a group, might be an effective and economically feasible strategy in the control of metabolic parameters of MetS and improvement of QOL compared to SI, even in a dose-effect relationship. PMID:27982160

  4. A randomized, double-blind, parallel-group, phase III study of shortening the dosing interval of subcutaneous tocilizumab monotherapy in patients with rheumatoid arthritis and an inadequate response to subcutaneous tocilizumab every other week: Results of the 12-week double-blind period.

    Science.gov (United States)

    Ogata, Atsushi; Tanaka, Yoshiya; Ishii, Tomonori; Kaneko, Motohide; Miwa, Hiroko; Ohsawa, Shino

    2017-06-16

    To determine the efficacy and safety of subcutaneous tocilizumab (TCZ-SC) monotherapy every week (qw) versus every other week (q2w) in patients with rheumatoid arthritis who had an inadequate response to TCZ-SC q2w. Adult patients in Japan with inadequate response to TCZ-SC q2w were randomized to either TCZ-SC 162 mg qw monotherapy or TCZ-SC 162 mg q2w monotherapy for 12 weeks (double-blind). The primary endpoint was the change from baseline in adjusted Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) at week 12. Efficacy, safety and pharmacokinetics were assessed. TCZ-SC qw was superior to TCZ-SC q2w for adjusted mean change in DAS28-ESR from baseline to week 12. The difference in the change in DAS28-ESR between TCZ-SC qw and q2w was -1.21 (95%CI: -2.13, -0.30, p = .0108). A higher proportion of patients receiving TCZ-SC qw achieved DAS28-ESR remission/low disease activity than TCZ-SC q2w. Adverse events were 71.4% and 66.7% for TCZ-SC qw and q2w, respectively; infection was the most common event with one fatal case with TCZ-SC qw. In patients with inadequate response to TCZ-SC q2w, shortening the dosing interval to qw improved efficacy with acceptable tolerability. Occurrence of infection for both TCZ q2w and qw is important and needs careful attention.

  5. Randomized Trial of a Social Networking Intervention for Cancer-Related Distress.

    Science.gov (United States)

    Owen, Jason E; O'Carroll Bantum, Erin; Pagano, Ian S; Stanton, Annette

    2017-02-27

    Web and mobile technologies appear to hold promise for delivering evidence-informed and evidence-based intervention to cancer survivors and others living with trauma and other psychological concerns. Health-space.net was developed as a comprehensive online social networking and coping skills training program for cancer survivors living with distress. The purpose of this study was to evaluate the effects of a 12-week social networking intervention on distress, depression, anxiety, vigor, and fatigue in cancer survivors reporting high levels of cancer-related distress. We recruited 347 participants from a local cancer registry and internet, and all were randomized to either a 12-week waiting list control group or to immediate access to the intervention. Intervention participants received secure access to the study website, which provided extensive social networking capabilities and coping skills training exercises facilitated by a professional facilitator. Across time, the prevalence of clinically significant depression symptoms declined from 67 to 34 % in both conditions. The health-space.net intervention had greater declines in fatigue than the waitlist control group, but the intervention did not improve outcomes for depression, trauma-related anxiety symptoms, or overall mood disturbance. For those with more severe levels of anxiety at baseline, greater engagement with the intervention was associated with higher levels of symptom reduction over time. The intervention resulted in small but significant effects on fatigue but not other primary or secondary outcomes. Results suggest that this social networking intervention may be most effective for those who have distress that is not associated with high levels of anxiety symptoms or very poor overall psychological functioning. The trial was registered with the ClinicalTrials.gov database ( ClinicalTrials.gov #NCT01976949).

  6. Positive performance and health effects of a football training program over 12 weeks can be maintained over a 1-year period with reduced training frequency

    DEFF Research Database (Denmark)

    Randers, Morten Bredsgaard; Nielsen, Jens Jung; Krustrup, Birgitte Rejkjær

    2010-01-01

    We examined whether improvements in the performance and health profile of an intensive 12-week football intervention could be maintained with a reduced training frequency. Seventeen healthy untrained males completed the study. Ten subjects trained 2.4 times/week for 12 weeks and another 52 weeks ...

  7. Randomized controlled trial of the MEND program: a family-based community intervention for childhood obesity.

    Science.gov (United States)

    Sacher, Paul M; Kolotourou, Maria; Chadwick, Paul M; Cole, Tim J; Lawson, Margaret S; Lucas, Alan; Singhal, Atul

    2010-02-01

    The aim of this study was to evaluate the effectiveness of the Mind, Exercise, Nutrition, Do it (MEND) Program, a multicomponent community-based childhood obesity intervention (www.mendcentral.org). One hundred and sixteen obese children (BMI >or= 98 th percentile, UK 1990 reference data) were randomly assigned to intervention or waiting list control (6-month delayed intervention). Parents and children attended eighteen 2-h group educational and physical activity sessions held twice weekly in sports centers and schools, followed by a 12-week free family swimming pass. Waist circumference, BMI, body composition, physical activity level, sedentary activities, cardiovascular fitness, and self-esteem were assessed at baseline and at 6 months. Children were followed up 12 months from baseline (0 and 6 months postintervention for the control and intervention group, respectively). Participants in the intervention group had a reduced waist circumference z-score (-0.37; P children in the intervention group had reduced their waist and BMI z-scores by 0.47 (P < 0.0001) and 0.23 (P < 0.0001), respectively, and benefits in cardiovascular fitness, physical activity levels, and self-esteem were sustained. High-attendance rates suggest that families found this intensive community-based intervention acceptable. Further larger controlled trials are currently underway to confirm the promising findings of this initial trial.

  8. Diabetes NetPLAY: A physical activity website and linked email counselling randomized intervention for individuals with type 2 diabetes

    Directory of Open Access Journals (Sweden)

    Courneya Kerry S

    2009-03-01

    Full Text Available Abstract Background - This pilot study evaluated the feasibility (recruitment, retention, adherence and satisfaction and preliminary efficacy of a 12-week website and email-linked counselling intervention on physical activity behaviour change in individuals with type 2 diabetes. Methods - A total of 49 individuals with type 2 diabetes (59% female, average age 54.1 years were randomized to the Diabetes NetPLAY intervention or control condition. The intervention condition received information grounded in the Social Cognitive Theory (SCT, personalized weekly emails, an on-line logbook and message board. Key outcomes included physical activity behaviour and related cognition changes. The control condition was provided links to the Canadian Diabetes Association's Clinical Practice Guidelines for Physical Activity and Canada's Guide to Physical Activity. Results - Intervention participants indicated high levels of satisfaction for this mode of delivery and study results demonstrated the feasibility of web-based mediums for the delivery of physical activity information in this population. The intervention group demonstrated a significant improvement in total vigorous and moderate minutes of physical activity (p = 0.05 compared to the control group over the 12-week study. Among the SCT variables, behavioural capacity, showed a significant increase (p Conclusion - Web-based interventions for individuals with type 2 diabetes are feasible and show promise for improving positive physical activity outcomes.

  9. A Comparison of 12 Weeks of Pilates and Aquatic Training on the Dynamic Balance of Women with Mulitple Sclerosis

    Science.gov (United States)

    Marandi, Sayyed Mohammad; Nejad, Vahid Shayegan; Shanazari, Zohreh; Zolaktaf, Vahid

    2013-01-01

    Background: Multiple Sclerosis (MS) is a disabling chronic disease of the nervous system in which the myelin system of the central nervous system is deteriorated. The objective of this study is to understand the effect of Pilates exercises and aquatic training for a 12 week period on the dynamic balance of MS patients. Methods: The research method is semi-experimental. As a result, among the female patients visiting the MS clinic of Kashani hospital in Esfahan, 57 patients with disease intensity levels between 0 and 4.5 were taken as samples. The average length of the disease was 8 ± 2 years, 20;40 years old, and they were randomly divided into three groups of Pilates exercise group, aquatic training group, and the control group. The exercise schedule for the experiment groups consisted of 12 weeks, three sessions per week, and 1 hour for each session. The dynamic balance of the patients, before and after the exercises was measured by Six Spot Step Test. Results: The adjusted mean differences of Timed Up and Go Test (TUGT) scores of the experimental groups are significantly different (PPilates exercise interventions and aquatic training can significantly increase the dynamic balance of the examinees in the post-experiment stage. Conclusions: Performing the Pilate exercises and aquatic training increases dynamic balance of the MS patients. Considering the role of dynamic balance on physical fitness and enabling the person in doing is daily chores and routines, and its direct effect on the quality of life, it leads the specialists in applying these exercises as a supplementary treatment along with the medicinal treatments for MS patients. PMID:23717760

  10. Gut microbiota composition in relation to the metabolic response to 12-week combined polyphenol supplementation in overweight men and women.

    Science.gov (United States)

    Most, J; Penders, J; Lucchesi, M; Goossens, G H; Blaak, E E

    2017-09-01

    The intestinal microbiota may have a profound impact on host metabolism. As evidence suggests that polyphenols affect substrate utilization, the present study aimed to investigate the effects of polyphenol supplementation on intestinal microbiota composition in humans. Furthermore, we examined whether (changes in) gut microbiota composition may determine the metabolic response to polyphenol supplementation. In this randomized, double-blind, placebo (PLA)-controlled trial, 37 overweight and obese men and women (18 males/19 females, 37.8±1.6 years, body mass index: 29.6±0.5 kg/m(2)) received either epigallocatechin-3-gallate and resveratrol (EGCG+RES, 282 and 80 mg/day, respectively) or PLA for 12 weeks. Before and after intervention, feces samples were collected to determine microbiota composition. Fat oxidation was assessed by indirect calorimetry during a high-fat mixed meal test (2.6 MJ, 61 energy% fat) and skeletal muscle mitochondrial oxidative capacity by means of ex vivo respirometry on isolated skeletal muscle fibers. Body composition was measured by dual-energy X-ray absorptiometry. Fecal abundance of Bacteroidetes was higher in men as compared with women, whereas other assessed bacterial taxa were comparable. EGCG+RES supplementation significantly decreased Bacteroidetes and tended to reduce Faecalibacterium prausnitzii in men (P=0.05 and P=0.10, respectively) but not in women (P=0.15 and P=0.77, respectively). Strikingly, baseline Bacteroidetes abundance was predictive for the EGCG+RES-induced increase in fat oxidation in men but not in women. Other bacterial genera and species were not affected by EGCG+RES supplementation. We demonstrated that 12-week EGCG+RES supplementation affected the gut microbiota composition in men but not in women. Baseline microbiota composition determined the increase in fat oxidation after EGCG+RES supplementation in men.

  11. Happy Family Kitchen II: A Cluster Randomized Controlled Trial of a Community-Based Family Intervention for Enhancing Family Communication and Well-being in Hong Kong.

    Science.gov (United States)

    Ho, Henry C Y; Mui, Moses; Wan, Alice; Ng, Yin-Lam; Stewart, Sunita M; Yew, Carol; Lam, Tai Hing; Chan, Sophia S

    2016-01-01

    Long working hours and stressful urban lifestyles pose major challenges to family communication and well-being in Hong Kong. A community-based family intervention derived from a positive psychology framework, by using cooking and dining as a platform, was developed for improving family communication and well-being. Social workers and teachers from 31 social service units and schools in collaboration with an academic partner organized and conducted the intervention programs for 2,070 individuals from 973 families in a deprived district in Hong Kong. The participants were randomly assigned into the intervention or control group in a cluster randomized controlled trial (cRCT). The core intervention covered one of five positive psychology themes: joy, gratitude, flow, savoring, and listening. Assessments at pre-intervention, immediate post-intervention, and 4 and 12 weeks post-intervention showed improved family communication and well-being with sustainable effects up to 12 weeks. Positive changes in family happiness and family health were greater in the intervention group than in the control group. The savoring intervention had the most improved outcomes among the five themes. We concluded that this large-scale brief cRCT developed and conducted in real-world settings provided evidence for the feasibility and effectiveness of a community-based family intervention. This study was registered under ClinicalTrials.gov (NCT01796275).

  12. Outcomes from a Randomized Controlled Trial of a Group Intervention for HIV Positive Men and Women Coping with AIDS-Related Loss and Bereavement

    Science.gov (United States)

    Sikkema, Kathleen J.; Hansen, Nathan B.; Kochman, Arlene; Tate, David C.; DiFranceisco, Wayne

    2004-01-01

    The purpose of this study was to examine the impact of a group coping intervention for HIV-positive men and women who have lost a loved one(s) to AIDS in the past 2 years. Two hundred thirty-five participants, diverse with respect to race/ethnicity and sexual orientation, were randomly assigned to a 12-week cognitive-behavioral group intervention…

  13. 12 weeks of simulated barefoot running changes foot-strike patterns in female runners.

    Science.gov (United States)

    McCarthy, C; Fleming, N; Donne, B; Blanksby, B

    2014-05-01

    To investigate the effect of a transition program of simulated barefoot running (SBR) on running kinematics and foot-strike patterns, female recreational athletes (n=9, age 29 ± 3 yrs) without SBR experience gradually increased running distance in Vibram FiveFingers SBR footwear over 12 weeks. Matched controls (n=10, age 30 ± 4 yrs) continued running in standard footwear. A 3-D motion analysis of treadmill running at 12 km/h(-1) was performed by both groups, barefoot and shod, pre- and post-intervention. Post-intervention data indicated a more-forefoot strike pattern in the SBR group compared to controls; both running barefoot (P>0.05), and shod (Pbarefoot, there were significant kinematic differences across time in the SBR group for ankle flexion angle at toe-off (Pbarefoot" kinematics, regardless of preferred footwear.

  14. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study.

    Science.gov (United States)

    Merolli, Mark; Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-08-07

    Chronic pain places an enormous burden on health care systems. Multidisciplinary pain management services are well documented as an effective means to improve patient outcomes. However, waiting lists to access these services are long and outcomes deteriorate. Innovative solutions such as social media are gaining attention as a way to decrease this burden and improve outcomes. It is a challenge to design research that demonstrates whether social media are acceptable to patients and clinically effective. The aim was to conduct a longitudinal pilot study to understand what aspects of research design are key to the success of running a larger-scale study of social media use in the clinical management of chronic pain. A 12-week study examined social media use by patients on the waiting list for the Royal Melbourne Hospital Pain Management Service. Selected social media resources were suggested for use by patients waiting for an appointment at the clinic. Patients filled out measures for pain interference and pain self-efficacy before and after the study. Follow-up was conducted at monthly intervals via telephone semistructured interviews to discuss engagement and garner individual perceptions towards social media use. A social media-use instrument was also administered as part of the after-study questionnaire. Targeted recruitment refined 235 patient referrals to 138 (58.7%) suitable potential participants. Contact was made with 84 out of 138 (60.9%) patients. After a further exclusion of 54 out of 84 (64%) patients for various reasons, this left 30 out of 84 (36%) patients fitting the inclusion criteria and interested in study participation. A final study cohort of 17 out of 30 (57%) was obtained. Demographics of the 17 patients were mixed. Low back pain was the primary condition reported as leading to chronic pain. Semistructured interviews collected data from 16 out of 17 (94%) patients who started the trial, and at final follow-up 9 out of 17 (53%) patients

  15. Response of Leptin and C-reactive Protein Serum Levels to 12 Weeks Moderate Intensity Aerobic Exercise in Obese Men

    Directory of Open Access Journals (Sweden)

    Sonia Ghiasi

    2017-01-01

    Full Text Available The aim of this study was to investigate the effect of 12 weeks moderate intensity aerobic exercise on leptin and C-reactive protein serum levels in obese men. The study was conducted in Urmia- Iran in 2015. Twenty-four obese men with an aged range 40-50 yrs. were enrolled into the study. Subjects were randomized to one of 2 groups exercise (n=12 and control groups (n=12. The exercise group performed aerobic exercise training up to 50-70 % heart rate reserve, three times a week for 12 weeks. Leptin and CRP serum level was measured by ELISA method before and after the 12 weeks. After 12 weeks exercise training, leptin and CRP serum level in the exercise group compared to the control group, were decreased significantly (P<0.05. To sum up, 12 weeks moderate intensity aerobic exercise in the reduction of CRP and leptin concentration had a prominent role that might be effective in reducing weight and improving cardiovascular risk factors.

  16. Intake of Novel Red Clover Supplementation for 12 Weeks Improves Bone Status in Healthy Menopausal Women

    Directory of Open Access Journals (Sweden)

    Anne Cathrine Thorup

    2015-01-01

    Full Text Available Objective. To investigate the effect by which daily consumption of a novel red clover (RC extract influences bone health, inflammatory status, and cardiovascular health in healthy menopausal women. Design. A 12-week randomized, double-blinded, placebo-controlled trial involving 60 menopausal women receiving a daily dose of 150 mL RC extract containing 37.1 mg isoflavones (33.8 mg as aglycones or placebo. Methods. Bone parameters were changes in bone mineral density (BMD, bone mineral content (BMC, and T-score at the lumbar spine and femoral neck. Bone turnover (CTx and inflammatory markers were measured in plasma and finally blood pressure (BP was evaluated. Results. RC extract had positive effect on bone health, and only the women receiving the placebo experienced a decline in BMD (p<0.01 at the lumbar spine. T-score at the lumbar spine only decreased in the placebo group (p<0.01. CTx decreased in the RC group with −9.94 (±4.93%, although not significant. Conclusion. Daily consumption of RC extract over a 12-week period was found to have a beneficial effect on bone health in menopausal women based on BMD and T-score at the lumbar spine and plasma CTx levels. No changes in BP or inflammation markers were found and no side effects were observed.

  17. Effect of individualized worksite exercise training on aerobic capacity and muscle strength among construction workers - a randomized controlled intervention study

    DEFF Research Database (Denmark)

    Gram, Bibi; Holtermann, Andreas; Søgaard, Karen;

    2012-01-01

    tailored exercise programs on their physical fitness and muscular capacity. METHOD: The study was a randomized controlled trial of male constructions workers allocated to either an exercise or control group. The intervention lasted 12 weeks, and the exercise group trained 3 x 20 minutes a week....... The participants completed health checks before and after the intervention period. Data from the first health check were used to tailor the exercise in the interventions. RESULTS: At baseline, participants had maximal oxygen consumption (VO (2max)) of 2.9 [standard deviation (SD) 0.7L/min] and body mass index (BMI......) of 28.3 (SD 4.7). Compared to representative data on employees in Denmark (N=78), this study population (N=67) had significantly lower relative aerobic capacity [difference in z-score -1.13 (SE 0.1), P...

  18. Computer-Assisted Dieting: Effects of a Randomized Nutrition Intervention

    Science.gov (United States)

    Schroder, Kerstin E. E.

    2011-01-01

    Objectives: To compare the effects of a computer-assisted dieting intervention (CAD) with and without self-management training on dieting among 55 overweight and obese adults. Methods: Random assignment to a single-session nutrition intervention (CAD-only) or a combined CAD plus self-management group intervention (CADG). Dependent variables were…

  19. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    Science.gov (United States)

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  20. Effects of a 12-week healthy-life exercise program on oxidized low-density lipoprotein cholesterol and carotid intima-media thickness in obese elderly women

    OpenAIRE

    Park, Jong-Hwan; Park, Hyuntae; Lim, Seung-Taek; Park, Jin-Kee

    2015-01-01

    [Purpose] This study examined the effects of a 12-week exercise program on plasma level of oxidized low-density lipoprotein cholesterol in obese elderly women, who are at increased risk of heart disease morbidity. [Subjects and Methods] Twenty participants were assigned into either a control (n = 10) or a supervised exercise program (n = 10) group. The 12-week exercise intervention was performed 3 days per week and involved combined aerobic exercise, resistance exercise, and traditional Korea...

  1. De-Escalation Strategies in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (BC): Final Analysis of the West German Study Group Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early BC HER2- and Hormone Receptor-Positive Phase II Randomized Trial-Efficacy, Safety, and Predictive Markers for 12 Weeks of Neoadjuvant Trastuzumab Emtansine With or Without Endocrine Therapy (ET) Versus Trastuzumab Plus ET.

    Science.gov (United States)

    Harbeck, Nadia; Gluz, Oleg; Christgen, Matthias; Kates, Ronald Ernest; Braun, Michael; Küemmel, Sherko; Schumacher, Claudia; Potenberg, Jochem; Kraemer, Stefan; Kleine-Tebbe, Anke; Augustin, Doris; Aktas, Bahriye; Forstbauer, Helmut; Tio, Joke; von Schumann, Raquel; Liedtke, Cornelia; Grischke, Eva-Maria; Schumacher, Johannes; Wuerstlein, Rachel; Kreipe, Hans Heinrich; Nitz, Ulrike Anneliese

    2017-09-10

    Purpose Human epidermal growth factor receptor 2 (HER2)-positive/hormone receptor (HR)-positive breast cancer is a distinct subgroup associated with lower chemotherapy sensitivity and slightly better outcome than HER2-positive/HR-negative disease. Little is known about the efficacy of the combination of endocrine therapy (ET) with trastuzumab or with the potent antibody-cytotoxic, anti-HER2 compound trastuzumab emtansine (T-DM1) with or without ET for this subgroup. The West German Study Group trial, ADAPT (Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer) compares pathologic complete response (pCR) rates of T-DM1 versus trastuzumab with ET in early HER2-positive/HR-positive breast cancer. Patients and Methods In this prospective, neoadjuvant, phase II trial, 375 patients with early breast cancer with HER2-positive and HR-positive status (n = 463 screened) were randomly assigned to 12 weeks of T-DM1 with or without ET or to trastuzumab with ET. The primary end point was pCR (ypT0/is/ypN0). Early response was assessed in 3-week post-therapeutic core biopsies (proliferation decrease ≥ 30% Ki-67 or cellularity response). Secondary end points included safety and predictive impact of early response on pCR. Adjuvant therapy followed national standards. Results Baseline characteristics were well balanced among the arms. More than 90% of patients completed the therapy per protocol. pCR was observed in 41.0% of patients treated with T-DM1, 41.5% of patients treated with T-DM1 and ET, and 15.1% with trastuzumab and ET ( P < .001). Early responders (67% of patients with assessable response) achieved pCR in 35.7% compared with 19.8% in nonresponders (odds ratio, 2.2; 95% CI, 1.24 to 4.19). T-DM1 was associated with a significantly higher prevalence of grade 1 to 2 toxicities, especially thrombocytopenia, nausea, and elevation of liver enzymes. Overall toxicity was low; seventeen

  2. Impact of an integrated intervention program on atorvastatin adherence: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Goswami NJ

    2013-07-01

    Full Text Available Nilesh J Goswami,1 Mitch DeKoven,2 Andreas Kuznik,3 Jack Mardekian,3 Michelle R Krukas,2 Larry Z Liu,3,4 Patrick Bailey,1 Cynthia Deitrick,5 John Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfizer Inc, New York, NY, USA; 4Weill Cornell Medical College, Cornell University, New York, NY, USA; 5Prairie Heart Education and Research Cooperative, Springfield, IL, USA Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment. Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm. After data linkage, 53 control patients and 155 intervention patients were included in the analysis. Results: Mean age was 67.8 years (control and 69.5 years (intervention; 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day; for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24 and for the intervention group was 0.84 (SD, 0.22. For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2 compared with 150.9 days

  3. Effects of 12-week high-intensity interval training on plasma visfatin concentration and insulin resistance in overweight men

    Directory of Open Access Journals (Sweden)

    Hasan Matinhomaee

    2014-06-01

    Full Text Available The purpose of this study was to determine the effects of 12 weeks of high-intensity interval training (HIIT on visfatin and insulin resistance (IR in overweight adult men during a weight-loss program. Eighteen overweight men (age = 31.8 ± 9.2 years; body mass index = 28.6 ± 1.4 kg/m2 were randomly recruited into one of the two groups, namely, HIIT (3 days/week, 20 minutes/day; 85–95% peak oxygen uptake and diet-induced weight-loss combined (DHIIT; n = 10 and diet-induced weight loss only (DIO; n = 8. The DHIIT and DIO groups undertook a 12-week weight-loss intervention using a moderate isocaloric energy-deficit diet. Both DHIIT and DIO groups demonstrated a significant reduction in body weight (p < 0.01. Total fat mass (p < 0.05 and lean body mass (p < 0.05 were decreased in the DIO group with no significant changes in abdominal fat mass, plasma insulin concentration, homeostasis model assessment-estimated IR (HOMA-IR, blood glucose level, and plasma visfatin. In the DHIIT group, total fat mass (p < 0.01, abdominal fat mass (p < 0.05, plasma insulin concentration (p < 0.05, plasma visfatin (p < 0.01, and HOMA-IR (p < 0.05 were reduced and lean body mass remained unchanged. In conclusion, adding a low-volume 20-minute HIIT (three times/week to an energy-deficit diet not only can improve the efficiency of weight-loss program in the reduction of body fat, plasma visfatin levels, and HOMA-IR, but also has a reservation effect on lean body mass.

  4. Clinical pharmacology study of cariprazine (MP-214) in patients with schizophrenia (12-week treatment)

    Science.gov (United States)

    Nakamura, Tadakatsu; Kubota, Tomoko; Iwakaji, Atsushi; Imada, Masayoshi; Kapás, Margit; Morio, Yasunori

    2016-01-01

    Purpose Cariprazine is a potent dopamine D3-preferring D3/D2 receptor partial agonist in development for the treatment of schizophrenia, bipolar mania, and depression. Pharmacokinetics of cariprazine and the two clinically relevant metabolites (desmethyl- and didesmethyl-cariprazine) was evaluated in a clinical pharmacology study. Methods This was a multicenter, randomized, open-label, parallel-group, fixed-dose (3, 6, or 9 mg/day) study of 28-week duration (≤4-week observation, 12-week open-label treatment, and 12-week follow-up). Once-daily cariprazine was administered to 38 adult patients with schizophrenia. The pharmacokinetics of cariprazine, metabolites, and total active moieties (sum of cariprazine and two metabolites) was evaluated; efficacy and safety were also assessed. Results Steady state was reached within 1–2 weeks for cariprazine and desmethyl-cariprazine, 4 weeks for didesmethyl-cariprazine, and 3 weeks for total active moieties. Cariprazine and desmethyl-cariprazine levels decreased >90% within 1 week after the last dose, didesmethyl-cariprazine decreased ~50% at 1 week, and total active moieties decreased ~90% within 4 weeks. Terminal half-lives of cariprazine, desmethyl-cariprazine, and didesmethyl-cariprazine ranged from 31.6 to 68.4, 29.7 to 37.5, and 314 to 446 hours, respectively. Effective half-life (calculated from time to steady state) of total active moieties was ~1 week. Incidence of treatment-emergent adverse events was 97.4%; 15.8% of patients discontinued due to adverse events. No abnormal laboratory values or major differences from baseline in extrapyramidal symptoms were observed. Conclusion Cariprazine and its active metabolites reached steady state within 4 weeks, and exposure was dose proportional over the range of 3–9 mg/day. Once-daily cariprazine was generally well tolerated in adult patients with schizophrenia. PMID:26834462

  5. Stimulant Reduction Intervention using Dosed Exercise (STRIDE - CTN 0037: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Morris David W

    2011-09-01

    Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions

  6. Changes in physical activity and sedentary behavior in a randomized trial of an internet-based versus workbook-based family intervention study.

    Science.gov (United States)

    Catenacci, Victoria A; Barrett, Christopher; Odgen, Lorraine; Browning, Ray; Schaefer, Christine Adele; Hill, James; Wyatt, Holly

    2014-02-01

    The America on the Move (AOM) Family Intervention Program has been shown to prevent excess weight gain in overweight children. Providing intervention materials via the internet would have the potential to reach more families but may increase sedentary behavior. The purpose was to evaluate whether delivering the AOM Family Intervention via the internet versus printed workbook would have a similar impact on sedentary behaviors in children. 131 children (age 8-12) were randomized to receive the AOM Family Intervention via the internet or workbook for 12 weeks. Changes in objectively measured sedentary time and moderate-to vigorous physical activity (MVPA) as well as self-reported screen time were compared between groups. There were no significant differences between groups in screen time, sedentary time, or MVPA at the end of the 12 week intervention. Families receiving the intervention via the internet were more likely to remain in the study (98% vs. 82%, P = .016). Using the internet to deliver the lifestyle intervention did not increase sedentary behavior in children. Attrition rates were lower when the program was delivered by internet versus via printed materials. These results provide support for using the internet to deliver healthy lifestyle programs for children.

  7. The effects of a pedometer-based intervention on first-year university students: A randomized control trial.

    Science.gov (United States)

    Sharp, Paul; Caperchione, Cristina

    2016-01-01

    To assess the effects of a 12-week pedometer-based intervention on the physical activity behavior, health-related quality of life (HRQOL), and psychological well-being of first-year university students. First-year university students (N = 184) were recruited during September 2012 and randomly assigned to an intervention or a control group. Intervention participants were provided with a pedometer, monthly tracking logs, and follow-up e-mails. Control participants received no intervention. Physical activity, HRQOL, and psychological well-being were measured at baseline and post intervention. Data were analyzed using multivariate/univariate analysis of variance (MANOVA/ANOVA). All participants experienced an increase in mild physical activity (p < .01) from baseline to follow-up. The intervention failed to produce significant differences between groups for physical activity (p = .28), HRQOL (p = .80), or psychological well-being (p = .72). Psychological well-being (p < .001), vigorous physical activity (p = .04), and mental health status (p < .001) decreased across the duration of the study. More intensive interventions may be required to elicit physical activity behavior change.

  8. Evaluation of effects of nutrition intervention on healing of pressure ulcers and nutritional states (randomized controlled trial).

    Science.gov (United States)

    Ohura, Takehiko; Nakajo, Toshio; Okada, Shingo; Omura, Kenji; Adachi, Kayoko

    2011-01-01

    The objective of this study was to evaluate the effects of nutrition intervention on nutritional states and healing of pressure ulcers by standardizing or unified factors including nursing, care and treatment in a multicenter open randomized trial. Tube-fed patients with Stage III-IV pressure ulcers were selected. The control group (30 patients) received the same nutrition management as before participating in this trial, whereas the intervention group (30 patients) was given calories in the range of Basal Energy Expenditure (BEE) × 1.1 × 1.3 to 1.5. The intervention period was 12 weeks. The efficacy and safety were evaluated based on the nutritional states and the sizes of ulcers (length × width), and on the incidence of adverse events related to the study, respectively. The calories administered to the control and intervention groups were 29.1 ± 4.9 and 37.9 ± 6.5 kcal/kg/day, respectively. Significant interactions between the presence or absence of the intervention and the intervention period were noted for nutritional states (pnutrition intervention could directly enhance the healing process in pressure ulcer patients.

  9. Improved glycemic control with no weight increase in patients with type 2 diabetes after once-daily treatment with the long-acting glucagon-like peptide 1 analog liraglutide (NN2211): a 12-week, double-blind, randomized, controlled trial

    DEFF Research Database (Denmark)

    Madsbad, Sten; Schmitz, Ole; Ranstam, Jonas

    2004-01-01

    -group, placebo-controlled trial with an open-label comparator arm was conducted among 193 outpatients with type 2 diabetes. The mean age was 56.6 years and the mean HbA(1c) was 7.6% across the treatment groups. Patients were randomly assigned to one of five fixed-dosage groups of liraglutide (0.045, 0.225, 0....... Patients treated with glimepiride had decreased HbA(1c) and fasting glucose, but slightly increased body weight. No safety issues were raised for liraglutide; observed adverse events were mild and transient. CONCLUSIONS: A once-daily dose of liraglutide provides efficacious glycemic control...

  10. The Comparison between Effects of 12 weeks Combined Training and Vitamin D Supplement on Improvement of Sensory-motor Neuropathy in type 2 Diabetic Women

    Directory of Open Access Journals (Sweden)

    Maryam Nadi

    2017-01-01

    Full Text Available Background: Peripheral neuropathy is a common complaint of diabetes. This study aimed to determine the effects of 12 weeks combined training with Vitamin D supplement on improvement of sensory-motor neuropathy in women with diabetic neuropathy. Materials and Methods: This clinical trial study conducted on 90 patients were selected and randomly divided into two groups. Finally, 81 adult females with diabetes type II (20–55 years old were interred in this study. The control group had no training, but received Vitamin D. The experimental group received Vitamin D and 12 weeks training program (3 days a week, 60 min/session including aerobic exercises, strength, and flexibility. Aerobic exercise intensity was set at 60–70% maximum heart rate and resistance training intensity was determined by 10 R.M. Michigan neuropathy questionnaire, reflex hammer and tuning fork 128 Hz used to screening tense of neuropathy (Michigan Neuropathy Screening Instrument that were used for pretest and posttest. Results: Following 3 months combined training and supplementation with Vitamin D, had observed a significant reduction in numbness (P = 0.001, pain (0.002, tingling (P = 0.001, and weakness (P = 0.002 in the lower limb and also increases in sense of touch intervention (P = 0.005, detects the position of the fingers (P = 0.001 and vibration perception (P = 0.001 in tissues. Knee reflexes (P = 0.77 and ankles reflexes (P = 0.47 did not significantly change after interventions. Conclusion: It seems that taking part in combined training and supplementation with Vitamin D can improve the symptoms of sensory-motor neuropathy.

  11. Analyzing randomized controlled interventions: Three notes for applied linguists

    Directory of Open Access Journals (Sweden)

    Jan Vanhove

    2015-01-01

    Full Text Available I discuss three common practices that obfuscate or invalidate the statistical analysis of randomized controlled interventions in applied linguistics. These are (a checking whether randomization produced groups that are balanced on a number of possibly relevant covariates, (b using repeated measures ANOVA to analyze pretest-posttest designs, and (c using traditional significance tests to analyze interventions in which whole groups were assigned to the conditions (cluster randomization. The first practice is labeled superfluous, and taking full advantage of important covariates regardless of balance is recommended. The second is needlessly complicated, and analysis of covariance is recommended as a more powerful alternative. The third produces dramatic inferential errors, which are largely, though not entirely, avoided when mixed-effects modeling is used. This discussion is geared towards applied linguists who need to design, analyze, or assess intervention studies or other randomized controlled trials. Statistical formalism is kept to a minimum throughout.

  12. Effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in type 2 diabetes mellitus patients.

    Science.gov (United States)

    Kang, Seol-Jung; Ko, Kwang-Jun; Baek, Un-Hyo

    2016-07-01

    [Purpose] This study evaluated the effects of 12 weeks combined aerobic and resistance exercise on heart rate variability in patients with Type 2 diabetes mellitus. [Subjects and Methods] The subjects were 16 female patients with Type 2 diabetes mellitus selected among the participants of a chronic disease management exercise class at C Region Public Health Center in South Korea. Subjects were randomly assigned to the exercise group (n=8; age, 55.97 ± 7.37) or the control group (n=8; age, 57.53 ± 4.63) The exercise group performed aerobic and resistance exercises for 60 minutes per day, 3 times per week for 12 weeks. Anthropometric measurements, biochemical markers, physical fitness, and heart rate variability were examined. [Results] After 12 weeks of exercise, weight, body fat percentage, waist circumference, blood glucose, insulin resistance, glycated hemoglobin level, systolic blood pressure, and diastolic blood pressure significantly decreased and cardiorespiratory fitness and muscular strength significantly increased in the exercise group. Although heart rate variability measures showed favorable changes with the exercise program, none were significant. [Conclusion] Although the exercise program did not show notable changes in heart rate variability in patients with Type 2 diabetes within the timeframe of the study, exercise may contribute to the prevention and control of cardiovascular autonomic neuropathy.

  13. The effect of 12-week Pilates exercises on wellness in the elderly.

    Science.gov (United States)

    Roh, Su Yeon

    2016-04-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, PPilates exercises helped improve wellness of the elderly.

  14. The effect of 12-week Pilates exercises on wellness in the elderly

    OpenAIRE

    Roh, Su Yeon

    2016-01-01

    The purpose of this study is to examine the efficiency of 12-week Pilates exercises on wellness in the elderly. Before Pilates exercises training, the 88 elderly (63 females, 25 males) were given and completed a Wellness Scale. Then, the elderly participated in Pilates exercises and completed the same scale afterwards. Results of paired t-test showed that participants in 12-week Pilates exercises experienced significant improvement in physical (t=2.762, P

  15. Evaluating Changes in Omega-3 Fatty Acid Intake after Receiving Personal FADS1 Genetic Information: A Randomized Nutrigenetic Intervention.

    Science.gov (United States)

    Roke, Kaitlin; Walton, Kathryn; Klingel, Shannon L; Harnett, Amber; Subedi, Sanjeena; Haines, Jess; Mutch, David M

    2017-03-06

    Nutrigenetics research is anticipated to lay the foundation for personalized dietary recommendations; however, it remains unclear if providing individuals with their personal genetic information changes dietary behaviors. Our objective was to evaluate if providing information for a common variant in the fatty acid desaturase 1 (FADS1) gene changed omega-3 fatty acid (FA) intake and blood levels in young female adults (18-25 years). Participants were randomized into Genetic (intervention) and Non-Genetic (control) groups, with measurements taken at Baseline and Final (12 weeks). Dietary intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) was assessed using an omega-3 food frequency questionnaire. Red blood cell (RBC) FA content was quantified by gas chromatography. Implications of participation in a nutrigenetics study and awareness of omega-3 FAs were assessed with online questionnaires. Upon completion of the study, EPA and DHA intake increased significantly (p = 1.0 × 10(-4)) in all participants. This change was reflected by small increases in RBC %EPA. Participants in the Genetic group showed increased awareness of omega-3 terminology by the end of the study, reported that the dietary recommendations were more useful, and rated cost as a barrier to omega-3 consumption less often than those in the Non-Genetic group. Providing participants FADS1 genetic information did not appear to influence omega-3 intake during the 12 weeks, but did change perceptions and behaviors related to omega-3 FAs in this timeframe.

  16. A 12-week interdisciplinary rehabilitation trial in patients with gliomas – a feasibility study

    DEFF Research Database (Denmark)

    Hansen, Anders; Søgaard, Karen; Minet, Lisbeth Rosenbek

    2017-01-01

    %) was achieved at part one. However, the failure to meet predefined feasibility objectives of drop-out, adherence and patient satisfaction of the unsupervised intervention at part two have led to a protocol revision for a future randomized controlled trial. CONCLUSION: This study demonstrates that an intensive...... limitations in physical functioning, cognition, and emotional wellbeing. In a relatively small sample this study shows that supervised physical- and occupational therapy in patients with gliomas is safe and feasible in the initial treatment phase. Patients with gliomas can potentially improve functioning......PURPOSE: This report aims to assess the safety and feasibility of using an interdisciplinary rehabilitation intervention for a future randomized controlled trial in patients with gliomas in the initial treatment phase. METHOD: We conducted an outpatient two-part rehabilitation intervention...

  17. Exercise and quality of life in patients with cystic fibrosis: A 12-week intervention study

    DEFF Research Database (Denmark)

    Schmidt, Anne Mette; Jacobsen, Ulla; Bregnballe, Vibeke

    2011-01-01

    no significant change in total QoL score. However, the scores in the domain of treatment burden and emotional functioning increased significantly. There was no significant difference in QoL and lung function between patients participating in the exercise programme (n = 24) and non-participants (n = 14). A 12...

  18. NSAID Use after Bariatric Surgery: a Randomized Controlled Intervention Study.

    Science.gov (United States)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N

    2016-12-01

    Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID use in patients who underwent bariatric surgery, and to determine the use of PPIs in patients who use NSAIDs after bariatric surgery. A randomized controlled intervention study in patients after bariatric surgery. Patients were randomized to an intervention or a control group. The intervention consisted of sending a letter to patients and their general practitioners on the risks of use of NSAIDs after bariatric surgery and the importance of avoiding NSAID use. The control group received care-as-usual. Dispensing data of NSAIDs and PPIs were collected from patients' pharmacies: from a period of 6 months before and from 3 until 9 months after the intervention. Two hundred forty-eight patients were included (intervention group: 124; control group: 124). The number of users of NSAIDs decreased from 22 to 18 % in the intervention group and increased from 20 to 21 % in the control group (NS). The use of a PPI with an NSAID rose from 52 to 55 % in the intervention group, and from 52 to 69 % in the control group (NS). Informing patients and their general practitioners by letter, in addition to care-as-usual, is not an effective intervention to reduce the use of NSAIDs after bariatric surgery (trial number NTR3665).

  19. Self-presentation in exercise: changes over a 12-week cardiovascular programme for overweight and obese sedentary females.

    Science.gov (United States)

    Pearson, Erin S; Hall, Craig R; Gammage, Kimberley L

    2013-01-01

    Self-presentational concerns, shown to influence exercise-related cognitions and behaviours, are evaluated frequently in the absence of exercise or following a single bout of physical activity. The purpose of the present study was to examine longitudinally, the extent to which participating in a structured 12-week cardiovascular exercise intervention elicited changes in self-presentational efficacy expectancy (SPEE) and social physique anxiety (SPA). Participants were 80 sedentary women with overweight or obesity (mean body mass index 29.02 kg/m(2), SD=4.71) between the ages of 19 and 45 wanting to begin an exercise programme (mean age 33.4 years, SD=7.6). The Self-Presentational Efficacy Scale (SPES) and the Social Physique Anxiety Scale (SPAS) were completed by each participant prior to commencing the study, and at the 6- and 12-week time points. For those who completed the programme, repeated measures ANOVAs indicated significant increases in SPEE between baseline and week 6 (Pcorrelation analyses revealed that length of participation in the study was positively related to SPEE and negatively related to SPA. Implications of focusing on these variables within a physical activity intervention are discussed with respect to exercise behaviour, programme development and adherence.

  20. Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    John O Younge

    Full Text Available Evidence is accumulating that mindfulness training has favorable effects on psychological outcomes, but studies on physiological outcomes are limited. Patients with heart disease have a high incidence of physiological and psychological problems and may benefit from mindfulness training. Our aim was to determine the beneficial physiological and psychological effects of online mindfulness training in patients with heart disease.The study was a pragmatic randomized controlled single-blind trial. Between June 2012 and April 2014 we randomized 324 patients (mean age 43.2 years, 53.7% male with heart disease in a 2:1 ratio (n = 215 versus n = 109 to a 12-week online mindfulness training in addition to usual care (UC compared to UC alone. The primary outcome was exercise capacity measured with the 6 minute walk test (6MWT. Secondary outcomes were other physiological parameters (heart rate, blood pressure, respiratory rate, and NT-proBNP, subjective health status (SF-36, perceived stress (PSS, psychological well-being (HADS, social support (PSSS12 and a composite endpoint (all-cause mortality, heart failure, symptomatic arrhythmia, cardiac surgery, and percutaneous cardiac intervention. Linear mixed models were used to evaluate differences between groups on the repeated outcome measures.Compared to UC, mindfulness showed a borderline significant improved 6MWT (effect size, meters: 13.2, 95%CI: -0.02; 26.4, p = 0.050. There was also a significant lower heart rate in favor of the mindfulness group (effect size, beats per minute: -2.8, 95%CI: -5.4;-0.2, p = 0.033. No significant differences were seen on other outcomes.Mindfulness training showed positive effects on the physiological parameters exercise capacity and heart rate and it might therefore be a useful adjunct to current clinical therapy in patients with heart disease.Dutch Trial Register 3453.

  1. Simeprevir plus sofosbuvir for eight or 12 weeks in treatment-naïve and treatment-experienced hepatitis C virus genotype 4 patients with or without cirrhosis.

    Science.gov (United States)

    El Raziky, M; Gamil, M; Ashour, M K; Sameea, E A; Doss, W; Hamada, Y; Van Dooren, G; DeMasi, R; Keim, S; Lonjon-Domanec, I; Hammad, R; Hashim, M S; Hassany, M; Waked, I

    2017-02-01

    The OSIRIS study investigated efficacy and safety of simeprevir plus sofosbuvir for eight or 12 weeks in hepatitis C virus (HCV) genotype 4-infected patients with METAVIR F0-F4 fibrosis. Sixty-three patients (33 treatment-naïve and 30 peg-interferon/ribavirin (Peg-IFN/RBV)-experienced) enrolled in a partly randomized, open-label, multicentre, phase IIa study. Patients with F0-F3 fibrosis were randomized (1:1) into two groups (A1 and A2), stratified according to treatment experience and METAVIR score, to receive either eight weeks (Group A1, n=20) or 12 weeks (Group A2, n=20) of treatment. Patients with compensated cirrhosis (METAVIR F4) received 12 weeks of treatment (Group B, n=23). Treatment comprised simeprevir 150 mg and sofosbuvir 400 mg daily. The primary efficacy endpoint was sustained virologic response 12 weeks after planned end of treatment (SVR12). Safety and tolerability were assessed throughout. Overall, 92% (95% CI: 82-97) of patients achieved SVR12; 75% (15/20) in Group A1 and 100% in groups A2 and B. Patients who did not achieve SVR12 (n=5) experienced viral relapse during the first 32 days following treatment and were all prior Peg-IFN/RBV null responders. The most commonly reported treatment-emergent adverse events (TEAEs) were asymptomatic lipase increase (14%), pruritus (14%), headache (13%) and hyperbilirubinaemia (11%). No patients discontinued due to TEAEs. In conclusion, simeprevir plus sofosbuvir for 12 weeks achieved a 100% SVR rate in HCV genotype 4-infected patients with or without compensated cirrhosis (ClinicalTrials.gov: NCT02278419). The AE and laboratory profile were favourable and consistent with previous data for simeprevir plus sofosbuvir in eight- and 12-week regimens.

  2. Effect of physical activity intervention based on a pedometer on physical activity level and anthropometric measures after childbirth: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Maturi Masumeh S

    2011-12-01

    Full Text Available Abstract Background Pregnancy and childbirth are associated with weight gain in women, and retention of weight gained during pregnancy can lead to obesity in later life. Diet and physical activity are factors that can influence the loss of retained pregnancy weight after birth. Exercise guidelines exist for pregnancy, but recommendations for exercise after childbirth are virtually nonexistent. The aim of this study was to evaluate the effect of physical activity intervention based on pedometer on physical activity level and anthropometric measures of women after childbirth. Methods We conducted a randomized controlled trial in which 66 women who had given birth 6 weeks to 6 months prior were randomly assigned to receive either a 12 week tailored program encouraging increased walking using a pedometer (intervention group, n = 32 or routine postpartum care (control group, n = 34. During the 12-week study period, each woman in the intervention group wore a pedometer and recorded her daily step count. The women were advised to increase their steps by 500 per week until they achieved the first target of 5000 steps per day and then continued to increase it to minimum of 10,000 steps per day by the end of 12th week. Assessed outcomes included anthropometric measures, physical activity level, and energy expenditure per week. Data were analyzed using the paired t-test, independent t-test, Mann-Whitney, chi-square, Wilcoxon, covariance analysis, and the general linear model repeated measures procedure as appropriate. Results After 12 weeks, women in the intervention group had significantly increased their physical activity and energy expenditure per week (4394 vs. 1651 calorie, p P = 0.001, Body Mass Index (P = 0.001, waist circumference (P = 0.001, hip circumference (P = 0.032 and waist-hip ratio (P = 0.02 were presented after the intervention. The intervention group significantly increased their mean daily step count over the study period (from 3249

  3. Inadequate description of educational interventions in ongoing randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Pino Cécile

    2012-05-01

    Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63

  4. Myogenic response of human skeletal muscle to 12 weeks of resistance training at light loading intensity

    DEFF Research Database (Denmark)

    Mackey, Abigail; Holm, L; Reitelseder, S

    2011-01-01

    There is strong evidence for enhanced numbers of satellite cells with heavy resistance training. The satellite cell response to very light muscle loading is, however, unknown. We, therefore, designed a 12-week training protocol where volunteers trained one leg with a high load (H) and the other leg....... A significant main effect of time was observed (Pinduce an increase in the number of satellite...

  5. The response of the lactate minimum test to a 12-week swimming training

    DEFF Research Database (Denmark)

    Campos, Eduardo Zapaterra; Nordsborg, Nikolai Baastrup; Da Silva, Adelino Sanchez Ramos

    2014-01-01

    Despite the utilization of lactate minimum test (LMT) in training, its intensity response to training remains controversial. The aim of the present study was to verify alterations of LMT intensity in swimmers during a 12-week training protocol. Eight swimmers were submitted to three LMT assessmen...

  6. Does 12-Week Latin Dance Training Affect the Self-Confidence of the University Students?

    Science.gov (United States)

    Meric, Odemis; Ilhan, Adilogullari

    2016-01-01

    In this research, it is aimed to investigate the effect of 12-week Latin dance training on the self-confidence of university students. This research was conducted with a total of 60 students, including 30 students as control and 30 students as the working group. A 33-item self-confidence scale developed by Akin (2007) was applied to both control…

  7. Effects of cognitive and skilled rehabilitative training on deficiencies of theory of mind in patients with traumatic brain injury: A 12-week random, single-blind clinical trial%脑外伤患者心理推理能力缺陷的认知性和技巧性干预:一项12周随机单盲对照试验

    Institute of Scientific and Technical Information of China (English)

    张登科; 徐水琴; 苏巧荣; 潘一楠; 沈雪艳; 陈三妹; 葛建荣; 单兴尧

    2012-01-01

    cognitive and skilled rehabilitative training on theory of mind and social function deficiencies in traumatic brain injury patients. Methods: Totally 90 brain injury patients who were injured six or more months ago and whose condition was stable were selected. They were randomly assigned into cognitive intervention group (n = 30), skilled intervention group (n = 30) and control group ( n = 30). The cognitive intervention group received the cognitive orientated training focused on their real life behaviors, including life events discussing, contextual play and home works. The skill intervention group received the training focused on their examination skills, including the theory of mind stories comprehension, graph comprehension. The control group received normal outpatient follow-up health services. The classic Theory of Mind Tasks, Family Member Evaluated Scale of Theory of Mind in Traumatic Brain Injuries and Social Disability Screening Schedule (SDSS) were used to access the subjects' theory of mind and social function before and after intervention, and 3 months after intervention. Results: Before intervention, there was no significant difference between the three groups on all scores. After intervention, both intervention groups had higher scores of theory of mind classic tasks [ (14. 7 ±1. 3), (15. 2 ± 1. 7) vs. (12. 5 ± 1. 6), P 0. 05). Three months after the intervention, both intervention groups had higher scores of theory of mind classic tasks [ (16. 5 ± 1. 4), (15. 9 ± 1. 2) vs. (13. 3 ± 1. 5), P <0. 05] and family evaluated scale [ (146. 6 ± 15. 7), (134. 5 ± 14. 6) vs. (115. 8 ± 21. 2), P < 0. 05] than the control group, and their SDSS scores were lower than control group [(7. 1 ± 1. 2), (8. 0 ±0. 9) vs. (11.4 ±0. 8), P <0.05]. The scores of family evaluated scale was higher in the cognitive intervention group than in the skill intervention group [(146. 6 ± 15. 7) vs. (134. 5 ± 14. 6), P <0.05], the SDSS scores was lower in the cognitive

  8. 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

  9. Effect of a 12-week yoga therapy program on mental health status in elderly women inmates of a hospice

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    Ramanathan, Meena; Bhavanani, Ananda Balayogi; Trakroo, Madanmohan

    2017-01-01

    Aim and Objectives: This study was undertaken to evaluate the effectiveness of yoga on the mental health status of elderly women inmates residing in a hospice in Puducherry. Materials and Methods: Forty elderly women were randomly divided into yoga and wait-listed control group. A yoga therapy program of 60 min was given twice a week for 12 weeks. This protocol was specially designed for senior citizens, keeping in mind their health status and physical limitations that included simple warm-up and breath-body movement coordination practices (jathis and kriyas), static stretching postures (asanas), breathing techniques (pranayamas), and relaxation. Hamilton anxiety scale for measuring anxiety, Hamilton rating scale for depression, and Rosenberg self-esteem scale to measure self-esteem were administered to both groups before and after the 12-week study period. Data were assessed for normality, and appropriate parametric and nonparametric statistical methods were applied for intra- and inter-group comparisons. Results: Overall, intra- and inter-group comparison of prepost data showed statistically significant (P negative thoughts, and give them a sense of purpose and hope. PMID:28149064

  10. The impact of a 12-week resistance training program on strength, body composition, and self-concept of Hispanic adolescents.

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    Velez, Amelia; Golem, Devon L; Arent, Shawn M

    2010-04-01

    Current evidence suggests that a resistance training program may be physically and psychologically beneficial for adolescents. The purpose of this study was to examine the effects of a structured resistance training program on strength, body composition, and self-concept in normal and overweight Hispanic adolescents. Male and female participants (n = 28; 16.1 +/- 0.2 y; 164.5 +/- 1.4 cm; 63.3 +/- 2.5 kg; 20.0 +/- 1.7% body fat [BF]) were recruited from a predominantly Hispanic high school. Prior to the 12-week program, strength, body composition, and self-concept were assessed. Subjects were randomly assigned to a control group (CON; n = 15) or to a resistance training group (RT; n = 13) that participated in supervised strength training 3 days/week. All measures were repeated at the end of the 12-week program. RT had significantly greater strength increases for bench press (p training resulted in significant physiological and psychological improvements in Hispanic adolescents compared to typical school-based activities. These findings indicate that resistance training can be incorporated into the activities of Hispanic adolescents to promote improved health and fitness.

  11. An Interactive Text Message Intervention to Reduce Binge Drinking in Young Adults: A Randomized Controlled Trial with 9-Month Outcomes.

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    Brian Suffoletto

    Full Text Available Binge drinking is associated with numerous negative consequences. The prevalence and intensity of binge drinking is highest among young adults. This randomized trial tested the efficacy of a 12-week interactive text message intervention to reduce binge drinking up to 6 months after intervention completion among young adults.Young adult participants (18-25 y; n = 765 drinking above the low-risk limits (AUDIT-C score >3/4 women/men, but not seeking alcohol treatment, were enrolled from 4 Emergency Departments (EDs in Pittsburgh, PA. Participants were randomized to one of three conditions in a 2:1:1 allocation ratio: SMS Assessments + Feedback (SA+F, SMS Assessments (SA, or control. For 12 weeks, SA+F participants received texts each Thursday querying weekend drinking plans and prompting drinking limit goal commitment and each Sunday querying weekend drinking quantity. SA+F participants received tailored feedback based on their text responses. To contrast the effects of SA+F with self-monitoring, SA participants received texts on Sundays querying drinking quantity, but did not receive alcohol-specific feedback. The control arm received standard care. Follow-up outcome data collected through web-based surveys were provided by 78% of participants at 3- months, 63% at 6-months and 55% at 9-months. Multiple imputation-derived, intent-to-treat models were used for primary analysis. At 9-months, participants in the SA+F group reported greater reductions in the number of binge drinking days than participants in the control group (incident rate ratio [IRR] 0.69; 95% CI .59 to.79, lower binge drinking prevalence (odds ratio [OR] 0.52; 95% CI 0.26 to 0.98], less drinks per drinking day (beta -.62; 95% CI -1.10 to -0.15 and lower alcohol-related injury prevalence (OR 0.42; 95% CI 0.21 to 0.88. Participants in the SA group did not reduce drinking or alcohol-related injury relative to controls. Findings were similar using complete case analyses.An interactive

  12. A Systematic Review and Meta-Analysis Estimating the Expected Dropout Rates in Randomized Controlled Trials on Yoga Interventions

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    Holger Cramer

    2016-01-01

    Full Text Available A reasonable estimation of expected dropout rates is vital for adequate sample size calculations in randomized controlled trials (RCTs. Underestimating expected dropouts rates increases the risk of false negative results while overestimating rates results in overly large sample sizes, raising both ethical and economic issues. To estimate expected dropout rates in RCTs on yoga interventions, MEDLINE/PubMed, Scopus, IndMED, and the Cochrane Library were searched through February 2014; a total of 168 RCTs were meta-analyzed. Overall dropout rate was 11.42% (95% confidence interval [CI] = 10.11%, 12.73% in the yoga groups; rates were comparable in usual care and psychological control groups and were slightly higher in exercise control groups (rate = 14.53%; 95% CI = 11.56%, 17.50%; odds ratio = 0.82; 95% CI = 0.68, 0.98; p=0.03. For RCTs with durations above 12 weeks, dropout rates in yoga groups increased to 15.23% (95% CI = 11.79%, 18.68%. The upper border of 95% CIs for dropout rates commonly was below 20% regardless of study origin, health condition, gender, age groups, and intervention characteristics; however, it exceeded 40% for studies on HIV patients or heterogeneous age groups. In conclusion, dropout rates can be expected to be less than 15 to 20% for most RCTs on yoga interventions. Yet dropout rates beyond 40% are possible depending on the participants’ sociodemographic and health condition.

  13. A Randomized-Controlled Trial of School-Based Active Videogame Intervention on Chinese Children's Aerobic Fitness, Physical Activity Level, and Psychological Correlates.

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    Lau, Patrick Wing Chung; Wang, Jing Jing; Maddison, Ralph

    2016-12-01

    Active videogames (AVGs) that require body movements to play offer a novel opportunity to turn a traditionally sedentary behavior into a physically active one. We sought to determine the effect of a school-based AVG intervention on Chinese children's aerobic fitness, physical activity (PA) level, and PA-related psychological correlates. Eighty 8-11-year-old Chinese children (55 males) were recruited from one Hong Kong primary school and were allocated at random to either an AVG intervention or control group. Children in the intervention group played an AVG, Xbox 360, twice per week during after-school hours, each for 60 minutes over 12 weeks in duration. The control group received no intervention. Children's body-mass index (BMI), objective PA, aerobic fitness (maximum oxygen consumption [VO2max]), PA task efficacy, barrier efficacy, and enjoyment were assessed. Compared with the control group, significant increases were found in the intervention group in VO2max [mean and 95% confidence interval (CI): 1.58 (0.74, 2.42) mL/(kg·min)], objective moderate-to-vigorous PA [6.73 (1.70, 11.76) min/day], and total PA [27.19 (9.33, 45.04) min/day], but not for BMI. No significant differences in PA task efficacy, barrier efficacy, and enjoyment were observed. A 12-week (60 minutes × twice per week) school-based AVG intervention can improve Chinese children's aerobic fitness and PA level. These findings indicated that AVGs could be used as an alternative means to engage Chinese children in PA in school setting. However, the treatment effects of AVGs on PA-related psychological correlates and body composition need more investigation.

  14. Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial

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    Smith Sunyata

    2011-04-01

    Full Text Available Abstract Background Targeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH. High intakes of the omega-6 (n-6 polyunsaturated fatty acids (PUFAs, linoleic acid (LA and arachidonic acid (AA may promote physical pain by increasing the abundance, and subsequent metabolism, of LA and AA in immune and nervous system tissues. Here we describe methodology for an ongoing randomized clinical trial comparing the metabolic and clinical effects of a low n-6, average n-3 PUFA diet, to the effects of a low n-6 plus high n-3 PUFA diet, in patients with CDH. Our primary aim is to determine if: A both diets reduce n-6 PUFAs in plasma and erythrocyte lipid pools, compared to baseline; and B the low n-6 plus high n-3 diet produces a greater decline in n-6 PUFAs, compared to the low n-6 diet alone. Secondary clinical outcomes include headache-specific quality-of-life, and headache frequency and intensity. Methods Adults meeting the International Classification of Headache Disorders criteria for CDH are included. After a 6-week baseline phase, participants are randomized to a low n-6 diet, or a low n-6 plus high n-3 diet, for 12 weeks. Foods meeting nutrient intake targets are provided for 2 meals and 2 snacks per day. A research dietitian provides intensive dietary counseling at 2-week intervals. Web-based intervention materials complement dietitian advice. Blood and clinical outcome data are collected every 4 weeks. Results Subject recruitment and retention has been excellent; 35 of 40 randomized participants completed the 12-week intervention. Preliminary blinded analysis of composite data from the first 20 participants found significant reductions in erythrocyte n-6 LA, AA and %n-6 in HUFA, and increases in n-3 EPA, DHA and the omega-3 index, indicating adherence. Trial Registration ClinicalTrials.gov (NCT01157208

  15. Effects of a 12-week healthy-life exercise program on oxidized low-density lipoprotein cholesterol and carotid intima-media thickness in obese elderly women

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    Park, Jong-Hwan; Park, Hyuntae; Lim, Seung-Taek; Park, Jin-Kee

    2015-01-01

    [Purpose] This study examined the effects of a 12-week exercise program on plasma level of oxidized low-density lipoprotein cholesterol in obese elderly women, who are at increased risk of heart disease morbidity. [Subjects and Methods] Twenty participants were assigned into either a control (n = 10) or a supervised exercise program (n = 10) group. The 12-week exercise intervention was performed 3 days per week and involved combined aerobic exercise, resistance exercise, and traditional Korean dance. [Results] Two-factor analysis of variance revealed significant group × time interactions for body mass, diastolic blood pressure, appendicular muscle mass. For high-density lipoprotein cholesterol, oxidized low-density lipoprotein cholesterol, and the ratio of oxidized low-/high-density lipoprotein cholesterol, two-factor analysis of variance revealed significant interactions (group × time), indicating responses differed significantly between the control and exercise groups after 12 weeks. [Conclusion] A 12-week low- to moderate-intensity exercise program appears to be beneficial for obese elderly women by improving risk factors for cardiovascular disease. PMID:26157235

  16. The Effect of 12 Weeks of High-Intensity Interval Training (HIIT on Homocysteine and CRP Cardiovascular Risk Factors and Body Composition in Overweight Men

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    Mohammad Ebrahim Bahram

    2016-12-01

    Full Text Available Background & Objective: High levels of homocysteine inflammatory markers and C-Reactive Protein (CRP cause many complications, including atherosclerosis, venous thrombosis, and cardiovascular problems. The objective of the present study was to investigate the effect of 12-weekHigh Intensity Interval Training (HIIT on homocysteine, CRP, and body composition in overweight men. Materials & Methods: In this quasi-experimental study, 20 students of Kashan University of Medical Sciences with a body mass index between 25 and 30 kg/m2, were purposefully selected and were randomly divided into experimental and control groups. The experimental group had practiced in the HIIT program with the intensity of up to 90 percent of maximum heart rate for 12 weeks. Before and after exercise, the amount of homocysteine, CRP, weight, body fat percentage, body mass index, and waist-to-hip ratio were calculated. The data were analyzed by using dependent and independent t-test at a significance level of P<0.05. Results: The results showed that12 weeks of HIIT had significant effects on reducing serum levels of homocysteine and HSCRP, body weight, body fat percentage, BMI, and WHR in the experimental group compared to the control group (P<0.05. Conclusion: It seems that 12 weeks of intense interval training as a non-invasive method can have a positive effect on reducing the amount of homocysteine, HS-CRP, and some anthropometric indexes of obesity and overweight.

  17. The effect of a cognitive-motor intervention on voluntary step execution under single and dual task conditions in older adults: a randomized controlled pilot study

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    Pichierri G

    2012-07-01

    Full Text Available Giuseppe Pichierri,1 Amos Coppe,1 Silvio Lorenzetti,2 Kurt Murer,1 Eling D de Bruin11Institute of Human Movement Sciences and Sport, Department of Health Sciences and Technology, ETH Zurich, Switzerland; 2Institute for Biomechanics, Department of Health Sciences and Technology, ETH Zurich, SwitzerlandBackground: This randomized controlled pilot study aimed to explore whether a cognitive-motor exercise program that combines traditional physical exercise with dance video gaming can improve the voluntary stepping responses of older adults under attention demanding dual task conditions.Methods: Elderly subjects received twice weekly cognitive-motor exercise that included progressive strength and balance training supplemented by dance video gaming for 12 weeks (intervention group. The control group received no specific intervention. Voluntary step execution under single and dual task conditions was recorded at baseline and post intervention (Week 12.Results: After intervention between-group comparison revealed significant differences for initiation time of forward steps under dual task conditions (U = 9, P = 0.034, r = 0.55 and backward steps under dual task conditions (U = 10, P = 0.045, r = 0.52 in favor of the intervention group, showing altered stepping levels in the intervention group compared to the control group.Conclusion: A cognitive-motor intervention based on strength and balance exercises with additional dance video gaming is able to improve voluntary step execution under both single and dual task conditions in older adults.Keywords: fall prevention, exercise, dance, video game

  18. The effects of a 12-week program of static upper extremity weight bearing exercises on weight bearing in children with hemiplegic type of cerebral palsy

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    P. Jayaraman

    2010-02-01

    Full Text Available The  major  objective  of  this  study  was  to  quantify  the  effects  of a  12-week  program  of  weight  bearing  exercises  on  weight  borne  through  the hand and grip pressures in children with hemiplegic cerebral palsy. This study also sought to monitor the change in spasticity immediately following weight-bearing  exercises.  A  quasi-experimental,  one  group  pre-test,  post-test  study  was used. Eleven children with hemiplegic type of cerebral palsy from a special school in KwaZulu Natal participated after fully informed written consent. The intervention consisted of a 12-week program of weight bearing. The Tekscan Grip system was used to quantify weight borne through the hand during extended arm prone and quadruped positions and whilst holding a pencil and a tumbler. The modified Ashworth grading of spasticity was used to monitor spasticity. The data was analysed using the random effects GLS model Wald Chi Square test. Significant increases in contact pressure in extended arms prone (p=0,012 and quadruped (p=0,002 and when holding a pencil (p=0,045 was noted post-test compared to pre-test. Significant increases in contact area of the hand was also noted in prone (p=0,000, quadruped (p=0, 03 at assessment 7 and when holding a pencil (p=0,035.  A significant decrease in spasticity during elbow extension (p=0,004, and wrist flexion (p=0,026 and extension (p=0,004 was noted. An overall significant effect of static weight bearing exercises on weight borne through the hands, grip strength and spasticity justifies the use of static weight-bearing in therapy.

  19. Lung function profiles and aerobic capacity of adult cigarette and hookah smokers after 12 weeks intermittent training

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    Abdessalem Koubaa

    2015-02-01

    Full Text Available Introduction: Pulmonary function is compromised in most smokers. Yet it is unknown whether exercise training improves pulmonary function and aerobic capacity in cigarette and hookah smokers and whether these smokers respond in a similar way as do non-smokers. Aim: To evaluate the effects of an interval exercise training program on pulmonary function and aerobic capacity in cigarette and hookah smokers. Methods: Twelve cigarette smokers, 10 hookah smokers, and 11 non-smokers participated in our exercise program. All subjects performed 30 min of interval exercise (2 min of work followed by 1 min of rest three times a week for 12 weeks at an intensity estimated at 70% of the subject's maximum aerobic capacity (VO2max. Pulmonary function was measured using spirometry, and maximum aerobic capacity was assessed by maximal exercise testing on a treadmill before the beginning and at the end of the exercise training program. Results: As expected, prior to the exercise intervention, the cigarette and hookah smokers had significantly lower pulmonary function than the non-smokers. The 12-week exercise training program did not significantly affect lung function as assessed by spirometry in the non-smoker group. However, it significantly increased both forced expiratory volume in 1 second and peak expiratory flow (PEF in the cigarette smoker group, and PEF in the hookah smoker group. Our training program had its most notable impact on the cardiopulmonary system of smokers. In the non-smoker and cigarette smoker groups, the training program significantly improved VO2max (4.4 and 4.7%, respectively, v VO2max (6.7 and 5.6%, respectively, and the recovery index (7.9 and 10.5%, respectively. Conclusions: After 12 weeks of interval training program, the increase of VO2max and the decrease of recovery index and resting heart rate in the smoking subjects indicated better exercise tolerance. Although the intermittent training program altered pulmonary function only

  20. Partner randomized controlled trial: study protocol and coaching intervention

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    Garbutt Jane M

    2012-04-01

    Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications

  1. Lifestyle intervention using an internet-based curriculum with cell phone reminders for obese Chinese teens: a randomized controlled study.

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    Anisha A Abraham

    Full Text Available Obesity is an increasing public health problem affecting young people. The causes of obesity are multi-factorial among Chinese youth including lack of physical activity and poor eating habits. The use of an internet curriculum and cell phone reminders and texting may be an innovative means of increasing follow up and compliance with obese teens. The objectives of this study were to determine the feasibility of using an adapted internet curriculum and existing nutritional program along with cell phone follow up for obese Chinese teens.This was a randomized controlled study involving obese teens receiving care at a paediatric obesity clinic of a tertiary care hospital in Hong Kong. Forty-eight subjects aged 12 to 18 years were randomized into three groups. The control group received usual care visits with a physician in the obesity clinic every three months. The first intervention (IT group received usual care visits every three months plus a 12-week internet-based curriculum with cell phone calls/texts reminders. The second intervention group received usual care visits every three months plus four nutritional counselling sessions.The use of the internet-based curriculum was shown to be feasible as evidenced by the high recruitment rate, internet log-in rate, compliance with completing the curriculum and responses to phone reminders. No significant differences in weight were found between IT, sLMP and control groups.An internet-based curriculum with cell phone reminders as a supplement to usual care of obesity is feasible. Further study is required to determine whether an internet plus text intervention can be both an effective and a cost-effective adjunct to changing weight in obese youth.Chinese Clinical Trial Registry ChiCTR-TRC-12002624.

  2. The Effect of 12 Weeks Dance Education on Physical Fitness Values At Mentally Retarded Children

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    Asena DORSAN

    2014-08-01

    Full Text Available The purpose of the study was to examine the effect of 12 weeks of dance education on the values of physical fitness at children with mental retarded. 22 educable mentally retarded children from Dr. Günseli - Dr. Bülent Akınsal Secondary School and Working Sc hool participated in this study. Mentally Disabled children who participated voluntarily were grouped as the average age of 16.27± 1.00 year with11 people (9 males, 2females of the experimental group and the average age of 15.90± 0.83 year to 11people(7 males, 4 females as the control group. Participants in the experimental group was implemented 12 - weekdance education program including 2 days a week, 2 hours a day. Program contents included the basic posture correction, flexibility, ability to maintain a rhythm, motion diversity and self - expression skills, pair work and group work. Physical fitness values of experimental and control group were measured in before and after studies. After the 12 - week dance education, It was determined that there was st atistically significant differences in vertical jump, flexibility, sprint and balance parameters between the experimental and control groups.(p<0.05. In the study of comparing the experimental group in itself, statistically significant differences were fo und of the specified physical fitness parameters (p<0.01. As a result; physical fitness levels of the educable mentally retarded individuals who regularly participated in dance activities showed significant improvements. The results of this study, it was observed that after 12 - week education program there was more development of many physical fitness parameters in the experimental group than the control group and this revealed that the importance of dance education on educable mentally retarded children.

  3. The Efficacy and Safety of 12 Weeks of Sofosbuvir and Ledipasvir versus Sofosbuvir, Ledipasvir, and Ribavirin in Patients with Chronic Hepatitis C, Genotype 1, Who Have Cirrhosis and Have Failed Prior Therapy: A Systematic Review and Meta-Analysis

    Science.gov (United States)

    Fenton, Carol; James, Matthew; Tang, Karen L.

    2017-01-01

    Background. The recommended therapy for patients with chronic hepatitis C (CHC), genotype 1, who have cirrhosis and have failed prior therapy is 12 weeks of sofosbuvir (SOF), ledipasvir (LDV), and ribavirin (RBV). This recommendation is based on expert opinion, and the efficacy of 12 weeks of SOF/LDV compared to SOF/LDV/RBV in this patient population has not yet been established. Methods. We conducted a systematic review and meta-analysis. Two investigators independently searched electronic databases and relevant conference proceedings for randomized controlled trials comparing rates of sustained virologic response 12 weeks after therapy (SVR12) when using 12 weeks of SOF/LDV versus 12 weeks of SOF/LDV/RBV in patients with CHC, genotype 1, who have cirrhosis and failed previous therapy. Results. Our search strategy yielded 596 studies of which four met criteria for inclusion. The pooled RR of not achieving SVR12 with SOF/LDV versus SOF/LDV/RBV was 1.21 (95% CI: 0.42–3.48). Adverse events were lower in the SOF/LDV compared to the SOF/LDV/RBV arms (pooled RR: 0.11, 95% CI: 0.04–0.29). Conclusions. Our findings suggest that 12 weeks of SOF/LDV cannot be considered noninferior to 12 weeks of SOF/LDV/RBV to achieve SVR12 in patients with CHC who have cirrhosis and failed prior therapy. PMID:28367429

  4. Intensive practical lifestyle intervention improves endothelial function in metabolic syndrome independent of weight loss: a randomized controlled trial.

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    Seligman, Beatriz G S; Polanczyk, Carisi A; Santos, Angela S B; Foppa, Murilo; Junges, Mauricio; Bonzanini, Laisa; Nicolaidis, Gabriela; Camey, Suzi; Lopes, André L; Sehl, Paulo; Duncan, Bruce B; Clausell, Nadine

    2011-12-01

    The objective was to evaluate the metabolic and vascular effects of lifestyle interventions involving a healthy diet and either a moderate- or a high-intensity exercise regimen in nondiabetic subjects with metabolic syndrome. The effects of these interventions on flow-mediated vasodilation (FMD) and risk profiles were compared with a standard low-fat diet and engaging in daily walking (standard of care). Seventy-five healthy adults with metabolic syndrome (30-55 years old) were randomized to a 10,000-steps-a-day exercise program, a 3-times-a-week fitness (>75% peak VO(2)) program, or a 1-hour-walking-a-day program for 12 weeks. The first 2 interventions were combined with an accessible healthy, no-sugar diet; and the third was combined with a tailored low-fat diet. The outcomes, including FMD and risk factors, were examined at 12 weeks and at 1-year reassessment. Significant increase in FMD (mean difference = 1.51%, 95% confidence interval = 1.05%-3.017%, P = .0007) and decrease in arterial pressure (mean difference = 19.3 ± 2.3/-12.6 ± 1.8 mm Hg, P = .0001) were observed in all groups. However, the FMD changed most favorably in the high-intensity, low-sugar group (mean difference = 1.56%, 95% confidence interval = 0.1%-3.02%, P = .036). Significant improvements in body mass index, waist, insulin-like growth factor-1, homeostasis model assessment of insulin resistance, insulin, glucose, urinary albumin excretion, and lipid profiles occurred in all groups. Metabolic syndrome was resolved in 64%. One year later, weight loss (-9.1 ± 2.3 kg, P = .0001) and arterial pressure decrease (-18.5 ± 2.3/-12.3 ± 2.1 mm Hg, P = .0001) were maintained. Practical, health-centered diet combined with high-intensity exercise is associated with enhanced vascular protection. These data suggest that more intense exercise combined with a low-sugar diet modulates endothelium-dependent vasodilation. Copyright © 2011 Elsevier Inc. All rights reserved.

  5. A Randomized Controlled Pilot Trial of Different Mobile Messaging Interventions for Problem Drinking Compared to Weekly Drink Tracking.

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    Muench, Frederick; van Stolk-Cooke, Katherine; Kuerbis, Alexis; Stadler, Gertraud; Baumel, Amit; Shao, Sijing; McKay, James R; Morgenstern, Jon

    2017-01-01

    Recent evidence suggests that text messaging may help to reduce problem drinking as an extension to in-person services, but very little is known about the effectiveness of remote messaging on problem drinking as a stand-alone intervention, or how different types of messages may improve drinking outcomes in those seeking to moderate their alcohol consumption. We conducted an exploratory, single-blind randomized controlled pilot study comparing four different types of alcohol reduction-themed text messages sent daily to weekly drink self-tracking texts in order to determine their impact on drinking outcomes over a 12-week period in 152 participants (≈ 30 per group) seeking to reduce their drinking on the internet. Messaging interventions included: weekly drink self-tracking mobile assessment texts (MA), loss-framed texts (LF), gain-framed texts (GF), static tailored texts (ST), and adaptive tailored texts (TA). Poisson and least squares regressions were used to compare differences between each active messaging group and the MA control. When adjusting for baseline drinking, participants in all messaging groups except GF significantly reduced the number of drinks consumed per week and the number of heavy drinking days compared to MA. Only the TA and GF groups were significantly different from MA in reducing the number of drinking days. While the TA group yielded the largest effect sizes on all outcome measures, there were no significant differences between active messaging groups on any outcome measure. 79.6% of individuals enrolled in the study wanted to continue receiving messages for an additional 12 weeks at the end of the study. Results of this pilot study indicate that remote automated text messages delivered daily can help adult problem drinkers reduce drinking frequency and quantity significantly more than once-a-week self-tracking messages only, and that tailored adaptive texts yield the largest effect sizes across outcomes compared to MA. Larger samples are

  6. Attitudes and Learning through Practice Are Key to Delivering Brief Interventions for Heavy Drinking in Primary Health Care: Analyses from the ODHIN Five Country Cluster Randomized Factorial Trial

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    Peter Anderson

    2017-01-01

    Full Text Available In this paper, we test path models that study the interrelations between primary health care provider attitudes towards working with drinkers, their screening and brief advice activity, and their receipt of training and support and financial reimbursement. Study participants were 756 primary health care providers from 120 primary health care units (PHCUs in different locations throughout Catalonia, England, The Netherlands, Poland, and Sweden. Our interventions were training and support and financial reimbursement to providers. Our design was a randomized factorial trial with baseline measurement period, 12-week implementation period, and 9-month follow-up measurement period. Our outcome measures were: attitudes of individual providers in working with drinkers as measured by the Short Alcohol and Alcohol Problems Perception Questionnaire; and the proportion of consulting adult patients (age 18+ years who screened positive and were given advice to reduce their alcohol consumption (intervention activity. We found that more positive attitudes were associated with higher intervention activity, and higher intervention activity was then associated with more positive attitudes. Training and support was associated with both positive changes in attitudes and higher intervention activity. Financial reimbursement was associated with more positive attitudes through its impact on higher intervention activity. We conclude that improving primary health care providers’ screening and brief advice activity for heavy drinking requires a combination of training and support and on-the-job experience of actually delivering screening and brief advice activity.

  7. Introduction of misoprostol for the treatment of incomplete abortion beyond 12 weeks of pregnancy in Benin.

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    Adisso, Sosthène; Hounkpatin, Benjamin I B; Komongui, Gounnou D; Sambieni, Olivier; Perrin, René X

    2014-07-01

    Improving the care of women who have undergone a spontaneous or induced abortion is an important step in reducing abortion-related morbidity and mortality. Both the International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization recommend the use of manual vacuum aspiration (MVA) and misoprostol rather than sharp curettage to treat incomplete abortion. MVA was introduced into the public healthcare service in Benin in 2006 and since 2008 misoprostol has been available in 3 large maternity hospitals. The present study opted to use an oral dose of 800 μg and not to limit to pregnancies of up to 12 weeks, but to include women with second trimester abortions. After 5 years, results show that around three-quarters of the women treated with misoprostol at 13-18 weeks of pregnancy required MVA to complete uterine evacuation and approximately one-quarter had severe bleeding, confirming that the indication of misoprostol for incomplete abortion should be limited to pregnancies of up to 12 weeks. Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

  8. Blinded 12-week comparison of once-daily indacaterol and tiotropium in COPD.

    Science.gov (United States)

    Buhl, R; Dunn, L J; Disdier, C; Lassen, C; Amos, C; Henley, M; Kramer, B

    2011-10-01

    Two, once daily (q.d.) inhaled bronchodilators are available for the treatment of chronic obstructive pulmonary disease (COPD): the β(2)-agonist indacaterol and the anticholinergic tiotropium. This blinded study compared the efficacy of these two agents and assessed their safety and tolerability. Patients with moderate-to-severe COPD were randomised to treatment with indacaterol 150 μg q.d. (n=797) or tiotropium 18 μg q.d. (n=801) for 12 weeks. After 12 weeks, the two treatments had similar overall effects on "trough" (24 h post-dose) forced expiratory volume in 1 s. Indacaterol-treated patients had greater improvements in transition dyspnoea index (TDI) total score (least squares means 2.01 versus 1.43; pindacaterol versus tiotropium odds ratios of 1.49 for TDI and 1.43 for SGRQ, both pindacaterol and tiotropium treatment groups, respectively. The most frequent adverse events were COPD worsening, cough and nasopharyngitis. Both bronchodilators demonstrated spirometric efficacy. The two treatments were well tolerated with similar adverse event profiles. Compared with tiotropium, indacaterol provided significantly greater improvements in clinical outcomes.

  9. Myogenic response of human skeletal muscle to 12 weeks of resistance training at light loading intensity.

    Science.gov (United States)

    Mackey, A L; Holm, L; Reitelseder, S; Pedersen, T G; Doessing, S; Kadi, F; Kjaer, M

    2011-12-01

    There is strong evidence for enhanced numbers of satellite cells with heavy resistance training. The satellite cell response to very light muscle loading is, however, unknown. We, therefore, designed a 12-week training protocol where volunteers trained one leg with a high load (H) and the other leg with a light load (L). Twelve young healthy men [mean age 25 ± 3 standard deviation (SD) years] volunteered for the study. Muscle biopsies were collected from the m. vastus lateralis of both legs before and after the training period and satellite cells were visualized by CD56 immunohistochemistry. A significant main effect of time was observed (Pfiber (L: from 0.11 ± 0.02 to 0.13 ± 0.03; H: from 0.12 ± 0.03 to 0.15 ± 0.05, mean ± SD). The finding that 12 weeks of training skeletal muscle even with very light loads can induce an increase in the number of satellite cells reveals a new aspect of myogenic precursor cell activation and suggests that satellite cells may play a role in skeletal muscle adaptation over a broad physiological range.

  10. The EPIC Kids Study: a randomized family-focused YMCA-based intervention to prevent type 2 diabetes in at-risk youth.

    Science.gov (United States)

    Hingle, Melanie D; Turner, Tami; Kutob, Randa; Merchant, Nirav; Roe, Denise J; Stump, Craig; Going, Scott B

    2015-12-18

    It is well established that behavioral lifestyle interventions resulting in modest weight reduction in adults can prevent or delay type 2 diabetes mellitus; however in children, successful weight management interventions are rarely found outside of controlled clinical settings. The lack of effective community-based programs is a barrier to reducing obesity prevalence and diabetes risk in children. The objective of our study is to develop and test a group-randomized family-centered community-based type 2 diabetes prevention intervention targeting at-risk children, 9- to 12-years-old. Using participatory methods, the adult-focused YMCA Diabetes Prevention Program was adapted for families, creating a novel lifestyle behavior change program focused on healthy eating, physical activity, and a supportive home environment. The program will be tested in sixty 9- to 12-year-old children at risk of diabetes and sixty parents over 12 consecutive weeks with two intervention formats randomized by location: a face-to-face instructor-led program, or a hybrid program with alternating face-to-face and mobile technology-delivered content. Anthropometric, behavioral, psychosocial and physiological outcomes will be assessed at baseline, post-intervention (12 weeks), and follow-up (24 weeks). Secondary outcomes are participant acceptability, feasibility, and adherence. The RE-AIM framework (reach, efficacy, adoption, implementation, and maintenance) will guide intervention implementation and evaluation. Changes at 12 weeks will be assessed using a paired t-test combining both delivery formats. Exploratory models using linear regression analysis will estimate the magnitude of the difference between the face-to-face and hybrid format. The sample size of 60 children, informed by a previous YMCA intervention in which -4.3 % change in overweight (SE = 1.1) was observed over 6 months, will give us 80 % power to detect an effect size of this magnitude, assuming a one-sided test at alpha

  11. Using ecological momentary assessment in testing the effectiveness of an alcohol intervention: a two-arm parallel group randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Carmen V Voogt

    Full Text Available BACKGROUND: Alcohol consumption of college students has a fluctuating nature, which might impact the measurement of intervention effects. By using 25 follow-up time-points, this study tested whether intervention effects are robust or might vary over time. METHODS: Data were used from a two-arm parallel group randomized controlled trial applying ecological momentary assessment (EMA with 30 data time-points in total. Students between 18 and 24 years old who reported heavy drinking in the past six months and who were ready to change their alcohol consumption were randomly assigned to the experimental (n = 456: web-based brief alcohol intervention and control condition (n = 451: no intervention. Outcome measures were weekly alcohol consumption, frequency of binge drinking, and heavy drinking status. RESULTS: According to the intention-to-treat principle, regression analyses revealed that intervention effects on alcohol consumption varied when exploring multiple follow-up time-points. Intervention effects were found for a weekly alcohol consumption at 1, 2, 3, 4, and 7 weeks follow-up, b frequency of binge drinking at 1, 2, 7, and 12 weeks follow-up, and c heavy drinking status at 1, 2, 7, and 16 weeks follow-up. CONCLUSIONS: This research showed that the commonly used one and six month follow-up time-points are relatively arbitrary and not using EMA might bring forth erroneous conclusions on the effectiveness of interventions. Therefore, future trials in alcohol prevention research and beyond are encouraged to apply EMA when assessing outcome measures and intervention effectiveness. TRIAL REGISTRATION: Netherlands Trial Register NTR2665.

  12. Evaluation of occupational health interventions using a randomized controlled trial: challenges and alternative research designs

    NARCIS (Netherlands)

    Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van

    2015-01-01

    Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of a

  13. The effect of Christmas joy on the mood among medical doctors - a randomized, blinded intervention study

    DEFF Research Database (Denmark)

    Ilkjær, Christine; Møller, Marianne Birkebæk; Lauridsen, Mette H;

    2016-01-01

    -centre blinded intervention study with crossover at three hospital departments. JN intervention of three days was randomized. Median ± standard deviation was given. The level of significance was p laugh index increased...

  14. Do 12-Week Yoga Program Influence Respiratory Function Of Elderly Women?

    Directory of Open Access Journals (Sweden)

    Bezerra Lídia Aguiar

    2014-12-01

    Full Text Available Aging produces several respiratory limitations and reduces tolerance to physical efforts, sometimes leading to pulmonary diseases in the elderly. The literature draws attention to the possible benefits of Yoga practice among the elderly, presenting evidence for significant improvements in quality of life. It was hypothesized that yoga practice can improve respiratory function in the elderly. The effects of a yoga program on pulmonary volumes and respiratory muscle strength were verified in 36 elderly women divided into a yoga group [YG] (63.1 ± 13.3 years of age and a control group (61.0 ± 6.9 years of age. Maximal inspiratory and expiratory pressure (MIP and MEP were assessed by a manovacuometer and tidal volume (VT, vital capacity (VC and minute ventilation (VE were measured by a ventilometer. The program comprised 65 min sessions, 3 times/week during 12 weeks. The heart rate and respiratory rate decreased significantly in the YG (76-39 ± 8-03 vs. 74-61±10.26 bpm and 18.61 ± 3.15 vs. 16.72 ± 3.12 resp/min, respectively. In the YG, VT and VE increased significantly (0.55 ± 0.22 vs. 0.64 ± 0.2 ml and 9.19 ± 2.39 vs. 10.05 ± 2.11 ml, respectively, as well as VC (1.48 ± 0.45 vs. 2.03 ± 0.72 ml. Improvements were also found in MIP and MEP in the YG (62.17 ± 14.77 vs. 73.06 ± 20.16 cmH2O and 80.56 ± 23.94 vs. 86.39 ± 20.16 cmH2O, respectively. It was concluded that a 12-week yoga program significantly improves pulmonary function of aged women.

  15. The Columbia-Bronx VA amalgamative clerkship: an effective, 12-week, integrated, longitudinal clinical experience.

    Science.gov (United States)

    Diuguid-Gerber, Jillian; Porter, Samuel; Quiah, Samuel C; Nickerson, Katherine; Jones, Deborah; Audi, Zeena; Richards, Boyd F

    2017-01-01

    Many medical schools have adopted the longitudinal integrated clerkship (LIC) model in response to calls for increased continuity in clinical learning environments. However, because of implementation challenges, such programs are not feasible at some institutions or are limited to a small number of students. In January 2014, Columbia University College of Physicians and Surgeons (P&S) recognized the need to explore different LIC formats and began offering four, 12-week amalgamative clerkships (AC). Students within this curricular track experienced primary care, internal medicine 'away', orthopedic surgery, urology, and an elective in an integrated format. P&S developed the AC in partnership with the James J. Peters VA Medical Center in Bronx, NY (BVA). All patient care and educational conferences took place at the BVA during the 12-week experience. The learning objectives of the AC were aligned to the learning objectives of a 52-week20 LIC also offered at Columbia. An evaluation process was developed to determine studentlearning experiences and preliminary outcomes, including how well the LIC-related objectivescould be achieved in a shorter period of time. In 2015, P&S collected AC evaluation data through three student feedback sessions. Students reported that the AC provided opportunity for patient continuity, patient-centered care approaches, meaningful roles for students, career development opportunities, and health systems awareness. Early outcomes indicate that the BVA AC provides a degree of longitudinality that can influence student perceptions of patient care, career development, and health systems, consistent with the larger LIC. The team continues to gather additional data on students' experiences and investigate additional sites that have potential to serve as future AC learning environments.

  16. A Cognitive Behavioral Therapy-Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial.

    Science.gov (United States)

    Glasner-Edwards, Suzette; Patrick, Kevin; Ybarra, Michele L; Reback, Cathy J; Rawson, Richard A; Chokron Garneau, Helene; Chavez, Kathryn; Venegas, Alexandra

    2016-06-24

    Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Mobile phone-based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users.

  17. A Cognitive Behavioral Therapy–Based Text Messaging Intervention Versus Medical Management for HIV-Infected Substance Users: Study Protocol for a Pilot Randomized Trial

    Science.gov (United States)

    Patrick, Kevin; Ybarra, Michele L; Reback, Cathy J; Rawson, Richard A; Chokron Garneau, Helene; Chavez, Kathryn; Venegas, Alexandra

    2016-01-01

    Background Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Objective Mobile phone–based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. Methods With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. Results The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. Conclusions This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users. PMID:27341852

  18. A Randomized Clinical Trial of a Postdeployment Parenting Intervention for Service Members and Their Families With Very Young Children.

    Science.gov (United States)

    DeVoe, Ellen R; Paris, Ruth; Emmert-Aronson, Ben; Ross, Abigail; Acker, Michelle

    2016-10-06

    Objective: Parenting through the deployment cycle presents unique stressors for military families. To date, few evidence-based and military-specific parenting programs are available to support parenting through cycles of deployment separation and reintegration, especially for National Guard/Reserve members. The purpose of this research was to test the efficacy of a parenting program developed specifically to support military families during reintegration. Method: Within 1 year of returning from deployment to Afghanistan or Iraq, 115 service members with very young children were randomly assigned to receive either the Strong Families Strong Forces Parenting Program at baseline or after a 12-week waiting period. Using a home-based modality, service members, at-home parents, and their young child were assessed at baseline, 3 months posttreatment/wait period, and 6 months from baseline. Results: Service member parents in Strong Families evidenced greater reductions in parenting stress and mental health distress relative to those in the waitlist comparison group. Service members with more posttraumatic stress symptoms reported higher levels of perceived parental efficacy in the intervention group than service members in the comparison group. Intervention also resulted in enhanced parental reflective capacity, including increased curiosity and interest in the young child among those in the intervention group relative to comparison. Conclusion: Service member parents and their spouses demonstrated high interest in participating in a postdeployment parenting program targeting families with very young children. Findings point to the feasibility, appeal, and efficacy of Strong Families in this initial trial and suggest promise for implementation in broader military and community service systems. (PsycINFO Database Record

  19. Discourse-based intervention for modifying supervisory communication as leverage for safety climate and performance improvement: a randomized field study.

    Science.gov (United States)

    Zohar, Dov; Polachek, Tal

    2014-01-01

    The article presents a randomized field study designed to improve safety climate and resultant safety performance by modifying daily messages in supervisor-member communications. Supervisors in the experimental group received 2 individualized feedback sessions regarding the extent to which they integrated safety and productivity-related issues in daily verbal exchanges with their members; those in the control group received no feedback. Feedback data originated from 7-9 workers for each supervisor, reporting about received supervisory messages during the most recent verbal exchange. Questionnaire data collected 8 weeks before and after the 12-week intervention phase revealed significant changes for safety climate, safety behavior, subjective workload, teamwork, and (independently measured) safety audit scores for the experimental group. Data for the control group (except for safety behavior) remained unchanged. These results are explained by corresponding changes (or lack thereof in the control group) in perceived discourse messages during the 6-week period between the 1st and 2nd feedback sessions. Theoretical and practical implications for climate improvement and organizational discourse research are discussed.

  20. Pediatric endurance and limb strengthening for children with cerebral palsy (PEDALS – a randomized controlled trial protocol for a stationary cycling intervention

    Directory of Open Access Journals (Sweden)

    Simms Victoria

    2007-03-01

    Full Text Available Abstract Background In the past, effortful exercises were considered inappropriate for children with spastic cerebral palsy (CP due to concern that they would escalate abnormalities including spasticity and abnormal movement patterns. Current scientific evidence indicates that these concerns were unfounded and that therapeutic interventions focused on muscle strengthening can lead to improved functional ability. However, few studies have examined the potential benefits of cardiorespiratory fitness exercises in this patient population. Methods/design The rationale and design of a randomized controlled trial examining the effects of a stationary cycling intervention for children with CP are outlined here. Sixty children with spastic diplegic CP between the ages of 7 and 18 years and Gross Motor Function Classification System (GMFCS levels of I, II, or III will be recruited for this study. Participants will be randomly assigned to either an intervention (cycling or a control (no cycling group. The cycling intervention will be divided into strengthening and cardiorespiratory endurance exercise phases. During the strengthening phase, the resistance to lower extremity cycling will be progressively increased using a uniquely designed limb-loaded mechanism. The cardiorespiratory endurance phase will focus on increasing the intensity and duration of cycling. Children will be encouraged to exercise within a target heart rate (HR range (70 – 80% maximum HR. Thirty sessions will take place over a 10–12 week period. All children will be evaluated before (baseline and after (follow-up the intervention period. Primary outcome measures are: knee joint extensor and flexor moments, or torque; the Gross Motor Function Measure (GMFM; the 600 Yard Walk-Run test and the Thirty-Second Walk test (30 sec WT. Discussion This paper presents the rationale, design and protocol for Pediatric Endurance and Limb Strengthening (PEDALS; a Phase I randomized controlled trial

  1. Pediatric endurance and limb strengthening for children with cerebral palsy (PEDALS) – a randomized controlled trial protocol for a stationary cycling intervention

    Science.gov (United States)

    Fowler, Eileen G; Knutson, Loretta M; DeMuth, Sharon K; Sugi, Mia; Siebert, Kara; Simms, Victoria; Azen, Stanley P; Winstein, Carolee J

    2007-01-01

    Background In the past, effortful exercises were considered inappropriate for children with spastic cerebral palsy (CP) due to concern that they would escalate abnormalities including spasticity and abnormal movement patterns. Current scientific evidence indicates that these concerns were unfounded and that therapeutic interventions focused on muscle strengthening can lead to improved functional ability. However, few studies have examined the potential benefits of cardiorespiratory fitness exercises in this patient population. Methods/design The rationale and design of a randomized controlled trial examining the effects of a stationary cycling intervention for children with CP are outlined here. Sixty children with spastic diplegic CP between the ages of 7 and 18 years and Gross Motor Function Classification System (GMFCS) levels of I, II, or III will be recruited for this study. Participants will be randomly assigned to either an intervention (cycling) or a control (no cycling) group. The cycling intervention will be divided into strengthening and cardiorespiratory endurance exercise phases. During the strengthening phase, the resistance to lower extremity cycling will be progressively increased using a uniquely designed limb-loaded mechanism. The cardiorespiratory endurance phase will focus on increasing the intensity and duration of cycling. Children will be encouraged to exercise within a target heart rate (HR) range (70 – 80% maximum HR). Thirty sessions will take place over a 10–12 week period. All children will be evaluated before (baseline) and after (follow-up) the intervention period. Primary outcome measures are: knee joint extensor and flexor moments, or torque; the Gross Motor Function Measure (GMFM); the 600 Yard Walk-Run test and the Thirty-Second Walk test (30 sec WT). Discussion This paper presents the rationale, design and protocol for Pediatric Endurance and Limb Strengthening (PEDALS); a Phase I randomized controlled trial evaluating the

  2. Self-management support intervention to control cancer pain in the outpatient setting: a randomized controlled trial study protocol.

    Science.gov (United States)

    Hochstenbach, Laura M J; Courtens, Annemie M; Zwakhalen, Sandra M G; van Kleef, Maarten; de Witte, Luc P

    2015-05-19

    Pain is a prevalent and distressing symptom in patients with cancer, having an enormous impact on functioning and quality of life. Fragmentation of care, inadequate pain communication, and reluctance towards pain medication contribute to difficulties in optimizing outcomes. Integration of patient self-management and professional care by means of healthcare technology provides new opportunities in the outpatient setting. This study protocol outlines a two-armed multicenter randomized controlled trial that compares a technology based multicomponent self-management support intervention with care as usual and includes an effect, economic and process evaluation. Patients will be recruited consecutively via the outpatient oncology clinics and inpatient oncology wards of one academic hospital and one regional hospital in the south of the Netherlands. Irrespective of the stage of disease, patients are eligible when they are diagnosed with cancer and have uncontrolled moderate to severe cancer (treatment) related pain defined as NRS≥4 for more than two weeks. Randomization (1:1) will assign patients to either the intervention or control group; patients in the intervention group receive self-management support and patients in the control group receive care as usual. The intervention will be delivered by registered nurses specialized in pain and palliative care. Important components include monitoring of pain, adverse effects and medication as well as graphical feedback, education, and nurse support. Effect measurements for both groups will be carried out with questionnaires at baseline (T0), after 4 weeks (T1) and after 12 weeks (T2). Pain intensity and quality of life are the primary outcomes. Secondary outcomes include self-efficacy, knowledge, anxiety, depression and pain medication use. The final questionnaire contains also questions for the economic evaluation that includes both cost-effectiveness and cost-utility analysis. Data for the process evaluation will be

  3. ¡Cocinar Para Su Salud!: Randomized Controlled Trial of a Culturally Based Dietary Intervention among Hispanic Breast Cancer Survivors.

    Science.gov (United States)

    Greenlee, Heather; Gaffney, Ann Ogden; Aycinena, A Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M; Lim, Emerson; Tsai, Wei-Yann; Crew, Katherine; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L

    2015-05-01

    There is a need for culturally relevant nutrition programs targeted to underserved cancer survivors. Our aim was to examine the effect of a culturally based approach to dietary change on increasing fruit/vegetable (F/V) intake and decreasing fat intake among Hispanic breast cancer survivors. Participants were randomized to Intervention and Control groups. Diet recalls, detailed interviews, fasting blood, and anthropometric measures were collected at baseline, 3, 6, and 12 months. Hispanic women (n=70) with stage 0 to III breast cancer who completed adjuvant treatment and lived in New York City were randomized between April 2011 and March 2012. The Intervention group (n=34) participated in ¡Cocinar Para Su Salud!, a culturally based nine-session (24 hours over 12 weeks) intervention including nutrition education, cooking classes, and food-shopping field trips. The Control group (n=36) received written dietary recommendations for breast cancer survivors. Change at 6 months in daily F/V servings and percent calories from total fat were the main outcome measures. Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to 3 and 6 months. Baseline characteristics were the following: mean age 56.6 years (standard deviation 9.7 years), mean time since diagnosis 3.4 years (standard deviation 2.7 years), mean body mass index (calculated as kg/m²) 30.9 (standard deviation 6.0), 62.9% with annual household income ≤$15,000, mean daily servings of all F/V was 5.3 (targeted F/V 3.7 servings excluding legumes/juices/starchy vegetables/fried foods), and 27.7% of daily calories from fat. More than 60% in the Intervention group attended seven or more of nine classes, with overall study retention of 87% retention at 6 months. At month 6, the Intervention group compared with Control group reported an increase in mean servings of F/V from baseline (all F/V: +2.0 vs -0.1; P=0.005; targeted F/V: +2

  4. A written language intervention for at-risk second grade students: a randomized controlled trial of the process assessment of the learner lesson plans in a tier 2 response-to-intervention (RtI) model.

    Science.gov (United States)

    Hooper, Stephen R; Costa, Lara-Jeane C; McBee, Matthew; Anderson, Kathleen L; Yerby, Donna Carlson; Childress, Amy; Knuth, Sean B

    2013-04-01

    In a randomized controlled trial, 205 students were followed from grades 1 to 3 with a focus on changes in their writing trajectories following an evidence-based intervention during the spring of second grade. Students were identified as being at-risk (n=138), and then randomized into treatment (n=68) versus business-as-usual conditions (n=70). A typical group also was included (n=67). The writing intervention comprised Lesson Sets 4 and 7 from the Process Assessment of the Learner (PAL), and was conducted via small groups (three to six students) twice a week for 12 weeks in accordance with a response-to-intervention Tier 2 model. The primary outcome was the Wechsler Individual Achievement Test-II Written Expression Scale. Results indicated modest support for the PAL lesson plans, with an accelerated rate of growth in writing skills following treatment. There were no significant moderator effects, although there was evidence that the most globally impaired students demonstrated a more rapid rate of growth following treatment. These findings suggest the need for ongoing examination of evidence-based treatments in writing for young elementary students.

  5. An Exploratory Analysis of the Smoking and Physical Activity Outcomes From a Pilot Randomized Controlled Trial of an Exercise Assisted Reduction to Stop Smoking Intervention in Disadvantaged Groups.

    Science.gov (United States)

    Thompson, Tom Paul; Greaves, Colin J; Ayres, Richard; Aveyard, Paul; Warren, Fiona C; Byng, Richard; Taylor, Rod S; Campbell, John L; Ussher, Michael; Green, Colin; Michie, Susan; West, Robert; Taylor, Adrian

    2016-03-01

    Economically disadvantaged smokers not intending to stop may benefit from interventions aimed at reducing their smoking. This study assessed the effects of a behavioral intervention promoting an increase in physical activity versus usual care in a pilot randomized controlled trial. Disadvantaged smokers who wanted to reduce but not quit were randomized to either a counseling intervention of up to 12 weeks to support smoking reduction and increased physical activity (n = 49) or usual care (n = 50). Data at 16 weeks were collected for various smoking and physical activity outcomes. Primary analyses consisted of an intention to treat analysis based on complete case data. Secondary analyses explored the impact of handling missing data. Compared with controls, intervention smokers were more likely to initiate a quit attempt (36 vs. 10%; odds ratio 5.05, [95% CI: 1.10; 23.15]), and a greater proportion achieved at least 50% reduction in cigarettes smoked (63 vs. 32%; 4.21 [1.32; 13.39]). Postquit abstinence measured by exhaled carbon monoxide at 4-week follow-up showed promising differences between groups (23% vs. 6%; 4.91 [0.80; 30.24]). No benefit of intervention on physical activity was found. Secondary analyses suggested that the standard missing data assumption of "missing" being equivalent to "smoking" may be conservative resulting in a reduced intervention effect. A smoking reduction intervention for economically disadvantaged smokers which involved personal support to increase physical activity appears to be more effective than usual care in achieving reduction and may promote cessation. The effect does not appear to be influenced by an increase in physical activity. © The Author 2015. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  6. The effects of the music-with-movement intervention on the cognitive functions of people with moderate dementia: a randomized controlled trial.

    Science.gov (United States)

    Cheung, Daphne Sze Ki; Lai, Claudia Kam Yuk; Wong, Frances Kam Yuet; Leung, Mason Chin Pang

    2016-11-07

    The aim of this study was to examine the effects of the six-week music-with-movement (MM) intervention, as compared with music listening (ML) and social activity (SA), on the cognitive functions of people with moderate dementia over time. A multi-center randomized controlled trial was conducted on 165 nursing home residents with moderate dementia. The MM intervention protocol was developed based on a critical literature review, and tested in three rounds of pilot studies before undergoing testing in this study. The participants were randomly allocated into three groups. Intervention participants (n = 58) received a 12-week MM program led by a trained health care professional, while the participants in the comparison ML group (n = 54) listened to their preferred music, and those in the SA group (n = 53) engaged in social chatting. Cognitive functions, depressive symptoms, and anxiety were measured at baseline, the sixth week, and six weeks post-intervention. Greater improvements in memory and depressive symptoms for the MM group were revealed in the univariate analysis and pairwise comparisons. The effects on memory could last for at least six weeks post-intervention. However, a mixed multivariate analysis of variance (MANOVA) analysis indicated that there were no significant interactions of group by time effect Conclusion: The findings revealed that the MM intervention may be useful for enhancing the cognitive functions of people with dementia. However, there is insufficient evidence to show that the effects of the MM intervention on outcome variables over time significantly different from those observed among the comparison groups.

  7. Exercise as an Intervention to Reduce Study-Related Fatigue among University Students: A Two-Arm Parallel Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Juriena D de Vries

    Full Text Available Many university students experience high levels of study-related fatigue. This high prevalence, and the negative impact of fatigue on health and academic performance, call for prevention and reduction of these symptoms. The primary aim of the current study was to investigate to what extent an exercise intervention is effective in reducing three indicators of study-related fatigue (emotional exhaustion, overall fatigue, and need for recovery. Effects of exercise on secondary outcomes (sleep quality, self-efficacy, physical fitness, and cognitive functioning were also investigated.Participants were students with high levels of study-related fatigue, currently not exercising or receiving other psychological or pharmacological treatments, and with no medical cause of fatigue. They were randomly assigned to either a six-week exercise intervention (low-intensity running three times a week, n = 49 or wait list (no intervention, n = 48. All participants were measured before the intervention (T0, and immediately after the intervention (T1. Exercisers were also investigated 4 weeks (T2 and 12 weeks (T3 after the intervention.Participants in the exercise condition showed a larger decrease in two of the three indicators of study-related fatigue (i.e., overall fatigue and need for recovery as compared to controls. Additionally, sleep quality and some indicators of cognitive functioning improved more among exercisers than among controls. No effects were found for self-efficacy, and physical fitness. The initial effects of the exercise intervention lasted at follow-up (T2 and T3. At 12-week follow up (T3, 80% of participants in the exercise condition still engaged in regular exercise, and further enhancements were seen for emotional exhaustion, overall fatigue, and sleep quality.These results underline the value of low-intensity exercise for university students with high levels of study-related fatigue. The follow-up effects that were found in this study imply

  8. Effects of 12 weeks nutrition education on nutritional status in hemodialysis patients

    Directory of Open Access Journals (Sweden)

    Harin Rhee

    2012-06-01

    Full Text Available Protein-energy malnutrition is present in a large proportion of patients with end stage renal disease and, is a strong risk factor for mortality in these patients. This study was aimed to evaluate the effectiveness of 12-weeks nutrition education during the hemodialysis session for the improvement of nutritional status. From the June 2011 to the September 2011, patients who were on regular hemodialysis in Pusan National University Hospital were enrolled in this study. In education group, intensive nutrition education was performed by the hemodialysis nurse, for fifty to sixty minutes during the hemodialysis session, once a week. Curriculum for renal nutrition includes regular taking of their medication, intake of moderate amount of protein and sufficient calories, reduction of water, salt, potassium and phosphate intake. Otherwise, any education program was not performed in patients of control group. Nutrition status was assessed by the subjective global assessment (SGA,body mass index (BMI, triceps skinfold thickness (TSF, arm muscle area(AMC and laboratory markers such as serum albumin, serum blood urea nitrogen(BUN and hemoglobin(Hb level before and after the education. Effect of nutrition education was analyzed using ANCOVA test. A total of 49 patients were enrolled in this study and nutrition education was provided to 25 hemodialysis patients. Their mean age was 57.20±15.49 in education group and 55.13±14.42 in control groupand male was 56.0% in education group and 50.0% in control group and, other baseline characteristics were not significantly different between two groups. After the 12-week education, significant improvement was found in SGA, serum albumin, BUN and Hb level. SGA score was improved from 6.36±0.99 to 6.72±0.61 in education group, compared to control group(6.38±0.88 to 6.42±0.88, p=0.029 . Improvement of serum albumin level, BUN and Hb was as follows: serum albumin(4.23±0.28 to 4.30±0.25 in education group, 4.28±0

  9. Randomized Impact Evaluation of Education Interventions: Experiences and Lessons from a Reading to Learn Intervention in East Africa

    Science.gov (United States)

    Ngware, Moses Waithanji; Abuya, Benta; Oketch, Moses; Admassu, Kassahun; Mutisya, Maurice; Musyoka, Peter

    2015-01-01

    This paper presents the experiences and lessons learnt during the design and implementation of the randomized impact evaluation (IE) of a reading to learn (RtL) intervention in early primary grades. The study was to assess the impact of RtL on literacy and numeracy among pupils in low-performing districts in East Africa. The intervention was…

  10. Behavioral Mediators of Weight Loss in Two Group-Based Behavioral Interventions in Older Adults

    Science.gov (United States)

    Baruth, Meghan; Schlaff, Rebecca A.

    2017-01-01

    Background: Understanding the mechanisms by which behavioral interventions exert their effects is important. Purpose: To examine behavioral mediators of weight loss in a sample of older adults participating in an evidence-based physical activity (PA) or nutrition intervention. Methods: Participants (n = 46) were randomized to a 12-week,…

  11. Effects of 12 weeks of treatment with fermented milk on blood pressure, glucose metabolism and markers of cardiovascular risk in patients with type 2 diabetes

    DEFF Research Database (Denmark)

    Hove, K D; Brøns, C; Færch, K

    2015-01-01

    ) (n=23) or 300 ml artificially acidified milk (placebo yogurt) (n=18) for 12 weeks. BPs were measured over 24-h, and blood samples were collected in the fasting state and during a meal test before and after the intervention. RESULTS: Cardi04 yogurt did not reduce 24-h, daytime or nighttime systolic...... or diastolic BPs compared with placebo (P>0.05). Daytime and 24-h heart rate (HR) were significantly reduced in the group treated by Cardi04 yogurt compared with the placebo group (P

  12. Efficacy of a randomized controlled self-regulation based physical activity intervention for chronic fatigue: Mediation effects of physical activity progress and self-regulation skills.

    Science.gov (United States)

    Marques, M M; de Gucht, V; Leal, I; Maes, S

    2017-03-01

    Examine the medium-term effects of a brief physical activity (PA) self-regulation (SR) based intervention (4-STEPS program) for chronic fatigue, and explore the mediating effects of PA related variables and SR skills. A two-arm randomized controlled trial (Usual Care vs 4-STEPS) was carried out. The 4-STEPS program consisted of Motivational Interviewing and SR-skills training. Fatigue severity (primary outcome) and impact, PA, health-related quality of life (HrQoL), and somatic and psychological distress were assessed at baseline, post-treatment (12weeks) and 12months follow-up. Ninety-one patients (45 intervention and 46 controls) were included. At follow-up, there were significant treatment effects on fatigue severity (g=0.72) and fatigue impact, leisure-time PA, and physical and psychological HrQoL. No significant effects were found for number of daily steps and somatic and psychological distress. Fatigue severity at follow-up was partially mediated by post-treatment progress on a personal PA goal (effect ratio=18%). Results suggest that a brief intervention, focusing on the formulation and pursuit of personal PA goals and the use of SR skills, produces sustained benefits for fatigue severity. Despite these promising results, dropout was high and the intervention was not beneficial for all secondary outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

  13. Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population.

    Science.gov (United States)

    To, Yasuo; Kinoshita, Masaharu; Lee, Sang Haak; Hang, Liang-Wen; Ichinose, Masakazu; Fukuchi, Yoshinosuke; Kitawaki, Tetsuji; Okino, Naoko; Prasad, Niyati; Lawrence, David; Kramer, Benjamin

    2012-12-01

    This post hoc analysis evaluated the efficacy of indacaterol, a novel inhaled once-daily long-acting β(2)-agonist, by disease severity (GOLD 2005) in patients with moderate-to-severe COPD from six Asian countries/areas (Hong Kong, India, Japan, Korea, Singapore, Taiwan). Data from a 12-week, double-blind, placebo-controlled, parallel-group study in patients randomized to indacaterol 150 μg, indacaterol 300 μg or placebo once daily were analyzed based on baseline disease severity (moderate or severe). Endpoints were: trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) at Week 12. Safety data were collected. Of 347 patients randomized, 59.7% had moderate, and 40.3% had severe COPD. Least squares means (LSMs) indacaterol-placebo differences in trough FEV(1) at Week 12 exceeded the pre-specified minimal clinically important difference (MCID) of 0.12L and were statistically superior (p indacaterol (150 μg, 300 μg) versus placebo in the two subgroups [0.19L, 0.20L (moderate); 0.15L, 0.19L (severe) respectively]. LSM TDI scores for both indacaterol doses versus placebo in both subgroups were statistically superior (p indacaterol doses showed improvements in LSM SGRQ total scores at Week 12 which exceeded the MCID (4 units) versus placebo in both subgroups, with indacaterol 300 μg-placebo difference in the severe subgroup being statistically significant (p indacaterol than with placebo across both subgroups. Indacaterol demonstrated clinically relevant improvements versus placebo in lung function, dyspnea and health status in Asian COPD patients irrespective of disease severity. NCT00794157. Copyright © 2012 Elsevier Ltd. All rights reserved.

  14. Design of the Resistance and Endurance exercise After ChemoTherapy (REACT study: A randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue

    Directory of Open Access Journals (Sweden)

    van Mechelen Willem

    2010-11-01

    Full Text Available Abstract Background Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. Methods After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group. After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to. Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities. Measurements will be performed at baseline (t = 0, 12 weeks after randomization (t = 1, and 64 weeks after randomization (t = 2. The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance

  15. Exercise Training in Treatment and Rehabilitation of Hip Osteoarthritis: A 12-Week Pilot Trial

    Directory of Open Access Journals (Sweden)

    Kirsti Uusi-Rasi

    2017-01-01

    Full Text Available Introduction. Osteoarthritis (OA of the hip is one of the major causes of pain and disability in the older population. Although exercise is an effective treatment for knee OA, there is lack of evidence regarding hip OA. The aim of this trial was to test the safety and feasibility of a specifically designed exercise program in relieving hip pain and improving function in hip OA participants and to evaluate various methods to measure changes in their physical functioning. Materials and Methods. 13 women aged ≥ 65 years with hip OA were recruited in this 12-week pilot study. Results. Pain declined significantly over 30% from baseline, and joint function and health-related quality of life improved slightly. Objective assessment of physical functioning showed statistically significant improvement in the maximal isometric leg extensor strength by 20% and in the hip extension range of motion by 30%. Conclusions. The exercise program was found to be safe and feasible. The present evidence indicates that the exercise program is effective in the short term. However, adequate powered RCTs are needed to determine effects of long-term exercise therapy on pain and progression of hip OA.

  16. Exercise Training in Treatment and Rehabilitation of Hip Osteoarthritis: A 12-Week Pilot Trial.

    Science.gov (United States)

    Uusi-Rasi, Kirsti; Patil, Radhika; Karinkanta, Saija; Tokola, Kari; Kannus, Pekka; Sievänen, Harri

    2017-01-01

    Introduction. Osteoarthritis (OA) of the hip is one of the major causes of pain and disability in the older population. Although exercise is an effective treatment for knee OA, there is lack of evidence regarding hip OA. The aim of this trial was to test the safety and feasibility of a specifically designed exercise program in relieving hip pain and improving function in hip OA participants and to evaluate various methods to measure changes in their physical functioning. Materials and Methods. 13 women aged ≥ 65 years with hip OA were recruited in this 12-week pilot study. Results. Pain declined significantly over 30% from baseline, and joint function and health-related quality of life improved slightly. Objective assessment of physical functioning showed statistically significant improvement in the maximal isometric leg extensor strength by 20% and in the hip extension range of motion by 30%. Conclusions. The exercise program was found to be safe and feasible. The present evidence indicates that the exercise program is effective in the short term. However, adequate powered RCTs are needed to determine effects of long-term exercise therapy on pain and progression of hip OA.

  17. Better understanding of homologous recombination through a 12-week laboratory course for undergraduates majoring in biotechnology.

    Science.gov (United States)

    Li, Ming; Shen, Xiaodong; Zhao, Yan; Hu, Xiaomei; Hu, Fuquan; Rao, Xiancai

    2017-07-08

    Homologous recombination, a central concept in biology, is defined as the exchange of DNA strands between two similar or identical nucleotide sequences. Unfortunately, undergraduate students majoring in biotechnology often experience difficulties in understanding the molecular basis of homologous recombination. In this study, we developed and implemented a 12-week laboratory course for biotechnology undergraduates in which gene targeting in Streptococcus suis was used to facilitate their understanding of the basic concept and process of homologous recombination. Students worked in teams of two to select a gene of interest to create a knockout mutant using methods that relied on homologous recombination. By integrating abstract knowledge and practice in the process of scientific research, students gained hands-on experience in molecular biology techniques while learning about the principle and process of homologous recombination. The learning outcomes and survey-based assessment demonstrated that students substantially enhanced their understanding of how homologous recombination could be used to study gene function. Overall, the course was very effective for helping biotechnology undergraduates learn the theory and application of homologous recombination, while also yielding positive effects in developing confidence and scientific skills for future work in research. © 2017 by The International Union of Biochemistry and Molecular Biology, 45(4):329-335, 2017. © 2017 The International Union of Biochemistry and Molecular Biology.

  18. Trazodone for the treatment of fibromyalgia: an open-label, 12-week study

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    Morillas-Arques Piedad

    2010-09-01

    Full Text Available Abstract Background Despite its frequent use as a hypnotic, trazodone has not been systematically assessed in fibromyalgia patients. In the present study have we evaluated the potential effectiveness and tolerability of trazodone in the treatment of fibromyalgia. Methods A flexible dose of trazodone (50-300 mg/day, was administered to 66 fibromyalgia patients for 12 weeks. The primary outcome measure was the Pittsburgh Sleep Quality Index (PSQI. Secondary outcome measures included the Fibromyalgia Impact Questionnaire (FIQ, the Beck Depression Inventory (BDI, the Hospital Anxiety and Depression Scale (HADS, the Brief Pain Inventory (BPI, the Short-Form Health Survey (SF-36, and the Patients' Global Improvement Scale (PGI. Trazodone's emergent adverse reactions were recorded. Data were analyzed with repeated measures one-way ANOVA and paired Student's t test. Results Trazodone markedly improved sleep quality, with large effect sizes in total PSQI score as well on sleep quality, sleep duration and sleep efficiency. Significant improvement, although with moderate effect sizes, were also observed in total FIQ scores, anxiety and depression scores (both HADS and BDI, and pain interference with daily activities. Unexpectedly, the most frequent and severe side effect associated with trazodone in our sample was tachycardia, which was reported by 14 (21.2% patients. Conclusions In doses higher than those usually prescribed as hypnotic, the utility of trazodone in fibromyalgia management surpasses its hypnotic activity. However, the emergence of tachycardia should be closely monitored. Trial registration This trial has been registered with ClinicalTrials.gov number NCT-00791739.

  19. The response of the lactate minimum test to a 12-week swimming training

    Directory of Open Access Journals (Sweden)

    Eduardo Zapaterra Campos

    2014-09-01

    Full Text Available Despite the utilization of lactate minimum test (LMT in training, its intensity response to training remains controversial. The aim of the present study was to verify alterations of LMT intensity in swimmers during a 12-week training protocol. Eight swimmers were submitted to three LMT assessments: beginning of the season, T0; after four, T4; and twelve weeks, T12. The LMT consisted of a 200m maximal effort and, after eight minutes of passive rest, five incremental stages of 200m swimming. The intensities of the incremental stages were defined subjectively ("very light," "light," "moderate," "hard," and "all-out". The training was divided in two blocks of periodization: endurance training period (ETP, T0 - T4, and quality plus taper period (QTP, T4 - T12. The LMT intensity of T4 and T12 were significantly higher than T0. We conclude that LMT is modified due to swimming training and can be used for training prescription and detection of aerobic capacity alterations during a season.

  20. The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411

    Directory of Open Access Journals (Sweden)

    Dale Jeremy

    2006-07-01

    Full Text Available Abstract Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months and following an agreed protocol change over 7% (months 13 to 18. Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

  1. A Body Image and Disordered Eating Intervention for Women in Midlife: A Randomized Controlled Trial

    Science.gov (United States)

    McLean, Sian A.; Paxton, Susan J.; Wertheim, Eleanor H.

    2011-01-01

    Objective: This study examined the outcome of a body image and disordered eating intervention for midlife women. The intervention was specifically designed to address risk factors that are pertinent in midlife. Method: Participants were 61 women aged 30 to 60 years (M = 43.92, SD = 8.22) randomly assigned to intervention (n = 32) or (delayed…

  2. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    Science.gov (United States)

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  3. Maintenance of behaviour change after a 12-week mHealth lifestyle programme for young adults.

    Directory of Open Access Journals (Sweden)

    Margaret Allman-Farinelli

    2015-09-01

    Conclusions: Young adulthood is a period of rapid weight gain but this group are hard to reach for health promotion. Despite the relatively low intensity of the TXT2BFiT programme, behaviours were maintained during the six months following the intervention. mHealth shows promise to deliver intervention with wide reach and low cost.

  4. Perspectives on randomization and readiness for change in a workplace intervention study

    DEFF Research Database (Denmark)

    Nabe-Nielsen, Kirsten; Persson, Roger; Nielsen, Karina;

    2015-01-01

    , it is important to investigate differences between study groups in readiness for change. To meet this aim, we used data from an intervention study of the effects of work-time control. The study design entailed both self-selection (i.e. non-random) and random allocation into intervention and control groups. Some...... team leaders rejected randomization because they considered it to be fairest to increase work-time control among employees in most need. Others accepted randomization arguing that it was fairer to allocate a potential benefi t by random. We found no difference in readiness for changes when comparing...

  5. Improvement in Patient Performance of Skin Self-examinations After Intervention With Interactive Education and Telecommunication Reminders: A Randomized Controlled Study.

    Science.gov (United States)

    Aneja, Savina; Brimhall, Angela K; Kast, Douglas R; Aneja, Sanjay; Carlson, Diana; Cooper, Kevin D; Bordeaux, Jeremy S

    2012-11-01

    OBJECTIVE To determine if interactive computerized patient education, skin self-examination (SSE) tutorials, and telecommunication reminders could be combined to increase patient performance of SSEs, increase confidence in ability to identify melanoma, and influence individual melanoma risk perception. DESIGN A total of 132 adult participants from our dermatology clinics were enrolled in an interventional study and randomized to a control group or an intervention group. Survey data were collected from all participants on the day of enrollment and 3 months after enrollment. SETTING University Hospitals Case Medical Center outpatient dermatology clinics. PARTICIPANTS English speakers older than 18 years. INTERVENTIONS The intervention group (1) participated in a computer-assisted learning tutorial, (2) took part in a hands-on SSE tutorial, (3) received monthly telecommunication reminders to perform SSEs for 12 weeks, and (4) received a brochure on melanoma detection. The control group received only the brochure on melanoma detection. MAIN OUTCOME MEASURES Self-report of performance of SSEs. Melanoma risk perception and confidence in ability to identify melanoma were secondary considerations. Logistic regressions, controlling for race, age, sex, education, and family history of melanoma, were used to assess the effectiveness of the intervention. RESULTS At the 3-month follow-up, those in the intervention group were more likely to perform SSEs (odds ratio [OR], 2.36; P ≤ .05). In addition, those who participated in the intervention were more likely to report being confident in their ability to identify melanoma during an SSE (OR, 2.72; P ≤ .05). CONCLUSION Computer-assisted patient education used in conjunction with a hands-on SSE tutorial and telecommunication reminders can increase patient performance of SSEs and confidence in the ability to identify melanoma.

  6. Improving Parental Stress Levels Among Mothers Living with HIV: A Randomized Control Group Intervention Study

    OpenAIRE

    Johnson, Erica R.; Davies, Susan L.; Aban, Inmaculada; Mugavero, Michael J.; Shrestha, Sadeep; Kempf, Mirjam-Colette

    2015-01-01

    Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of P...

  7. Long-term Diet and Biomarker Changes after a Short-term Intervention among Hispanic Breast Cancer Survivors: The ¡Cocinar Para Su Salud! Randomized Controlled Trial.

    Science.gov (United States)

    Greenlee, Heather; Ogden Gaffney, Ann; Aycinena, A Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M; Shi, Zaixing; Lim, Emerson; Tsai, Wei-Yann; Santella, Regina M; Blaner, William S; Clugston, Robin D; Cremers, Serge; Pollak, Susan; Sirosh, Iryna; Crew, Katherine D; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L

    2016-11-01

    Among Hispanic breast cancer survivors, we examined the long-term effects of a short-term culturally based dietary intervention on increasing fruits/vegetables (F/V), decreasing fat, and changing biomarkers associated with breast cancer recurrence risk. Spanish-speaking women (n = 70) with a history of stage 0-III breast cancer who completed treatment were randomized to ¡Cocinar Para Su Salud! (n = 34), a culturally based 9-session program (24 hours over 12 weeks, including nutrition education, cooking classes, and food-shopping field trips), or a control group (n = 36, written dietary recommendations for breast cancer survivors). Diet recalls, fasting blood, and anthropometric measures were collected at baseline, 6, and 12 months. We report changes between groups at 12 months in dietary intake and biomarkers using 2-sample Wilcoxon t tests and generalized estimating equation (GEE) models. At 12 months, the intervention group compared with the control group reported higher increases in mean daily F/V servings (total: +2.0 vs. -0.4; P Salud! program was effective at increasing long-term F/V intake in Hispanic breast cancer survivors and changed biomarkers associated with breast cancer recurrence risk. It is possible for short-term behavioral interventions to have long-term effects on behaviors and biomarkers in minority cancer patient populations. Results can inform future study designs. Cancer Epidemiol Biomarkers Prev; 25(11); 1491-502. ©2016 AACR. ©2016 American Association for Cancer Research.

  8. Perspectives on randomization and readiness for change in a workplace intervention study

    DEFF Research Database (Denmark)

    Nabe-Nielsen, Kirsten; Persson, Roger; Nielsen, Karina

    2015-01-01

    team leaders rejected randomization because they considered it to be fairest to increase work-time control among employees in most need. Others accepted randomization arguing that it was fairer to allocate a potential benefi t by random. We found no difference in readiness for changes when comparing......, it is important to investigate differences between study groups in readiness for change. To meet this aim, we used data from an intervention study of the effects of work-time control. The study design entailed both self-selection (i.e. non-random) and random allocation into intervention and control groups. Some...... refl ect the local leaders’ rather than the employees’ readiness for changes and that randomization may infl uence the participants’ attitude towards the intervention perhaps by evoking an experience of ‘winning or losing in the lottery’....

  9. A 12-Week Exercise Program for Pregnant Women with Obesity to Improve Physical Activity Levels: An Open Randomised Preliminary Study.

    Directory of Open Access Journals (Sweden)

    Michèle Bisson

    Full Text Available To evaluate whether a 12-week supervised exercise program promotes an active lifestyle throughout pregnancy in pregnant women with obesity.In this preliminary randomised trial, pregnant women (body mass index ≥ 30 kg/m2 were allocated to either standard care or supervised training, from 15 to 27 weeks of gestation. Physical activity was measured by accelerometry at 14, 28 and 36 weeks, while fitness (oxygen consumption (VO2 at the anaerobic threshold, nutrition (caloric intake and macronutrients percentage and anthropometry were assessed at 14 and 28 weeks of gestation. Analyses were performed using repeated measures ANOVA.A total of fifty (50 women were randomised, 25 in each group. There was no time-group interaction for time spent at moderate and vigorous activity (pinteraction = 0.064, but the exercise group's levels were higher than controls' at all times (pgroup effect = 0.014. A significant time-group interaction was found for daily physical activity (p = 0.023; similar at baseline ((22.0 ± 6.7 vs 21.8 ± 7.3 x 10(4 counts/day the exercise group had higher levels than the control group following the intervention ((22.8 ± 8.3 vs 19.2 ± 4.5 x 10(4 counts/day, p = 0.020 and at 36 weeks of gestation ((19.2 ± 1.5 vs 14.9 ± 1.5 x 10(4 counts/day, p = 0.034. Exercisers also gained less weight than controls during the intervention period despite similar nutritional intakes (difference in weight change = -0.1 kg/week, 95% CI -0.2; -0.02, p = 0.016 and improved cardiorespiratory fitness (difference in fitness change = 8.1%, 95% CI 0.7; 9.5, p = 0.041.Compared with standard care, a supervised exercise program allows pregnant women with obesity to maintain fitness, limit weight gain and attenuate the decrease in physical activity levels observed in late pregnancy.ClinicalTrials.gov NCT01610323.

  10. The effect of 12 weeks Prop Pilates Exercise Program (PPEP) on body stability and pain for fruit farmers with MSDs.

    Science.gov (United States)

    Kim, Hye-Jin; Nam, Sang-Nam; Bae, Ung Ryel; Hwang, Ryong; Lee, Jong-Bok; Kim, Jong-Hyuck

    2014-01-01

    The purpose of this study was to determine possible effects of 12-week Prop Pilates Exercise Program (PPEP) for the fruit farmers (grape, tomato, apple) with musculoskeletal disorders (MSD) on body stability and pain. 131 fruit farmers with MSD were selected and asked to join a 12-week Prop Pilates Exercise Program (PPEP) from 2009 to 2012. The subjects (female=74, male=57) aged 50 to 65 years old voluntarily participated. As a result, it was found that lateral-medial and anterior-posterior of body stability significantly improved in male and female fruit farmers. It was found that pain index (VAS) after 12-week Prop Pilates Exercise Program (PPEP) showed a significant decrease.

  11. Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

    Science.gov (United States)

    Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

    2015-01-01

    Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

  12. Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-Income Latinos: Latinos en Control

    Directory of Open Access Journals (Sweden)

    Lemon Stephenie C

    2009-12-01

    Full Text Available Abstract Background US Latinos have greater prevalence of type 2 diabetes (diabetes, uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos. Methods and design This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control on glycemic control among low-income Latinos with diabetes, compared to usual care (control. Participants were recruited from five community health centers (CHCs in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c. Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%. Discussion Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need. Trial registration http://www.clinicaltrials.gov # NCT00848315

  13. Can Musical or Painting Interventions Improve Chronic Pain, Mood, Quality of Life, and Cognition in Patients with Mild Alzheimer's Disease? Evidence from a Randomized Controlled Trial.

    Science.gov (United States)

    Pongan, Elodie; Tillmann, Barbara; Leveque, Yohana; Trombert, Béatrice; Getenet, Jean Claude; Auguste, Nicolas; Dauphinot, Virginie; El Haouari, Hanane; Navez, Malou; Dorey, Jean-Michel; Krolak-Salmon, Pierre; Laurent, Bernard; Rouch, Isabelle

    2017-01-01

    Among non-pharmacological therapies, musical intervention is often used for patients with Alzheimer's disease (AD) and patients presenting chronic pain. However, their efficacy is still under debate. Our aim was to determine the efficacy of choral singing versus painting sessions on chronic pain, mood, quality of life, and cognition in AD patients. In this multicenter randomized controlled trial, 59 mild AD patients were randomized to a 12-week singing (SG; n = 31) or painting group (PG; n = 28). Chronic pain, anxiety, depression, and quality of life were assessed before, after, and 1 month after the sessions. Cognitive abilities were assessed before and after interventions. The evolution of these different measures was assessed with mixed linear models. The primary data analysis was by intention-to-treat, and completed by a 'per protocol' approach. Both singing and painting interventions led to significant pain reduction (Time effect: F = 4.71; p = 0.01), reduced anxiety (Time effect: F = 10.74; p effect: F = 6.79; p = 0.002), improved digit span (F = 12.93; p = 0.001), and inhibitory processes (Time effect: F = 4.93; p = 0.03). Depression was reduced over time in PG only (Time x Group effect: F = 4.53; p = 0.01). Verbal Memory performance remained stable over time in SG, but decreased in PG (Time x group effect: F = 9.29; p = 0.004). Findings suggest that singing and painting interventions may reduce pain and improve mood, quality of life, and cognition in patients with mild AD, with differential effects of painting for depression and singing for memory performance.

  14. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    National Research Council Canada - National Science Library

    Pitchford, Nicola J

    2015-01-01

    .... This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi...

  15. Effects of a 12-week intervention period with football and running for habitually active men with mild hypertension

    DEFF Research Database (Denmark)

    Knoepfli-Lenzin, C.; Sennhauser, C.; Toigo, M.

    2010-01-01

    /L) but was not altered in R and C. We conclude that football training, consisting of high-intensity intermittent exercise, results in positive effects on blood pressure, body composition, stroke volume and supine heart rate variability, and elicits at least the same cardiovascular health benefits as continuous running......) and total fat mass (-2.0 +/- 1.5 vs -1.6 +/- 1.5 kg) and in increasing supine heart rate variability, whereas no changes were detected for C. Maximal stroke volume improved in F (+13.1%) as well as in R (+10.1%) compared with C (-4.9%). Total cholesterol decreased in F (5.8 +/- 1.2 to 5.5 +/- 0.9 mmol...... exercise in habitually active men with mild hypertension....

  16. Bifidogenic effect of whole-grain wheat during a 12-week energy-restricted dietary intervention in postmenopausal women

    DEFF Research Database (Denmark)

    Christensen, Ellen Gerd; Licht, Tine Rask; Kristensen, M.

    2013-01-01

    Background/Objectives:Consumption of whole-grain products is known to have beneficial effects on human health. The effects of whole-grain products on the intestinal microbiota and intestinal integrity have, however, only been studied limitedly. We investigate changes of the human gut microbiota c...... Nutrition advance online publication, 23 October 2013; doi:10.1038/ejcn.2013.207....

  17. Biliary effects of liraglutide and sitagliptin, a 12-week randomized placebo-controlled trial in type 2 diabetes patients

    NARCIS (Netherlands)

    Smits, Mark M.; Tonneijck, Lennart; Muskiet, Marcel H. A.; Hoekstra, Trynke; Kramer, Mark H. H.; Diamant, Michaela; Nieuwdorp, Max; Groen, Albert K.; Cahen, Djuna L.; van Raalte, Daniel H.

    2016-01-01

    AimsTreatment with glucagon-like peptide (GLP)-1 receptor agonists or dipeptidyl peptidase (DPP)-4 inhibitors might increase gallstone formation; however, the mechanisms involved are unknown. We aimed to assess the effects of these drugs on gallbladder volume and bile acid profile. Materials and met

  18. Biliary effects of liraglutide and sitagliptin, a 12-week randomized placebo-controlled trial in type 2 diabetes patients

    NARCIS (Netherlands)

    M.M. Smits (Mark M.); L. Tonneijck (Lennart); M.H.A. Muskiet (Marcel H. A.); T. Hoekstra (Trynke); M.H.H. Kramer (Mark); M. Diamant (Michaela); M. Nieuwdorp (Max); A. Groen (Albert); D.L. Cahen (Djuna); D.H. van Raalte (Daniël H.)

    2016-01-01

    textabstractAims: Treatment with glucagon-like peptide (GLP)-1 receptor agonists or dipeptidyl peptidase (DPP)-4 inhibitors might increase gallstone formation; however, the mechanisms involved are unknown. We aimed to assess the effects of these drugs on gallbladder volume and bile acid profile. Mat

  19. Biliary effects of liraglutide and sitagliptin, a 12-week randomized placebo-controlled trial in type 2 diabetes patients

    NARCIS (Netherlands)

    M.M. Smits (Mark M.); L. Tonneijck (Lennart); M.H.A. Muskiet (Marcel H. A.); T. Hoekstra (Trynke); M.H.H. Kramer (Mark); M. Diamant (Michaela); M. Nieuwdorp (Max); A. Groen (Albert); D.L. Cahen (Djuna); D.H. van Raalte (Daniël H.)

    2016-01-01

    textabstractAims: Treatment with glucagon-like peptide (GLP)-1 receptor agonists or dipeptidyl peptidase (DPP)-4 inhibitors might increase gallstone formation; however, the mechanisms involved are unknown. We aimed to assess the effects of these drugs on gallbladder volume and bile acid profile.

  20. Biliary effects of liraglutide and sitagliptin, a 12-week randomized placebo-controlled trial in type 2 diabetes patients

    NARCIS (Netherlands)

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, Trynke; Kramer, Mark H H; Diamant, Michaela; Nieuwdorp, Max; Groen, Albert K; Cahen, Djuna L; van Raalte, Daniël H

    2016-01-01

    AIMS: Treatment with glucagon-like peptide (GLP)-1 receptor agonists or dipeptidyl peptidase (DPP)-4 inhibitors might increase gallstone formation; however, the mechanisms involved are unknown. We aimed to assess the effects of these drugs on gallbladder volume and bile acid profile. MATERIALS AND M

  1. Home-Based Intervention Program to Reduce Food Insecurity in Elderly Populations Using a TV App: Study Protocol of the Randomized Controlled Trial Saúde.Come Senior.

    Science.gov (United States)

    Rodrigues, Ana Maria; Gregório, Maria João; Gein, Pierre; Eusébio, Mónica; Santos, Maria José; de Sousa, Rute Dinis; Coelho, Pedro S; Mendes, Jorge M; Graça, Pedro; Oliveira, Pedro; Branco, Jaime C; Canhão, Helena

    2017-03-13

    considering that 50% of the target individuals are food insecure (based on INFOFAMÍLIA Survey) (567) and about 50% of those will adhere to the study (282). The randomized controlled trial with the 12-week home-based intervention with a comprehensive program on healthy eating and physical activity delivery is planned to start recruiting participants at the end of 2017. This study will assess the efficacy of this innovative tool (Saúde.Come Senior) for disseminating relevant health information, modifying behaviors, and decreasing food insecurity in an easy, low-cost, and massive way.

  2. Overcoming Perfectionism: Protocol of a Randomized Controlled Trial of an Internet-Based Guided Self-Help Cognitive Behavioral Therapy Intervention.

    Science.gov (United States)

    Kothari, Radha; Egan, Sarah; Wade, Tracey; Andersson, Gerhard; Shafran, Roz

    2016-11-11

    Perfectionism is elevated across, and increases risk for, a range of psychological disorders as well as having a direct negative effect on day-to-day function. A growing body of evidence shows that cognitive behavioral therapy (CBT) reduces perfectionism and psychological disorders, with medium to large effect sizes. Given the increased desire for Web-based interventions to facilitate access to evidence-based therapy, Internet-based CBT self-help interventions for perfectionism have been designed. Existing Web-based interventions have not included personalized guidance which has been shown to improve outcome rates. To assess the efficacy of an Internet-based guided self-help CBT intervention for perfectionism at reducing symptoms of perfectionism and psychological disorders posttreatment and at 6-month follow-up. A randomized controlled trial method is employed, comparing the treatment arm (Internet-based guided self-help CBT) with a waiting list control group. Outcomes are examined at 3 time points, T1 (baseline), T2 (postintervention at 12 weeks), T3 (follow-up at 24 weeks). Participants will be recruited through universities, online platforms, and social media and if eligible will be randomized using an automatic randomizer. Data will be analyzed to estimate the between group (intervention, control) effect on perfectionism, depression, and anxiety. Completer and intent-to-treat analyses will be conducted. Additional analysis will be conducted to investigate whether the number of modules completed is associated with change. Data collection should be finalized by December 2016, with submission of results for publication expected in mid-year 2017. Results will be reported in line with recommendations in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH). Findings will contribute to the literature on treatment of perfectionism, the effect of

  3. Home-Based Intervention Program to Reduce Food Insecurity in Elderly Populations Using a TV App: Study Protocol of the Randomized Controlled Trial Saúde.Come Senior

    Science.gov (United States)

    Gregório, Maria João; Gein, Pierre; Eusébio, Mónica; Santos, Maria José; de Sousa, Rute Dinis; Coelho, Pedro S; Mendes, Jorge M; Graça, Pedro; Oliveira, Pedro; Branco, Jaime C; Canhão, Helena

    2017-01-01

    recruit a total of 1,128 subjects considering that 50% of the target individuals are food insecure (based on INFOFAMÍLIA Survey) (567) and about 50% of those will adhere to the study (282). Results The randomized controlled trial with the 12-week home-based intervention with a comprehensive program on healthy eating and physical activity delivery is planned to start recruiting participants at the end of 2017. Conclusions This study will assess the efficacy of this innovative tool (Saúde.Come Senior) for disseminating relevant health information, modifying behaviors, and decreasing food insecurity in an easy, low-cost, and massive way. PMID:28288956

  4. A Mixed Methods Evaluation of a 12-Week Insurance-Sponsored Weight Management Program Incorporating Cognitive-Behavioral Counseling

    Science.gov (United States)

    Abildso, Christiaan; Zizzi, Sam; Gilleland, Diana; Thomas, James; Bonner, Daniel

    2010-01-01

    Physical activity is critical in healthy weight loss, yet there is still much to be learned about psychosocial mechanisms of physical activity behavior change in weight loss. A sequential mixed methods approach was used to assess the physical and psychosocial impact of a 12-week cognitive-behavioral weight management program and explore factors…

  5. Physiological changes following a 12 week gym based stair-climbing, elliptical trainer and treadmill running program in females

    OpenAIRE

    EGANA, MIKEL

    2004-01-01

    PUBLISHED Despite the growing popularity of the elliptical trainer aerobic exercise modality the physiological changes induced following a training program using elliptical trainers remains unknown. Donne investigates the metabolic and cardiorespiratory improvements following a 12-week aerobic training program using elliptical trainer, treadmill or stair-climbing modalities. Findings reveal that in moderately active females similar physiological improvements were observed using stair-climb...

  6. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement

    DEFF Research Database (Denmark)

    Skou, Søren Thorgaard; Rasmussen, Sten; Laursen, Mogens Berg

    2015-01-01

    secondary care with knee OA, confirmed by radiography (Kellgren-Lawrence grade ≥1), but not eligible for a TKR. The 12-week non-surgical treatment program consisted of individualized progressed neuromuscular exercise, patient education, insoles, dietary advice and prescription of pain medication...

  7. A Mixed Methods Evaluation of a 12-Week Insurance-Sponsored Weight Management Program Incorporating Cognitive-Behavioral Counseling

    Science.gov (United States)

    Abildso, Christiaan; Zizzi, Sam; Gilleland, Diana; Thomas, James; Bonner, Daniel

    2010-01-01

    Physical activity is critical in healthy weight loss, yet there is still much to be learned about psychosocial mechanisms of physical activity behavior change in weight loss. A sequential mixed methods approach was used to assess the physical and psychosocial impact of a 12-week cognitive-behavioral weight management program and explore factors…

  8. Effect of an herbal/botanical supplement on strength, balance, and muscle function following 12-weeks of resistance training: a placebo controlled study.

    Science.gov (United States)

    Furlong, Jonathan; Rynders, Corey A; Sutherlin, Mark; Patrie, James; Katch, Frank I; Hertel, Jay; Weltman, Arthur

    2014-01-01

    StemSport (SS; StemTech International, Inc. San Clemente, CA) contains a proprietary blend of the botanical Aphanizomenon flos-aquae and several herbal antioxidant and anti-inflammatory substances. SS has been purported to accelerate tissue repair and restore muscle function following resistance exercise. Here, we examine the effects of SS supplementation on strength adaptations resulting from a 12-week resistance training program in healthy young adults. Twenty-four young adults (16 males, 8 females, mean age = 20.5 ± 1.9 years, mass = 70.9 ± 11.9 kg, stature = 176.6 ± 9.9 cm) completed the twelve week training program. The study design was a double-blind, placebo controlled parallel group trial. Subjects either received placebo or StemSport supplement (SS; mg/day) during the training. 1-RM bench press, 1-RM leg press, vertical jump height, balance (star excursion and center of mass excursion), isokinetic strength (elbow and knee flexion/extension) and perception of recovery were measured at baseline and following the 12-week training intervention. Resistance training increased 1-RM strength (p 0.10). These data suggest that compared to placebo, the SS herbal/botanical supplement did not enhance training induced adaptations to strength, balance, and muscle function above strength training alone.

  9. A 12-week low-carbohydrate, high-fat diet improves metabolic health outcomes over a control diet in a randomised controlled trial with overweight defence force personnel.

    Science.gov (United States)

    Zinn, Caryn; McPhee, Julia; Harris, Nigel; Williden, Micalla; Prendergast, Kate; Schofield, Grant

    2017-07-12

    Overweight, obesity, and poor health is becoming a global concern for defence force personnel. Conventional nutrition guidelines are being questioned for their efficacy in achieving optimal body composition and long-term health. This study compared the effects of a 12-week low-carbohydrate, high-fat diet with a conventional, high-carbohydrate, low-fat diet on weight reduction and metabolic health outcomes in at-risk New Zealand Defence Force personnel. In this randomised controlled trial, 41 overweight personnel were assigned to intervention and control groups. Weight, waist circumference, fasting lipids, and glycaemic control were assessed at baseline and at 12 weeks. Within-group change scores were analysed using the t statistic and interpreted using a p resistance; moderate, likely beneficial effects for HDL cholesterol, triglyceride:HDLc ratio and HbA1c; and a small, likely harmful effect for low-density lipoprotein cholesterol. This dietary approach shows promise for short-term weight loss and improved metabolic health outcomes conditions compared with mainstream recommendations. It should be offered to defence force personnel at least as a viable alternative means to manage their weight and health.

  10. Smoking Cessation Intervention After Ischemic Stroke or Transient Ischemic Attack. A Randomized Controlled Pilot Trial

    DEFF Research Database (Denmark)

    Brunner Frandsen, Nicole; Sørensen, Margit; Hyldahl, Tanja Kirstine;

    2012-01-01

    BACKGROUND: Smoking cessation is widely recommended for secondary stroke prevention. However, little is known about the efficacy of smoking cessation intervention after stroke or transient ischemic attack (TIA). METHODS: Ninety-four smokers under age 76, admitted with ischemic stroke or TIA were......-report and verified by measurement of exhaled carbon monoxide (CO). Fewer patients than expected were recruited, which renders this report a pilot study. RESULTS: The 6-month self-reported smoking cessation rate was 37.8% in the minimal intervention group and 42.9% in the intensive intervention group. Smoking...... randomized to minimal smoking cessation intervention or intensive smoking cessation intervention. All patients attended a 30-min individual counseling by the study nurse. Patients randomized to intensive smoking cessation intervention also participated in a 5-session outpatient smoking cessation program...

  11. NSAID Use after Bariatric Surgery : a Randomized Controlled Intervention Study

    NARCIS (Netherlands)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N.

    2016-01-01

    Background Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. Aim To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID

  12. NSAID Use after Bariatric Surgery : a Randomized Controlled Intervention Study

    NARCIS (Netherlands)

    Yska, Jan Peter; Gertsen, Sanneke; Flapper, Gerbrich; Emous, Marloes; Wilffert, Bob; van Roon, Eric N.

    2016-01-01

    Background Use of nonsteroidal anti-inflammatory drugs (NSAIDs) should be avoided in bariatric surgery patients. If use of an NSAID is inevitable, a proton pump inhibitor (PPI) should also be used. Aim To determine the effect of an, compared to care-as-usual, additional intervention to reduce NSAID

  13. A Randomized Trial of a Multifaceted Intervention to Reduce Falls among Community-Dwelling Adults

    Science.gov (United States)

    Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.

    2010-01-01

    Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…

  14. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  15. Brief report : An intervention program for parents of pediatric cancer patients: A randomized controlled trial

    NARCIS (Netherlands)

    Luteijn, EEF; Jackson, SAE; Volkmar, FR; Minderaa, RB

    1998-01-01

    Objective: To evaluate a psychoeducational intervention program for parents of pediatric cancer patients, using cognitive and behavioral techniques. Methods: Parents were randomly assigned to an intervention (n = 39) and a control condition (n = 42). Baseline assessment took place at diagnosis. Shor

  16. Behavioral approach with or without surgical intervention to the vulvar vestibulitis syndrome : A prospective randomized and non randomized study

    NARCIS (Netherlands)

    Schultz, WCMW; Gianotten, WL; vanderMeijden, WI; vandeWiel, HBM; Blindeman, L; Chadha, S; Drogendijk, AC

    1996-01-01

    This article describes the outcome of a behavioral approach with or without preceding surgical intervention in 48 women with the vulvar vestibulitis syndrome. In the first part of the study, 14 women with the vulvar vestibulitis syndrome were randomly assigned to one of two treatment programs: eithe

  17. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    OpenAIRE

    Nicola ePitchford

    2015-01-01

    Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi. A total sample of 318 children, spanning Standards 1-3,...

  18. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    OpenAIRE

    Pitchford, Nicola J.

    2015-01-01

    Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi. A total sample of 318 children, spanning Standards 1–3,...

  19. A pilot randomized controlled trial testing a minimal intervention to prepare breast cancer survivors for recovery

    Science.gov (United States)

    Sterba, Katherine Regan; Armeson, Kent; Franco, Regina; Harper, Jennifer; Patten, Rebecca; Kindall, Stacey; Bearden, James; Zapka, Jane

    2015-01-01

    Background Interventions addressing cancer survivors’ post-treatment concerns can be time-intensive and require specialized staff. Research is needed to identify feasible minimal intervention strategies to improve survivors’ quality of life after treatment. Objectives The objectives of this study were to evaluate the feasibility and short-term impact of a minimal clinic intervention on breast cancer survivors’ quality of life, unmet needs, distress and cancer worry. Interventions/Methods In this randomized controlled pilot trial, we enrolled breast cancer survivors at the end of treatment and administered baseline surveys. Participants were randomized to study arm (4-week video plus educational booklet intervention group and usual care group) and completed follow-up surveys at 10 weeks. Linear regression was used to examine intervention effects on quality of life outcomes controlling for clinical and demographic factors. Open-ended questions were used to examine program satisfaction and obtain feedback to improve the intervention. Results We enrolled 92 survivors in the trial. Participants rated the intervention highly and reported feeling less isolated and having more realistic expectations about their recovery after completing the program. Despite positive qualitative findings, no significant intervention effects were observed for quality of life, unmet needs, distress or cancer worry in unadjusted or adjusted analyses. Conclusions Future research is needed to define optimal intervention elements to prepare breast cancer survivors for the post-treatment period. Implications for Practice Effective survivorship interventions may require more intensive components such as clinical input and longer follow-up periods. PMID:24831043

  20. Low Baseline Interleukin-17A Levels Are Associated with Better Treatment Response at 12 Weeks to Tocilizumab Therapy in Rheumatoid Arthritis Patients

    Directory of Open Access Journals (Sweden)

    Sang Jin Lee

    2015-01-01

    Full Text Available T helper 17-related cytokines have been implicated in rheumatoid arthritis (RA pathogenesis. The study aimed to identify cytokines associated with the treatment response of RA patients to tocilizumab (TCZ, a humanized monoclonal antibody against the interleukin- (IL- 6 receptor. As an independent substudy of the 24-week, randomized, double-blinded CWP-TCZ301 trial of TCZ in RA patients with an inadequate response to disease-modifying antirheumatic drugs, serum levels of cytokines including tumor necrosis factor-alpha, IL-17A, IL-21, IL-23, IL-6, and soluble IL-6 receptor were measured. Baseline IL-17A levels were significantly lower in RA patients who achieved disease activity score 28 (DAS28 remission at 12 weeks of TCZ treatment, compared to patients not in remission. Patients were stratified into IL-17A low group and IL-17A high group. Significantly more patients in the IL-17A low group achieved remission as compared to the IL-17A high group (47.6 versus 17.4%, P=0.032. DAS28 improvement was significantly better in the IL-17A low group than in the IL-17A high group at 12 weeks (P=0.045 and 24 weeks (P=0.046 after adjustment. Other baseline cytokines were not associated with treatment response to TCZ. The data demonstrate that low baseline IL-17A levels are associated with better clinical response to TCZ treatment in RA patients.

  1. Low baseline interleukin-17A levels are associated with better treatment response at 12 weeks to tocilizumab therapy in rheumatoid arthritis patients.

    Science.gov (United States)

    Lee, Sang Jin; Park, Won; Park, Sung Hwan; Shim, Seung-Cheol; Baek, Han Joo; Yoo, Dae-Hyun; Kim, Hyun Ah; Lee, Soo Kon; Leee, Yun Jong; Park, Young Eun; Cha, Hoon-Suk; Park, Jin Kyun; Lee, Eun Young; Lee, Eun Bong; Song, Yeong Wook

    2015-01-01

    T helper 17-related cytokines have been implicated in rheumatoid arthritis (RA) pathogenesis. The study aimed to identify cytokines associated with the treatment response of RA patients to tocilizumab (TCZ), a humanized monoclonal antibody against the interleukin- (IL-) 6 receptor. As an independent substudy of the 24-week, randomized, double-blinded CWP-TCZ301 trial of TCZ in RA patients with an inadequate response to disease-modifying antirheumatic drugs, serum levels of cytokines including tumor necrosis factor-alpha, IL-17A, IL-21, IL-23, IL-6, and soluble IL-6 receptor were measured. Baseline IL-17A levels were significantly lower in RA patients who achieved disease activity score 28 (DAS28) remission at 12 weeks of TCZ treatment, compared to patients not in remission. Patients were stratified into IL-17A low group and IL-17A high group. Significantly more patients in the IL-17A low group achieved remission as compared to the IL-17A high group (47.6 versus 17.4%, P = 0.032). DAS28 improvement was significantly better in the IL-17A low group than in the IL-17A high group at 12 weeks (P = 0.045) and 24 weeks (P = 0.046) after adjustment. Other baseline cytokines were not associated with treatment response to TCZ. The data demonstrate that low baseline IL-17A levels are associated with better clinical response to TCZ treatment in RA patients.

  2. A post-hoc analysis of reduction in diabetic foot ulcer size at 4 weeks as a predictor of healing by 12 weeks.

    Science.gov (United States)

    Snyder, Robert J; Cardinal, Matthew; Dauphinée, Damien M; Stavosky, James

    2010-03-01

    Percent area reduction (PAR) after 4 weeks of diabetic foot ulcer (DFU) treatment has been suggested as a clinical monitoring parameter to distinguish DFUs that will heal within 12 weeks from those that will not despite standard wound care. The purpose of this post-hoc analysis of control DFU treatment outcomes from two published, randomized, controlled studies was to assess the relationship between PAR during early standard wound care and ulcer closure by week 12. The proportion of DFUs healed after 12 weeks was 57% (39 out of 69; 95% confidence interval [CI], 44% to 68%) in study A and 52% (38 out of 73; 95% CI, 40% to 64%) in study B for wounds with > or = 50% PAR by week 4 and 5% (three out of 64; 95% CI, 1% to 13%) and 2% (one out of 44; 95% CI, 0.1% to 12%), respectively, for DFUs with or = 50% PAR (P protocols of care should be re-evaluated if > or = 50% PAR is not achieved. Studies to assess DFU healing before and after 4 weeks of standard wound care are needed to further refine these guidelines of care.

  3. Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

    Science.gov (United States)

    Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty

    2017-01-01

    Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

  4. Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

    Science.gov (United States)

    Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty

    2017-01-01

    Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

  5. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    Science.gov (United States)

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  6. Pragmatic randomized trials with new interventions : An ethical analysis

    NARCIS (Netherlands)

    Kalkman, Shona

    2017-01-01

    Randomized controlled clinical trials (RCTs) are considered fundamental to the optimization of health care decision-making. Today, the drug development and evaluation process is dominated by so-called explanatory RCTs. Such RCTs are carried out in highly-controlled conditions to deliver the best evi

  7. The Social Health Intervention Project (SHIP): protocol for a randomized controlled clinical trial assessing the effectiveness of a brief motivational intervention for problem drinking and intimate partner violence in an urban emergency department.

    Science.gov (United States)

    Rhodes, Karin V; Rodgers, Melissa; Sommers, Marilyn; Hanlon, Alexandra; Crits-Christoph, Paul

    2014-04-18

    There is a strong reciprocal association between two highly prevalent public health problems: intimate partner violence and heavy drinking, both of which remain major sources of morbidity and mortality. Brief interventions in the Emergency Department setting have been found to be effective in reducing alcohol-related injury but neither classic intimate partner violence nor substance abuse interventions have adequately integrated assessment and treatment for these co-occurring conditions. The overall goal of this study is to determine whether a motivational intervention delivered at the time of an Emergency Department visit will reduce heavy drinking and improve the safety of women experiencing intimate partner violence. We are completing data collection for a randomized controlled trial enrolling 600 female patients, age 18-64, presenting to one of two urban Emergency Departments, who self-disclose both problem drinking and intimate partner violence. Eligible patients are randomized to a brief manual-guided motivational intervention, and a phone booster at 10 days. The intervention, which is delivered by masters-level therapists during the Emergency Department visit, is recorded and monitored for fidelity. Primary outcomes are episodes of heavy drinking and incidents of intimate partner violence, assessed weekly by Interactive Voice Response System for 12 weeks and at 3, 6 and 12 months by interviewers blinded to group assignment. To identify the impact of assessment alone, we included a no-contact control group assessed only once at 3 months. Secondary outcomes include violence severity, changes in the Composite Abuse Scale and alcohol quantity/frequency, along with other health-related behaviors. The analysis will also explore the impact of likely mediators and moderators of the intervention. While screening and intervention for intimate partner violence is now recommended for women of child bearing age in health care settings, there is a need for rigorous

  8. Can the Onset of Type 2 Diabetes Be Delayed by a Group-Based Lifestyle Intervention in Women with Prediabetes following Gestational Diabetes Mellitus (GDM? Findings from a Randomized Control Mixed Methods Trial

    Directory of Open Access Journals (Sweden)

    Angela O’Dea

    2015-01-01

    Full Text Available Objective. To evaluate a 12-week group-based lifestyle intervention programme for women with prediabetes following gestational diabetes (GDM. Design. A two-group, mixed methods randomized controlled trial in which 50 women with a history of GDM and abnormal glucose tolerance postpartum were randomly assigned to intervention (n=24 or wait control (n=26 and postintervention qualitative interviews with participants. Main Outcome Measures. Modifiable biochemical, anthropometric, behavioural, and psychosocial risk factors associated with the development of type 2 diabetes. The primary outcome variable was the change in fasting plasma glucose (FPG from study entry to one-year follow-up. Results. At one-year follow-up, the intervention group showed significant improvements over the wait control group on stress, diet self-efficacy, and quality of life. There was no evidence of an effect of the intervention on measures of biochemistry or anthropometry; the effect on one health behaviour, diet adherence, was close to significance. Conclusions. Prevention programmes must tackle the barriers to participation faced by this population; home-based interventions should be investigated. Strategies for promoting long-term health self-management need to be developed and tested.

  9. A 12-Week Exercise Therapy Program in Middle-Aged Patients With Degenerative Meniscus Tears

    DEFF Research Database (Denmark)

    Stensrud, Silje; Roos, Ewa M.; Risberg, May Arna

    2012-01-01

    , progression, tolerance, and potential benefit from an exercise therapy program in these patients who have not had surgery. This study describes a progressive exercise therapy program aiming at improving neuromuscular function and muscle strength in middle-aged patients with degenerative meniscus tears......Normal 0 false false false EN-US X-NONE X-NONE MicrosoftInternetExplorer4 STUDY DESIGN: Case Series. BACKGROUND: Exercise is a viable treatment alternative to arthroscopic partial meniscectomy in patients with degenerative meniscus tears. No study has reported in detail type of exercises...... global rating of change scale, isokinetic knee muscle strength tests, and 3 lower extremity performance tests. Post intervention there were clinically meaningful changes (greater than 10 points) in 16 of 20 patients on the KOOS knee related quality of life, 19 of 20 patients rated themselves as "a lot...

  10. ¡Cocinar Para Su Salud!: Randomized Controlled Trial of a Culturally Based Dietary Intervention among Hispanic Breast Cancer Survivors.

    Science.gov (United States)

    Greenlee, Heather; Gaffney, Ann Ogden; Aycinena, A Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M; Lim, Emerson; Tsai, Wei-Yann; Crew, Katherine; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L

    2015-05-01

    There is a need for culturally relevant nutrition programs targeted to underserved cancer survivors. Our aim was to examine the effect of a culturally based approach to dietary change on increasing fruit/vegetable (F/V) intake and decreasing fat intake among Hispanic breast cancer survivors. Participants were randomized to Intervention and Control groups. Diet recalls, detailed interviews, fasting blood, and anthropometric measures were collected at baseline, 3, 6, and 12 months. Hispanic women (n=70) with stage 0 to III breast cancer who completed adjuvant treatment and lived in New York City were randomized between April 2011 and March 2012. The Intervention group (n=34) participated in ¡Cocinar Para Su Salud!, a culturally based nine-session (24 hours over 12 weeks) intervention including nutrition education, cooking classes, and food-shopping field trips. The Control group (n=36) received written dietary recommendations for breast cancer survivors. Change at 6 months in daily F/V servings and percent calories from total fat were the main outcome measures. Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to 3 and 6 months. Baseline characteristics were the following: mean age 56.6 years (standard deviation 9.7 years), mean time since diagnosis 3.4 years (standard deviation 2.7 years), mean body mass index (calculated as kg/m(2)) 30.9 (standard deviation 6.0), 62.9% with annual household income ≤$15,000, mean daily servings of all F/V was 5.3 (targeted F/V 3.7 servings excluding legumes/juices/starchy vegetables/fried foods), and 27.7% of daily calories from fat. More than 60% in the Intervention group attended seven or more of nine classes, with overall study retention of 87% retention at 6 months. At month 6, the Intervention group compared with Control group reported an increase in mean servings of F/V from baseline (all F/V: +2.0 vs -0.1; P=0.005; targeted F

  11. Efficacy of a reading and language intervention for children with Down syndrome: a randomized controlled trial.

    Science.gov (United States)

    Burgoyne, Kelly; Duff, Fiona J; Clarke, Paula J; Buckley, Sue; Snowling, Margaret J; Hulme, Charles

    2012-10-01

    This study evaluates the effects of a language and literacy intervention for children with Down syndrome. Teaching assistants (TAs) were trained to deliver a reading and language intervention to children in individual daily 40-min sessions. We used a waiting list control design, in which half the sample received the intervention immediately, whereas the remaining children received the treatment after a 20-week delay. Fifty-seven children with Down syndrome in mainstream primary schools in two U.K. locations (Yorkshire and Hampshire) were randomly allocated to intervention (40 weeks of intervention) and waiting control (20 weeks of intervention) groups. Assessments were conducted at three time points: pre-intervention, after 20 weeks of intervention, and after 40 weeks of intervention. After 20 weeks of intervention, the intervention group showed significantly greater progress than the waiting control group on measures of single word reading, letter-sound knowledge, phoneme blending and taught expressive vocabulary. Effects did not transfer to other skills (nonword reading, spelling, standardised expressive and receptive vocabulary, expressive information and grammar). After 40 weeks of intervention, the intervention group remained numerically ahead of the control group on most key outcome measures; but these differences were not significant. Children who were younger, attended more intervention sessions, and had better initial receptive language skills made greater progress during the course of the intervention. A TA-delivered intervention produced improvements in the reading and language skills of children with Down syndrome. Gains were largest in skills directly taught with little evidence of generalization to skills not directly taught in the intervention. © 2012 The Authors. Journal of Child Psychology and Psychiatry © 2012 Association for Child and Adolescent Mental Health.

  12. Facilitating sunscreen use in women by a theory-based online intervention: a randomized controlled trial.

    Science.gov (United States)

    Craciun, Catrinel; Schüz, Natalie; Lippke, Sonia; Schwarzer, Ralf

    2012-03-01

    This study compares a motivational skin cancer prevention approach with a volitional planning and self-efficacy intervention to enhance regular sunscreen use. A randomized controlled trial (RCT) was conducted with 205 women (mean age 25 years) in three groups: motivational; volitional; and control. Sunscreen use, action planning, coping planning and coping self-efficacy were assessed at three points in time. The volitional intervention improved sunscreen use. Coping planning emerged as the only mediator between the intervention and sunscreen use at Time 3. Findings point to the role played by coping planning as an ingredient of sun protection interventions.

  13. An intervention for reducing secondary traumatization and improving professional self-efficacy in well baby clinic nurses following war and terror: a random control group trial.

    Science.gov (United States)

    Berger, Rony; Gelkopf, Marc

    2011-05-01

    Due to the terror and war-related situation in Israel, well baby clinic nurses dealing with a large number of traumatized and highly distressed infants, toddlers and their parents have become overwhelmed. (1) Assess the level of secondary traumatization, including lack of compassion satisfaction, burnout and compassion fatigue of well baby clinic nurses living under chronic threat of war and terror. (2) Assess the efficacy of an intervention aimed at providing well baby clinic nurses with psycho-educational knowledge pertaining to stress and trauma in infants, young children and parents. This intervention provides the nurses with screening tools for identifying children and parents at risk of developing stress-related problems and equips them with stress management techniques. Quasi-random control trial. The intervention took place in Israel, in war (North) and terror (South) affected areas. Ninety well baby clinic nurses from the most war and terror affected areas in Israel were approached, 42 were randomly assigned the experimental intervention and 38 served as a waiting list group. The intervention was comprised of 12 weekly 6-h sessions. Each session included theoretical knowledge, experiential exercises based on the nurses' work or personal life experience, and the learning of skills accompanied by homework assignments. Participants were assessed on self-report measures of secondary traumatization, professional self-efficacy, hope, sense of mastery and self-esteem before and after the intervention. (1) Well baby clinic nurses were found to have elevated secondary traumatization levels. (2) Compared to the waiting list group, the intervention group improved significantly on the professional self-efficacy measure as well as reducing the level of secondary traumatization. Furthermore, improvement on all secondary traumatization measures covaried with the improvement on the professional self-efficacy assessments. Based on additional informal reports, the

  14. A 12-week resistance training program elicits positive changes in hemodynamic responses in the elderly

    Directory of Open Access Journals (Sweden)

    Cinthya Campos Salazar

    2009-03-01

    Full Text Available The aim of the study was to determine the effect of a resistance training program in hemodynamic responses and adaptations in 60 yr. old elderly. Volunteers were 60 healthy-elderly who underwent a training program 3 times/wk. for 12 wk. Participants were randomly assigned to either a control group, an exercise group who trained at 30% intensity of 5 maximal repetitions (5RM (30% of 5RM or an exercise group at an intensity of 70% (70% of 5RM. Hemodynamic variables measured were mean arterial pressure (MAP, calculated before and immediately after the training session, and rate pressure product (RPP, estimated once a month and before and after finishing the program. Results indicated that resistance exercise training at 30% and 70% of 5RM, with a total exercise work of 872.7 and 890.9 kg did not elicited cardiovascular risks for the elderly. A 12-wk resistance exercise training reduced the cardiovascular strain as shown by the RPP (~16% and the MAP (~9%, with no adverse effects throughout the program. Unfortunately, all the hemodynamic benefits were reverted 6 days following completion of the program. In conclusion, a healthy elderly population must perform resistance training exercises to significantly reduce the cardiovascular stress. We suggest to conduct further research that looks into different exercise intensities in longer program duration and to determine the mechanisms responsible for the deleterious effects of the detraining by using physiological, biochemical and biomechanical variables.

  15. Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors : A cluster randomized trial

    NARCIS (Netherlands)

    Verdurmen, Jacqueline E E; Koning, Ina M.; Vollebergh, Wilma A M; van den Eijnden, Regina J J M; Engels, Rutger C M E

    2014-01-01

    Objective: To examine risk moderation of an alcohol intervention targeting parents and adolescents. Design: A cluster randomized trial including 2937 Dutch early adolescents (m=12.68. years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention, combin

  16. Effectiveness of a Multidimensional Randomized Control Intervention to Reduce Quartz Exposure Among Construction Workers.

    Science.gov (United States)

    van Deurssen, Erik; Meijster, Tim; Oude Hengel, Karen M; Boessen, Ruud; Spaan, Suzanne; Tielemans, Erik; Heederik, Dick; Pronk, Anjoeka

    2015-10-01

    There is little evidence with respect to the effectiveness of intervention programs that focus on the reduction of occupational quartz exposure in the construction industry. This article evaluates the effectiveness of a multidimensional intervention which was aimed at reducing occupational quartz exposure among construction workers by increasing the use of technical control measures. Eight companies participating in the cluster randomized controlled trial were randomly allocated to the intervention (four companies) or control condition (four companies). The multidimensional intervention included engineering, organizational, and behavioural elements at both organizational and individual level. Full-shift personal quartz exposure measurements and detailed observations were conducted before and after the intervention among bricklayers, carpenters, concrete drillers, demolishers, and tuck pointers (n = 282). About 59% of these workers measured at baseline were reassessed during follow-up. Bayesian hierarchical models were used to evaluate the intervention effect on exposure levels. Concrete drillers in the intervention group used technical control measures, particularly water suppression, for a significantly greater proportion of the time spent on abrasive tasks during follow-up compared to baseline (93 versus 62%; P quartz exposure (73 versus 40% in the intervention and control group respectively; P quartz exposure among high exposed construction workers.

  17. A randomized controlled trial of an appearance-based dietary intervention

    OpenAIRE

    2013-01-01

    Objective: Inadequate fruit and vegetable consumption precipitates preventable morbidity and mortality. The efficacy of an appearance-based dietary intervention was investigated, which illustrates the beneficial effect that fruit and vegetable consumption has on skin appearance. Methods: Participants were randomly allocated to three groups receiving information-only or a generic or own-face appearance-based intervention. Diet was recorded at baseline and 10 weekly follow-ups. Participants in ...

  18. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials

    OpenAIRE

    Van Der Heijden, Marianne J. E.; Araghi, Sadaf Oliai; Jeekel, Hans; Reiss, Irwin; Hunink, M G M; van Dijk, Monique

    2016-01-01

    textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants' well-being. Methods: We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were ...

  19. Study protocol: a pragmatic randomised controlled trial of a 12-week physical activity and nutritional education program for overweight Aboriginal and Torres Strait Islander women

    Directory of Open Access Journals (Sweden)

    Cargo Margaret

    2011-08-01

    Full Text Available Abstract Background Aboriginal and Torres Strait Islander women have a higher prevalence and incidence of obesity and type 2 diabetes than non-Indigenous Australian women. Physical inactivity is a key modifiable risk factor for obesity and evidence shows that even modest reductions in waist circumference (WC have significant health benefits. Trialing physical activity programs in difficult-to-reach high risk groups, especially urban Indigenous Australians poses distinct implementation challenges. Methods/Design The trial objective is to evaluate the effectiveness of a structured 12-week physical activity group program with nutritional advice. The design is a pragmatic randomised controlled trial. This study protocol describes the implementation and evaluation of the program. Participants are randomised into either an intervention or waitlisted group. The waitlisted group have a 12 month waiting period before commencing the 12-week program. Participant data is collected at baseline, 12, 24 and 52 weeks. Participants are Aboriginal and Torres Strait Islander women, aged 18-64 years with a waist circumference greater than 80 centimetres residing in Adelaide. The primary outcome measure is WC change immediately post program from baseline. Secondary outcomes include short term and long term changes in WC, weight, blood pressure, fasting blood glucose, insulin, insulin resistance (calculated HOMA, haemoglobin A1C (HbA1C, triglycerides and C-reactive protein (CRP. Behavioural and psychosocial surveys are administered to assess physical activity, dietary intake and the participant's motivation, self-efficacy and perceived social support for physical activity. Qualitative interviews focusing on participants' motivation, enablers and barriers to healthy eating and physical activity will be undertaken. Implementation fidelity and participation are also assessed. Discussion The Aboriginal and Torres Strait Islander Women's Fitness Program (WFP is designed

  20. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials

    OpenAIRE

    Bradley, Clare

    1993-01-01

    The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partial...

  1. Testing a workplace physical activity intervention: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jackson Cath

    2011-04-01

    Full Text Available Abstract Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg and resting heart rate (B = -2.08 beats and significantly increased body mass index (B = .18 units compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396

  2. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    Directory of Open Access Journals (Sweden)

    Sang Hyuk Park

    2016-01-01

    Full Text Available Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%–8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6–12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6–12 weeks (47.4% versus 26.7%, P=0.191 than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6–12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks.

  3. Clinical Application of Revised Laboratory Classification Criteria for Antiphospholipid Antibody Syndrome: Is the Follow-Up Interval of 12 Weeks Instead of 6 Weeks Significantly Useful?

    Science.gov (United States)

    Park, Sang Hyuk; Jang, Seongsoo; Park, Chan-Jeoung; Chi, Hyun-Sook

    2016-01-01

    Background. According to revised classification criteria of true antiphospholipid antibody syndrome, at least one of three antiphospholipid antibodies should be present on two or more occasions at least 12 weeks apart. However, it can be inconvenient to perform follow-up tests with interval of 12 weeks. We investigated clinical application of follow-up tests with interval of 12 weeks. Method. Totals of 67, 199, and 332 patients tested positive initially for the lupus anticoagulants confirm, the anti-β 2 glycoprotein-I antibody, and the anti-cardiolipin antibody test, respectively, from Jan 2007 to Jul 2009. We investigated clinical symptoms of patients, follow-up interval, and results of each test. Results. Among patients with initial test positive, 1.5%-8.5% were subjected to follow-up tests at interval of more than 12 weeks. Among 25 patients with negative conversion in tests, patients with interval of more than 12 weeks showed clinical symptom positivity of 33.3%, which was higher than that of 12.5% with 6-12 weeks. Among 34 patients with persistent test positive, clinical symptoms positivity trended to be more evident in patients at interval of 6-12 weeks (47.4% versus 26.7%, P = 0.191) than more than 12 weeks. Conclusion. Less than 10% of patients with initial test positive had follow-up tests at interval of more than 12 weeks and the patients with persistent test positive at interval of more than 12 weeks showed trends toward having lower clinical symptoms than 6-12 weeks. More research is needed focused on the evidence that follow-up test at interval of more than 12 weeks should be performed instead of 6 weeks.

  4. The effect of a prenatal lifestyle intervention on glucose metabolism: results of the Norwegian Fit for Delivery randomized controlled trial

    National Research Council Canada - National Science Library

    Linda R Sagedal; Ingvild Vistad; Nina C Overby; Elling Bere; Monica K Torstveit; Hilde Lohne-Seiler; Elisabet R Hillesund; Are Pripp; Tore Henriksen

    2017-01-01

    .... The Norwegian Fit for Delivery (NFFD) randomized, controlled trial studied the effect of a combined lifestyle intervention provided to a general population, and found significantly lower gestational weight gain among intervention...

  5. A randomized controlled trial of the efficacy of a stigma reduction intervention for HIV-infected women in the Deep South.

    Science.gov (United States)

    Barroso, Julie; Relf, Michael V; Williams, Megan Scull; Arscott, Joyell; Moore, Elizabeth D; Caiola, Courtney; Silva, Susan G

    2014-09-01

    The aim of this study was to compare outcomes (self-esteem, coping self-efficacy, and internalized stigma) across time in HIV-infected women living in the Deep South who received a stigma reduction intervention (n=51) with those of a control group (n=49) who received the usual care at baseline, and at 30 and 90 days. We recruited 99 women from clinics and an AIDS service organization; they were randomized by recruitment site. A video developed from the results of a qualitative metasynthesis study of women with HIV infection was loaded onto iPod Touch devices. Participants were asked to watch the video weekly for 4 weeks, and to record the number of times they viewed it over a 12-week period. We examined the trajectory model results for efficacy outcomes for the intent-to-treat and the supplemental completers groups. There was a treatment-by-time effect for improved self-esteem (intent-to-treat: p=0.0308; completers: p=0.0284) and decreases in internalized stigma (intent-to-treat: p=0.0036; completers: p=0.0060), and a treatment-by-time-by-time effect for improved coping self-efficacy (intent-to-treat: p=0.0414; completers: p=0.0321). A medium effect of the intervention in terms of improving self-esteem was observed when compared with the control condition in those who completed the study. The magnitude of the intervention effect, however, was large with regard to reducing overall stigma, improving social relationships, and decreasing stereotypes in both groups.

  6. Reduced bone resorption by intake of dietary vitamin D and K from tailor-made Atlantic salmon: a randomized intervention trial

    Science.gov (United States)

    Graff, Ingvild Eide; Øyen, Jannike; Kjellevold, Marian; Frøyland, Livar; Gjesdal, Clara Gram; Almås, Bjørg; Rosenlund, Grethe; Lie, Øyvind

    2016-01-01

    Suboptimal vitamin D status is common among humans, and might increase bone resorption with subsequent negative effects on bone health. Fatty fish, including Atlantic salmon, is an important dietary vitamin D source. However, due to a considerable change in fish feed composition, the contribution of vitamin D from salmon fillet has been reduced. The main objective was to investigate if intake of vitamin D3 enriched salmon or vitamin D3 tablets decreased bone biomarkers (urinary N-telopeptides, deoxypyridinoline, serum bone-specific alkaline phosphatase, and osteocalcin) compared to a low vitamin D3 intake. The 122 healthy postmenopausal women included in this 12 weeks intervention trial were randomized into four groups: three salmon groups (150 grams/two times/week) and one tablet group (800 IU vitamin D and 1000 mg calcium/day). The salmon groups also received calcium supplements. The salmon had three different vitamin D3/vitamin K1 combinations: high D3+high K1, low D3+high K1, or high D3+low K1. Increased intake of salmon containing high levels of vitamin D3 (0.35-0.38 mg/kg/fillet) and supplements with the same weekly contribution had a positive influence on bone health as measured by bone biomarkers in postmenopausal women. Consequently, an increased level of vitamin D3 at least to original level in feed for salmonids will contribute to an improved vitamin D3 status and may improve human bone health. PMID:27542236

  7. The impact of an empowerment intervention on people with schizophrenia: Results of a randomized controlled trial.

    Science.gov (United States)

    Hasan, Abdalhadi; Musleh, Mahmoud

    2017-05-01

    The aim of the study was to assess what empowerment intervention has on people with schizophrenia. A randomized controlled trial was carried out between November 2015 and May 2016 involving 112 participants who had been diagnosed with schizophrenia. Patients, who were 18 years and above diagnosed with Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-V) schizophrenia or schizoaffective disorder from the outpatient mental health clinics in Jordan, were randomly assigned to take part in an intervention that consisted of receiving 6 weeks' worth of information booklets, with face to face discussions, while receiving their usual medication or allocated treatment as usual. The participants were assessed at baseline, immediately after the intervention and at 3-month follow-up. The primary outcome was a change in the helplessness score. Secondary outcomes were psychiatric symptoms, recovery rate, empowerment and quality of life. This study showed that people with schizophrenia in the intervention group showed more improvement in the helplessness score immediately post-intervention ( F = 74.53, p < .001) and at 3-month follow-up ( F = 75.56, p < .001), they reported significant improvements in all secondary outcomes. This study indicated that the empowering intervention was an effective intervention when integrated with treatment as usual.

  8. A randomized trial of a community-based cognitive intervention for obese senior adults.

    Science.gov (United States)

    Beck, Cornelia; Fausett, Jennifer Kleiner; Krukowski, Rebecca A; Cornell, Carol E; Prewitt, T Elaine; Lensing, Shelly; Bursac, Zoran; Felix, Holly C; Love, ShaRhonda; McDougall, Graham; West, Delia Smith

    2013-02-01

    To determine whether a cognitive intervention delivered by lay health educators (LHEs) in senior centers was effective in improving cognition in obese older adults. This cluster randomized trial was conducted in 16 senior centers from which 228 senior adults were recruited. The centers were randomized to either the cognitive intervention or a control, weight-loss intervention. The primary outcome variable, cognitive function, was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Analyses of RBANS indices as continuous variables did not indicate significant differences between arms. However, after adjusting for baseline delayed memory, gender, and baseline body mass index, seniors in the cognitive intervention arm had a 2.7 times higher odds of a reliable improvement (clinically significant) in delayed memory from baseline as compared to those in the control intervention (95% CI, 1.3-5.6, p = .011). The intervention effect was not significant for the proportion showing reliable improvement in immediate memory or in attention. Attendance at the 12-session program was high with an average of 83% (67%-92%) sessions attended and 87% of participants in the cognitive arm indicating they would recommend the program. Cognitive interventions can be effectively delivered in the community by LHEs.

  9. Comparison of the effectiveness of two different interventions to reduce preoperative anxiety: A randomized controlled study.

    Science.gov (United States)

    Ertuğ, Nurcan; Ulusoylu, Özge; Bal, Ayça; Özgür, Hazal

    2017-06-01

    This study was conducted to determine and compare the effectiveness of nature sounds and relaxation exercises for reducing preoperative anxiety. A repeated measures randomized controlled trial design was used. We divided 159 preoperative patients into three groups: nature sounds (n = 53), relaxation exercises (n = 53), and control groups (n = 53). We evaluated anxiety using the visual analog scale and state anxiety inventory scores immediately before, immediately after, and 30 min after interventions in nature sounds and relaxation exercises groups, and silent rest in the control. We found no differences between the measurement values in the intervention groups, but we did observe a difference between the intervention and control groups. The two interventions were similarly effective in reducing preoperative anxiety. These simple and low-cost interventions can be used to reduce preoperative anxiety in surgical clinics. © 2017 John Wiley & Sons Australia, Ltd.

  10. The Effect of a 12-Week Omega-3 Supplementation on Body Composition, Muscle Strength and Physical Performance in Elderly Individuals with Decreased Muscle Mass

    Directory of Open Access Journals (Sweden)

    Roma Krzymińska-Siemaszko

    2015-08-01

    Full Text Available The aim of the study was to assess the effect of a polyunsaturated omega-3 fatty acids (PUFA supplementation on the parameters of body composition, muscle strength and physical performance in elderly people with decreased muscle mass (DMM. Fifty three elderly people with an ALM index (the ratio of appendicular lean mass to squared height either below (−2SD: low muscle mass-LMM or between (−1SD and −2SD: the risk of LMM-rLMM the ALM index for the young Polish reference population were randomly assigned to PUFA-treated groups (LMM-PUFA, rLMM-PUFA or control groups (LMM-control, rLMM-control. PUFA-treated groups received capsules containing 1.3 g of PUFA and 10 mg of vitamin E, while the control groups received 11 mg of vitamin E daily for 12 weeks. Body composition (BIA analysis, muscle strength (hand grip measured with dynamometer and physical performance (Timed Up and Go test-TUG were assessed before and after supplementation. No statistically significant differences were observed either in muscle mass or in the hand grip and TUG in any group. The post-pre difference (mean ± SD in ALM index was as follows (kg/m2: LMM-PUFA: 0.00 ± 0.30, rLMM-PUFA: 0.00 ± 0.22, LMM-control: 0.03 ± 0.36, rLMM-control: –0.03 ± 0.20. In our study, a 12 week supplementation of PUFA did not affect the evaluated parameters in elderly individuals with DMM.

  11. Efficacy of indacaterol 75 μg once-daily on dyspnea and health status: results of two double-blind, placebo-controlled 12-week studies.

    Science.gov (United States)

    Gotfried, Mark H; Kerwin, Edward M; Lawrence, David; Lassen, Cheryl; Kramer, Benjamin

    2012-12-01

    Indacaterol is an inhaled, once-daily, long-acting ®(2)-agonist for the treatment of COPD. Most previous studies were conducted with doses of 150 and/or 300 μg once-daily, and data with the 75 μg dose are limited. Two identically designed studies were, therefore, conducted to evaluate the efficacy and safety of the 75 μg once-daily dose. In two double-blind studies conducted in the USA, patients with moderate-to-severe COPD were randomized to treatment with indacaterol 75 μg once-daily (n = 163 and 159) or matching placebo (n = 160 and 159) for 12 weeks. The primary variable was forced expiratory volume in 1 s measured 24 h post-dose after 12 weeks (reported elsewhere). This report describes secondary efficacy endpoints, including transition dyspnea index (TDI) and St George's Respiratory Questionnaire (SGRQ) total scores, and the percentages of patients with improvements of or above the minimal clinically important difference (MCID; ≥1 in TDI score and ≥4 in SGRQ score). Differences between indacaterol and placebo for TDI total score at week 12 were 1.23 (p indacaterol at week 12 (2.0 and 0.9 with placebo), with odds ratios for achieving the MCID of 1.80 (p = 0.024) and 1.71 (p = 0.031). Patients receiving indacaterol had statistically significant or numerical improvements in diary-derived symptom variables compared with placebo. Treatment with indacaterol 75 μg may provide useful improvements in patient-reported outcomes in patients with moderate-to-severe COPD.

  12. Effects of 12-week proprioception training program on postural stability, gait, and balance in older adults: a controlled clinical trial.

    Science.gov (United States)

    Martínez-Amat, Antonio; Hita-Contreras, Fidel; Lomas-Vega, Rafael; Caballero-Martínez, Isabel; Alvarez, Pablo J; Martínez-López, Emilio

    2013-08-01

    The purpose of this study was to evaluate the effect of a 12-week-specific proprioceptive training program on postural stability, gait, balance, and fall prevention in adults older than 65 years. The present study was a controlled clinical trial. Forty-four community dwelling elderly subjects (61-90 years; mean age, 78.07 ± 5.7 years) divided into experimental (n = 20) and control (n = 24) groups. The participants performed the Berg balance test before and after the training program, and we assessed participants' gait, balance, and the risk of falling, using the Tinetti scale. Medial-lateral plane and anterior-posterior plane displacements of the center of pressure, Sway area, length and speed, and the Romberg quotient about surface, speed, and distance were calculated in static posturography analysis (EPS pressure platform) under 2 conditions: eyes open and eyes closed. After a first clinical evaluation, patients were submitted to 12 weeks proprioception training program, 2 sessions of 50 minutes every week. This program includes 6 exercises with the BOSU and Swiss ball as unstable training tools that were designed to program proprioceptive training. The training program improved postural balance of older adults in mediolateral plane with eyes open (p 0.05). After proprioception training, gait (Tinetti), and balance (Berg) test scores improved 14.66% and 11.47% respectively. These results show that 12 weeks proprioception training program in older adults is effective in postural stability, static, and dynamic balance and could lead to an improvement in gait and balance capacity, and to a decrease in the risk of falling in adults aged 65 years and older.

  13. Management of osteoarthritis (OA) with the pharma-standard supplement FlexiQule (Boswellia): a 12-week registry.

    Science.gov (United States)

    Belcaro, G; Dugall, M; Luzzi, R; Ledda, A; Pellegrini, L; Hu, S; Ippolito, E

    2015-10-22

    This registry study assessed the pharma-standard supplement FlexiQule (Boswellia extract in capsules) in the management of symptoms associated to osteoarthritis (OA) also managed with the 'standard management' (SM) in comparison with a group of patients managed only with SM. The 12- week registry included patients with symptomatic knee arthrosis. They were able to walk on a treadmill for a walking test and to complete the WOMAC questionnaire. 32 patients used the supplement and 34 acted as controls (SM). No safety problems were observed. At 12 weeks, the Karnofsky scale was significantly improved in both groups: the variation was higher (p<0.05) in the supplement group. The WOMAC score was decreased significantly more in the supplement+SM group in comparison with controls considering pain, stiffness and physical functions (p<0.05). For social and emotional functions the decrease in score was also more evident in the supplement group (p<0.05). Both groups improved in pain-free and total walking distance at 12 weeks. Pain-free walking distance (treadmill) was higher (p<0.05) with the supplement (from 93.4;11.6 m to 271.3;19.3 m) than in controls (from 90.5;13.5 m to 158.3;22.3)(p<0.05). The improvement in total walking distance was also higher in the supplement group (p<0.05) (from 164.3;23.2 to 322.3;22.3 m) in comparison with the SM- only group ( from 158.3;18,4 to 240.2;19.3 m). The need for concomitant drugs and medical attention during the registry was reduced more in the supplement group (p<0.05). In conclusion the difference between SM and the Flexiqule+SM was in favor of the management with the supplement for all target measurements. The product is safe and well tolerated.

  14. Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project

    Science.gov (United States)

    Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny

    2012-01-01

    Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…

  15. Stability of Tranexamic Acid after 12-Week Storage at Temperatures from -20 deg C to 50 deg C

    Science.gov (United States)

    2013-07-01

    by thromboelastography (to measure the units/mL of SK needed to get 100% fibri- nolysis at 60 minutes [LY60]), and by high -performance liq- uid...Prescribed by ANSI Std Z39-18 de Guzman et al. TXA STABILITY AT DIFFERENT TEMPERATURES 395 in Afghanistan.7 Because of this survival benefit and the low ... fibrinogen , DD, protein C, von Willebrand’s factor, antithrombin III, and factors II, V, VII, VIII, IX, X, XI, XII, and XIII at 1, 2, 4, and 12 weeks

  16. Positive Family Intervention for Severe Challenging Behavior I: A Multisite Randomized Clinical Trial

    Science.gov (United States)

    Durand, V. Mark; Hieneman, Meme; Clarke, Shelley; Wang, Mo; Rinaldi, Melissa L.

    2013-01-01

    The present study was a multisite randomized clinical trial assessing the effects of adding a cognitive-behavioral intervention to positive behavior support (PBS). Fifty-four families who met the criteria of (a) having a child with a developmental disability, (b) whose child displayed serious challenging behavior (e.g., aggression, self-injury,…

  17. Do hospitalized premature infants benefit from music interventions? A systematic review of randomized controlled trials

    NARCIS (Netherlands)

    M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); J. Jeekel (Hans); I.K.M. Reiss (Irwin); M.G.M. Hunink (Myriam); M. Van Dijk (Monique)

    2016-01-01

    textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the poss

  18. Fraction Intervention for Students with Mathematics Difficulties: Lessons Learned from Five Randomized Control Trials

    Science.gov (United States)

    Fuchs, Lynn S.; Malone, Amelia S.; Schumacher, Robin F.; Namkung, Jessica; Wang, Amber

    2016-01-01

    The purpose of this article was to summarize results from 5 randomized control trials assessing the effects of intervention to improve the fraction performance of 4th-grade students at-risk for difficulty in learning about fractions. We begin by explaining the importance of competence with fractions and why an instructional focus on fractions…

  19. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    Science.gov (United States)

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2013-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30…

  20. Do hospitalized premature infants benefit from music interventions? A systematic review of randomized controlled trials

    NARCIS (Netherlands)

    M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); J. Jeekel (Hans); I.K.M. Reiss (Irwin); M.G.M. Hunink (Myriam); M. Van Dijk (Monique)

    2016-01-01

    textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the

  1. Randomized Comparison of Augmented and Nonaugmented Language Interventions for Toddlers with Developmental Delays and Their Parents

    Science.gov (United States)

    Romski, MaryAnn; Sevcik, Rose A.; Adamson, Lauren B.; Cheslock, Melissa; Smith, Ashlyn; Barker, R. Michael; Bakeman, Roger

    2010-01-01

    Purpose: This study compared the language performance of young children with developmental delays who were randomly assigned to 1 of 3 parent-coached language interventions. Differences in performance on augmented and spoken word size and use, vocabulary size, and communication interaction skills were examined. Method: Sixty-eight toddlers with…

  2. Extensions of a Versatile Randomization Test for Assessing Single-Case Intervention Effects

    Science.gov (United States)

    Levin, Joel R.; Lall, Venessa F.; Kratochwill, Thomas R.

    2011-01-01

    The purpose of the present study was to investigate the statistical properties of two extensions of the Levin-Wampold (1999) single-case simultaneous start-point model's comparative effectiveness randomization test. The two extensions were (a) adapting the test to situations where there are more than two different intervention conditions and (b)…

  3. Randomized Feeding Intervention in Infants at High Risk for Celiac Disease

    NARCIS (Netherlands)

    Vriezinga, S. L.; Auricchio, R.; Bravi, E.; Castillejo, G.; Chmielewska, A.; Crespo Escobar, P.; Kolacek, S.; Koletzko, S.; Korponay-Szabo, I. R.; Mummert, E.; Polanco, I.; Putter, H.; Ribes-Koninckx, C.; Shamir, R.; Szajewska, H.; Werkstetter, K.; Greco, L.; Gyimesi, J.; Hartman, C.; Esch, C. Hogen; Hopman, E.; Ivarsson, A.; Koltai, T.; Koning, F.; Martinez-Ojinaga, E.; te Marvelde, C.; Pavic, A. Mocic; Romanos, J.; Stoopman, E.; Villanacci, V.; Wijmenga, C.; Troncone, R.; Mearin, M. L.

    2014-01-01

    BACKGROUND A window of opportunity has been suggested for reducing the risk of celiac disease by introducing gluten to infants at 4 to 6 months of age. METHODS We performed a multicenter, randomized, double-blind, placebo-controlled dietary-intervention study involving 944 children who were positive

  4. Do hospitalized premature infants benefit from music interventions? A systematic review of randomized controlled trials

    NARCIS (Netherlands)

    M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); J. Jeekel (Hans); I.K.M. Reiss (Irwin); Hunink, M.G.M. (M.G. Myriam); M. Van Dijk (Monique)

    2016-01-01

    textabstractObjective: Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the poss

  5. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

    Science.gov (United States)

    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

    2008-01-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

  6. The effects of psychological interventions on wound healing: A systematic review of randomized trials.

    Science.gov (United States)

    Robinson, Hayley; Norton, Sam; Jarrett, Paul; Broadbent, Elizabeth

    2017-11-01

    Psychological stress has been shown to delay wound healing. Several trials have investigated whether psychological interventions can improve wound healing, but to date, this evidence base has not been systematically synthesized. The objective was to conduct a systematic review of randomized controlled trials in humans investigating whether psychological interventions can enhance wound healing. A systematic review was performed using PsychINFO, CINAHL, Web of Science, and MEDLINE. The searches included all papers published in English up until September 2016. The reference lists of relevant papers were screened manually to identify further review articles or relevant studies. Nineteen studies met inclusion criteria and were included in the review. Fifteen of nineteen studies were of high methodological quality. Six studies were conducted with acute experimentally created wounds, five studies with surgical patients, two studies with burn wounds, two studies with fracture wounds, and four studies were conducted with ulcer wounds. Post-intervention standardized mean differences (SMD) between groups across all intervention types ranged from 0.13 to 3.21, favouring improved healing, particularly for surgical patients and for relaxation interventions. However, there was some evidence for publication bias suggesting negative studies may not have been reported. Due to the heterogeneity of wound types, population types, and intervention types, it is difficult to pool effect sizes across studies. Current evidence suggests that psychological interventions may aid wound healing. Although promising, more research is needed to assess the efficacy of each intervention on different wound types. Statement of contribution What is already known on this subject? Psychological stress negatively affects wound healing. A number of studies have investigated whether psychological interventions can improve healing. However, no systematic reviews have been conducted. What does this study add

  7. A Randomized Clinical Trial of a Money Management Intervention for Veterans With Psychiatric Disabilities.

    Science.gov (United States)

    Elbogen, Eric B; Hamer, Robert M; Swanson, Jeffrey W; Swartz, Marvin S

    2016-10-01

    The study evaluated an intervention to help veterans with psychiatric disabilities, who face a unique set of challenges concerning money management. A randomized clinical trial was conducted of a brief (one to three hours) psychoeducational, recovery-oriented money management intervention called $teps for Achieving Financial Empowerment ($AFE). Analyses revealed no main effects on outcomes of random assignment to $AFE (N=67) or a control condition consisting of usual care (N=77). Veterans who reported using $AFE skills showed significantly lower impulsive buying, more responsible spending, higher rates of engaging in vocational activities, and greater number of work hours compared with veterans in the control condition. Findings have clinical implications for case management services involving informal money management assistance. Offering veterans with psychiatric disabilities a one-time money management intervention is unlikely to lead to substantial changes. Results imply that efforts to improve psychosocial outcomes among veterans must not only teach but also increase use of money management skills.

  8. THE EFFECT OF A 12-WEEK LOW-IMPACT EXERCISE PROGRAM IN BONE MINERAL DENSITY IN ADULT MALES AND FEMALES WITH QUADRIPLEGIC CEREBRAL PALSY

    Directory of Open Access Journals (Sweden)

    Kitsios A,

    2009-10-01

    Full Text Available The purpose of this study was to examine the effect of an intervention physiotherapy program in adultmales and females with cerebral palsy on bone mineral density. 10 adults (7 males/3 females with quadriplegiccerebral palsy (CP consisted the experimental group and 10 people (7males/3 females serving as control grouptook part in the study. Measurements including bone mineral density (g/cm² assessment with DEXAabsorptiometry of lumbar spine were tested before and after a 12-week physical low-impact program. Treatmentprovided by community trainers consisted of conscious movement control and low-impact resistance training 3times a week. The study revealed the following: The pre-test and post-test examined variables of both groupswere within normal limits. CP patients group had significantly higher levels of bone density in their lumbar spineafter the intervention program compared to baseline values. The same trend was not found for the case of controlgroup. The BMD in the selected area of the experimental group was increased about 7% compared to baselinevalues and this was statistically significant (p<0.05. The results support application and development of thetreatment concept and highlight that physical activity at its simple status can increase BMD in CP patients. Ifsustained, the increases in BMD may reduce the risk of osteoporotic fracture and augments the quality of life ofthese people

  9. Effect of 12 Weeks of Accelerated Rehabilitation Exercise on Muscle Function of Patients with ACL Reconstruction of the Knee Joint.

    Science.gov (United States)

    Lee, Joong-Chul; Kim, Ji Youn; Park, Gi Duck

    2013-12-01

    [Purpose] To examine changes in the knee joint's isokinetic muscle functions following systematic and gradual rehabilitation exercises lasting for 12 weeks for male and female patients who underwent anterior cruciate ligament (ACL) reconstruction. Differences in muscle functions between the uninvolved side (US) and the involved side (IS) before surgery, differences in muscle functions between US and IS after rehabilitation exercises lasting for 12 weeks, and changes in muscle functions on US and IS between before and after surgery were analyzed to examine the effects of accelerated rehabilitation exercises after ACL reconstruction. [Subjects] The study subjects were 10 patients, five females and five males, who underwent ACL reconstruction performed by the same surgeon. [Methods] As a measuring tool, a Biodex Multi-joint system 3pro (USA), which is an isokinetic measuring device, was used to examine the flexion and extension forces of the knee joint. During isokinetic muscle strength evaluation, the ROM of US was set to be the same as that of IS for consistency of measurement. [Results] At 60°/s, the isokinetic muscle functions of the females did not show any significant change between before and after surgery in any of the variables on both US and IS. At 60°/s, the isokinetic muscle functions of the males did not show any significant change between before and after surgery in the peak torque, average power, and entire work done on US. In extension, peak torque on IS did not show any significant change.

  10. Effects of 12-week core stabilization exercise on the Cobb angle and lumbar muscle strength of adolescents with idiopathic scoliosis.

    Science.gov (United States)

    Ko, Kwang-Jun; Kang, Seol-Jung

    2017-04-01

    To identify the effects of core stabilization exercise on the Cobb angle and lumbar muscle strength of adolescent patients with idiopathic scoliosis. Subjects in the present study consisted of primary school students who were confirmed to have scoliosis on radiologic examination performed during their visit to the National Fitness Center in Seoul, Korea. Depending on whether they participated in a 12-week core stabilization exercise program, subjects were divided into the exercise (n=14, age 12.71±0.72 years) or control (n=15, age 12.80±0.86 years) group. The exercise group participated in three sessions of core stabilization exercise per week for 12 weeks. The Cobb angle, flexibility, and lumbar muscle strength tests were performed before and after core stabilization exercise. Repeated-measure two-way analysis of variance was performed to compare the treatment effects between the exercise and control groups. There was no significant difference in thoracic Cobb angle between the groups. The exercise group had a significant decrease in the lumbar Cobb angle after exercise compared to before exercise (Pstrength after exercise compared to before exercise (PCore stabilization exercise can be an effective therapeutic exercise to decrease the Cobb angle and improve lumbar muscle strength in adolescents with idiopathic scoliosis.

  11. Factors influencing childhood cancer patients to participate in a combined physical and psychosocial intervention program : Quality of Life in Motion

    NARCIS (Netherlands)

    Van Dijk-Lokkart, Elisabeth M.; Braam, Katja I.; Huisman, Jaap; Kaspers, Gertjan Jl; Takken, Tim; Veening, Margreet A.; Bierings, MB; Merks, Hans; Grootenhuis, Martha A.; Eibrink, Marry; Streng, Isabelle C.; Van Dulmen-Den Broeder, Eline

    2015-01-01

    Background For a multi-center randomized trial investigating the effects of a 12-week physical and psychosocial intervention program for children with cancer, we invited 174 patients (8-18 years old) on treatment or within 1 year after treatment; about 40% participated. Reasons for non-participation

  12. Factors influencing childhood cancer patients to participate in a combined physical and psychosocial intervention program : Quality of Life in Motion

    NARCIS (Netherlands)

    Van Dijk-Lokkart, Elisabeth M.; Braam, Katja I.; Huisman, Jaap; Kaspers, Gertjan Jl; Takken, Tim; Veening, Margreet A.; Bierings, MB; Merks, Hans; Grootenhuis, Martha A.; Eibrink, Marry; Streng, Isabelle C.; Van Dulmen-Den Broeder, Eline

    Background For a multi-center randomized trial investigating the effects of a 12-week physical and psychosocial intervention program for children with cancer, we invited 174 patients (8-18 years old) on treatment or within 1 year after treatment; about 40% participated. Reasons for non-participation

  13. Moderators of intervention effects on parenting practices in a randomized controlled trial in early childhood.

    Science.gov (United States)

    Theise, Rachelle; Huang, Keng-Yen; Kamboukos, Dimitra; Doctoroff, Greta L; Dawson-McClure, Spring; Palamar, Joseph J; Brotman, Laurie Miller

    2014-01-01

    The current study examined whether parent psychological resources (parenting stress, depression, and social support from friends and family) moderated the effects of early family preventive intervention on parenting among high-risk families. Ninety-two preschool-age children (M age = 3.94 years) at familial risk for conduct problems participated in a randomized controlled trial of a family intervention to prevent conduct problems. The majority of families were African American or Latino and experienced multiple stressors associated with poverty and familial antisocial behavior. Families were randomized to a 22-session group-based intervention or to a no-intervention, assessment-only control condition. Parents reported on their psychological resources (parenting stress, depression and social support from friends and family) at baseline. Parenting (responsive, harsh, stimulation for learning) was assessed through self-report and observational measures four times over 24 months. Previously-reported intervention effects on responsive parenting and stimulation for learning were moderated by depression and social support from friends, respectively, such that benefits were concentrated among those at greatest risk (i.e., depressed, limited support from friends). The intervention effect on harsh parenting was not moderated by any of the parent psychological resources examined, such that parents with high and low resources benefited comparably. Consideration of moderators of preventive intervention effects on parenting provides important information about intervention impact among families experiencing multiple barriers to engagement and effective parenting. Findings suggest that parents with diminished psychological resources are just as likely to benefit. Family-focused, group-based intervention is promising for strengthening parenting among the highest risk families.

  14. Randomized Controlled Theory-Based, E-Mail-Mediated Walking Intervention.

    Science.gov (United States)

    Richards, Elizabeth A; Ogata, Niwako; Cheng, Ching-Wei

    2017-02-01

    The purpose of this study was to evaluate the ability of two concurrent randomized controlled interventions based on social cognitive theory to increase walking. A second purpose was to compare the efficacy of the intervention between two distinct groups: dog owners and non-dog owners. Adult dog owners ( n = 40) and non-dog owners ( n = 65) were randomized into control or intervention groups. Intervention groups received bi-weekly emails for first 4 weeks and then weekly email for the next 8 weeks targeting self-efficacy, social support, goal setting, and benefits/barriers to walking. Dog owner messages focused on dog walking while non-dog owners received general walking messages. Control groups received a 1-time email reviewing current physical activity guidelines. At 6 months, both intervention groups reported greater increases in walking and maintained these increases at 12 months. The greatest increases were seen in the dog owner intervention group. In conclusion, dog owners accumulated more walking, which may be attributed to the dog-owner relationship.

  15. Randomized, controlled trial of three levels of critical incident stress intervention.

    Science.gov (United States)

    Macnab, Andrew; Sun, Charles; Lowe, John

    2003-01-01

    Stress debriefing following exposure to a critical incident is becoming more prevalent. Its aim is to prevent or minimize the development of excessive stress response symptoms that lead to loss of productivity or effectiveness in the workplace or at home. There is little evidence that any form of psychological debriefing is effective. This study evaluated the effectiveness of three intervention strategies, and attempted to correlate the symptoms with the severity of the incident and level of intervention. A randomized, controlled trial of three levels of critical stress intervention was conducted in the British Columbia Ambulance Service (BCAS), in British Columbia, Canada, among paramedics and emergency medical technicians (EMTs), reporting critical incident stress. Outcomes were measured at one week (Stanford Acute Stress Reaction Questionnaire (SASRQ), the Life Impact Score (LIS), and Schedule of Recent Events (SRE)), and at three months and six months following the intervention (Impact of Events (IE), Coping Mechanisms, LIS, and SRE). Fifty calls were received during the 26-month study period (incident and scores on the SASRQ, IE, or LIS, or between any of these scores. There was no consistent pattern in the stress scores over time. Requests for critical incident stress intervention were uncommon. The need for intervention may not be as great as generally is assumed. Further randomized trials, ideally multicenter studies, are indicated.

  16. Effekt of a two-stage nursing assesment and intervention - a randomized intervention study

    DEFF Research Database (Denmark)

    Rosted, Elizabeth Emilie; Poulsen, Ingrid; Hendriksen, Carsten

    to the geriatric outpatient clinic, community health centre, primary physician or arrangements with next-of-kin. Findings: Primary endpoints will be presented as unplanned readmission to ED; admission to nursing home; and death. Secondary endpoints will be presented as physical function; depressive symptoms......Background: Geriatric patients recently discharged from hospital are at risk of unplanned readmissions and admission to nursing home. When discharged directly from Emergency Department (ED) the risk increases, as time pressure often requires focus on the presenting problem, although 80...... % of geriatric patients have complex and often unresolved caring needs. The objective was to examine the effect of a two-stage nursing assessment and intervention to address the patients uncompensated problems given just after discharge from ED and one and six months after. Method: We conducted a prospective...

  17. Effects of a randomized intervention to improve workplace social capital in community health centers in China.

    Science.gov (United States)

    Sun, Xiaojie; Zhang, Nan; Liu, Kun; Li, Wen; Oksanen, Tuula; Shi, Lizheng

    2014-01-01

    To examine whether workplace social capital improved after implementing a workplace social capital intervention in community health centers in China. This study was conducted in 20 community health centers of similar size in Jinan of China during 2012-2013. Using the stratified site randomization, 10 centers were randomized into the intervention group; one center was excluded due to leadership change in final analyses. The baseline survey including 447 staff (response rate: 93.1%) was conducted in 2012, and followed by a six-month workplace social capital intervention, including team building courses for directors of community health centers, voluntarily public services, group psychological consultation, and outdoor training. The follow-up survey in July 2013 was responded to by 390 staff members (response rate: 86.9%). Workplace social capital was assessed with the translated and culturally adapted scale, divided into vertical and horizontal dimensions. The facility-level intervention effects were based on all baseline (n = 427) and follow-up (n = 377) respondents, except for Weibei respondents. We conducted a bivariate Difference-in-Difference analysis to estimate the facility-level intervention effects. No statistically significant intervention effects were observed at the center level; the intervention increased the facility-level workplace social capital, and its horizontal and vertical dimensions by 1.0 (p = 0.24), 0.4 (p = 0.46) and 0.8 (p = 0.16), respectively. The comprehensive intervention seemed to slightly improve workplace social capital in community health centers of urban China at the center level. High attrition rate limits any causal interpretation of the results. Further studies are warranted to test these findings.

  18. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    Directory of Open Access Journals (Sweden)

    Nicola ePitchford

    2015-04-01

    Full Text Available Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi. A total sample of 318 children, spanning Standards 1-3, attending a medium-sized urban primary school, were randomized to one of three groups: maths tablet intervention, non-maths tablet control, and standard face-to-face practice. Children were pre-tested using tablets at the start of the school year on two tests of mathematical knowledge and a range of basic skills related to scholastic progression. Class teachers then delivered the intervention over an 8-week period, for the equivalent of 30-minutes per day. Technical support was provided from the local Voluntary Service Overseas. Children were then post-tested on the same assessments as given at pre-test.A final sample of 283 children from Standards 1-3, present at both pre- and post-test, was analyzed to investigate the effectiveness of the maths tablet intervention. Significant effects of the maths tablet intervention over and above standard face-to-face practice or using tablets without the maths software were found in Standard 2 and 3. In Standard 3 the greater learning gains shown by the maths tablet intervention group compared to both of the control groups on the tablet-based assessments transferred to paper and pencil format, illustrating generalization of knowledge gained. Thus, tablet technology can effectively support early years mathematical skills in developing countries if the software is carefully designed to engage the child in the learning process and the content is grounded in a solid well-constructed curriculum appropriate for the child

  19. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi.

    Science.gov (United States)

    Pitchford, Nicola J

    2015-01-01

    Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi. A total sample of 318 children, spanning Standards 1-3, attending a medium-sized urban primary school, were randomized to one of three groups: maths tablet intervention, non-maths tablet control, and standard face-to-face practice. Children were pre-tested using tablets at the start of the school year on two tests of mathematical knowledge and a range of basic skills related to scholastic progression. Class teachers then delivered the intervention over an 8-weeks period, for the equivalent of 30-min per day. Technical support was provided from the local Voluntary Service Overseas (VSO). Children were then post-tested on the same assessments as given at pre-test. A final sample of 283 children, from Standards 1-3, present at both pre- and post-test, was analyzed to investigate the effectiveness of the maths tablet intervention. Significant effects of the maths tablet intervention over and above standard face-to-face practice or using tablets without the maths software were found in Standards 2 and 3. In Standard 3 the greater learning gains shown by the maths tablet intervention group compared to both of the control groups on the tablet-based assessments transferred to paper and pencil format, illustrating generalization of knowledge gained. Thus, tablet technology can effectively support early years mathematical skills in developing countries if the software is carefully designed to engage the child in the learning process and the content is grounded in a solid well-constructed curriculum appropriate for the child's developmental

  20. An Intervention To Reduce Postpartum Depressive Symptoms: A Randomized Controlled Trial

    Science.gov (United States)

    Howell, Elizabeth A; Bodnar-Deren, Susan; Balbierz, Amy; Loudon, Holly; Mora, Pablo A.; Zlotnick, Caron; Wang, Jason; Leventhal, Howard

    2013-01-01

    Depressive symptoms and depression are a common complication of childbirth and a growing body of literature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high income mothers in a second randomized trial. Mothers in the intervention arm received a 2-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depressive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3-weeks, 3-months, and 6-months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum were unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention vs. enhanced usual care post hospitalization: 3-weeks (6.0 % vs. 5.6%, p=.83), 3-months (5.1% vs. 6.5%, p=.53) and 6-months (3.6% vs. 4.6%, p=.53). PMID:24019052

  1. A cluster randomized controlled trial testing the effectiveness of Houvast: A strengths-based intervention for homeless young adults

    NARCIS (Netherlands)

    Krabbenborg, M.A.M.; Boersma, S.N.; Veld, W.M. van der; Hulst, B. van; Vollebergh, W.A.M.; Wolf, J.R.L.M.

    2017-01-01

    Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed

  2. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials

    Science.gov (United States)

    Oliai Araghi, Sadaf; Jeekel, Johannes; Reiss, Irwin K. M; Hunink, M. G. Myriam; van Dijk, Monique

    2016-01-01

    Objective Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants’ well-being. Methods We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data. Results After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music. Conclusions Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants. PMID

  3. Interventions with family caregivers of cancer patients: meta-analysis of randomized trials.

    Science.gov (United States)

    Northouse, Laurel L; Katapodi, Maria C; Song, Lixin; Zhang, Lingling; Mood, Darlene W

    2010-01-01

    Family caregivers of cancer patients receive little preparation, information, or support to perform their caregiving role. However, their psychosocial needs must be addressed so they can maintain their own health and provide the best possible care to the patient. The purpose of this article is to analyze the types of interventions offered to family caregivers of cancer patients, and to determine the effect of these interventions on various caregiver outcomes. Meta-analysis was used to analyze data obtained from 29 randomized clinical trials published from 1983 through March 2009. Three types of interventions were offered to caregivers: psychoeducational, skills training, and therapeutic counseling. Most interventions were delivered jointly to patients and caregivers, but they varied considerably with regard to dose and duration. The majority of caregivers were female (64%) and Caucasian (84%), and ranged in age from 18 to 92 years (mean age, 55 years). Meta-analysis indicated that although these interventions had small to medium effects, they significantly reduced caregiver burden, improved caregivers' ability to cope, increased their self-efficacy, and improved aspects of their quality of life. Various intervention characteristics were also examined as potential moderators. Clinicians need to deliver research-tested interventions to help caregivers and patients cope effectively and maintain their quality of life.

  4. Meta-analyses including non-randomized studies of therapeutic interventions: a methodological review

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    Timor Faber

    2016-03-01

    Full Text Available Abstract Background There is an increasing number of meta-analyses including data from non-randomized studies for therapeutic evaluation. We aimed to systematically assess the methods used in meta-analyses including non-randomized studies evaluating therapeutic interventions. Methods For this methodological review, we searched MEDLINE via PubMed, from January 1, 2013 to December 31, 2013 for meta-analyses including at least one non-randomized study evaluating therapeutic interventions. Etiological assessments and meta-analyses with no comparison group were excluded. Two reviewers independently assessed the general characteristics and key methodological components of the systematic review process and meta-analysis methods. Results One hundred eighty eight meta-analyses were selected: 119 included both randomized controlled trials (RCTs and non-randomized studies of interventions (NRSI and 69 only NRSI. Half of the meta-analyses (n = 92, 49 % evaluated non-pharmacological interventions. “Grey literature” was searched for 72 meta-analyses (38 %. An assessment of methodological quality or risk of bias was reported in 135 meta-analyses (72 % but this assessment considered the risk of confounding bias in only 33 meta-analyses (18 %. In 130 meta-analyses (69 %, the design of each NRSI was not clearly specified. In 131 (70 %, whether crude or adjusted estimates of treatment effect for NRSI were combined was unclear or not reported. Heterogeneity across studies was assessed in 182 meta-analyses (97 % and further explored in 157 (84 %. Reporting bias was assessed in 127 (68 %. Conclusions Some key methodological components of the systematic review process—search for grey literature, description of the type of NRSI included, assessment of risk of confounding bias and reporting of whether crude or adjusted estimates were combined—are not adequately carried out or reported in meta-analyses including NRSI.

  5. Context by treatment interactions as the primary object of study in cluster randomized controlled trials of population health interventions.

    Science.gov (United States)

    Fuller, Daniel; Potvin, Louise

    2012-06-01

    Cluster randomized controlled trials are increasingly used in population health intervention research. Through randomization, researchers attempt to isolate the treatment effect and remove all other effects, including any effects of social context. In many cases, the constant effect assumption cannot be satisfied in cluster randomized controlled trials. We argue that when studying population health interventions, the effective mechanism of intervention lies in the interaction between the treatment and social context. Researchers should be cognizant that attempts to remove the effect of social context using CRTC may fail. The interaction between the treatment and social context should be the primary object of study in population health intervention research.

  6. Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

    Science.gov (United States)

    Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

    2016-12-01

    To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (pmusic days (pmusic during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    Science.gov (United States)

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  8. Short-term effects of an educational intervention on physical restraint use: a cluster randomized trial

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    Gulpers Math JM

    2006-10-01

    Full Text Available Abstract Background Physical restraints are still frequently used in nursing home residents despite growing evidence for the ineffectiveness and negative consequences of these methods. Therefore, reduction in the use of physical restraints in psycho-geriatric nursing home residents is very important. The aim of this study was to investigate the short-term effects of an educational intervention on the use of physical restraints in psycho-geriatric nursing home residents. Methods A cluster randomized trial was applied to 5 psycho-geriatric nursing home wards (n = 167 residents with dementia. The wards were assigned at random to either educational intervention (3 wards or control status (2 wards. The restraint status was observed and residents' characteristics, such as cognitive status, were determined by using the Minimum Data Set (MDS at baseline and 1 month after intervention. Results Restraint use did not change significantly over time in the experimental group (55%–56%, compared to a significant increased use (P Conclusion An educational programme for nurses combined with consultation with a nurse specialist did not decrease the use of physical restraints in psycho-geriatric nursing home residents in the short term. However, the residents in the control group experienced more restraint use during the study period compared to the residents in the experimental group. Whether the intervention will reduce restraint use in the long term could not be inferred from these results. Further research is necessary to gain insight into the long-term effects of this educational intervention.

  9. Effect of 12 weeks of Chosen Pilates Exercise on the Quality of Iife of Healthy Nonathletic People

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    ME Bahram

    2014-05-01

    Results:There was a significant difference in the quality of life and the following results emerged (P≥0.05: physical health (P=0.0001, F=146.929, mental health (P=0.0001, F=186.508, social contacts (P=0.0001, F=335.657, environmental health (P=0.0001, F=287.57 and the quality of life (P=0.0001, F=69.317. However, no significant differences was found in the control group (P≥0.05. Conclusion:Totally, the results showed that 12 weeks of Pilates Exercises leads to better quality of life and related variables in nonathletic men. This can be regarded as a nonaggressive way to improve the quality of life of the older people.

  10. A 12-week supervised exercise therapy program for young adults with a meniscal tear: Program development and feasibility study

    DEFF Research Database (Denmark)

    Skou, Søren T.; Thorlund, Jonas B.

    2017-01-01

    To describe the development and feasibility of an exercise therapy program for treatment of young adults (18–40 years of age) with a meniscal tear. Researchers and experienced physical therapists developed a 12-week supervised neuromuscular and strengthening exercise therapy program based...... on clinical expertise and available evidence. Six patients (age range 22–39 years) considered eligible for meniscal surgery by an orthopedic surgeon underwent the program. Patients completed the Knee Injury and Osteoarthritis Outcome Score (KOOS) and evaluated the program during a semi-structured qualitative...... of life. The patients found the program relevant and effective with only a few short-lasting adverse events and important clinical improvements after four to ten weeks. Physical therapist supervision was considered important. No patients wanted surgery up to 6 month after the exercise therapy program...

  11. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

    Science.gov (United States)

    Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto

    2014-03-01

    This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety.

  12. Child Support Grant access and receipt among 12-week-old infants in an urban township setting in South Africa

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    Wanga Zembe-Mkabile

    2014-08-01

    Full Text Available Background: Cash transfers (CTs are increasingly used as a strategy to alleviate poverty and improve child health outcomes in low- and middle-income countries. The Child Support Grant (CSG is the largest CT programme in South Africa, and on the continent, targeting poor children from birth until the age of 18 with a monthly sum of R300 (USD30. Evidence on the CSG shows that early receipt of the grant is associated with improved child health outcomes. Since its implementation, one of the major concerns about the grant has been take-up rates, particularly for younger children. This paper reports results on take-up rates for 12-week-old infants residing in an urban township in South Africa. Methods: This is a descriptive study utilising data from a community-based, cluster-randomised trial which evaluated a programme providing pregnancy and post-natal home visits by community health workers to 3,494 mothers in Umlazi township, South Africa. Results: At the 12-week visit, half (52% of the mothers who had enrolled in the study had applied for the CSG on behalf of their children, while 85% of the mothers who had not applied were still planning to apply. Only 38% (1,327 of all children had received the CSG. Conclusions: In this study, many mothers had not applied for the CSG in the first few months after delivery, and only a third of children had accessed the grant. Further research is needed to understand what the current barriers are that prevent mothers from applying for this important form of social protection in the early months after delivery.

  13. A Novel Functional Electrical Stimulation Treatment for Recovery of Hand Function in Hemiplegia: 12-Week Pilot Study

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    Knutson, Jayme S.; Hisel, Terri Z.; Harley, Mary Y.; Chae, John

    2011-01-01

    Background Loss of finger extension is common after stroke and can severely limit hand function. Contralaterally controlled functional electrical stimulation (CCFES) is a new treatment aimed at restoring volitional finger and thumb extension. A previous pilot study showed reductions in hand impairment after 6 weeks of CCFES, but the effect did not persist after end of treatment. Objective This study aimed to evaluate the feasibility of achieving greater and more persistent gains with CCFES by increasing the treatment period to 12 weeks. Methods CCFES uses neuromuscular electrical stimulation to open the paretic hand in direct proportion to the degree of volitional opening of the unimpaired contralateral hand, which is detected by an instrumented glove. Three subjects with chronic hemiplegia participated in a 12-week CCFES treatment, which consisted of daily CCFES-assisted active repetitive hand-opening exercises and twice weekly functional task practice with CCFES. Results Maximum voluntary finger extension increased by 101° and 68° for subjects 1 and 2, respectively, but subject 3 had no improvement in finger extension. Box and Block score increased by 6, 15, and 7 blocks, and upper extremity Fugl-Meyer score increased by 11, 15, and 7 points for subjects 1, 2, and 3, respectively. The finger extension gains declined at the 1-month and 3-month follow-up for subjects 1 and 2, but the gains in Box and Block and Fugl-Meyer scores persisted at follow-up. Conclusions Greater reductions in hand impairment were achieved by extending the treatment period. The effect and its longevity may be related to baseline impairment level. PMID:18812432

  14. Changes of Heart Rate Variability during Methylphenidate Treatment in Attention-Deficit Hyperactivity Disorder Children: A 12-Week Prospective Study.

    Science.gov (United States)

    Kim, Hayeon Jennifer; Yang, Jaewon; Lee, Moon Soo

    2015-09-01

    The aim of this study was to clarify the relationship between the autonomic nervous system and attention deficit hyperactivity disorder (ADHD) rating scales and to evaluate the usefulness of heart rate variability (HRV) as a psychophysiological biomarker for ADHD. Subjects were recruited from outpatients in the Department of Child and Adolescent Psychiatry at the Korea University Medical Center from August 2007 to December 2010. Subjects received methylphenidate. Time- and frequency-domain analyses of HRV, the Korean ADHD rating scale (K-ARS), and computerized ADHD diagnostic system were evaluated before treatment. After a 12-week period of medication administration, we repeated the HRV measurements and K-ARS rating. Eighty-six subjects were initially enrolled and 37 participants completed the 12-week treatment and HRV measurements subsequent to the treatment. Significant correlations were found between the K-ARS inattention score and some HRV parameters. All of the HRV parameters, except the standard deviations of the normal-to-normal interval, very low frequency, and low frequency to high frequency, showed a significant positive correlation between baseline and endpoint measures in completers. High frequency (HF) and the square root of the mean squared differences of successive normal-to-normal intervals (RMSSD), which are related to parasympathetic vagal tone, showed significant decreases from baseline to endpoint. The HRV test was shown to be reproducible. The decrease in HF and RMSSD suggests that parasympathetic dominance in ADHD can be altered by methylphenidate treatment. It also shows the possibility that HRV parameters can be used as psychophysiological markers in the treatment of ADHD.

  15. Effects of 12-weeks resistance training on sprint and jump performance in competitive adolescent rugby union players.

    Science.gov (United States)

    Harries, Simon K; Lubans, David R; Buxton, Anthony; MacDougall, Thomas H J; Callister, Robin

    2017-07-17

    Sprint performance is an important characteristic for success in many sports, including rugby union. Resistance training is used to increase muscular fitness (i.e. strength, endurance and power) and may also be effective for improving sprint and jump performances. The aims of this study were to examine the effects of resistance training using two different periodized programs (linear and daily undulating) on sprint and jump performance and explore relationships between performance measures. Sixteen male (16.9 ± 1.0 y) adolescent rugby union players participated in 12 weeks of resistance training. A further 10 male (15.5 ± 1.0 y) participants were recruited as a control group. Assessments of strength (box squat), 10 and 20 m sprint (electronically timed), and jump height (maximal unloaded (body mass only) and loaded (body mass + 10 kg) countermovement jumps) were conducted before and after 12 weeks training. Large to very large increases in 1RM box squat (linear: 33.9%; p < 0.001; ES = 1.64; daily undulating: 44.5%; p < 0.001; ES = 2.33) were observed after training. Small decreases were seen in 10 (linear: -1.6%; p = 0.171; ES = -0.84; daily undulating: -2.5%; p = 0.038; ES = -0.36) and 20 m (linear: -0.5%; p = 0.506; ES = -0.20; daily undulating: -1.7%; p = 0.047; ES = -0.27) sprint times. Small-to-moderate associations between changes in lower body strength and improvements in 10 and 20 m sprint times were found. Resistance training increases lower body strength in adolescent rugby union players and increases in lower body strength may transfer to improved sprinting performance with improvements following daily undulating periodized resistance training slightly superior.

  16. A Randomized Controlled Trial of a Cognitive Behavioural Intervention for Anger Management in Children Diagnosed with Asperger Syndrome

    Science.gov (United States)

    Sofronoff, Kate; Attwood, Tony; Hinton, Sharon; Levin, Irina

    2007-01-01

    The purpose of the study described was to evaluate the effectiveness of a cognitive behavioural intervention for anger management with children diagnosed with Asperger syndrome. Forty-five children and their parents were randomly assigned to either intervention or wait-list control conditions. Children in the intervention participated in six 2-h…

  17. A Randomized Controlled Trial of a Cognitive Behavioural Intervention for Anger Management in Children Diagnosed with Asperger Syndrome

    Science.gov (United States)

    Sofronoff, Kate; Attwood, Tony; Hinton, Sharon; Levin, Irina

    2007-01-01

    The purpose of the study described was to evaluate the effectiveness of a cognitive behavioural intervention for anger management with children diagnosed with Asperger syndrome. Forty-five children and their parents were randomly assigned to either intervention or wait-list control conditions. Children in the intervention participated in six 2-h…

  18. Video-Feedback Intervention to Promote Positive Parenting Adapted to Autism (VIPP-AUTI): A Randomized Controlled Trial

    Science.gov (United States)

    Poslawsky, Irina E; Naber, Fabiënne BA; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H

    2015-01-01

    In a randomized controlled trial, we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI) with 78 primary caregivers and their child (16-61 months) with Autism Spectrum Disorder. VIPP-AUTI is a brief attachment-based intervention program, focusing on improving parent-child…

  19. Early intervention in panic: randomized controlled trial and cost-effectiveness analysis

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    van Balkom Anton

    2008-11-01

    Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an

  20. Effectiveness of a web-based intervention for injured claimants: a randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background There is considerable evidence showing that injured people who are involved in a compensation process show poorer physical and mental recovery than those with similar injuries who are not involved in a compensation process. One explanation for this reduced recovery is that the legal process and the associated retraumatization are very stressful for the claimant. The aim of this study was to empower injured claimants in order to facilitate recovery. Methods Participants were recruited by three Dutch claims settlement offices. The participants had all been injured in a traffic crash and were involved in a compensation process. The study design was a randomized controlled trial. An intervention website was developed with (1) information about the compensation process, and (2) an evidence-based, therapist-assisted problem-solving course. The control website contained a few links to already existing websites. Outcome measures were empowerment, self-efficacy, health status (including depression, anxiety, and somatic symptoms), perceived fairness, ability to work, claims knowledge and extent of burden. The outcomes were self-reported through online questionnaires and were measured four times: at baseline, and at 3, 6, and 12 months. Results In total, 176 participants completed the baseline questionnaire after which they were randomized into either the intervention group (n = 88) or the control group (n = 88). During the study, 35 participants (20%) dropped out. The intervention website was used by 55 participants (63%). The health outcomes of the intervention group were no different to those of the control group. However, the intervention group considered the received compensation to be fairer (P users versus nonusers did not reveal significant results. The intervention website was evaluated positively. Conclusions Although the web-based intervention was not used enough to improve the health of injured claimants in compensation processes, it increased

  1. Meta-analysis of non-randomized studies in interventional cardiology: a critical appraisal

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    Eliano Pio Navarese

    2009-12-01

    Full Text Available Utilisation of meta-analysis is becoming more and more common in interventional cardiology. The aim of this statistical approach is to collect a large number of patients from randomized clinical studies and nonrandomized registries in order to obtain a pooled estimate of the results. Nevertheless, simply pooling these results without a correct methodological approach can easily lead to biased conclusions. In this report we analyse the possible methodological drawbacks of such an approach and we suggest a simplified check-list of items to be considered in the effort of building-up a meta-analysis from non-randomized studies.

  2. Effects of the X:IT smoking intervention: a school-based cluster randomized trial.

    Science.gov (United States)

    Andersen, Anette; Krølner, Rikker; Bast, Lotus Sofie; Thygesen, Lau Caspar; Due, Pernille

    2015-12-01

    Uptake of smoking in adolescence is still of major public health concern. Evaluations of school-based programmes for smoking prevention show mixed results. The aim of this study was to examine the effect of X:IT, a multi-component school-based programme to prevent adolescent smoking. Data from a Danish cluster randomized trial included 4041 year-7 students (mean age: 12.5) from 51 intervention and 43 control schools. Outcome measure 'current smoking' was dichotomized into smoking daily, weekly, monthly or more seldom vs do not smoke. Analyses were adjusted for baseline covariates: sex, family socioeconomic position (SEP), best friend's smoking and parental smoking. We performed multilevel, logistic regression analyses of available cases and intention-to-treat (ITT) analyses, replacing missing outcome values by multiple imputation. At baseline, 4.7% and 6.8% of the students at the intervention and the control schools smoked, respectively. After 1 year of the intervention, the prevalence was 7.9% and 10.7%, respectively. At follow-up, 553 students (13.7%) did not answer the question on smoking. Available case analyses: crude odds ratios (OR) for smoking at intervention schools compared with control schools: 0.65 (0.48-0.88) and adjusted: 0.70 (0.47-1.04). ITT analyses: crude OR for smoking at intervention schools compared with control schools: 0.67 (0.50-0.89) and adjusted: 0.61 (0.45-0.82). Students at intervention schools had a lower risk of smoking after a year of intervention in year 7. This multi-component intervention involving educational, parental and context-related intervention components seems to be efficient in lowering or postponing smoking uptake in Danish adolescents. © The Author 2015; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

  3. Early psychological intervention in accidentally injured children ages 2–16: a randomized controlled trial

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    Didier N. Kramer

    2014-06-01

    Full Text Available Background: Road traffic accidents (RTA and burns are frequent events in children. Although many children recover spontaneously, a considerable number develop long-term psychological sequelae. Evidence on early psychological interventions to prevent such long-term problems is still scarce for school-age children and completely lacking for pre-school children. Objectives: To evaluate the efficacy of an early two-session cognitive-behavioral intervention in 108 children ages 2–16 after RTAs and burns. Methods: Children assessed at risk for the development of posttraumatic stress disorder (PTSD were randomly assigned to either a control group offered treatment as usual or an intervention group. Primary outcomes were PTSD, behavioral problems, and depression symptoms. Baseline and blinded 3- and 6-month follow-up assessments were conducted. Results: In pre-school children, no intervention effects were found. School-age children in the intervention group exhibited significantly fewer internalizing problems at 3-month follow-up relative to controls and a borderline significant time-by-group effect for PTSD intrusion symptoms was found (p=0.06. Conclusions: This is the first study examining the efficacy of an indicated, early psychological intervention among both school-age and pre-school-age children. Because the intervention was ineffective for young children, no evidence-based practice can currently be suggested. Given that parents of pre-school children perceived the intervention as helpful, brief counseling of parents in terms of psychoeducation and training in coping skills still should be provided by clinicians, despite the current lack of evidence. To prevent trauma-related disorders in school-age children, the intervention might be used in a step-wise manner, where only children at risk for long-term psychological maladjustment are provided with psychological support.

  4. Delirium prevention in critically ill adults through an automated reorientation intervention - A pilot randomized controlled trial.

    Science.gov (United States)

    Munro, Cindy L; Cairns, Paula; Ji, Ming; Calero, Karel; Anderson, W McDowell; Liang, Zhan

    Explore the effect of an automated reorientation intervention on ICU delirium in a prospective randomized controlled trial. Delirium is common in ICU patients, and negatively affects outcomes. Few prevention strategies have been tested. Thirty ICU patients were randomized to 3 groups. Ten received hourly recorded messages in a family member's voice during waking hours over 3 ICU days, 10 received the same messages in a non-family voice, and 10 (control) did not receive any automated reorientation messages. The primary outcome was delirium free days during the intervention period (evaluated by CAM-ICU). Groups were compared by Fisher's Exact Test. The family voice group had more delirium free days than the non-family voice group, and significantly more delirium free days (p = 0.0437) than the control group. Reorientation through automated, scripted messages reduced incidence of delirium. Using identical scripted messages, family voice was more effective than non-family voice. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Effects of a 12-week Pilates course on lower limb muscle strength and trunk flexibility in women living in the community.

    Science.gov (United States)

    Kao, Yu-Hsiu; Liou, Tsan-Hon; Huang, Yi-Ching; Tsai, Ya-Wen; Wang, Kuo-Ming

    2015-01-01

    Researchers in Taiwan studying regular adult physical activity found that among married women aged 26 to 55 years, 56% participated in physical activity, and that the convenience and safety of the activity were major factors contributing to their willingness to exercise. Muscle weakness and poor trunk flexibility are closely related to some chronic diseases in women. In this cross-sectional survey, we used the Polestar Pilates™ method to explore the effects of a 12-week Pilates course on the physical fitness of women living in the community. Fifty-three members of the experimental group (mean age: 42.30 ± 9.97) and 43 of the control group (mean age: 41.23 ± 9.83) were included. We confirm that a convenient Pilates exercise intervention can significantly improve muscle strength and trunk flexibility in women. Our findings serve as an important reference for health authorities in Taiwan and provide higher awareness of women's health and physical fitness, which can help prevent chronic and cardiovascular diseases.

  6. A 12-Week Assessment of the Treatment of White Spot Lesions with CPP-ACP Paste and/or Fluoride Varnish

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    Zeynep Aslı Güçlü

    2016-01-01

    Full Text Available This 12-week clinical study evaluated the impact of 10% CPP-ACP and 5% sodium fluoride varnish regimes on the regression of nonorthodontic white spot lesions (WSLs. The study included 21 children with 101 WSLs who were randomised into four treatment regimes: weekly clinical applications of fluoride varnish for the first month (FV; twice daily self-applications of CPP-ACP paste (CPP-ACP; weekly applications of fluoride varnish for the first month and twice daily self-applications of CPP-ACP paste (CPP-ACP-FV; and no intervention (control. All groups undertook a standard oral hygiene protocol and weekly consultation. Visual appraisals and laser fluorescence (LF measurements were made in weeks one and twelve. The majority of WSLs in the control and FV groups exhibited no shift in appearance, whereas, in the CPP-ACP and CPP-ACP-FV groups, the lesions predominantly regressed. The visual and LF assessments indicated that the extent of remineralisation afforded by the treatments was of the following order: control ~ FV < CPP-ACP ~ CPP-ACP-FV. Self-applications of CPP-ACP paste as an adjunct to standard oral hygiene significantly improved the appearance and remineralisation of WSLs. No advantage was observed for the use of fluoride varnish as a supplement to either the standard or CPP-ACP-enhanced oral hygiene regimes.

  7. A 12-Week Assessment of the Treatment of White Spot Lesions with CPP-ACP Paste and/or Fluoride Varnish.

    Science.gov (United States)

    Güçlü, Zeynep Aslı; Alaçam, Alev; Coleman, Nichola Jayne

    2016-01-01

    This 12-week clinical study evaluated the impact of 10% CPP-ACP and 5% sodium fluoride varnish regimes on the regression of nonorthodontic white spot lesions (WSLs). The study included 21 children with 101 WSLs who were randomised into four treatment regimes: weekly clinical applications of fluoride varnish for the first month (FV); twice daily self-applications of CPP-ACP paste (CPP-ACP); weekly applications of fluoride varnish for the first month and twice daily self-applications of CPP-ACP paste (CPP-ACP-FV); and no intervention (control). All groups undertook a standard oral hygiene protocol and weekly consultation. Visual appraisals and laser fluorescence (LF) measurements were made in weeks one and twelve. The majority of WSLs in the control and FV groups exhibited no shift in appearance, whereas, in the CPP-ACP and CPP-ACP-FV groups, the lesions predominantly regressed. The visual and LF assessments indicated that the extent of remineralisation afforded by the treatments was of the following order: control ~ FV fluoride varnish as a supplement to either the standard or CPP-ACP-enhanced oral hygiene regimes.

  8. Family-based models for childhood-obesity intervention: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Sung-Chan, P; Sung, Y W; Zhao, X; Brownson, R C

    2013-04-01

    Effective interventions are needed to address the growing epidemic of childhood obesity. In the past 35 years, family-based approach has gradually developed as a preferred intervention. This review aimed to examine the methodological rigour and treatment effectiveness of family-based interventions according to intervention types and theoretical orientations. A total of 15 randomized controlled trials (RCTs) of family-based lifestyle interventions for children and adolescents aged 2-19 years were included. The adapted Methodological Quality Rating Scales (MQRS) and a four-grade qualitative scoring scheme were adopted to evaluate the methodological rigour and the effectiveness of treatment, respectively. The average MQRS score was 7.93 out of 14 points. Ten of the 15 RCTs had well aligned their research questions with appropriate research methods. The overall short-term outcome of the15 RCTs were satisfactory with an average score of 3.1. Family-based interventions rooted in behaviour theory achieved better results than those theoretically connected to family systems theory in terms of treatment effectiveness. Results suggest future studies to improve the methodological design and continue to explore the potential of the family systems approach.

  9. An Intervention to Enhance Obstetric and Newborn Care in India: A cluster randomized-trial

    Science.gov (United States)

    Goudar, Shivaprasad S.; Derman, Richard J.; Honnungar, Narayan V.; Patil, Kamal P.; Swamy, Mallaiah K.; Moore, Janet; Wallace, Dennis D.; McClure, Elizabeth M.; Kodkany, Bhalchandra S.; Pasha, Omrana; Sloan, Nancy L.; Wright, Linda L.; Goldenberg, Robert L.

    2016-01-01

    Objectives This study assessed whether community mobilization and interventions to improve emergency obstetric and newborn care (EmONC) reduced perinatal mortality (PMR) and neonatal mortality rates (NMR) in Belgaum, India. Methods The cluster-randomised controlled trial was conducted in Belgaum District, Karnataka State, India. Twenty geographic clusters were randomized to control or the intervention. The intervention engaged and mobilized community and health authorities to leverage support; strengthened community-based stabilization, referral, and transportation; and aimed to improve quality of care at facilities. Results 17,754 intervention births and 15,954 control births weighing ≥1000 g, respectively, were enrolled and analysed. Comparing the baseline period to the last 6 months period, the NMR was lower in the intervention vs. control clusters (OR=0.60, 95% CI 0.34–1.06, p=.076) as was the PMR (OR = 0.74, 95% CI 0.46–1.19, p=.20) although neither reached statistical significance. Rates of facility birth and caesarean section increased among both groups. There was limited influence on quality of care measures. Conclusions The intervention had large but not statistically significant effects on neonatal and perinatal mortality. Community mobilization and increased facility care may ultimately improve neonatal and perinatal survival, and are important in the context of the global transition towards institutional delivery. PMID:26205277

  10. Multifaceted intervention to improve obstetric practices: The OPERA cluster-randomized controlled trial.

    Science.gov (United States)

    Dupont, Corinne; Winer, Norbert; Rabilloud, Muriel; Touzet, Sandrine; Branger, Bernard; Lansac, Jacques; Gaucher, Laurent; Duclos, Antoine; Huissoud, Cyril; Boutitie, Florent; Rudigoz, René-Charles; Colin, Cyrille

    2017-08-01

    Suboptimal care contributes to perinatal morbidity and mortality. We investigated the effects of a multifaceted program designed to improve obstetric practices and outcomes. A cluster-randomized trial was conducted from October 2008 to November 2010 in 95 French maternity units randomized either to receive an information intervention about published guidelines or left to apply them freely. The intervention combined an outreach visit with a morbidity/mortality conference (MMC) to review perinatal morbidity/mortality cases. Within the intervention group, the units were randomized to have MMCs with or without clinical psychologists. The primary outcome was the rate of suboptimal care among perinatal morbidity/mortality cases. The secondary outcomes included the rate of suboptimal care among cases of morbidity, the rate of suboptimal care among cases of mortality, the rate of avoidable morbidity and/or mortality cases, and the incidence of, morbidity and/or mortality. A mixed logistic regression model with random intercept was used to quantify the effect of the intervention on the main outcome. The study reviewed 2459 cases of morbidity or mortality among 165,353 births. The rate of suboptimal care among morbidity plus mortality cases was not significantly lower in the intervention than in the control group (8.1% vs. 10.6%, OR [95% CI]: 0.75 [0.50-1.12], p=0.15. However, the cases of suboptimal care among morbidity cases were significantly lower in the intervention group (7.6% vs. 11.5%, 0.62 [0.40-0.94], p=0.02); the incidence of perinatal morbidity was also lower (7.0 vs. 8.1‰, p=0.01). No differences were found between psychologist-backed and the other units. The intervention reduced the rate of suboptimal care mainly in morbidity cases and the incidence of morbidity but did not succeed in improving morbidity plus mortality combined. More clear-cut results regarding mortality require a longer study period and the inclusion of structures that intervene before and

  11. A randomized controlled trial of an intervention for infants’ behavioral sleep problems

    OpenAIRE

    Hall, Wendy A.; Hutton, Eileen; Brant, Rollin F.; Collet, Jean Paul; Gregg, Kathy; Saunders, Roy; Ipsiroglu, Osman; Gafni, Amiram; Triolet, Kathy; Tse, Lillian; Bhagat, Radhika; Wooldridge, Joanne

    2015-01-01

    Background Infant behavioral sleep problems are common, with potential negative consequences. We conducted a randomized controlled trial to assess effects of a sleep intervention comprising a two-hour group teaching session and four support calls over 2 weeks. Our primary outcomes were reduced numbers of nightly wakes or parent report of sleep problem severity. Secondary outcomes included improvement in parental depression, fatigue, sleep, and parent cognitions about infant sleep. Methods Two...

  12. An adaptive physical activity intervention for overweight adults: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Marc A Adams

    Full Text Available BACKGROUND: Physical activity (PA interventions typically include components or doses that are static across participants. Adaptive interventions are dynamic; components or doses change in response to short-term variations in participant's performance. Emerging theory and technologies make adaptive goal setting and feedback interventions feasible. OBJECTIVE: To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm. The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention. METHODS: Participants (N = 20 were randomized to one of two 6-month treatments: 1 static intervention (SI or 2 adaptive intervention (AI. Inactive overweight adults (85% women, M = 36.9 ± 9.2 years, 35% non-white in both groups received a pedometer, email and text message communication, brief health information, and biweekly motivational prompts. The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment. This algorithm adjusted goals based on a moving window; an approach that responded to each individual's performance and ensured goals were always challenging but within participants' abilities. The SI group received a static 10,000 steps/day goal with incentives linked to uploading the pedometer's data. RESULTS: A random-effects repeated-measures model accounted for 180 repeated measures and autocorrelation. After adjusting for covariates, the treatment phase showed greater steps/day relative to the baseline phase (p<.001 and a group by study phase interaction was observed (p  .017. The SI group increased by 1,598 steps/day on average between baseline and treatment while the AI group increased by 2,728 steps/day on average between baseline and treatment; a significant between-group difference of 1,130 steps/day (Cohen's d = .74. CONCLUSIONS: The adaptive

  13. A post cardiac surgery intervention to manage delirium involving families: a randomized pilot study.

    Science.gov (United States)

    Mailhot, Tanya; Cossette, Sylvie; Côté, José; Bourbonnais, Anne; Côté, Marie-Claude; Lamarche, Yoan; Denault, André

    2017-07-01

    As many delirium manifestations (e.g., hallucinations or fears) are linked to patients' experiences and personality traits, it is suggested that interventions should be tailored to optimize its management. The inclusion of family members, as part of an intervention, has recently emerged as a solution to developing individualised patient care, but has never been assessed in post-cardiac surgery intensive care unit where almost half of patients will present with delirium. To assess the feasibility, acceptability and preliminary efficacy of an nursing intervention involving family caregivers (FC) in delirium management following cardiac surgery. A randomized pilot study. A total of 30 patient/FC dyads were recruited and randomized to usual care (n = 14) or intervention (n = 16). The intervention was based on the Human Caring Theory, a mentoring model, and sources informing self-efficacy. It comprised seven planned encounters spread over 3 days between an intervention nurse and the FC, each including a 30-min visit at the patient's bedside. During this bedside visit, the FC used delirium management strategies, e.g. reorient the person with delirium. The primary indicator of acceptability was to obtain consent from 75% of approached FCs. The preliminary effect of the intervention on patient outcomes was assessed on (1) delirium severity using the Delirium Index, (2) occurrence of complications, such as falls, (3) length of postoperative hospital stay and (4) psycho-functional recovery using the Sickness Impact Profile. The preliminary effect on FC outcomes was assessed on FC anxiety and self-efficacy. Data were analysed using descriptive statistics, ANCOVAs and logistic regressions. The primary indicator of obtaining consent from FC was achieved (77%). Of the 14 dyads, thirteen (93%) dyads received all seven encounters planned in the experimental intervention. Intervention group patients presented better psycho-functional recovery scores when compared with

  14. Interventions for Preventing Childhood Obesity with Smartphones and Wearable Device: A Protocol for a Non-Randomized Controlled Trial.

    Science.gov (United States)

    Yang, Hye Jung; Kang, Jae-Heon; Kim, Ok Hyun; Choi, Mona; Oh, Myungju; Nam, Jihyun; Sung, Eunju

    2017-02-13

    Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named "HAPPY ME," which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10-12 years of age using HAPPY ME. A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference), body mass index (BMI) percentiles (obesity rate), and psychological perceptions among participants. The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach.

  15. Randomized double blind placebo control studies, the "Gold Standard" in intervention based studies

    Directory of Open Access Journals (Sweden)

    Shobha Misra

    2012-01-01

    Full Text Available Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; "Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.

  16. Randomized double blind placebo control studies, the "Gold Standard" in intervention based studies.

    Science.gov (United States)

    Misra, Shobha

    2012-07-01

    Studies follow a hierarchy in terms of the quality of evidence that they can provide. Randomized double blind placebo control (RDBPC) studies are considered the "gold standard" of epidemiologic studies. And the same is discussed at length in this paper taking example of a real journal article employing this study design to answer the research question; "Does once daily dose of Valacyclovir reduce the risk of transmission of genital herpes in a susceptible partner?" RDBPC studies remain the most convincing research design in which randomly assigning the intervention can eliminate the influence of unknown or immeasurable confounding variables that may otherwise lead to biased and incorrect estimate of treatment effect. Also, randomization eliminates confounding by baseline variables and blinding eliminates confounding by co-interventions, thus eliminating the possibility that the observed effects of intervention are due to differential use of other treatments. The best comparison is placebo control that allows participants, investigators and study staff to be blinded. The advantage of trial over an observational study is the ability to demonstrate causality. Hope, this will be useful to neophyte researchers to understand causal hierarchy when critically evaluating epidemiologic literature.

  17. Reducing antibiotic prescriptions for acute cough by motivating GPs to change their attitudes to communication and empowering patients: a cluster-randomized intervention study

    National Research Council Canada - National Science Library

    Altiner, Attila; Brockmann, Silke; Sielk, Martin; Wilm, Stefan; Wegscheider, Karl; Abholz, Heinz-Harald

    2007-01-01

    .... GPs randomized to receive the intervention were visited by peers. The intervention strategy was focused on the communication within the encounter, not on sharing knowledge about antibiotic prescribing...

  18. Effectiveness of humor intervention for patients with schizophrenia: a randomized controlled trial.

    Science.gov (United States)

    Cai, Chunfeng; Yu, Liping; Rong, Lan; Zhong, Hanling

    2014-12-01

    The primary aim of this pilot study was to evaluate the possible therapeutic effects of a 10-session humor intervention program in improving rehabilitative outcomes and the effects of the intervention on patients' sense of humor among patients with schizophrenia. Thirty subjects were randomly assigned into either the intervention (humor skill training) group (n = 15) or the control (doing handwork) group (n = 15). The results were analyzed using descriptive statistics, t-tests and ANOVA. Repeated measures analysis of variance (ANOVA) tests were conducted to examine the differences across conditions and time. A group by time interaction effect was observed on all of the outcomes, except positive symptoms of PANSS. The time main effect was also significant on the total score (p humor skill training in a mental health service can improve rehabilitative outcomes and sense of humor for schizophrenia patients who were in the rehabilitation stage. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. A randomized controlled intervention trial to relieve and prevent neck/shoulder pain

    DEFF Research Database (Denmark)

    Andersen, Lars L; Jørgensen, Marie B; Blangsted, Anne Katrine;

    2008-01-01

    PURPOSE: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS: A 1-yr randomized controlled intervention trial was done with three groups: specific...... in maximal muscle strength, and changes in intensity of neck/shoulder pain (scale 0-9) in those with and without pain at baseline. RESULTS: Regular participation was achieved by 54%, 31%, and 16% of those of the participants who answered the questionnaire in SRT (78%), APE (81%), and REF (80%), respectively......, during the first half of the intervention period, and decreased to 35%, 28% and 9%, respectively, during the second half. Shoulder elevation strength increased 9-11% in SRT and APE (P pain at baseline decreased the intensity of neck pain through SRT, from 5.0 +/- 0...

  20. Programming generality into a performance feedback writing intervention: A randomized controlled trial.

    Science.gov (United States)

    Hier, Bridget O; Eckert, Tanya L

    2016-06-01

    Substantial numbers of students in the United States are performing below grade-level expectations in core academic areas, and these deficits are most pronounced in the area of writing. Although performance feedback procedures have been shown to produce promising short-term improvements in elementary-aged students' writing skills, evidence of maintenance and generalization of these intervention effects is limited. The purpose of this study was to examine the immediate, generalized, and sustained effects of incorporating multiple exemplar training into the performance feedback procedures of a writing intervention using a randomized controlled trial (RCT). Results indicated that although the addition of multiple exemplar training did not improve students' writing performance on measures of stimulus and response generalization, it did result in greater maintenance of intervention effects in comparison to students who received performance feedback without generality programming and students who engaged in weekly writing practice alone.

  1. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Orla Doyle

    Full Text Available This study examined the impact of a targeted Irish early intervention program on children's emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally.ISRCTN Registry ISRCTN04631728.

  2. Effects of butter from mountain-pasture grazing cows on risk markers of the metabolic syndrome compared with conventional Danish butter: a randomized controlled study

    DEFF Research Database (Denmark)

    Werner, Louise Bruun; Hellgren, Lars; Raff, Marianne

    2013-01-01

    -blind, randomized, 12-week, parallel intervention study, 38 healthy subjects replaced part of their habitual dietary fat intake with 39 g fat from test butter made from milk from mountain-pasture grazing cows or from cows fed conventional winter fodder. Glucose-tolerance and circulating risk markers were analysed...

  3. Effect of a medical food on body mass index and activities of daily living in patients with Alzheimer's disease: secondary analyses from a randomized, controlled trial

    NARCIS (Netherlands)

    Kamphuis, P.J.; Verhey, F.R.J.; Olde Rikkert, M.G.M.; Twisk, J.W.R.; Swinkels, S.H.N.; Scheltens, P.

    2011-01-01

    OBJECTIVES: To investigate the effect of a medical food (Souvenaid) on body mass index (BMI) and functional abilities in patients with mild Alzheimer's disease (AD). DESIGN/SETTING/PARTICIPANTS/INTERVENTION /MEASUREMENTS: These analyses were performed on data from a 12-week, double-blind, randomized

  4. ¡Cocinar Para Su Salud!: Randomized controlled trial of a culturally-based dietary intervention among Hispanic breast cancer survivors

    Science.gov (United States)

    Greenlee, Heather; Gaffney, Ann Ogden; Aycinena, A. Corina; Koch, Pam; Contento, Isobel; Karmally, Wahida; Richardson, John M.; Lim, Emerson; Tsai, Wei-Yann; Crew, Katherine; Maurer, Matthew; Kalinsky, Kevin; Hershman, Dawn L.

    2015-01-01

    BACKGROUND There is a need for culturally-relevant nutrition programs targeted to underserved cancer survivors. OBJECTIVE To examine the effect of a culturally-based approach to dietary change on increasing fruit/vegetable intake and decreasing fat intake among Hispanic breast cancer (BC) survivors. DESIGN Participants were randomized to intervention (IG) and control (CG) groups. Diet recalls, detailed interviews, fasting blood, and anthropometric measures were collected at baseline, 3-, 6- and 12-months. PARTICIPANTS/SETTING Hispanic women (n=70) with stage 0-III BC who completed adjuvant treatment and lived in New York City were randomized between April 2011 and March 2012. INTERVENTION The IG (n=34) participated in ¡Cocinar Para Su Salud! (¡CPSS!), a culturally-based 9-session (24-hours over 12 weeks) intervention including nutrition education, cooking classes and food shopping field trips. The CG (n=36) received written dietary recommendations for BC survivors. MAIN OUTCOME MEASURES Change at 6 months in daily fruit/vegetable servings and % calories from total fat. STATISTICAL ANALYSES Linear regression models adjusted for stratification factors and estimated marginal means were used to compare changes in diet from baseline to 3- and 6-months. RESULTS Baseline characteristics: mean age 56.6 years (SD 9.7), mean time since diagnosis 3.4 years (SD 2.7), mean BMI 30.9 kg/m2 (SD 6.0), 62.9% with annual household income ≤$15,000, average daily servings of all fruits/vegetables 5.3 (targeted fruits/vegetables 3.7 servings excluding legumes/juices/starchy vegetables/fried foods) and 27.7% of daily calories from fat. Over 60% in the IG attended ≥7/9 classes with overall study retention of 87% retention at 6 months. At month 6, the IG compared to CG reported an increase in mean servings of fruits/vegetables from baseline (all fruits/vegetables: +2.0 vs. −0.1, P=0.005; targeted fruits/vegetables: +2.7 vs. +0.5, P=0.002) and a non-significant decrease in

  5. Non-pharmacological interventions in hypertension: A community-based cross-over randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hema Subramanian

    2011-01-01

    Full Text Available Background: Hypertension is the most prevalent non-communicable disease causing significant morbidity/mortality through cardiovascular, cerebrovascular, and renal complications. Objectives: This community-based study tested the efficacy of non-pharmacological interventions in preventing/controlling hypertension. Materials and Methods: This is a cross-over randomized controlled trial (RCT of the earlier RCT (2007 of non-pharmacological interventions in hypertension, conducted in the urban service area of our Institute. The subjects, prehypertensive and hypertensive young adults (98 subjects: 25, 23, 25, 25 in four groups were randomly allotted into a group that he/she had not belonged to in the earlier RCT: Control (New Group I, Physical Exercise (NG II-brisk walking for 50 to 60 minutes, three to four days/week, Salt Intake Reduction (NG III to at least half of their previous intake, Yoga (NG IV for 30 to 45 minutes/day, five days/week. Blood pressure was measured before and after eight weeks of intervention. Analysis was by ANOVA with a Games-Howell post hoc test. Results: Ninety-four participants (25, 23, 21, 25 completed the study. All three intervention groups showed significant reduction in BP (SBP/DBP mmHg: 5.3/6.0 in NG II, 2.5/2.0 in NG III, and 2.3/2.4 in NG IV, respectively, while the Control Group showed no significant difference. Persistence of significant reduction in BP in the three intervention groups after cross-over confirmed the biological plausibility of these non-pharmacological interventions. This study reconfirmed that physical exercise was more effective than Salt Reduction or Yoga. Salt Reduction, and Yoga were equally effective. Conclusion: Physical exercise, salt intake reduction, and yoga are effective non-pharmacological methods for reducing blood pressure in young pre-hypertensive and hypertensive adults.

  6. Feasibility Study of a Randomized Controlled Trial of a Telephone-Delivered Problem Solving-Occupational Therapy Intervention to Reduce Participation Restrictions in Rural Breast Cancer Survivors Undergoing Chemotherapy

    Science.gov (United States)

    Hegel, Mark T.; Lyons, Kathleen D.; Hull, Jay G.; Kaufman, Peter; Urquhart, Laura; Li, Zhongze; Ahles, Tim A.

    2010-01-01

    Objective Breast cancer patients receiving adjuvant chemotherapy often experience functional effects of treatment that limit participation in life activities. The purpose of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) of a novel intervention for these restrictions, determine acceptability of the intervention, and preliminarily assess its effects. Methods A pilot RCT of a telephone-delivered Problem Solving and Occupational Therapy intervention (PST-OT) to improve participation restrictions in rural breast cancer patients undergoing chemotherapy. Thirty-one participants with Stages 1-3 breast cancer were randomized to 6 weekly sessions of PST-OT (n=15) and Usual Care (n=16). The primary study outcome was the feasibility of conducting the trial. Secondary outcomes were functional, quality of life and emotional status as assessed at baseline, 6 weeks and 12 weeks. Results Of 46 patients referred 31 were enrolled (67% recruitment rate), of which 6 participants withdrew (81% retention rate). Twenty-four participants completed all study-related assessments (77%). Ninety-two percent of PST-OT participants were highly satisfied with the intervention, and 92% reported PST-OT to be helpful/very helpful for overcoming participation restrictions. Ninety-seven percent of planned PST-OT treatment sessions were completed. Completion rates for PST-OT homework tasks were high. Measures of functioning, quality of life and emotional state favored the PST-OT condition. Conclusion This pilot study suggests that an RCT of the PST-OT intervention is feasible to conduct with rural breast cancer patients undergoing adjuvant chemotherapy and that PST-OT may have positive effects on function, quality of life, and emotional state. PMID:20821373

  7. Feasibility study of a randomized controlled trial of a telephone-delivered problem-solving-occupational therapy intervention to reduce participation restrictions in rural breast cancer survivors undergoing chemotherapy.

    Science.gov (United States)

    Hegel, Mark T; Lyons, Kathleen D; Hull, Jay G; Kaufman, Peter; Urquhart, Laura; Li, Zhongze; Ahles, Tim A

    2011-10-01

    Breast cancer patients receiving adjuvant chemotherapy often experience functional effects of treatment that limit participation in life activities. The purpose of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) of a novel intervention for these restrictions, determine acceptability of the intervention, and preliminarily assess its effects. A pilot RCT of a telephone-delivered Problem-solving and Occupational Therapy intervention (PST-OT) to improve participation restrictions in rural breast cancer patients undergoing chemotherapy. Thirty-one participants with Stages 1-3 breast cancer were randomized to 6 weekly sessions of PST-OT (n = 15) and usual care (n = 16). The primary study outcome was the feasibility of conducting the trial. Secondary outcomes were functional, quality of life and emotional status as assessed at baseline, 6 and 12 weeks. Of 46 patients referred 31 were enrolled (67% recruitment rate), of which 6 participants withdrew (81% retention rate). Twenty-four participants completed all study-related assessments (77%). Ninety-two percent of PST-OT participants were highly satisfied with the intervention, and 92% reported PST-OT to be helpful/very helpful for overcoming participation restrictions. Ninety-seven percent of planned PST-OT treatment sessions were completed. Completion rates for PST-OT homework tasks were high. Measures of functioning, quality of life, and emotional state favored the PST-OT condition. This pilot study suggests that an RCT of the PST-OT intervention is feasible to conduct with rural breast cancer patients undergoing adjuvant chemotherapy and that PST-OT may have positive effects on function, quality of life, and emotional state. 2010 John Wiley & Sons, Ltd.

  8. A randomized trail comparing primary percutaneous coronary intervention with a strategy of short-acting thrombolysis and immediate planned primary percutaneous coronary intervention in acute myocardial infarction

    Institute of Scientific and Technical Information of China (English)

    傅向华

    2003-01-01

    A randomized trail comparing primary percutaneous coronary intervention with a strategy of short-acting thrombolysis and immediate planned primary percutaneous coronary intervention in acute myocardial infarction!050000$河北医科大学第二医院河北医科大学心脏介入中心@傅向华

  9. Absorption of silicon from artesian aquifer water and its impact on bone health in postmenopausal women: a 12 week pilot study

    Directory of Open Access Journals (Sweden)

    Lee Tsz

    2010-10-01

    Full Text Available Abstract Background Decreased bone mineral density and osteoporosis in postmenopausal women represents a growing source of physical limitations and financial concerns in our aging population. While appropriate medical treatments such as bisphosphonate drugs and hormone replacement therapy exist, they are associated with serious side effects such as osteonecrosis of the jaw or increased cardiovascular risk. In addition to calcium and vitamin D supplementation, previous studies have demonstrated a beneficial effect of dietary silicon on bone health. This study evaluated the absorption of silicon from bottled artesian aquifer water and its effect on markers of bone metabolism. Methods Seventeen postmenopausal women with low bone mass, but without osteopenia or osteoporosis as determined by dual x-ray absorptiometry (DEXA were randomized to drink one liter daily of either purified water of low-silicon content (PW or silicon-rich artesian aquifer water (SW (86 mg/L silica for 12 weeks. Urinary silicon and serum markers of bone metabolism were measured at baseline and after 12 weeks and analyzed with two-sided t-tests with p Results The urinary silicon level increased significantly from 0.016 ± 0.010 mg/mg creatinine at baseline to 0.037 ± 0.014 mg/mg creatinine at week 12 in the SW group (p = 0.003, but there was no change for the PW group (0.010 ± 0.004 mg/mg creatinine at baseline vs. 0.009 ± 0.006 mg/mg creatinine at week 12, p = 0.679. The urinary silicon for the SW group was significantly higher in the silicon-rich water group compared to the purified water group (p Conclusions These findings indicate that bottled water from artesian aquifers is a safe and effective way of providing easily absorbed dietary silicon to the body. Although the silicon did not affect bone turnover markers in the short-term, the mineral's potential as an alternative prevention or treatment to drug therapy for osteoporosis warrants further longer-term investigation

  10. Effect of 12 weeks aerobic exercise for along with folic acid supplementation on the levels of the ghrelin hormone amount of food intake and weight changes of female Wistar rats

    Directory of Open Access Journals (Sweden)

    A Parvizi

    2016-11-01

    Full Text Available Background & aim: Results of numerous studies have shown that approximately 1 to 78 percent of female athletes suffer from eating disorders. On the other hand, it has been mentioned that folic acid could increase appetite. The ghrelin hormone is known as a strong stimulant for appetite. Therefore, to clarify the role of exercise and food intake of folic acid on plasma acylated ghrelin the study aim was to evaluate the effect of 12 weeks of aerobic training on ghrelin supplementation of folic acid and quantity of food intake and weight change in female rats. Methods: In the present experimental study, 24 rats were randomly divided into three groups of 8 including: control, training and training along with folic acid supplementation. The training protocol consisted of aerobic exercise running on a treadmill for 12 weeks (5 days a week. Standard meal and water were freely provided for the subjects and in the supplement group 10 mg dissolved folic acid per liter of water were used and then the food intake and body weight was measured every week. 24 hours after the last session of training and 8 hours of overnight fasting, blood and tissue samples were collected and hormones levels were measured using Eliza method. To data analyzing, one way ANOVA and Tukey post hoc test was used. Results: The results showed that 12 weeks of  aerobic training with folic acid supplementation had significantly reduced serum acylated ghrelin levels (P0.05. The 12-week aerobic training with folic acid intake in comparison with other groups significantly increased food intake and body weight gain (p < 0.05. Conclusion: According to the acylated ghrelin reduction and lack of change in the stomach acylated ghrelin with increased food intake and body weight in rats, it seems that taking folic acid supplements inactive athletes with another strong mechanism, increasing consumption of food and influence on appetite center.

  11. The effect of complex rehabilitation training for 12 weeks on trunk muscle function and spine deformation of patients with SCI.

    Science.gov (United States)

    Sung, Dong-Hun; Yoon, Seong-Deok; Park, Gi Duck

    2015-03-01

    [Purpose] It is important for patients with incomplete spinal cord injury (SCI) to strengthen their muscle strength and return to the work force one of the ultimate objectives of rehabilitation. This study reports how a single patient with SCI became stabilized in terms of abdominal muscles and back extension muscles, as well as returning the back to the neutral position from spinal deformation, as result of complex exercises performed for 12 weeks. [Subjects] The degree of damage of the subject was rated as C grade. The subject of this study had unstable posture due to paralysis in the lower extremities of the left side after removal of a malignant tumor by surgical operation, and tilting and torsion in the pelvis increased followed by increase of kyphosis in the thoracolumbar spine. The subject was more than two years since diagnosis of incomplete SCI after surgery. [Methods] Using isokinetic lumbar muscle strength measurement equipment, peak torque/weight, total work and average power in flexion and extension of the lumbar region were measured. A trunk measurement system (Formetric 4D, DIERS, Germany), which is a 3D image processing apparatus with high resolution for vertebrae, was used in order to measure 3D vertebrae and pelvis deformation as well as static balance abilities. As an exercise method, a foam roller was used to conduct fascia relaxation massage for warming-up, and postural kyphosis was changed into postural lordosis by lat pull-down using equipment, performed in 5 sets of 15 times preset at 60% intensity of 1RM 4 set of 10 crunch exercises per set using Togu's were done while sitting at the end of Balance pad, and 4 sets of 15 bridge exercises. [Results] All angular speed tests showed a gradual increase in muscle strength. Flexion and extension showed 10% and 3% improvements, respectively. The spine deformation test showed that isokinetic exercise and lat pull-down exercise for 12 weeks resulted in improved spinal shape. [Conclusion] In this study

  12. Effects of 12 weeks of aerobic training on autonomic modulation, mucociliary clearance, and aerobic parameters in patients with COPD

    Science.gov (United States)

    Leite, Marceli Rocha; Ramos, Ercy Mara Cipulo; Kalva-Filho, Carlos Augusto; Freire, Ana Paula Coelho Figueira; de Alencar Silva, Bruna Spolador; Nicolino, Juliana; de Toledo-Arruda, Alessandra Choqueta; Papoti, Marcelo; Vanderlei, Luiz Carlos Marques; Ramos, Dionei

    2015-01-01

    Introduction Patients with chronic obstructive pulmonary disease (COPD) exhibit aerobic function, autonomic nervous system, and mucociliary clearance alterations. These parameters can be attenuated by aerobic training, which can be applied with continuous or interval efforts. However, the possible effects of aerobic training, using progressively both continuous and interval sessions (ie, linear periodization), require further investigation. Aim To analyze the effects of 12-week aerobic training using continuous and interval sessions on autonomic modulation, mucociliary clearance, and aerobic function in patients with COPD. Methods Sixteen patients with COPD were divided into an aerobic (continuous and interval) training group (AT) (n=10) and a control group (CG) (n=6). An incremental test (initial speed of 2.0 km·h−1, constant slope of 3%, and increments of 0.5 km·h−1 every 2 minutes) was performed. The training group underwent training for 4 weeks at 60% of the peak velocity reached in the incremental test (vVO2peak) (50 minutes of continuous effort), followed by 4 weeks of sessions at 75% of vVO2peak (30 minutes of continuous effort), and 4 weeks of interval training (5×3-minute effort at vVO2peak, separated by 1 minute of passive recovery). Intensities were adjusted through an incremental test performed at the end of each period. Results The AT presented an increase in the high frequency index (ms2) (P=0.04), peak oxygen uptake (VO2peak) (P=0.01), vVO2peak (P=0.04), and anaerobic threshold (P=0.02). No significant changes were observed in the CG (P>0.21) group. Neither of the groups presented changes in mucociliary clearance after 12 weeks (AT: P=0.94 and CG: P=0.69). Conclusion Twelve weeks of aerobic training (continuous and interval sessions) positively influenced the autonomic modulation and aerobic parameters in patients with COPD. However, mucociliary clearance was not affected by aerobic training. PMID:26648712

  13. Impact of a Home-Based Physical and Nutritional Intervention Program Conducted by Lay-Volunteers on Handgrip Strength in Prefrail and Frail Older Adults: A Randomized Control Trial

    Science.gov (United States)

    Haider, Sandra; Dorner, Thomas E.; Luger, Eva; Kapan, Ali; Titze, Sylvia; Lackinger, Christian; Schindler, Karin E.

    2017-01-01

    A randomized controlled trial was performed to compare the effects of a home-based physical and nutritional intervention program carried out by lay-volunteers to home visits with social support alone. Buddies visited 80 prefrail or frail older persons at home twice a week for 12 weeks. The physical training and nutrition group (PTN, n = 39) performed two sets of six strength exercises, discussed nutritional topics and received social support. The social support group (SoSu, n = 41) received home visits with social support only. In the PTN group, handgrip strength increased significantly by 2.4 kg (95% CI: 1.0–3.8). In the SoSu group we did not see a significant improvement. However, no significant between-group difference was found. Physical performance increased in both groups, although with a higher increase of 1.0 point (95% CI: 0.1–2.0) in the PTN group. In none of the groups muscle mass changed. Further results showed that frail individuals benefit more from the intervention than prefrail individuals (OR: 2.78; 95% CI: 1.01–7.66). Handgrip strength in the intervention group increased by a clinically relevant value and this effect is comparable to that obtained by health-care professionals. Therefore, home visits with a physical training and nutritional program could offer a new perspective in the care of community-dwelling prefrail and frail older persons. PMID:28085913

  14. Impact of a Home-Based Physical and Nutritional Intervention Program Conducted by Lay-Volunteers on Handgrip Strength in Prefrail and Frail Older Adults: A Randomized Control Trial.

    Science.gov (United States)

    Haider, Sandra; Dorner, Thomas E; Luger, Eva; Kapan, Ali; Titze, Sylvia; Lackinger, Christian; Schindler, Karin E

    2017-01-01

    A randomized controlled trial was performed to compare the effects of a home-based physical and nutritional intervention program carried out by lay-volunteers to home visits with social support alone. Buddies visited 80 prefrail or frail older persons at home twice a week for 12 weeks. The physical training and nutrition group (PTN, n = 39) performed two sets of six strength exercises, discussed nutritional topics and received social support. The social support group (SoSu, n = 41) received home visits with social support only. In the PTN group, handgrip strength increased significantly by 2.4 kg (95% CI: 1.0-3.8). In the SoSu group we did not see a significant improvement. However, no significant between-group difference was found. Physical performance increased in both groups, although with a higher increase of 1.0 point (95% CI: 0.1-2.0) in the PTN group. In none of the groups muscle mass changed. Further results showed that frail individuals benefit more from the intervention than prefrail individuals (OR: 2.78; 95% CI: 1.01-7.66). Handgrip strength in the intervention group increased by a clinically relevant value and this effect is comparable to that obtained by health-care professionals. Therefore, home visits with a physical training and nutritional program could offer a new perspective in the care of community-dwelling prefrail and frail older persons.

  15. Lifestyle intervention for gestational diabetes mellitus prevention: A cluster-randomized controlled study

    Institute of Scientific and Technical Information of China (English)

    Shuang Wang; Jing-Mei Ma; Hui-Xia Yang

    2015-01-01

    Objective: The study was to examine whether gestational diabetes mellitus (GDM) can be prevented by early trimester lifestyle counseling in a high-risk population.Methods: From September 2012 to January 2013, 1664 pregnancies in the Department of Obstetrics and Gynecology of First Hospital of Peking University were enrolled in the study during their first prenatal care visit before the 8 gestational weeks visit and asked to fill out a questionnaire on GDM risk evaluation.According to the questionnaire and medical records, those with at least one risk factor of GDM were included in the intervention study and randomly allocated to two groups, intervention group and control group.Routine prenatal care was offered, while standardized two-step lifestyle intervention was provided to the intervention group during 6-8 gestational weeks, and at 12-13 gestational weeks, enforcement intervention based on maternal anthropometrics were offered.Both groups were followed until 75 g oral glucose tolerance test (OGTT) testing at 24-28 gestational weeks.The weight gain after intervention and the prevalence of GDM were used to evaluate the effect.Results: (1) According to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria, the positive rate of GDM for the intervention group was 17.16% (23/134), lower than the control group which was 23.91% (33/138), P =0.168.(2) The weight gain during the first and second trimester for the intervention group was (1.38 ± 2.34) kg and (5.51 ± 2.18) kg, lower than in the control group which was (1.41 ± 2.58) kg and (5.66 ± 2.25) kg, (P =0.905, P =0.567).(3) Positive rate of GDM for those fasting plasma glucose (FPG) ≥5.1 mmol/L during early pregnancy was 11/36 (30.55%) for the intervention group that was lower than 17/37 (45.95%) for the control group, but the statistical difference was not significant (P =0.076).Conclusion: The positive rate of GDM could be reduced by a certain amount lifestyle

  16. What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

    Science.gov (United States)

    Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

    2015-11-01

    Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions.

  17. Randomized controlled trial of a brief dyadic cognitive-behavioral intervention designed to prevent PTSD

    Directory of Open Access Journals (Sweden)

    Alain Brunet

    2013-08-01

    Full Text Available Background : There is a dearth of effective interventions to prevent the development of post-traumatic stress disorder (PTSD. Method : We evaluated the efficacy of a brief dyadic two-session cognitive-behavioral intervention through a controlled trial involving trauma-exposed individuals recruited at the hospital's emergency room. Participants were randomly assigned to either the dyadic intervention group (n=37 or to a waiting list (assessment only group (n=37. Results : In an intent-to-treat analysis, a time-by-group interaction was found, whereby the treated participants had less PTSD symptoms at the post-treatment but not at the pre-treatment compared to controls. Controlling for the improvement observed in the control participants, the intervention yielded a net effect size of d=0.39. Conclusions : A brief, early, and effective intervention can be provided by nurses or social workers in hospital settings, at a fairly low cost to individuals presenting to the emergency room as the result of trauma exposure.

  18. Association of intervention outcomes with practice capacity for change: Subgroup analysis from a group randomized trial

    Directory of Open Access Journals (Sweden)

    Weyer Sharon

    2008-05-01

    Full Text Available Abstract Background The relationship between health care practices' capacity for change and the results and sustainability of interventions to improve health care delivery is unclear. Methods In the setting of an intervention to increase preventive service delivery (PSD, we assessed practice capacity for change by rating motivation to change and instrumental ability to change on a one to four scale. After combining these ratings into a single score, random effects models tested its association with change in PSD rates from baseline to immediately after intervention completion and 12 months later. Results Our measure of practices' capacity for change varied widely at baseline (range 2–8; mean 4.8 ± 1.6. Practices with greater capacity for change delivered preventive services to eligible patients at higher rates after completion of the intervention (2.7% per unit increase in the combined effort score, p Conclusion Greater capacity for change is associated with a higher probability that a practice will attain and sustain desired outcomes. Future work to refine measures of this practice characteristic may be useful in planning and implementing interventions that result in sustained, evidence-based improvements in health care delivery.

  19. Impact of a Social Work Care Coordination Intervention on Hospital Readmission: A Randomized Controlled Trial.

    Science.gov (United States)

    Bronstein, Laura R; Gould, Paul; Berkowitz, Shawn A; James, Gary D; Marks, Kris

    2015-07-01

    This study assessed how a social work-led care coordination intervention would reduce the within-30-day hospital readmission rate among moderate- and high-risk patients age 50 years or older. Authors ran a randomized controlled trial to determine whether there was a significant difference in within-30-day readmission rates between patients receiving usual care post-discharge and those receiving intervention from an MSW intern (one home visit and one to two phone calls). Results were obtained using a sample of hospitalized patients with a LACE index score of 7 or higher (N = 89). Analysis suggests that the intervention improved the likelihood of not being readmitted by some 22 percent (RR = 1.222; 95% CI = 1.063-1.405). The risk improvement with the intervention was highly statistically significant (p = .003). This study shows that a time-efficient care coordination intervention by MSW interns may decrease hospital readmission rates. Replications of this study in other communities, with more diverse populations, and with larger numbers of patients will indicate whether results are generalizable.

  20. A Pain Education Intervention for Patients Undergoing Ambulatory Inguinal Hernia Repair: A Randomized Controlled Trial.

    Science.gov (United States)

    Sawhney, Monakshi; Watt-Watson, Judy; McGillion, Michael

    2017-09-01

    Background Inguinal hernia repair is a common ambulatory surgery after which many patients experience moderate to severe post-operative pain. Limited research has examined the effect of education interventions to reduce pain after ambulatory surgery. Purpose This trial evaluated the effectiveness of an individualized Hernia Repair Education Intervention (HREI) for patients following inguinal hernia repair. Method Pre-operatively, participants (N = 82) were randomized to either the intervention (HREI) or the usual care group. The HREI included written and verbal information regarding managing pain and two telephone support calls (before and after surgery). The primary outcome was WORST 24-h pain intensity on movement on post-operative day 2. Secondary outcomes included pain intensity at rest and movement, pain-related interference with activities, pain quality, analgesics consumed, and adverse effects at post-operative days 2 and 7. Results At day 2, the intervention group reported significantly lower scores across pain intensity outcomes, including WORST 24-h pain on movement and at rest (p pain NOW on movement and at rest (p = 0.001). Conclusion These findings suggest that the HREI may improve patients' pain and function following ambulatory inguinal hernia repair. Further research should examine the effectiveness of an education intervention over a longer period of time.

  1. Estimating the health benefit of reducing indoor air pollution in a randomized environmental intervention

    Science.gov (United States)

    Peng, Roger D.; Butz, Arlene M.; Hackstadt, Amber J.; Williams, D'Ann L.; Diette, Gregory B.; Breysse, Patrick N.; Matsui, Elizabeth C.

    2016-01-01

    Recent intervention studies targeted at reducing indoor air pollution have demonstrated both the ability to improve respiratory health outcomes and to reduce particulate matter (PM) levels in the home. However, these studies generally do not address whether it is the reduction of PM levels specifically that improves respiratory health. In this paper we apply the method of principal stratification to data from a randomized air cleaner intervention designed to reduce indoor PM in homes of children with asthma. We estimate the health benefit of the intervention amongst study subjects who would experience a substantial reduction in PM in response to the intervention. For those subjects we find an increase in symptom-free days that is almost three times as large as the overall intention-to-treat effect. We also explore the presence of treatment effects amongst those subjects whose PM levels would not respond to the air cleaner. This analysis demonstrates the usefulness of principal stratification for environmental intervention trials and its potential for much broader application in this area. PMID:27695203

  2. Communication interventions for minimally verbal children with autism: a sequential multiple assignment randomized trial.

    Science.gov (United States)

    Kasari, Connie; Kaiser, Ann; Goods, Kelly; Nietfeld, Jennifer; Mathy, Pamela; Landa, Rebecca; Murphy, Susan; Almirall, Daniel

    2014-06-01

    This study tested the effect of beginning treatment with a speech-generating device (SGD) in the context of a blended, adaptive treatment design for improving spontaneous, communicative utterances in school-aged, minimally verbal children with autism. A total of 61 minimally verbal children with autism, aged 5 to 8 years, were randomized to a blended developmental/behavioral intervention (JASP+EMT) with or without the augmentation of a SGD for 6 months with a 3-month follow-up. The intervention consisted of 2 stages. In stage 1, all children received 2 sessions per week for 3 months. Stage 2 intervention was adapted (by increased sessions or adding the SGD) based on the child's early response. The primary outcome was the total number of spontaneous communicative utterances; secondary measures were the total number of novel words and total comments from a natural language sample. Primary aim results found improvements in spontaneous communicative utterances, novel words, and comments that all favored the blended behavioral intervention that began by including an SGD (JASP+EMT+SGD) as opposed to spoken words alone (JASP+EMT). Secondary aim results suggest that the adaptive intervention beginning with JASP+EMT+SGD and intensifying JASP+EMT+SGD for children who were slow responders led to better posttreatment outcomes. Minimally verbal school-aged children can make significant and rapid gains in spoken spontaneous language with a novel, blended intervention that focuses on joint engagement and play skills and incorporates an SGD. Future studies should further explore the tailoring design used in this study to better understand children's response to treatment. Clinical trial registration information-Developmental and Augmented Intervention for Facilitating Expressive Language (CCNIA); http://clinicaltrials.gov/; NCT01013545. Copyright © 2014 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

  3. Intervention to improve the quality of antimicrobial prescribing for urinary tract infection: a cluster randomized trial.

    Science.gov (United States)

    Vellinga, Akke; Galvin, Sandra; Duane, Sinead; Callan, Aoife; Bennett, Kathleen; Cormican, Martin; Domegan, Christine; Murphy, Andrew W

    2016-02-02

    Overuse of antimicrobial therapy in the community adds to the global spread of antimicrobial resistance, which is jeopardizing the treatment of common infections. We designed a cluster randomized complex intervention to improve antimicrobial prescribing for urinary tract infection in Irish general practice. During a 3-month baseline period, all practices received a workshop to promote consultation coding for urinary tract infections. Practices in intervention arms A and B received a second workshop with information on antimicrobial prescribing guidelines and a practice audit report (baseline data). Practices in intervention arm B received additional evidence on delayed prescribing of antimicrobials for suspected urinary tract infection. A reminder integrated into the patient management software suggested first-line treatment and, for practices in arm B, delayed prescribing. Over the 6-month intervention, practices in arms A and B received monthly audit reports of antimicrobial prescribing. The proportion of antimicrobial prescribing according to guidelines for urinary tract infection increased in arms A and B relative to control (adjusted overall odds ratio [OR] 2.3, 95% confidence interval [CI] 1.7 to 3.2; arm A adjusted OR 2.7, 95% CI 1.8 to 4.1; arm B adjusted OR 2.0, 95% CI 1.3 to 3.0). An unintended increase in antimicrobial prescribing was observed in the intervention arms relative to control (arm A adjusted OR 2.2, 95% CI 1.2 to 4.0; arm B adjusted OR 1.4, 95% CI 0.9 to 2.1). Improvements in guideline-based prescribing were sustained at 5 months after the intervention. A complex intervention, including audit reports and reminders, improved the quality of prescribing for urinary tract infection in Irish general practice. ClinicalTrials.gov, no. NCT01913860. © 2016 Canadian Medical Association or its licensors.

  4. Effect of birth weight and 12 weeks of exercise training on exercise-induced AMPK signaling in human skeletal muscle

    DEFF Research Database (Denmark)

    Mortensen, Brynjulf; Hingst, Janne Rasmuss; Frederiksen, Nicklas;

    2013-01-01

    Subjects with a low birth weight (LBW) display increased risk of developing type 2 diabetes (T2D). We hypothesized that this is associated with defects in muscle adaptations following acute and regular physical activity, evident by impairments in the exercise-induced activation of AMPK signaling....... the need for AMPK to control energy turnover during exercise. Thus, the remaining ¿3-associated AMPK activation by acute exercise after exercise training might be sufficient to maintain cellular energy balance........ We investigated 21 LBW and 21 normal birth weight (NBW) subjects during 1 hour of acute exercise performed at the same relative workload before and after 12 weeks of exercise training. Multiple skeletal muscle biopsies were obtained before and after exercise. Protein levels and phosphorylation status...... were determined by Western blotting. AMPK activities were measured using activity assays. Protein levels of AMPK isoforms a1 and ¿1 were significantly increased while ¿3 levels decreased with training independent of group. The LBW group had higher exercise-induced AMPK Thr(172) phosphorylation before...

  5. A physical fitness follow-up in children with cerebral palsy receiving 12-week individualized exercise training.

    Science.gov (United States)

    Jeng, Shiau-Chian; Yeh, Kuo-Kuang; Liu, Wen-Yu; Huang, Wei-Pin; Chuang, Yu-Fen; Wong, Alice M K; Lin, Yang-Hua

    2013-11-01

    Physical fitness in children with cerebral palsy (CP) is lower than in their peers. A 12-week individualized home-based exercise program completed by 11 children with CP 10 years earlier showed a favorable effect on physical fitness performance. We follow-up the physical fitness of those 11 children with CP, and compare their physical fitness and health-related quality of life (HRQoL) to children with CP without exercise training matched with age and motor levels. Eleven children with CP in the 2003 program as a follow-up group (FUG) and 12 volunteers recruited as a control group (CG) participated in this study. Physical fitness measures, including cardiopulmonary endurance, muscle strength, body mass index (BMI), flexibility, agility, balance, and the SF-36 Taiwan version, were assessed in both groups. After 10 years, the FUG showed better physical fitness in cardiopulmonary endurance and muscle strength (pexercise training is beneficial for children with CP. Over 10 years, the FUG was more devoted to physical activity than was the CG. Physical exercise may not directly affect the HRQoL in this study. Copyright © 2013 Elsevier Ltd. All rights reserved.

  6. Process and effects of a community intervention on malaria in rural Burkina Faso: randomized controlled trial

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    Gustafsson Lars

    2008-03-01

    Full Text Available Abstract Background In the rural areas of sub-Saharan Africa, the majority of young children affected by malaria have no access to formal health services. Home treatment through mothers of febrile children supported by mother groups and local health workers has the potential to reduce malaria morbidity and mortality. Methods A cluster-randomized controlled effectiveness trial was implemented from 2002–2004 in a malaria endemic area of rural Burkina Faso. Six and seven villages were randomly assigned to the intervention and control arms respectively. Febrile children from intervention villages were treated with chloroquine (CQ by their mothers, supported by local women group leaders. CQ was regularly supplied through a revolving fund from local health centres. The trial was evaluated through two cross-sectional surveys at baseline and after two years of intervention. The primary endpoint of the study was the proportion of moderate to severe anaemia in children aged 6–59 months. For assessment of the development of drug efficacy over time, an in vivo CQ efficacy study was nested into the trial. The study is registered under http://www.controlled-trials.com (ISRCTN 34104704. Results The intervention was shown to be feasible under program conditions and a total of 1.076 children and 999 children were evaluated at baseline and follow-up time points respectively. Self-reported CQ treatment of fever episodes at home as well as referrals to health centres increased over the study period. At follow-up, CQ was detected in the blood of high proportions of intervention and control children. Compared to baseline findings, the prevalence of anaemia (29% vs 16%, p P. falciparum parasitaemia, fever and palpable spleens was lower at follow-up but there were no differences between the intervention and control group. CQ efficacy decreased over the study period but this was not associated with the intervention. Discussion The decreasing prevalence of malaria

  7. Short-term effects of an educational intervention on physical restraint use: a cluster randomized trial

    Science.gov (United States)

    Huizing, Anna R; Hamers, Jan PH; Gulpers, Math JM; Berger, Martijn PF

    2006-01-01

    Background Physical restraints are still frequently used in nursing home residents despite growing evidence for the ineffectiveness and negative consequences of these methods. Therefore, reduction in the use of physical restraints in psycho-geriatric nursing home residents is very important. The aim of this study was to investigate the short-term effects of an educational intervention on the use of physical restraints in psycho-geriatric nursing home residents. Methods A cluster randomized trial was applied to 5 psycho-geriatric nursing home wards (n = 167 residents with dementia). The wards were assigned at random to either educational intervention (3 wards) or control status (2 wards). The restraint status was observed and residents' characteristics, such as cognitive status, were determined by using the Minimum Data Set (MDS) at baseline and 1 month after intervention. Results Restraint use did not change significantly over time in the experimental group (55%–56%), compared to a significant increased use (P < 0.05) in the control group (56%–70%). The mean restraint intensity and mean multiple restraint use in residents increased in the control group but no changes were shown in the experimental group. Logistic regression analysis showed that residents in the control group were more likely to experience increased restraint use than residents in the experimental group. Conclusion An educational programme for nurses combined with consultation with a nurse specialist did not decrease the use of physical restraints in psycho-geriatric nursing home residents in the short term. However, the residents in the control group experienced more restraint use during the study period compared to the residents in the experimental group. Whether the intervention will reduce restraint use in the long term could not be inferred from these results. Further research is necessary to gain insight into the long-term effects of this educational intervention. PMID:17067376

  8. Headache cessation by an educational intervention in grammar schools: a cluster randomized trial.

    Science.gov (United States)

    Albers, L; Heinen, F; Landgraf, M; Straube, A; Blum, B; Filippopulos, F; Lehmann, S; Mansmann, U; Berger, U; Akboga, Y; von Kries, R

    2015-02-01

    Headache is a common health problem in adolescents. There are a number of risk factors for headache in adolescents that are amenable to intervention. The aim of the study was to assess the effectiveness of a low-level headache prevention programme in the classroom setting to prevent these risk factors. In all, 1674 students in 8th-10th grade at 12 grammar schools in greater Munich, Germany, were cluster randomized into intervention and control groups. A standardized 60-min prevention lesson focusing on preventable risk factors for headache (physical inactivity, coffee consumption, alcohol consumption and smoking) and providing instructions on stress management and neck and shoulder muscle relaxation exercises was given in a classroom setting. Seven months later, students were reassessed. The main outcome parameter was headache cessation. Logistic regression models with random effects for cluster and adjustment for baseline risk factors were calculated. Nine hundred students (intervention group N = 450, control group N = 450) with headache at baseline and complete data for headache and confounders were included in the analysis. Headache cessation was observed in 9.78% of the control group compared with 16.22% in the intervention group (number needed to treat = 16). Accounting for cluster effects and confounders, the probability of headache cessation in the intervention group was 1.77 (95% confidence interval = [1.08; 2.90]) higher than in the control group. The effect was most pronounced in adolescents with tension-type headache: odds ratio = 2.11 (95% confidence interval = [1.15; 3.80]). Our study demonstrates the effectiveness of a one-time, classroom-based headache prevention programme. © 2014 EAN.

  9. Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

    Science.gov (United States)

    Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena J

    2017-03-21

    A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). 10 Duke University Health System community-based primary care clinics. 537 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. The study involved 1 health care network. Data on provider referrals were not collected. Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically

  10. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  11. Effects of Interventions on Use of Hearing Protectors among Farm Operators: A Randomized Controlled Trial

    Science.gov (United States)

    McCullagh, Marjorie C.; Banerjee, Tanima; Cohen, Michael A.; Yang, James J.

    2016-01-01

    Objective The purpose of this study was to compare the effectiveness of three interventions designed to promote hearing protector device (HPD) use. Design Randomized controlled trial. Study Sample Farm operators (n=491) were randomly assigned to one of 5 intervention groups: 1) interactive Web-based information with mailed assortment of HPDs; 2) Interactive Web-based information only; 3) static Web-based information with mailed assortment of HPDs; 4) Static Web-based information only; or 5) mailed assortment of HPDs only. Data were analyzed using a mixed model approach. Results HPD use increased among all participants, and increased more among participants receiving the mailed HPDs (with or without information) compared to participants receiving other interventions. Participants receiving the interactive Web-based information had comparable increased use of HPDs to those receiving the static Web-based information. Participants receiving the mailed HPDs had more positive situational influences scale scores than other participants. Program satisfaction was highest among mailed and Web-based information groups. Conclusions A mailed assortment of hearing protectors was more effective than information. Interactive and static information delivered via Web were similarly effective. Programs interested in increasing HPD use among farmers should consider making hearing protectors more available to farmers. PMID:26766172

  12. Randomized controlled trial of a positive affect intervention to reduce stress in people newly diagnosed with HIV; protocol and design for the IRISS study

    Directory of Open Access Journals (Sweden)

    Moskowitz JT

    2014-09-01

    currently few established interventions for people who are newly diagnosed with HIV. We present the design and methods for a randomized trial in which we test the efficacy of one such skills-based intervention that targets positive affect as a novel mechanism of change. The proposed research builds on observational findings of the important unique functions of positive affect. We aim to determine whether a five-session theory- and evidence-based intervention designed to teach skills for increasing the frequency and intensity of daily positive affect does so, and whether this intervention has beneficial effects on subsequent psychological well-being, health behaviors, and physical health up to 15 months after diagnosis with HIV. This is a randomized controlled trial in a sample of adults recruited within 12 weeks of testing positive for HIV. The control group is attention-matched, and follow up assessments will be conducted immediately post intervention (approximately 5 months post diagnosis and at 10 and 15 months post diagnosis. This study is an important next step in research concerning the adaptive functions of positive affect for people coping with HIV or other health-related life stress. Keywords: positive affect, HIV diagnosis, stress, coping, RCT, intervention, physical health

  13. Effectiveness of a tailor-made intervention for pregnancy-related pelvic girdle and/or low back pain after delivery: Short-term results of a randomized clinical trial [ISRCTN08477490

    Directory of Open Access Journals (Sweden)

    Bastiaanssen Janneke M

    2006-02-01

    Full Text Available Abstract Background For the moment, scientific evaluation of programs on treatment of pregnancy-related pelvic girdle and/or low back pain after delivery is hardly available with only one study with a positive result, suggesting uncertainty about the optimal approach. Investigators draw particular attention to biomedical factors but there is growing evidence that biopsychosocial factors appear to be even more important as a basis of an intervention program. Methods We studied the effectiveness of a tailor-made program with respect to biopsychosocial factors (intervention group in women with pregnancy-related pelvic girdle and/ or low back pain versus usual care based on a pain contingent basis (control group shortly after delivery in a randomized controlled trial. Women with severe complaints shortly after delivery were selected from a longitudinal prospective cohort study (n = 7526, aimed at pregnancy-related pelvic girdle and/or low back pain in the Netherlands. A concealed block randomization was performed after collecting baseline data. Researchers were blinded to treatment assignment. Outcomes were evaluated within the domains of the biopsychosocial approach. Primary outcome concerned limitations in activities (RDQ. Follow-up measurements were performed 12 weeks after delivery. Results Since May 2001 until July 2003, 869 women out of the cohort made a request for treatment by a physiotherapist, 10 days after delivery. Because of a quick recovery in two weeks time, we included only 126 women three weeks after delivery. There was a statistically significant and clinically relevant difference in improvement on the primary outcome (RDQ between the two groups in favor of the experimental intervention. Conclusion The results favored the hypotheses. Women's worries about their condition were major targets in the experimental intervention. The prognosis after delivery, especially in de first weeks, turned out to be favorable.

  14. Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial

    National Research Council Canada - National Science Library

    Serra-Paya, Noemi; Ensenyat, Assumpta; Castro-Viñuales, Iván; Real, Jordi; Sinfreu-Bergués, Xènia; Zapata, Amalia; Mur, Jose María; Galindo-Ortego, Gisela; Solé-Mir, Eduard; Teixido, Concepció

    2015-01-01

    .... The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group...

  15. Effects of a stepwise multidisciplinary intervention for challenging behavior in advanced dementia: a cluster randomized controlled trial.

    NARCIS (Netherlands)

    Pieper, M.J.C.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.A.; Twisk, J.W.R.; Kovach, C.R.; Achterberg, W.P.

    2016-01-01

    Objectives: To assess whether implementation of a stepwise multicomponent intervention (STA OP!) is effective in reducing challenging behavior and depression in nursing home residents with advanced dementia. Design: Cluster randomized controlled trial. Setting: Twenty-one clusters (single

  16. Effects of a Stepwise Multidisciplinary Intervention for Challenging Behavior in Advanced Dementia: A Cluster Randomized Controlled Trial

    NARCIS (Netherlands)

    Pieper, M.J.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.; Twisk, J.W.; Kovach, C.R.; Achterberg, W.P.

    2016-01-01

    OBJECTIVES: To assess whether implementation of a stepwise multicomponent intervention (STA OP!) is effective in reducing challenging behavior and depression in nursing home residents with advanced dementia. DESIGN: Cluster randomized controlled trial. SETTING: Twenty-one clusters (single

  17. A goal management intervention for polyarthritis patients: rationale and design of a randomized controlled trial.

    Science.gov (United States)

    Arends, Roos Y; Bode, Christina; Taal, Erik; Van de Laar, Mart A F J

    2013-08-13

    A health promotion intervention was developed for inflammatory arthritis patients, based on goal management. Elevated levels of depression and anxiety symptoms, which indicate maladjustment, are found in such patients. Other indicators of adaptation to chronic disease are positive affect, purpose in life and social participation. The new intervention focuses on to improving adaptation by increasing psychological and social well-being and decreasing symptoms of affective disorders. Content includes how patients can cope with activities and life goals that are threatened or have become impossible to attain due to arthritis. The four goal management strategies used are: goal maintenance, goal adjustment, goal disengagement and reengagement. Ability to use various goal management strategies, coping versatility and self-efficacy are hypothesized to mediate the intervention's effect on primary and secondary outcomes. The primary outcome is depressive symptoms. Secondary outcomes are anxiety symptoms, positive affect, purpose in life, social participation, pain, fatigue and physical functioning. A cost-effectiveness analysis and stakeholders' analysis are planned. The protocol-based psycho-educational program consists of six group-based meetings and homework assignments, led by a trained nurse. Participants are introduced to goal management strategies and learn to use these strategies to cope with threatened personal goals. Four general hospitals participate in a randomized controlled trial with one intervention group and a waiting list control condition. The purpose of this study is to evaluate the effectiveness of a goal management intervention. The study has a holistic focus as both the absence of psychological distress and presence of well-being are assessed. In the intervention, applicable goal management competencies are learned that assist people in their choice of behaviors to sustain and enhance their quality of life. Nederlands Trial Register = NTR3606

  18. The memory support system for mild cognitive impairment: randomized trial of a cognitive rehabilitation intervention.

    Science.gov (United States)

    Greenaway, M C; Duncan, N L; Smith, G E

    2013-04-01

    Individuals with amnestic mild cognitive impairment (MCI) have few empirically based treatment options for combating their memory loss. This study sought to examine the efficacy of a calendar/notebook rehabilitation intervention, the memory support system (MSS), for individuals with amnestic MCI. Forty individuals with single domain amnestic MCI and their program partners were randomized to receive the MSS, either with training or without (controls). Measures of adherence, activities of daily living, and emotional impact were completed at the first and last intervention sessions and again at 8 weeks and 6 months post intervention. Training in use of a notebook/calendar system significantly improved adherence over those who received the calendars but no training. Functional ability and memory self-efficacy significantly improved for those who received MSS training. Change in functional ability remained significantly better in the intervention group than in the control group out to 8-week follow-up. Care partners in the intervention group demonstrated improved mood by 8-week and 6-month follow-ups, whereas control care partners reported worse caregiver burden by 6-month follow-up. Memory support system training resulted in improvement in activities of daily living and sense of memory self-efficacy for individuals with MCI. Although activities of daily living benefits were maintained out to 8 weeks post intervention, future inclusion of booster sessions may help extend the therapeutic effect out even further. Improved mood of care partners of trained individuals and worsening sense of caregiver burden over time for partners of untrained individuals further support the efficacy of the MSS for MCI. Copyright © 2012 John Wiley & Sons, Ltd.

  19. Effects of a multifactorial injury prevention intervention in physical education teachers: A randomized controlled trial.

    Science.gov (United States)

    Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk

    2016-10-01

    Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies.

  20. Effect of Three Interventions on Contact Lens Comfort in Symptomatic Wearers: A Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Maria Navascues-Cornago

    Full Text Available To investigate whether carrying out various interventions part way through the day influences comfort in symptomatic daily disposable (DD contact lens wearers.A subject-masked, randomized, controlled clinical trial was conducted in thirty symptomatic soft lens wearers who wore their habitual DD contact lenses bilaterally for 12 h on two separate days. Five hours after lens application, one of the following three interventions or a control was performed on each eye: replacing the existing lens with a new lens; removing and reapplying the same lens; performing a 'scleral swish'; and no action (control. Comfort scores were recorded using SMS text messages every hour following lens application using a 0 (causes pain to 100 (excellent comfort scale. Comfort scores before lens application, at 6 mins post-application, and at 6 mins post-intervention were also recorded.There was a significant reduction in comfort from pre-lens application to 6 mins post-application for all groups (all p0.05. After the intervention, comfort continued to decline (p<0.0001 with slightly lower mean scores for the control group compared to the new lens group (p = 0.003. Change in comfort relative to pre-intervention (5 h was similar for all groups (p = 0.81. There was no difference in comfort at 12 h between groups (p = 0.83.This work has confirmed that comfort shows a continual and significant decline over a 12-h wearing period in symptomatic DD contact lens wearers. None of the interventions investigated had any significant impact on end-of-day comfort. These data suggest discomfort in lens wearers is more heavily influenced by changes to the ocular environment rather than to the lens itself.Controlled-Trials.com ISRCTN10419752 http://www.controlled-trials.com/ISRCTN10419752.

  1. Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial

    Science.gov (United States)

    Ondersma, Steven J.; Beatty, Jessica R.; Svikis, Dace S.; Strickler, Ronald C.; Tzilos, Golfo K.; Chang, Grace; Divine, W.; Taylor, Andrew R.; Sokol, Robert J.

    2015-01-01

    Background Although screening and brief intervention (SBI) for unhealthy alcohol use has demonstrated efficacy in some trials, its implementation has been limited. Technology-delivered approaches are a promising alternative, particularly during pregnancy when the importance of alcohol use is amplified. The present trial evaluated the feasibility and acceptability of an interactive, empathic, video-enhanced, and computer-delivered SBI (e-SBI) plus three separate tailored mailings, and estimated intervention effects. Methods We recruited 48 pregnant women who screened positive for alcohol risk at an urban prenatal care clinic. Participants were randomly assigned to the e-SBI plus mailings or to a control session on infant nutrition, and were reevaluated during their postpartum hospitalization. The primary outcome was 90-day period-prevalence abstinence as measured by timeline follow-back interview. Results Participants rated the intervention as easy to use and helpful (4.7-5.0 on a 5-point scale). Blinded follow-up evaluation at childbirth revealed medium-size intervention effects on 90-day period prevalence abstinence (OR = 3.4); similarly, intervention effects on a combined healthy pregnancy outcome variable (live birth, normal birthweight, and no NICU stay) were also of moderate magnitude in favor of e-SBI participants (OR=3.3). As expected in this intentionally under-powered pilot trial, these effects were non-significant (p = .19 and .09, respectively). Conclusions This pilot trial demonstrated the acceptability and preliminary efficacy of a computer-delivered screening and brief intervention (e-SBI) plus tailored mailings for alcohol use in pregnancy. These findings mirror the promising results of other trials using a similar approach, and should be confirmed in a fully-powered trial. PMID:26010235

  2. Intervention effects on adolescent physical activity in the multicomponent SPACE study: a cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Mette Toftager

    Full Text Available BACKGROUND: Multicomponent school-based interventions have the potential to reduce the age-related decline in adolescents' physical activity (PA, yet there is not consistent evidence to guide non-curricular and school environment interventions. The aim of this study was to assess the effectiveness of a multicomponent environmental school-based intervention, designed to reduce the age-related decline in PA among adolescents. METHODS: A cluster randomized controlled trial was conducted with 7 intervention and 7 control schools. Baseline measurements were carried out in spring 2010 with 2 years of follow-up. A total of 1,348 students (11-13 years, in grade 5 and 6 enrolled in the study at baseline. The 14 schools included in the study were located in the Region of Southern Denmark. The intervention consisted of organizational and physical changes in the school environment with a total of 11 intervention components. The primary outcome measure was overall PA (cpm, counts per minute and was supported by analyses of time spent in MVPA, and time spent sedentary. Furthermore, a secondary outcome measure was PA in school time and during recess. PA was measured using accelerometer (Actigraph GT3X. RESULTS: A total of 797 students completed the trial and had valid accelerometer data. No significant difference was found for overall PA with an adjusted difference of -19.1 cpm (95% CI: -93, 53 or for school time activity with an adjusted difference of 6 cpm (95% CI: -73, 85. A sensitivity analysis revealed a positive significant intervention effect of PA in recess with an adjusted difference of 95 cpm. CONCLUSIONS: No evidence was found of the overall effect of a non-curricular multicomponent school-based intervention on PA among Danish adolescents. The intervention was positively associated with PA during school time and recess, however, with small estimates. Lack of effect on overall PA could be due to both program theory and different degrees of

  3. Challenges in improving fitness: results of a community-based, randomized, controlled lifestyle change intervention.

    Science.gov (United States)

    Yancey, Antronette K; McCarthy, William J; Harrison, Gail G; Wong, Weng Kee; Siegel, Judith M; Leslie, Joanne

    2006-05-01

    This study tested the efficacy of an 8-week culturally targeted nutrition and physical activity intervention on body composition. A randomized, attention-controlled, two-group trial was conducted in a blackowned commercial gym with a sample of 366 predominantly healthy, obese African American women. A free 1-year membership to the study site gym was provided to participants in both groups. Data were collected at baseline, 2, 6, and 12 months. Sample retention at 1 year was 71%. Between-group longitudinal analysis including only participants with complete data revealed a trend toward weight stability in the intervention group at 2 months compared with controls (+0.05 kg/m(2), p = 0.75; +0.32 kg/m(2), p = 0.08, respectively), disappearing at 12 months (+1.37 kg/m(2), p = 0.0001; +1.02 kg/m(2), p = 0.001, respectively). Within-group analysis demonstrated that intervention and control participants' fitness (1-mile run-walk) improved by 1.9 minutes (p = 0.0001) and 2.3 minutes (p = 0.0001), respectively, at 12 months. Mixed model regression analyses demonstrated a significant main effect of the intervention on fitness (p = 0.0185) and a marginally significant effect on body mass index (BMI) (p = 0.057), at 2 months, disappearing by 6 months. By 12 months, however, the controls exhibited a significant advantage in waist circumference stability compared with intervention participants (+1.1 cm, p = 0.2763; +2.1 cm, p = 0.0002, respectively). The intervention produced modest short-term improvements in body composition, but the economic incentive of a free 1-year gym membership provided to all participants was a more potent intervention than the education and social support intervention tested. However, longer-term fitness enhancement remains elusive and demands research and policy attention. These findings have policy implications in that employer-/insurer-subsidized gym memberships may require interventions targeting other levels of change (e.g., physical or social

  4. Group Music Therapy as a Preventive Intervention for Young People at Risk: Cluster-Randomized Trial.

    Science.gov (United States)

    Gold, Christian; Saarikallio, Suvi; Crooke, Alexander Hew Dale; McFerran, Katrina Skewes

    2017-07-01

    Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown. The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on depressive symptoms, psychosocial well-being, rumination, and reflection. In an exploratory cluster-randomized trial in Australian schools, 100 students with self-reported unhealthy music use were invited to GMT (weekly sessions over 8 weeks) or SDML. Changes in the Healthy-Unhealthy Music Scale (HUMS) and mental health outcomes were measured over 3 months. Both interventions were well accepted. No effects were found between GMT and SDML (all p > 0.05); both groups tended to show small improvements over time. Younger participants benefited more from GMT, and older ones more from SDML (p = 0.018). GMT was associated with similar changes as SDML. Further research is needed to improve the processes of selecting participants for targeted interventions; to determine optimal dosage; and to provide more reliable evidence of effects of music-based interventions for adolescents.

  5. A randomized controlled intervention trial to relieve and prevent neck/shoulder pain.

    Science.gov (United States)

    Andersen, Lars L; Jørgensen, Marie B; Blangsted, Anne Katrine; Pedersen, Mogens T; Hansen, Ernst A; Sjøgaard, Gisela

    2008-06-01

    The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. A 1-yr randomized controlled intervention trial was done with three groups: specific resistance training (SRT, n = 180), all-round physical exercise (APE, n = 187), and reference intervention (REF, n = 182) with general health counseling. Physical tests were performed and questionnaires answered at pre-, mid-, and postintervention. The main outcome measures were compliance, changes in maximal muscle strength, and changes in intensity of neck/shoulder pain (scale 0-9) in those with and without pain at baseline. Regular participation was achieved by 54%, 31%, and 16% of those of the participants who answered the questionnaire in SRT (78%), APE (81%), and REF (80%), respectively, during the first half of the intervention period, and decreased to 35%, 28% and 9%, respectively, during the second half. Shoulder elevation strength increased 9-11% in SRT and APE (P change. For participants without shoulder pain at baseline, there was a significantly greater increase in pain over the 1-yr period in REF compared with SRT and APE (P < 0.01). Compliance was highest in SRT but generally decreased over time. SRT and APE caused increased shoulder elevation strength, were more effective than REF to decrease neck pain among those with symptoms at baseline, and prevent development of shoulder pain in those without symptoms at baseline.

  6. Psychological Outcomes After a Sexual Assault Video Intervention: A Randomized Trial.

    Science.gov (United States)

    Miller, Katherine E; Cranston, Christopher C; Davis, Joanne L; Newman, Elana; Resnick, Heidi

    2015-01-01

    Sexual assault survivors are at risk for a number of mental and physical health problems, including posttraumatic stress disorder and anxiety. Unfortunately, few seek physical or mental health services after a sexual assault (Price, Davidson, Ruggiero, Acierno, & Resnick, 2014). Mitigating the impact of sexual assault via early interventions is a growing and important area of research. This study adds to this literature by replicating and expanding previous studies (e.g., Resnick, Acierno, Amstadter, Self-Brown, & Kilpatrick, 2007) examining the efficacy of a brief video-based intervention that provides psychoeducation and modeling of coping strategies to survivors at the time of a sexual assault nurse examination. Female sexual assault survivors receiving forensic examinations were randomized to standard care or to the video intervention condition (N = 164). The participants completed mental health assessments 2 weeks (n = 69) and 2 months (n = 74) after the examination. Analyses of covariance revealed that women in the video condition had significantly fewer anxiety symptoms at the follow-up assessments. In addition, of those participants in the video condition, survivors reporting no previous sexual assault history reported significantly fewer posttraumatic stress symptoms 2 weeks after the examination than those with a prior assault history. Forensic nurses have the unique opportunity to intervene immediately after a sexual assault. This brief video intervention is a cost-effective tool to aid with that process.

  7. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    Science.gov (United States)

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  8. Influence of a Suggestive Placebo Intervention on Psychobiological Responses to Social Stress: A Randomized Controlled Trial.

    Science.gov (United States)

    Zimmermann-Viehoff, Frank; Steckhan, Nico; Meissner, Karin; Deter, Hans-Christian; Kirschbaum, Clemens

    2016-01-01

    We tested the hypothesis that a suggestive placebo intervention can reduce the subjective and neurobiological stress response to psychosocial stress. Fifty-four healthy male subjects with elevated levels of trait anxiety were randomly assigned in a 4:4:1 fashion to receive either no treatment (n = 24), a placebo pill (n = 24), or a herbal drug (n = 6) before undergoing a stress test. We repeatedly measured psychological variables as well as salivary cortisol, alpha-amylase, and heart rate variability prior to and following the stress test. The stressor increased subjective stress and anxiety, salivary cortisol, and alpha-amylase, and decreased heart rate variability (all P placebo or no treatment were found. Subjects receiving placebo showed increased wakefulness during the stress test compared with no-treatment controls (P placebo intervention increased alertness, but modulated neither subjective stress and anxiety nor the physiological response to psychosocial stress.

  9. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Farah Jindani

    2015-01-01

    Full Text Available Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25. KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  10. A randomized controlled trial on a multicomponent intervention for overweight school-aged children - Copenhagen, Denmark

    DEFF Research Database (Denmark)

    Harder-Lauridsen, Nina Majlund; Birk, Nina Marie; Ried-Larsen, Mathias

    2014-01-01

    BACKGROUND: Obesity amongst children is a growing problem worldwide. In contrast to adults, little is known on the effects of controlled weight loss on components of the metabolic syndrome in children. The primary aim of the study was to evaluate the effects of a 20-week exercise and diet guidance...... intervention on body mass index (BMI) in a group of overweight children. Our hypothesis was an observed reduction in BMI and secondarily in body fat content, insulin insensitivity, and other components of the metabolic syndrome in the intervention group. METHODS: School children from Copenhagen were randomly....../day, and fat mass. In addition, similar beneficial metabolic effects were found in the children as shown in adults, e.g. increase in peripheral insulin sensitivity. TRIAL REGISTRATION: Clinicaltrials.gov Identifier number NCT01660789....

  11. Dose-dependent biochemical changes in rat central nervous system after 12-week exposure to 1-bromopropane.

    Science.gov (United States)

    Wang, Hailan; Ichihara, Gaku; Ito, Hidenori; Kato, Kanefusa; Kitoh, Junzoh; Yamada, Tetsuya; Yu, Xiaozhong; Tsuboi, Seiji; Moriyama, Yoshinori; Takeuchi, Yasuhiro

    2003-03-01

    1-Bromopropane is used as a cleaning agent or adhesive solvent in the workplace. The present study investigated the long-term effects of exposure to 1-bromopropane on biochemical components in the central nervous system (CNS) of rats. Four groups, each of nine male Wistar rats, were exposed to 200, 400, or 800 ppm 1-bromopropane or fresh air only, 8h per day, 7 days a week for 12 weeks. We measured the levels of neuron-specific gamma-enolase, glia-specific beta-S100 protein, creatine kinase (CK) subunits B and M, heat shock protein Hsp27 (by enzyme immunoassay), enzymatic activity of CK and levels of glutathione (GSH), oxidized glutathione (GSSG) and sulfhydrul (SH) base in the cerebrum, cerebellum, brainstem and spinal cord. gamma-Enolase decreased dose-dependently in the cerebrum, which showed a decrease in wet weight, at 400 ppm or over, but no change was noted in beta-S100 protein in any brain region or spinal cord. Hsp27 decreased in the cerebellum, brainstem and spinal cord. Protein-bound SH base, non-protein SH base and total glutathione decreased in every brain region. CK activity decreased dose-dependently at 200 ppm or over, and the ratio of CK activity to CK-B concentration tended to decrease in all regions. The decrease in gamma-enolase in the cerebrum suggests the involvement of biochemical changes in neurons with decrease in the wet weight of the cerebrum. Glutathione depletion and changes in proteins containing SH base as a critical site might be the underlying neurotoxic mechanism of 1-bromopropane. The biochemical changes in the cerebrum indicate that long-term exposure to 1-bromopropane has effects on the CNS.

  12. Indacaterol once-daily provides superior efficacy to salmeterol twice-daily in COPD: a 12-week study.

    Science.gov (United States)

    Korn, Stephanie; Kerwin, Edward; Atis, Sibel; Amos, Carolynn; Owen, Roger; Lassen, Cheryl

    2011-05-01

    Indacaterol is a novel, inhaled once-daily ultra-long-acting β(2)-agonist for the treatment of COPD. This 12-week randomised, parallel-group study compared the efficacy of indacaterol 150 μg once-daily to salmeterol 50 μg twice-daily in patients with moderate-to-severe COPD. Assessments included FEV(1) standardised area under curve (AUC) from 5 min to 11 h 45 min at Week 12 (primary endpoint), 24-h trough FEV(1) (mean of 23 h 10 min and 23 h 45 min post-dose) at Week 12 (key secondary endpoint), FEV(1) and FVC measured over 24-h, transition dyspnoea index (TDI) and rescue medication use. Of 1123 patients randomised 92.1% completed. Mean ± SD age was 62.8±8.78 years, post-bronchodilator FEV(1) 51.8±12.32% predicted, FEV(1)/FVC 50.6±9.54%. At Week 12, FEV(1) AUC(5 min-11 h 45 min) for indacaterol was statistically superior (pIndacaterol also showed statistical superiority over salmeterol in terms of FEV(1) and FVC measured over 24-h at Week 12. For TDI at Week 12, the mean total score was statistically superior for indacaterol versus salmeterol (difference 0.63 [0.30, 0.97], pindacaterol used fewer puffs/day (difference -0.18 [-0.36, 0.00] puffs/day, pindacaterol provided statistically superior bronchodilation with an improvement in breathlessness and rescue use compared with twice-daily salmeterol. ClinicalTrials.gov NCT00821093. Copyright © 2011 Elsevier Ltd. All rights reserved.

  13. Agomelatine versus Sertraline: An Observational, Open-labeled and 12 Weeks Follow-up Study on Efficacy and Tolerability

    Science.gov (United States)

    Akpınar, Esma; Cerit, Cem; Talas, Anıl; Tural, Ümit

    2016-01-01

    Objective In this open-labeled, 12 weeks follow-up study, we aimed to compare the efficacy and tolerability of agomelatine with sertraline Methods The outpatients of adult psychiatry clinic who have a new onset of depression and diagnosed as ‘major depressive episode’ by clinician according to the Diagnostic and Statistical Manual of Mental Disorders 4th edition and prescribed agomelatine (25 mg/day) or sertraline (50 mg/day) were included in the study. Results The decline of mean Montgomery-Asberg Depression Rating Scale (MADRS) scores of agomelatine group was significantly higher than the sertraline group at the end of 2nd week; however, the difference was not significant at the end of 3 months. Mean Clinical Global Impression-Improvement scale (CGI-I) scores of agomelatine group was lower than sertraline group at first week. Mean CGI-Severity scale and CGI-I scores were favour to sertraline group at the end of the study. Remission rates were 46.7% for sertraline group and 33.3% for agomelatine group while response rates were 76.7% for both groups. Any patient from agomelatine group dropped-out due to adverse effects. The amount of side effects was also less with agomelatine. Conclusion Agomelatine has a rapid onset efficacy on depressive symptoms and this can be beneficial for some critical cases. Considering MADRS scores, agomelatine seems to have similar efficacy with sertraline but we also point the need for long term studies since CGI scores were favour to sertraline group at the end of the study. Agomelatine has a favourable tolerability profile both in terms of discontinuation and the amount of side effects compared to sertraline. PMID:27776387

  14. A cluster-randomized evaluation of a responsive stimulation and feeding intervention in bangladesh.

    Science.gov (United States)

    Aboud, Frances E; Akhter, Sadika

    2011-05-01

    The goal of this study was to determine if a responsive stimulation and feeding intervention improved developmental and nutritional outcomes compared with a regular information-based parenting program. The hypothesis was that mothers in the intervention would exhibit better parenting skills and children would exhibit better developmental and nutritional outcomes than controls. A cluster-randomized field trial was conducted with 302 children aged 8 to 20 months and their mothers in rural Bangladesh who were randomly assigned according to village to 1 of 3 groups. The control mothers received 12 informational sessions on health and nutrition. The intervention groups received an additional 6 sessions delivered by peer educators who included modeling and coached practice in self-feeding and verbal responsiveness with the child during play. A second intervention group received, along with the sessions, 6 months of a food powder fortified with minerals and vitamins. Developmental outcomes included the Home Observation for Measurement of the Environment (HOME) Inventory, mother-child responsive talk, and language development. Nutritional outcomes included weight, height, self-feeding, and mouthfuls eaten. We used analysis of covariance to compare the 3 groups at the posttest and at follow-up, covarying the pretest levels and confounders. At follow-up, responsive stimulation-feeding groups had better HOME inventory scores, responsive talking, language, mouthfuls eaten, and hand-washing. Micronutrient fortification resulted in more weight gain. A brief behavior-change program that focused on modeling and practice in stimulation and feeding was found to benefit children's nutrition and language development. Micronutrients benefited children's weight but not length.

  15. Brief interventions to reduce Ecstasy use: a multi-site randomized controlled trial.

    Science.gov (United States)

    Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan

    2014-11-01

    Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may

  16. Can Early Intervention Improve Maternal Well-Being? Evidence from a Randomized Controlled Trial

    Science.gov (United States)

    Doyle, Orla; Delaney, Liam; O’Farrelly, Christine; Fitzpatrick, Nick; Daly, Michael

    2017-01-01

    Objective This study estimates the effect of a targeted early childhood intervention program on global and experienced measures of maternal well-being utilizing a randomized controlled trial design. The primary aim of the intervention is to improve children’s school readiness skills by working directly with parents to improve their knowledge of child development and parenting behavior. One potential externality of the program is well-being benefits for parents given its direct focus on improving parental coping, self-efficacy, and problem solving skills, as well as generating an indirect effect on parental well-being by targeting child developmental problems. Methods Participants from a socio-economically disadvantaged community are randomly assigned during pregnancy to an intensive 5-year home visiting parenting program or a control group. We estimate and compare treatment effects on multiple measures of global and experienced well-being using permutation testing to account for small sample size and a stepdown procedure to account for multiple testing. Results The intervention has no impact on global well-being as measured by life satisfaction and parenting stress or experienced negative affect using episodic reports derived from the Day Reconstruction Method (DRM). Treatment effects are observed on measures of experienced positive affect derived from the DRM and a measure of mood yesterday. Conclusion The limited treatment effects suggest that early intervention programs may produce some improvements in experienced positive well-being, but no effects on negative aspects of well-being. Different findings across measures may result as experienced measures of well-being avoid the cognitive biases that impinge upon global assessments. PMID:28095505

  17. Promoting mammography: results of a randomized trial of telephone counseling and a medical practice intervention.

    Science.gov (United States)

    Costanza, M E; Stoddard, A M; Luckmann, R; White, M J; Spitz Avrunin, J; Clemow, L

    2000-07-01

    Despite widespread promotion of mammography screening, a distinct minority of women have remained underusers of this effective preventive measure. We sought to measure the effects of barrier-specific telephone counseling (BSTC) and a physician-based educational intervention (MD-ED) on mammography utilization among underusers of mammography screening. This was a randomized controlled trial. Women meeting criteria for mammography underuse at baseline (grouped by practice affiliation) were randomized to a reminder control condition (RC group received annual mailed reminders), BSTC or MD-ED interventions and followed for 3 years. Underuse was defined by failure to get two annual or biannual mammograms over a 2- to 4-year period prior to a baseline survey. The study included 1655 female underusers of mammography aged 50-80 years who were members of two health maintenance organizations (HMO) in central Massachusetts. BSTC consisted of periodic brief, scripted calls from trained counselors to women who had not had a mammogram in the preceding 15 months. Women could receive up to three annual calls during the study. MD-ED consisted of physician and office staff trainings aimed at improving counseling skills and office reminder systems. Self-report of mammography use during the study period was the main outcome measure. Regular use was defined as > or =1 mammogram every 24 months. Forty-four percent in each intervention group became regular users compared to 42% in the RC group. Among subjects who had prior but not recent mammograms at baseline, BSTC was effective (OR=1.48; 95% CI=1.04; 2. 10), and MD-ED marginally effective (OR=1.28; 95% CI=0.88, 1.85). Most recent users at baseline and few never users became regular users (61% and 17%, respectively) regardless of intervention status. Among mammography underusers BSTC modestly increases utilization for former users at a reasonable cost ($726 per additional regular user).

  18. Anger management for people with mild to moderate learning disabilities: Study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff

    Directory of Open Access Journals (Sweden)

    Nuttall Jacqueline

    2011-02-01

    Full Text Available Abstract Background Cognitive behaviour therapy (CBT is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited evidence base for the use of CBT with this client group. Anger treatment is the one area where there exists a reasonable number of small controlled trials. This study will evaluate the effectiveness of a manualized 12-week CBT intervention for anger. The intervention will be delivered by staff working in the day services that the participants attend, following training to act as 'lay therapists' by a Clinical Psychologist, who will also provide supervision. Methods/Design This is a multi-centre cluster randomized controlled trial of a group intervention versus a 'support as usual' waiting-list control group, with randomization at the level of the group. Outcomes will be assessed at the end of the intervention and again 6-months later. After completion of the 6-month follow-up assessments, the intervention will also be delivered to the waiting-list groups. The study will include a range of anger/aggression and mental health measures, some of which will be completed by service users and also by their day service key-workers and by home carers. Qualitative data will be collected to assess the impact of the intervention on participants, lay therapists, and services, and the study will also include a service-utilization cost and consequences analysis. Discussion This will be the first trial to investigate formally how effectively staff working in services providing day activities for people with learning disabilities are able to use a therapy manual to deliver a CBT based anger management intervention, following brief training by a Clinical Psychologist. The demonstration that service staff can successfully deliver anger management to people with learning disabilities, by widening the pool of potential therapists, would have

  19. Anger management for people with mild to moderate learning disabilities: study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff.

    Science.gov (United States)

    Willner, Paul; Jahoda, Andrew; Rose, John; Stenfert-Kroese, Biza; Hood, Kerenza; Townson, Julia K; Nuttall, Jacqueline; Gillespie, David; Felce, David

    2011-02-09

    Cognitive behaviour therapy (CBT) is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited evidence base for the use of CBT with this client group. Anger treatment is the one area where there exists a reasonable number of small controlled trials. This study will evaluate the effectiveness of a manualized 12-week CBT intervention for anger. The intervention will be delivered by staff working in the day services that the participants attend, following training to act as 'lay therapists' by a Clinical Psychologist, who will also provide supervision. This is a multi-centre cluster randomized controlled trial of a group intervention versus a 'support as usual' waiting-list control group, with randomization at the level of the group. Outcomes will be assessed at the end of the intervention and again 6-months later. After completion of the 6-month follow-up assessments, the intervention will also be delivered to the waiting-list groups. The study will include a range of anger/aggression and mental health measures, some of which will be completed by service users and also by their day service key-workers and by home carers. Qualitative data will be collected to assess the impact of the intervention on participants, lay therapists, and services, and the study will also include a service-utilization cost and consequences analysis. This will be the first trial to investigate formally how effectively staff working in services providing day activities for people with learning disabilities are able to use a therapy manual to deliver a CBT based anger management intervention, following brief training by a Clinical Psychologist. The demonstration that service staff can successfully deliver anger management to people with learning disabilities, by widening the pool of potential therapists, would have very significant benefits in relation to the current policy of

  20. Impact of a school-based intervention to promote fruit intake: a cluster randomized controlled trial

    OpenAIRE

    Rosário, R.; ARAÚJO, A.; Padrão, P.; Lopes, O; Moreira, A.; Abreu, S; Vale, S; Pereira, B.; Moreira, P.

    2016-01-01

    OBJECTIVE: There is evidence that fruit consumption among school children is below the recommended levels. This study aims to examine the effects of a dietary education intervention program me, held by teachers previously trained in nutrition, on the consumption of fruit as a dessert at lunch and dinner, among children 6-12 years old. STUDY DESIGN: This is a randomized trial with the schools as the unit of randomisation. METHODS: A total of 464 children (239 female, 6-12years) from seve...

  1. Mindfulness-Based Interventions and Sleep Among Cancer Survivors: a Critical Analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Christodoulou, Georgia; Black, David S

    2017-09-01

    The purpose of our critical examination is to present results and provide a synthesis of this body of work. Sleep problems among cancer survivors are gaining research attention. To our knowledge, there have been six randomized control trials published from 2013 to 2015 that test the effects of mindfulness-based interventions (MBIs) on sleep as a primary or secondary outcome. Our examination of the literature highlights important methodological issues and variability among trials. We conclude our review by offering solutions to facilitate more scientific rigor in future studies.

  2. Cardiorespiratory fitness, cardiovascular workload and risk factors among cleaners; a cluster randomized worksite intervention

    Directory of Open Access Journals (Sweden)

    Korshøj Mette

    2012-08-01

    Full Text Available Abstract Background Prevalence of cardiovascular risk factors is unevenly distributed among occupational groups. The working environment, as well as lifestyle and socioeconomic status contribute to the disparity and variation in prevalence of these risk factors. High physical work demands have been shown to increase the risk for cardiovascular disease and mortality, contrary to leisure time physical activity. High physical work demands in combination with a low cardiorespiratory fitness infer a high relative workload and an excessive risk for cardiovascular mortality. Therefore, the aim of this study is to examine whether a worksite aerobic exercise intervention will reduce the relative workload and cardiovascular risk factors by an increased cardiorespiratory fitness. Methods/design A cluster-randomized controlled trial is performed to evaluate the effect of the worksite aerobic exercise intervention on cardiorespiratory fitness and cardiovascular risk factors among cleaners. Cleaners are eligible if they are employed ≥ 20 hours/week, at one of the enrolled companies. In the randomization, strata are formed according to the manager the participant reports to. The clusters will be balanced on the following criteria: Geographical work location, gender, age and seniority. Cleaners are randomized to either I a reference group, receiving lectures concerning healthy living, or II an intervention group, performing worksite aerobic exercise “60 min per week”. Data collection will be conducted at baseline, four months and 12 months after baseline, at the worksite during working hours. The data collection will consist of a questionnaire-based interview, physiological testing of health and capacity-related measures, and objective diurnal measures of heart rate, physical activity and blood pressure. Primary outcome is cardiorespiratory fitness. Discussion Information is lacking about whether an improved cardiorespiratory fitness will affect

  3. A mixed methods pilot study with a cluster randomized control trial to evaluate the impact of a leadership intervention on guideline implementation in home care nursing

    Directory of Open Access Journals (Sweden)

    Tourangeau Ann

    2008-12-01

    Full Text Available Abstract Background Foot ulcers are a significant problem for people with diabetes. Comprehensive assessments of risk factors associated with diabetic foot ulcer are recommended in clinical guidelines to decrease complications such as prolonged healing, gangrene and amputations, and to promote effective management. However, the translation of clinical guidelines into nursing practice remains fragmented and inconsistent, and a recent homecare chart audit showed less than half the recommended risk factors for diabetic foot ulcers were assessed, and peripheral neuropathy (the most significant predictor of complications was not assessed at all. Strong leadership is consistently described as significant to successfully transfer guidelines into practice. Limited research exists however regarding which leadership behaviours facilitate and support implementation in nursing. The purpose of this pilot study is to evaluate the impact of a leadership intervention in community nursing on implementing recommendations from a clinical guideline on the nursing assessment and management of diabetic foot ulcers. Methods Two phase mixed methods design is proposed (ISRCTN 12345678. Phase I: Descriptive qualitative to understand barriers to implementing the guideline recommendations, and to inform the intervention. Phase II: Matched pair cluster randomized controlled trial (n = 4 centers will evaluate differences in outcomes between two implementation strategies. Primary outcome: Nursing assessments of client risk factors, a composite score of 8 items based on Diabetes/Foot Ulcer guideline recommendations. Intervention: In addition to the organization's 'usual' implementation strategy, a 12 week leadership strategy will be offered to managerial and clinical leaders consisting of: a printed materials, b one day interactive workshop to develop a leadership action plan tailored to barriers to support implementation; c three post-workshop teleconferences. Discussion This

  4. Reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention

    Directory of Open Access Journals (Sweden)

    Ravaud Philippe

    2009-05-01

    Full Text Available Abstract Background The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Methods The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected. A standardized abstraction form was used to extract data. Results 132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke were reported as primary or secondary outcomes in 107 reports (81%. However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22% and a definition of expected adverse events was provided in 47 (36%. The length of follow-up was reported in 95 reports (72%. Assessment of adverse events by an adjudication committee was described in 46 reports (35%, and adverse events were described as being followed up for 6 months in 24% of reports (n = 32, between 7 to 12 months in 42% (n = 55 and for more than 1 year in 4% (n = 5. In 115 reports (87%, numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%. The causality of adverse events was reported in only 4 articles. Conclusion Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials Registration Trials manuscript: 5534201182098351 (T80802P

  5. Improving blood pressure control in end stage renal disease through a supportive educative nursing intervention.

    Science.gov (United States)

    Kauric-Klein, Zorica

    2012-01-01

    Hypertension in patients on hemodialysis (HD) contributes significantly to their morbidity and mortality. This study examined whether a supportive nursing intervention incorporating monitoring, goal setting, and reinforcement can improve blood pressure (BP) control in a chronic HD population. A randomized controlled design was used and 118 participants were recruited from six HD units in the Detroit metro area. The intervention consisted of (1) BP education sessions; (2) a 12-week intervention, including monitoring, goal setting, and reinforcement; and (3) a 30-day post-intervention follow-up period. Participants in the treatment were asked to monitor their BP, sodium, and fluid intake weekly for 12 weeks in weekly logs. BP, fluid and sodium logs were reviewed weekly with the researcher to determine if goals were met or not met. Reinforcement was given for goals met and problem solving offered when goals were not met. The control group received standard care. Both systolic and diastolic BPs were significantly decreased in the treatment group.

  6. A social network-based intervention stimulating peer influence on children's self-reported water consumption: A randomized control trial

    NARCIS (Netherlands)

    Smit, C.R.; Leeuw, R.N.H. de; Bevelander, K.E.; Burk, W.J.; Buijzen, M.A.

    2016-01-01

    The current pilot study examined the effectiveness of a social network-based intervention using peer influence on self-reported water consumption. A total of 210 children (52% girls; M age = 10.75 ± SD = 0.80) were randomly assigned to either the intervention (n = 106; 52% girls) or control conditio

  7. Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents Outperforms Two Alternative Interventions: A Randomized Efficacy Trial

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2008-01-01

    In this depression prevention trial, 341 high-risk adolescents (mean age = 15.6 years, SD = 1.2) with elevated depressive symptoms were randomized to a brief group cognitive-behavioral (CB) intervention, group supportive-expressive intervention, bibliotherapy, or assessment-only control condition. CB participants showed significantly greater…

  8. Evaluation of a Randomized Intervention to Delay Sexual Initiation among Fifth-Graders Followed through the Sixth Grade

    Science.gov (United States)

    Koo, Helen P.; Rose, Allison; El-Khorazaty, M. Nabil; Yao, Qing; Jenkins, Renee R.; Anderson, Karen M.; Davis, Maurice; Walker, Leslie R.

    2011-01-01

    US adolescents initiate sex at increasingly younger ages, yet few pregnancy prevention interventions for children as young as 10-12 years old have been evaluated. Sixteen Washington, DC schools were randomly assigned to intervention versus control conditions. Beginning in 2001/02 with fifth-grade students and continuing during the sixth grade,…

  9. Effects of physiotherapy interventions on balance in multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials

    OpenAIRE

    Paltamaa, Jaana; Sjögren, Tuulikki; Peurala, Sinikka; Heinonen, Ari

    2012-01-01

    Objective: To determine the effects of physiotherapy interventions on balance in people with multiple sclerosis. Data sources: A systematic literature search was conducted in Medline, Cinahl, Embase, PEDro, both electronically and by manual search up to March 2011. Study selection: Randomized controlled trials of physiotherapy interventions in people with multiple sclerosis, with an outcome measure linked to the International Classification of Functioning, Disability a...

  10. A Parent-Directed Language Intervention for Children of Low Socioeconomic Status: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Suskind, Dana L.; Leffel, Kristin R.; Graf, Eileen; Hernandez, Marc W.; Gunderson, Elizabeth A.; Sapolich, Shannon G.; Suskind, Elizabeth; Leininger, Lindsey; Goldin-Meadow, Susan; Levine, Susan C.

    2016-01-01

    We designed a parent-directed home-visiting intervention targeting socioeconomic status (SES) disparities in children's early language environments. A randomized controlled trial was used to evaluate whether the intervention improved parents' knowledge of child language development and increased the amount and diversity of parent talk.…

  11. Non-Speech Oro-Motor Exercises in Post-Stroke Dysarthria Intervention: A Randomized Feasibility Trial

    Science.gov (United States)

    Mackenzie, C.; Muir, M.; Allen, C.; Jensen, A.

    2014-01-01

    Background: There has been little robust evaluation of the outcome of speech and language therapy (SLT) intervention for post-stroke dysarthria. Non-speech oro-motor exercises (NSOMExs) are a common component of dysarthria intervention. A feasibility study was designed and executed, with participants randomized into two groups, in one of which…

  12. 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, Albertine 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 g

  13. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Two Eating Disorder Prevention Programs

    Science.gov (United States)

    Stice, Eric; Presnell, Katherine; Gau, Jeff; Shaw, Heather

    2007-01-01

    The authors investigated mediators hypothesized to account for the effects of 2 eating disorder prevention programs using data from 355 adolescent girls who were randomized to a dissonance or a healthy weight intervention or an active control condition. The dissonance intervention produced significant reductions in outcomes (body…

  14. A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

    Science.gov (United States)

    Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

    2016-01-01

    Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

  15. 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, Albertine 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 g

  16. 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, Albertine 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

  17. A social network-based intervention stimulating peer influence on children's self-reported water consumption: A randomized control trial

    NARCIS (Netherlands)

    Smit, C.R.; Leeuw, R.N.H. de; Bevelander, K.E.; Burk, W.J.; Buijzen, M.A.

    2016-01-01

    The current pilot study examined the effectiveness of a social network-based intervention using peer influence on self-reported water consumption. A total of 210 children (52% girls; M age = 10.75 ± SD = 0.80) were randomly assigned to either the intervention (n = 106; 52% girls) or control

  18. A theory-based video messaging mobile phone intervention for smoking cessation: randomized controlled trial.

    Science.gov (United States)

    Whittaker, Robyn; Dorey, Enid; Bramley, Dale; Bullen, Chris; Denny, Simon; Elley, C Raina; Maddison, Ralph; McRobbie, Hayden; Parag, Varsha; Rodgers, Anthony; Salmon, Penny

    2011-01-21

    Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called "STUB IT") used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques. The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation. A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks. The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated. This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was

  19. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial

    Science.gov (United States)

    Montero-Marín, Jesús; Araya, Ricardo; Mayoral, Fermín; Gili, Margalida; Botella, Cristina; Baños, Rosa; Castro, Adoración; Romero-Sanchiz, Pablo; López-Del-Hoyo, Yolanda; Nogueira-Arjona, Raquel; Vives, Margarita; Riera, Antoni; García-Campayo, Javier

    2016-01-01

    Background Depression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain. Objective Our aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression. Methods Multicenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken. Results There was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings. Conclusions An Internet

  20. Activity monitor intervention to promote physical activity of physicians-in-training: randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Anne N Thorndike

    Full Text Available BACKGROUND: Physicians are expected to serve as role models for healthy lifestyles, but long work hours reduce time for healthy behaviors. A hospital-based physical activity intervention could improve physician health and increase counseling about exercise. METHODS: We conducted a two-phase intervention among 104 medical residents at a large hospital in Boston, Massachusetts. Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed (intervention or to a blinded monitor (control. Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback. Phase 1 outcomes were: 1 median steps/day and 2 proportion of days activity monitor worn. The Phase 2 outcome was mean steps/day on days monitor worn (≥500 steps/day. Physiologic measurements were collected at baseline and study end. Median steps/day were compared using Wilcoxon rank-sum tests. Mean steps were compared using repeated measures regression analyses. RESULTS: In Phase 1, intervention and control groups had similar activity (6369 vs. 6063 steps/day, p = 0.16 and compliance with wearing the monitor (77% vs. 77% of days, p = 0.73. In Phase 2 (team competition, residents recorded more steps/day than during Phase 1 (CONTROL: 7,971 vs. 7,567, p = 0.002; INTERVENTION: 7,832 vs. 7,739, p = 0.13. Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 (60% vs. 77%, p<0.001. Mean systolic blood pressure decreased (p = 0.004 and HDL cholesterol increased (p<0.001 among all participants at end of study compared to baseline. CONCLUSIONS: Although the activity monitor intervention did not have a major impact on activity or health, the high participation rates of busy residents and modest changes in steps, blood pressure, and HDL suggest that more

  1. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Arija Victoria

    2012-05-01

    Full Text Available Abstract Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain. These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0–6–12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA, food intake, dentures, degree of dependency (Barthel test, cognitive state (Pfeiffer test, mood status (Yesavage test, and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin. Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits up to 6 months. The North American Nursing Diagnosis Association (NANDA methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient’s nutritional status using the MNA test, diet, anthropometry, and biochemical parameters. Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention. The SPSS/PC program will be used for statistical analysis. Discussion The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of

  2. Motivational intervention to reduce rapid subsequent births to adolescent mothers: a community-based randomized trial.

    Science.gov (United States)

    Barnet, Beth; Liu, Jiexin; DeVoe, Margo; Duggan, Anne K; Gold, Melanie A; Pecukonis, Edward

    2009-01-01

    One-quarter of adolescent mothers bear another child within 2 years, compounding their risk of poorer medical, educational, economic, and parenting outcomes. Most efforts to prevent rapid subsequent birth to teenagers have been unsuccessful but have seldom addressed motivational processes. We conducted a randomized trial to determine the effectiveness of a computer-assisted motivational intervention (CAMI) in preventing rapid subsequent birth to adolescent mothers. Pregnant teenagers (N = 235), aged 18 years and older who were at more than 24 weeks' gestation, were recruited from urban prenatal clinics serving low-income, predominantly African American communities. After completing baseline assessments, they were randomly assigned to 3 groups: (1) those in CAMI plus enhanced home visit (n = 80) received a multi-component home-based intervention (CAMI+); (2) those in CAMI-only (n = 87) received a single component home-based intervention; (3) and those in usual-care control (n = 68) received standard usual care. Teens in both intervention groups received CAMI sessions at quarterly intervals until 2 years' postpartum. Those in the CAMI+ group also received monthly home visits with parenting education and support. CAMI algorithms, based on the transtheoretical model, assessed sexual relationships and contraception-use intentions and behaviors, and readiness to engage in pregnancy prevention. Trained interventionists used CAMI risk summaries to guide motivational interviewing. Repeat birth by 24 months' postpartum was measured with birth certificates. Intent-to-treat analysis indicated that the CAMI+ group compared with the usual-care control group exhibited a trend toward lower birth rates (13.8% vs 25.0%; P = .08), whereas the CAMI-only group did not (17.2% vs 25.0%; P = .32). Controlling for baseline group differences, the hazard ratio (HR) for repeat birth was significantly lower for the CAMI+ group than it was with the usual-care group (HR = 0.45; 95% CI, 0

  3. Multidisciplinary intervention reducing readmissions in medical inpatients: a prospective, non-randomized study

    Directory of Open Access Journals (Sweden)

    Torisson G

    2013-09-01

    Full Text Available Gustav Torisson,1 Lennart Minthon,1 Lars Stavenow,2 Elisabet Londos1 1Clinical Memory Research Unit, Department of Clinical Sciences, Lund University, 2Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden Background: The purpose of this study was to examine whether a multidisciplinary intervention targeting drug-related problems, cognitive impairment, and discharge miscommunication could reduce readmissions in a general hospital population. Methods: This prospective, non-randomized intervention study was carried out at the department of general internal medicine at a tertiary university hospital. Two hundred medical inpatients living in the community and aged over 60 years were included. Ninety-nine patients received interventions and 101 received standard care. Control/intervention allocation was determined by geographic selection. Interventions consisted of a comprehensive medication review, improved discharge planning, post-discharge telephone follow-up, and liaison with the patient's general practitioner. The main outcome measures recorded were readmissions and hospital nights 12 months after discharge. Separate analyses were made for 12-month survivors and from an intention-to-treat perspective. Comparative analyses were made between groups as well as within groups over time. Results: After 12 months, survivors in the control group had 125 readmissions in total, compared with 58 in the intervention group (Mann–Whitney U test, P = 0.02. For hospital nights, the numbers were 1,228 and 492, respectively (P = 0.009. Yearly admissions had increased from the previous year in the control group from 77 to 125 (Wilcoxon signed-rank test, P = 0.002 and decreased from 75 to 58 in the intervention group (P = 0.25. From the intention-to-treat perspective, the same general pattern was observed but was not significant (1,827 versus 1,008 hospital nights, Mann–Whitney test, P = 0.054. Conclusion: A multidisciplinary approach

  4. Effects of a Web-Based Tailored Intervention to Reduce Alcohol Consumption in Adults: Randomized Controlled Trial

    OpenAIRE

    Daniela N Schulz; Candel, Math JJM; Kremers, Stef PJ; Reinwand, Dominique A; Jander, Astrid; de Vries, Hein

    2013-01-01

    Background Web-based tailored interventions provide users with information that is adapted to their individual characteristics and needs. Randomized controlled trials assessing the effects of tailored alcohol self-help programs among adults are scarce. Furthermore, it is a challenge to develop programs that can hold respondents’ attention in online interventions. Objective To assess whether a 3-session, Web-based tailored intervention is effective in reducing alcohol intake in high-risk adult...

  5. A Chinese Chan-Based Mind-Body Intervention Improves Sleep on Patients with Depression: A Randomized Controlled Trial

    OpenAIRE

    Chan, Agnes S.; Wong, Queenie Y.; Sze, Sophia L.; Kwong, Patrick P. K.; Han, Yvonne M. Y.; Mei-chun Cheung

    2012-01-01

    Sleep disturbance is a common problem associated with depression, and cognitive-behavioral therapy (CBT) is a more common behavioral intervention for sleep problems. The present study compares the effect of a newly developed Chinese Chan-based intervention, namely Dejian mind-body intervention (DMBI), with the CBT on improving sleep problems of patients with depression. Seventy-five participants diagnosed with major depressive disorder were randomly assigned to receive 10 weekly sessions of C...

  6. Randomized trial of a DVD intervention to improve readiness to self-manage joint pain.

    Science.gov (United States)

    Elander, James; Robinson, Georgina; Morris, John

    2011-10-01

    A DVD (digital video disk) intervention to increase readiness to self-manage joint pain secondary to hemophilia was informed by a 2-phase, motivational-volitional model of readiness to self-manage pain, and featured the personal experiences of individuals with hemophilia. The DVD was evaluated in a randomized controlled trial in which 108 men with hemophilia completed measures of readiness to self-manage pain (Pain Stages of Change Questionnaire) before and 6 months after receiving the DVD plus information booklet (n=57) or just the booklet (n=51). The effect of the DVD was assessed by comparing changes in Pain Stages of Change Questionnaire scores (precontemplation, contemplation, and action/maintenance) between groups. The impact on pain coping, pain acceptance, and health-related quality of life was tested in secondary analyses. Repeated-measures analysis of variance, including all those with complete baseline and follow-up data regardless of use of the intervention, showed a significant, medium-sized, group×time effect on precontemplation, with reductions among the DVD group but not the booklet group. Significant use×time effects showed that benefits in terms of contemplation and action/maintenance were restricted to those who used the interventions at least once. The results show that low-intensity interventions in DVD format can improve the motivational impact of written information, and could be used to help prepare people with chronic pain for more intensive self-management interventions. The findings are consistent with a 2-phase, motivational-volitional model of pain self-management, and provide the first insights to our knowledge of readiness to self-manage pain in hemophilia.

  7. Lifestyle intervention and antioxidant therapy in children with nonalcoholic fatty liver disease: a randomized, controlled trial.

    Science.gov (United States)

    Nobili, Valerio; Manco, Melania; Devito, Rita; Di Ciommo, Vincenzo; Comparcola, Donatella; Sartorelli, Maria Rita; Piemonte, Fiorella; Marcellini, Matilde; Angulo, Paul

    2008-07-01

    No proven treatment exists for nonalcoholic fatty liver disease (NAFLD) in children and adolescents. We sought to determine the efficacy of lifestyle intervention with or without antioxidant therapy in pediatric NAFLD. A total of 53 patients (age 5.7-18.8 years, 37 boys) were included. Lifestyle intervention consisting of a diet tailored to the patient's calorie needs, and increased physical activity was prescribed in all. Patients were concomitantly randomized to alpha-tocopherol 600 IU/day plus ascorbic acid 500 mg/day (n = 25) or placebo (n = 28), and treated for 24 months. The study was an extension of a previous study aimed at evaluating the effect of 12-month lifestyle intervention and antioxidant therapy on serum levels of aminotransferases. The primary end point of the present study was change in liver histology on repeated biopsy at 24 months. Secondary end points were changes in body weight, liver enzymes, and insulin sensitivity indices on 2-hour oral glucose tolerance test. The amount of weight lost at 24 months was similar in the placebo and antioxidant groups (-4.75 [range, -16-4.0] versus -5.5 [range, -12.2-0.4] kg, respectively, P = 0.9). A significant improvement occurred in the grade of steatosis, lobular inflammation, and hepatocyte ballooning, and in the NAFLD activity score in both groups. Levels of aminotransferases, triglycerides, cholesterol, fasting glucose, and insulin, and insulin sensitivity indices improved significantly as well. The improvement in all these parameters was not significantly different between the two groups. Lifestyle intervention with diet and increased physical activity induces weight loss and is associated with a significant improvement in liver histology and laboratory abnormalities in pediatric NAFLD. Alpha-tocopherol plus ascorbic acid does not seem to increase the efficacy of lifestyle intervention alone.

  8. Physiological adaptation after a 12-week physical activity program for patients with Prader-Willi syndrome: two case reports.

    Science.gov (United States)

    Amaro, Alexandre Slowetzky; Teixeira, Maria Cristina Triguero Veloz; de Mesquita, Maria Luiza Guedes; Rodrigues, Graciele Massoli; Rubin, Daniela Andrea; Carreiro, Luiz Renato Rodrigues

    2016-06-23

    Physical activity programs are a powerful tool against several diseases including obesity and their comorbidities. Prader-Willi syndrome is the most common genetic disease associated with obesity, and brings with it behavioral and emotional problems that need complex management. Research into the effect of physical activity programs on Prader-Willi syndrome is limited and it is frequently argued that if a physical activity program is too complex, the participants are more likely to drop out. Therefore, in this study, we assessed the physiological adaptation effect of a physical activity program with increasing complexity and load, in a boy and a girl with Prader-Willi syndrome by assessing changes in lipid profile, body composition, and physical fitness parameters. Case 1 was an 11-year-old girl, mixed race (brown), with an intelligence quotient of 68, 52.0 % body fat, and a body mass index of 45.3 kg/m(2). The Prader-Willi syndrome diagnosis was made when she was 5-years old and was found to be due to an imprinting genomic defect. Case 2 was a 14-year-old boy, mixed race (brown), with an intelligence quotient of 74, 48.8 % body fat, and a body mass index of 37.3 kg/m(2). The diagnosis was made when he was 10-years old and was found to be caused by gene deletion. Both participants presented physical characteristics and behavior problems typical of Prader-Willi syndrome. Case 2 presented high blood pressure, high cholesterol and sleep apnea and had to use continuous positive airway pressure to sleep. Both participants were assessed for 12 weeks (three times a week) using a physical activity program designed to improve strength and muscle hypertrophy. The work load was progressively adjusted as necessary and new exercises were added to the program. Prior to the program, the participants' parents received instructions about managing problem behavior and advice about nutrition. After physical activity program several health markers assessed by biological tests and

  9. Trichloroethylene and trichloroethanol-induced formic aciduria and renal injury in male F-344 rats following 12 weeks exposure.

    Science.gov (United States)

    Yaqoob, Noreen; Evans, Andrew; Foster, John R; Lock, Edward A

    2014-09-02

    Trichloroethylene (TCE) is widely used as a cleaning and decreasing agent and has been shown to cause liver tumours in rodents and a small incidence of renal tubule tumours in male rats. The basis for the renal tubule injury is believed to be related to metabolism of TCE via glutathione conjugation to yield the cysteine conjugate that can be activated by the enzyme cysteine conjugate β-lyase in the kidney. More recently TCE and its major metabolite trichloroethanol (TCE-OH) have been shown to cause formic aciduria which can cause renal injury after chronic exposure in rats. In this study we have compared the renal toxicity of TCE and TCE-OH in rats to try and ascertain whether the glutathione pathway or formic aciduria can account for the toxicity. Male rats were given TCE (500mg/kg/day) or TCE-OH at (100mg/kg/day) for 12 weeks and the extent of renal injury measured at several time points using biomarkers of nephrotoxicity and prior to termination assessing renal tubule cell proliferation. The extent of formic aciduria was also determined at several time points, while renal pathology and plasma urea and creatinine were determined at the end of the study. TCE produced a very mild increase in biomarkers of renal injury, total protein, and glucose over the first two weeks of exposure and increased Kim-1 and NAG in urine after 1 and 5 weeks exposure, while TCE-OH did not produce a consistent increase in these biomarkers in urine. However, both chemicals produced a marked and sustained increase in the excretion of formic acid in urine to a very similar extent. The activity of methionine synthase in the liver of TCE and TCE-OH treated rats was inhibited by about 50% indicative of a block in folate synthesis. Both renal pathology and renal tubule cell proliferation were reduced after TCE and TCE-OH treatment compared to controls. Our findings do not clearly identify the pathway which is responsible for the renal toxicity of TCE but do provide some support for metabolism

  10. Promoting first relationships: randomized trial of a relationship-based intervention for toddlers in child welfare.

    Science.gov (United States)

    Spieker, Susan J; Oxford, Monica L; Kelly, Jean F; Nelson, Elizabeth M; Fleming, Charles B

    2012-11-01

    We conducted a community-based, randomized control trial with intent-to-treat analyses of Promoting First Relationships (PFR) to improve parenting and toddler outcomes for toddlers in state dependency. Toddlers (10-24 months; N = 210) with a recent placement disruption were randomized to 10-week PFR or a comparison condition. Community agency providers were trained to use PFR in the intervention for caregivers. From baseline to postintervention, observational ratings of caregiver sensitivity improved more in the PFR condition than in the comparison condition, with an effect size for the difference in adjusted means postintervention of d = .41. Caregiver understanding of toddlers' social emotional needs and caregiver reports of child competence also differed by intervention condition postintervention (d = .36 and d = .42) with caregivers in the PFR condition reporting more understanding of toddlers and child competence. Models of PFR effects on within-individual change were significant for caregiver sensitivity and understanding of toddlers. At the 6-month follow-up, only 61% of original sample dyads were still intact and there were no significant differences on caregiver or child outcomes.

  11. Diffusion of an Evidence-Based Smoking Cessation Intervention Through Facebook: A Randomized Controlled Trial.

    Science.gov (United States)

    Cobb, Nathan K; Jacobs, Megan A; Wileyto, Paul; Valente, Thomas; Graham, Amanda L

    2016-06-01

    To examine the diffusion of an evidence-based smoking cessation application ("app") through Facebook social networks and identify specific intervention components that accelerate diffusion. Between December 2012 and October 2013, we recruited adult US smokers ("seeds") via Facebook advertising and randomized them to 1 of 12 app variants using a factorial design. App variants targeted components of diffusion: duration of use (t), "contagiousness" (β), and number of contacts (Z). The primary outcome was the reproductive ratio (R), defined as the number of individuals installing the app ("descendants") divided by the number of a seed participant's Facebook friends. We randomized 9042 smokers. App utilization metrics demonstrated between-variant differences in expected directions. The highest level of diffusion (R = 0.087) occurred when we combined active contagion strategies with strategies to increase duration of use (incidence rate ratio = 9.99; 95% confidence interval = 5.58, 17.91; P < .001). Involving nonsmokers did not affect diffusion. The maximal R value (0.087) is sufficient to increase the numbers of individuals receiving treatment if applied on a large scale. Online interventions can be designed a priori to spread through social networks.

  12. Short-term effects of a randomized controlled worksite relaxation intervention in Greece

    Directory of Open Access Journals (Sweden)

    Evangelos C Alexopoulos

    2014-06-01

    Full Text Available objective. To evaluate the short-term benefits of simple relaxation techniques in white-collar employees. materials and methods. The study was a two-arm parallel group randomized controlled trial. 152 employees were randomly assigned to receive the 8-week programme (N=80 (relaxation breathing and progressive muscle relaxation, twice a day or not (wait-list group N=72. Self-reported validated measures were used to evaluate perceived stress, health locus of control, job and lifestyle related variables. Saliva cortisol were also sampled and measured. Adjusted mean changes on outcomes were estimated by linear mixed model analysis. 127 employees were finally analyzed (68 in the intervention and 59 in the control group. results. Specific stress-related symptoms, psychological job demands and cortisol levels were found to be significantly decreased after 8-weeks in the intervention group. The result was probably affected by the general socio-economic condition during the study period. Cortisol levels were also significantly related with age, family situation, gender and sampling time. conclusions. Simple relaxation training (diaphragmatic breathing and progressive muscle relaxation could benefit employees and it is strongly proposed that these and other similar techniques should be tested in various labour settings

  13. A Randomized Controlled Trial of a Theoretically-Based Behavioral Nutrition Intervention for Community Elders: Lessons Learned from the Behavioral Nutrition Intervention for Community Elders Study

    OpenAIRE

    Locher, JL; Vickers, KS; Buys, DR; Ellis, A; Lawrence, JC; Newton, LE; Roth, DL; Ritchie, CS; Bales, CW

    2013-01-01

    Older adults with multiple comorbidities are often undernourished or at high risk for becoming so, especially after a recent hospitalization. Randomized controlled trials of effective, innovative interventions are needed to support evidence-based approaches for solving nutritional problems in this population. Self-management approaches where participants select their own behavioral goals can enhance success of interventions. The purpose of this study was to evaluate the feasibility and effica...

  14. Interventions for Preventing Childhood Obesity with Smartphones and Wearable Device: A Protocol for a Non-Randomized Controlled Trial

    Science.gov (United States)

    Yang, Hye Jung; Kang, Jae-Heon; Kim, Ok Hyun; Choi, Mona; Oh, Myungju; Nam, Jihyun; Sung, Eunju

    2017-01-01

    Background: Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named “HAPPY ME,” which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10–12 years of age using HAPPY ME. Methods: A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference), body mass index (BMI) percentiles (obesity rate), and psychological perceptions among participants. Conclusions: The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach. PMID:28208839

  15. Interventions for Preventing Childhood Obesity with Smartphones and Wearable Device: A Protocol for a Non-Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hye Jung Yang

    2017-02-01

    Full Text Available Background: Childhood obesity is a critical health issue, both currently and for the foreseeable future. To prevent obesity, behavior changes are essential. Smartphones can be a good tool, as the number of child smartphone users is rapidly increasing. We have developed a mobile platform system named “HAPPY ME,” which is a smartphone application coupled with a wearable device, designed to improve healthy behaviors to prevent childhood obesity. This study aimed to evaluate the effectiveness of obesity prevention among children 10–12 years of age using HAPPY ME. Methods: A total of 1000 participants, all fifth and sixth graders from four schools, were assigned to either control or intervention groups by school. Students in the intervention group used HAPPY ME. The study comprises a safety test, a 12-week efficacy test, and a six-month follow-up test to determine the long-term effects of preventive intervention via the integrated service platform. The integrated service platform aims to facilitate child-parent-school participation, involving the child-parent mobile application, a child-teacher mobile web, and a school website. Primary outcome measures are behavioral changes, including healthy eating, increased physical activity, and fitness. Secondary outcome measures are changes in anthropometric parameters (body weight, height, body mass index z-score, and waist circumference, body mass index (BMI percentiles (obesity rate, and psychological perceptions among participants. Conclusions: The results of this study will offer evidence of the effectiveness of a mobile platform service with a multi-component intervention program based on a comprehensive approach.

  16. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p yoga intervention and walking control over the course of the study. Conclusion Among Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing

  17. Randomized Controlled Trial of Social Media: Effect of Increased Intensity of the Intervention.

    Science.gov (United States)

    Fox, Caroline S; Gurary, Ellen B; Ryan, John; Bonaca, Marc; Barry, Karen; Loscalzo, Joseph; Massaro, Joseph

    2016-04-27

    A prior randomized controlled trial of social media exposure at Circulation determined that social media did not increase 30-day page views. Whether insufficient social media intensity contributed to these results is uncertain. Original article manuscripts were randomized to social media exposure compared with no social media exposure (control) at Circulation beginning in January 2015. Social media exposure consisted of Facebook and Twitter posts on the journal's accounts. To increase social media intensity, a larger base of followers was built using advertising and organic growth, and posts were presented in triplicate and boosted on Facebook and retweeted on Twitter. The primary outcome was 30-day page views. Stopping rules were established at the point that 50% of the manuscripts were randomized and had 30-day follow-up to compare groups on 30-day page views. The trial was stopped for futility on September 26, 2015. Overall, 74 manuscripts were randomized to receive social media exposure, and 78 manuscripts were randomized to the control arm. The intervention and control arms were similar based on article type (P=0.85), geographic location of the corresponding author (P=0.33), and whether the manuscript had an editorial (P=0.80). Median number of 30-day page views was 499.5 in the social media arm and 450.5 in the control arm; there was no evidence of a treatment effect (P=0.38). There were no statistically significant interactions of treatment by manuscript type (P=0.86), by corresponding author (P=0.35), by trimester of publication date (P=0.34), or by editorial status (P=0.79). A more intensive social media strategy did not result in increased 30-day page views of original research. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  18. Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Allen Kelli D

    2012-04-01

    Full Text Available Abstract Background Osteoarthritis (OA of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care. Methods / Design One study is being conducted within the Department of Veterans Affairs (VA health care system and will compare a Combined Patient and Provider intervention relative to usual care among n = 300 patients (10 from each of 30 primary care providers. Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider interventions relative to usual care among n = 560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection, based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function, and

  19. Family nurture intervention (FNI: methods and treatment protocol of a randomized controlled trial in the NICU

    Directory of Open Access Journals (Sweden)

    Welch Martha G

    2012-02-01

    Full Text Available Abstract Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT with blinded assessment comparing Standard Care (SC with a novel Family Nurture Intervention (FNI. FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1 In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2 Outside the isolette during holding and feeding via the Calming Cycle; and 3 through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA, maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group. Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally

  20. Mindfulness Training Improves Attentional Task Performance in Incarcerated Youth: A Group Randomized Controlled Intervention Trial

    Directory of Open Access Journals (Sweden)

    Noelle R Leonard

    2013-11-01

    Full Text Available We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16 to 18, to a CBT/MT intervention (youth n = 147 or an active control intervention (youth n = 117. Both arms received approximately 750 minutes of intervention in a small-group setting over a 3-5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. Keywords: adolescent development, incarcerated adolescents, detained adolescents, stress, attention, mindfulness meditation.

  1. A Group-Based Yoga Therapy Intervention for Urinary Incontinence in Women: A Pilot Randomized Trial

    Science.gov (United States)

    Huang, Alison J.; Jenny, Hillary E.; Chesney, Margaret A.; Schembri, Michael; Subak, Leslee L.

    2015-01-01

    Objective To examine the feasibility, efficacy, and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence. Methods We conducted a pilot randomized trial of ambulatory women aged 40 years and older with stress, urgency, or mixed-type incontinence. Women were randomized to a 6-week yoga therapy program (N=10) consisting of twice weekly group classes and once weekly home practice or a waitlist control group (N=9). All participants also received written pamphlets about standard behavioral self-management strategies for incontinence. Changes in incontinence were assessed by 7-day voiding diaries. Results Mean (±SD) age was 61.4 (±8.2) years, and mean baseline frequency of incontinence was 2.5 (±1.3) episodes/day. After 6 weeks, total incontinence frequency decreased by 66% (1.8 [±0.9] fewer episodes/day) in the yoga therapy versus 13% (0.3 [±1.7] fewer episodes/day) in the control group (P=0.049). Participants in the yoga therapy group also reported an average 85% decrease in stress incontinence frequency (0.7 [±0.8] fewer episodes/day) compared to a 25% increase in controls (0.2 [± 1.1] more episodes/day) (P=0.039). No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups (1.0 [±1.0] versus 0.5 [±0.5] fewer episodes/day, P=0.20). All women starting the yoga therapy program completed at least 90% of group classes and practice sessions. Two participants in each group reported adverse events unrelated to the intervention. Conclusions Findings provide preliminary evidence to support the feasibility, efficacy, and safety of a group-based yoga therapy intervention to improve urinary incontinence in women. PMID:24763156

  2. Brief intervention to reduce risky drinking in pregnancy: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wilson Graeme B

    2012-09-01

    Full Text Available Abstract Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742 attending their booking appointment with a community midwife (n = 31 in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C. Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120. Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention. As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention

  3. Ethical challenges in cluster randomized controlled trials: experiences from public health interventions in Africa and Asia.

    Science.gov (United States)

    Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M

    2009-10-01

    Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.

  4. Intervention for homeless, substance abusing mothers: findings from a non-randomized pilot.

    Science.gov (United States)

    Slesnick, Natasha; Erdem, Gizem

    2012-01-01

    Little empirically-based information is available regarding how best to intervene with substance-abusing homeless mothers. This study pilot-tested a comprehensive intervention with 15 homeless women and their 2- to 6-year-old children, recruited from a local family shelter. All participants were offered integrated intervention with three major components. The first component was housing which included 3 months of rental and utility assistance, and these services were not contingent upon women's abstinence from drugs or alcohol. The second and third components included 6 months of case management services and an evidence-based substance abuse treatment (Community Reinforcement Approach; CRA). Analysis revealed that women showed reductions in substance use (F(2,22) = 3.63; p homelessness (F(2,24) = 25.31; p intervention is a promising approach to meet the multiple needs of this vulnerable population. These positive outcomes support the need for future research to replicate the findings with a larger sample using a randomized design.

  5. [Cost-consequence analysis of respiratory preventive intervention among institutionalized older people: randomized controlled trial].

    Science.gov (United States)

    Cebrià I Iranzo, Maria Dels Àngels; Tortosa-Chuliá, M Ángeles; Igual-Camacho, Celedonia; Sancho, Patricia; Galiana, Laura; Tomás, José Manuel

    2014-01-01

    The institutionalized elderly with functional impairment show a greater decline in respiratory muscle (RM) function. The aims of the study are to evaluate outcomes and costs of RM training using Pranayama in institutionalized elderly people with functional impairment. A randomized controlled trial was conducted on institutionalized elderly people with walking limitation (n=54). The intervention consisted of 6 weeks of Pranayama RM training (5 times/week). The outcomes were measured at 4 time points, and were related to RM function: the maximum respiratory pressures and the maximum voluntary ventilation. Perceived satisfaction in the experimental group (EG) was assessed by means of an ad hoc questionnaire. Direct and indirect costs were estimated from the social perspective. The GE showed a significant improvement related with strength (maximum respiratory pressures) and endurance (maximum voluntary ventilation) of RM. Moreover, 92% of the EG reported a high satisfaction. The total social costs, direct and indirect, amounted to Euro 21,678. This evaluation reveals that RM function improvement is significant, that intervention is well tolerated and appreciated by patients, and the intervention costs are moderate. Copyright © 2013 SEGG. Published by Elsevier Espana. All rights reserved.

  6. Randomized controlled trial of parental responsiveness intervention for toddlers at high risk for autism.

    Science.gov (United States)

    Kasari, Connie; Siller, Michael; Huynh, Linh N; Shih, Wendy; Swanson, Meghan; Hellemann, Gerhard S; Sugar, Catherine A

    2014-11-01

    This study tested the effects of a parent-mediated intervention on parental responsiveness with their toddlers at high risk for an autism spectrum disorder (ASD). Participants included caregivers and their 66 toddlers at high risk for ASD. Caregivers were randomized to 12 sessions of an individualized parent education intervention aimed at improving parental responsiveness or to a monitoring control group involving 4 sessions of behavioral support. Parental responsiveness and child outcomes were measured at three time points: at beginning and end of the 3-month treatment and at 12-months post-study entry. Parental responsiveness improved significantly in the treatment group but not the control group. However, parental responsiveness was not fully maintained at follow up. There were no treatment effects on child outcomes of joint attention or language. Children in both groups made significant developmental gains in cognition and language skills over one year. These results support parental responsiveness as an important intervention target given its general association with child outcomes in the extant literature; however, additional supports are likely needed to fully maintain the treatment effect and to affect child outcomes.

  7. Cost-effectiveness of interventions to prevent HIV and STDs among women: a randomized controlled trial.

    Science.gov (United States)

    Ruger, Jennifer Prah; Abdallah, Arbi Ben; Ng, Nora Y; Luekens, Craig; Cottler, Linda

    2014-10-01

    Injection drug use is a leading transmission route of HIV and STDs, and disease prevention among drug users is an important public health concern. This study assesses cost-effectiveness of behavioral interventions for reducing HIV and STDs infections among injection drug-using women. Cost-effectiveness analysis was conducted from societal and provider perspectives for randomized trial data and Bernoullian model estimates of infections averted for three increasingly intensive interventions: (1) NIDA's standard intervention (SI); (2) SI plus a well woman exam (WWE); and (3) SI, WWE, plus four educational sessions (4ES). Trial results indicate that 4ES was cost-effective relative to WWE, which was dominated by SI, for most diseases. Model estimates, however, suggest that WWE was cost-effective relative to SI and dominated 4ES for all diseases. Trial and model results agree that WWE is cost-effective relative to SI per hepatitis C infection averted ($109 308 for in trial, $6 016 in model) and per gonorrhea infection averted ($9 461 in trial, $14 044 in model). In sensitivity analysis, trial results are sensitive to 5 % change in WWE effectiveness relative to SI for hepatitis C and HIV. In the model, WWE remained cost-effective or cost-saving relative to SI for HIV prevention across a range of assumptions. WWE is cost-effective relative to SI for preventing hepatitis C and gonorrhea. WWE may have similar effects as the costlier 4ES.

  8. Interventions employing mobile technology for overweight and obesity: an early systematic review of randomized controlled trials

    Science.gov (United States)

    Bacigalupo, R; Cudd, P; Littlewood, C; Bissell, P; Hawley, M S; Buckley Woods, H

    2013-01-01

    Summary Obesity is a global epidemic with major healthcare implications and costs. Mobile technologies are potential interventions to promote weight loss. An early systematic review of this rapidly growing area of research was conducted. Electronic databases were searched for articles published between January 1998 and October 2011. Data sources included Medline, Embase and the Cochrane Central Register of Controlled Trials. Ongoing research was searched for using clinical trials databases and registers. Out of 174 articles retrieved, 21 met the inclusion criteria of randomized controlled trials (RCTs) on mobile technology interventions facilitating weight loss in overweight and obese adults with any other comparator. A narrative synthesis was undertaken. Seven articles were included and appraised using the Cochrane risk of bias tool: four presented a low risk of bias and three presented a high risk of bias. There is consistent strong evidence across the included multiple high-quality RCTs that weight loss occurs in the short-term because of mobile technology interventions, with moderate evidence for the medium-term. Recommendations for improving the reporting and quality of future trials are made including reporting weight loss in percent to meet clinical standards, and including features such as long-term follow-up, cost-effectiveness and patient acceptability. PMID:23167478

  9. A randomized clinical trial of the effectiveness of premarital intervention: moderators of divorce outcomes.

    Science.gov (United States)

    Markman, Howard J; Rhoades, Galena K; Stanley, Scott M; Peterson, Kristina M

    2013-02-01

    This study examined the effects of premarital relationship intervention on divorce during the first 8 years of first marriage. Religious organizations were randomly assigned to have couples marrying through them complete the Prevention and Relationship Education Program (PREP) or their naturally occurring premarital services. Results indicated no differences in overall divorce rates between naturally occurring services (n = 44), PREP delivered by clergy at religious organizations (n = 66), or PREP delivered by professionals at a university (n = 83). Three moderators were also tested. Measured premaritally and before intervention, the level of negativity of couples' interactions moderated effects. Specifically, couples observed to have higher levels of negative communication in a video task were more likely to divorce if they received PREP than if they received naturally occurring services; couples with lower levels of premarital negative communication were more likely to remain married if they received PREP. A history of physical aggression in the current relationship before marriage and before intervention showed a similar pattern as a moderator, but the effect was only marginally significant. Family-of-origin background (parental divorce and/or aggression) was not a significant moderator of prevention effects across the two kinds of services. Implications for defining risk, considering divorce as a positive versus negative outcome, the practice of premarital relationship education, and social policy are discussed.

  10. A randomized controlled trial of a theoretically-based behavioral nutrition intervention for community elders: lessons learned from the Behavioral Nutrition Intervention for Community Elders Study.

    Science.gov (United States)

    Locher, Julie L; Vickers, Kristin S; Buys, David R; Ellis, Amy; Lawrence, Jeannine C; Newton, Laura Elizabeth; Roth, David L; Ritchie, Christine S; Bales, Connie W

    2013-12-01

    Older adults with multiple comorbidities are often undernourished or at high risk for becoming so, especially after a recent hospitalization. Randomized controlled trials of effective, innovative interventions are needed to support evidence-based approaches for solving nutritional problems in this population. Self-management approaches where participants select their own behavioral goals can enhance success of interventions. The purpose of this study was to evaluate the feasibility and efficacy of a multilevel self-management intervention to improve nutritional status in a group of high-risk older adults. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether the intervention, compared to standard care, maintained or increased caloric intake (depending on baseline body mass index) and, consequently, stabilized or increased body weight. Participants were 34 Medicare-eligible, age 65 years old or older, homebound adults who were consuming insufficient calories and/or had a history of weight loss ≥2.5% over 6 months. The intervention took place within participants' homes. Outcome measures, including energy intake (based on collection of three 24-hour dietary recalls) and body weights were assessed at baseline and at 60 days post randomization. The primary analyses included analyses of covariance and Pearson's χ(2). We hypothesized that the intervention would result in increased caloric intake and weight gain in underweight older adults and increased or stabilized caloric intake and weight for everyone else. The intervention was feasible; however, it did not result in differences between groups for desired outcomes of either caloric intake or body weight. Future interventions might either deliberately involve caregivers or reduce burden for both patients and caregivers.

  11. Effects of a three-month therapeutic lifestyle modification program to improve bone health in postmenopausal Korean women in a rural community: a randomized controlled trial.

    Science.gov (United States)

    Oh, Eui Geum; Yoo, Jae Yong; Lee, Jung Eun; Hyun, Sa Saeng; Ko, Il Sun; Chu, Sang Hui

    2014-08-01

    In this randomized controlled trial, we examined the effects of a 3-month therapeutic lifestyle modification (TLM) intervention on knowledge, self-efficacy, and health behaviors related to bone health in postmenopausal women in rural Korea. Forty-one women ages 45 or older were randomly assigned to either the intervention (n = 21) or control (n = 20) group. The intervention group completed a 12-week, 24-session TLM program of individualized health monitoring, group health education, exercise, and calcium-vitamin D supplementation. Compared with the control group, the intervention group showed significant increases in knowledge and self-efficacy and improvement in diet and exercise after 12 weeks, providing evidence that a comprehensive TLM program can be effective in improving health behaviors to maintain bone health in women at high risk of osteoporosis.

  12. Efficacy of alcohol interventions for first-year college students: a meta-analytic review of randomized controlled trials.

    Science.gov (United States)

    Scott-Sheldon, Lori A J; Carey, Kate B; Elliott, Jennifer C; Garey, Lorra; Carey, Michael P

    2014-04-01

    Alcohol use established during the first-year of college can result in adverse consequences during the college years and beyond. In this meta-analysis, we evaluated the efficacy of interventions to prevent alcohol misuse by first-year college students. Studies were included if the study reported an individual- or group-level intervention using a randomized controlled trial, targeted 1st-year college students, and assessed alcohol use. Forty-one studies with 62 separate interventions (N = 24,294; 57% women; 77% White) were included. Independent raters coded sample, design, methodological features, and intervention content. Weighted mean effect sizes, using fixed- and random-effects models, were calculated. Potential moderators, determined a priori, were examined to explain variability in effect sizes. Relative to controls, students receiving an intervention reported lower quantity and frequency of drinking and fewer problems (d(+)s = 0.07-0.14). These results were more pronounced when the interventions were compared with an assessment-only control group (d(+)s = 0.11-0.19). Intervention content (e.g., personalized feedback) moderated the efficacy of the intervention. Behavioral interventions for 1st-year college students reduce alcohol consumption and alcohol-related problems. Interventions that include personalized feedback, moderation strategies, expectancy challenge, identification of risky situations, and goal-setting optimize efficacy. Strategies to prevent alcohol misuse among first-year students are recommended.

  13. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial

    National Research Council Canada - National Science Library

    Hoa L Nguyen; Jeroan J Allison; Duc A Ha; German Chiriboga; Ha N Ly; Hanh T Tran; Cuong K Nguyen; Diem M Dang; Ngoc T Phan; Nguyen C Vu; Quang P Nguyen; Robert J Goldberg

    2017-01-01

    ...,” and a didactic intervention. Methods The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy...

  14. 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

  15. Interventions for atopic dermatitis in dogs: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Olivry, Thierry; Foster, Aiden P; Mueller, Ralf S; McEwan, Neil A; Chesney, Christopher; Williams, Hywel C

    2010-02-01

    The objective of this systematic review, which was performed following the guidelines of the Cochrane collaboration, was to assess the effects of interventions for treatment of atopic dermatitis (AD) in dogs. Citations identified from three databases (MEDLINE, Thomson's Science Citation Index Expanded and CAB Abstracts) and trials published by December 2007 were selected. Proceedings books from the major veterinary dermatology international congresses were hand searched for relevant citations. The authors selected randomized controlled trials (RCTs), published from January 1980 to December 2007, which reported the efficacy of topical or systemic interventions for treatment or prevention of canine AD. Studies had to report assessments of either pruritus or skin lesions, or both. Studies were selected and data extracted by two reviewers, with discrepancies resolved by a third arbitrator. Missing data were requested from study authors of recently published trials. Pooling of results and meta-analyses were performed for studies reporting similar interventions and outcome measures. A total of 49 RCTs were selected, which had enrolled 2126 dogs. This review found some evidence of efficacy of topical tacrolimus (3 RCTs), topical triamcinolone (1), oral glucocorticoids (5), oral ciclosporin (6), subcutaneous recombinant gamma-interferon (1) and subcutaneous allergen-specific immunotherapy (3) to decrease pruritus and/or skin lesions of AD in dogs. One high-quality RCT showed that an oral essential fatty acid supplement could reduce prednisolone consumption by approximately half. Additional RCTs of high design quality must be performed to remedy previous flaws and to test interventions for prevention of flares of this disease.

  16. Randomized trial of a cellular phone-enhanced home visitation parenting intervention.

    Science.gov (United States)

    Carta, Judith J; Lefever, Jennifer Burke; Bigelow, Kathryn; Borkowski, John; Warren, Steven F

    2013-11-01

    Although home visiting programs have been documented to improve parenting in high-risk families, their effectiveness is diminished when parents disengage from programs. Cellular phones offer an approach to promoting parent engagement and enhancing parenting outcomes. Our objective was to examine whether mothers in a parenting intervention, Planned Activities Training (PAT), or cellular phone-enhanced version (CPAT) of the intervention would demonstrate greater use of parenting strategies after treatment and at 6 months post-treatment compared with a wait-list control (WLC). A sample of 371 low-income mothers and their 3.5- to 5.5-year-old children were randomly assigned to condition and assessed at pre-test, post-intervention, and 6 months post-intervention. Treatment efficacy was evaluated through observations of mother-child interactions as well as maternal interviews about depression, parenting stress, and child behaviors. Mothers receiving PAT and CPAT demonstrated more frequent use of parenting strategies and engaged in more responsive parenting than mothers in the WLC. Mothers receiving CPAT used more PAT parenting strategies than mothers in the other 2 groups and experienced greater reductions in depression and stress. Children of mothers receiving PAT and CPAT demonstrated higher rates of positive engagement, and children of CPAT mothers demonstrated higher levels of adaptive behaviors than children in the WLC. Importantly, changes in parenting, depression, and stress predicted positive child behaviors. PAT and CPAT conditions improved parenting strategies and child engagement and reduced children's challenging behaviors. The addition of cellular phones to a home visiting program enhanced maternal responsivity and reduced depression and stress.

  17. Motivational brief intervention for the prevention of sexually transmitted infections in travelers: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Berdoz Didier

    2011-11-01

    Full Text Available Abstract Background Sexually transmitted infections (STIs are among the frequent risks encountered by travelers. Efficient interventions are needed to improve the understanding of the risks of STIs. We investigated the potential benefits of a motivational brief intervention (BI and the provision of condoms on the engagement in unprotected casual sex. Methods 3-arm randomized controlled trial performed among single travelers aged 18-44 years visiting a travel clinic in Switzerland. The main outcomes were the prevalence of casual unprotected sexual intercourse and their predictors. Results 5148 eligible travelers were seen from 2006 to 2008. 1681 agreed to participate and 1115 subjects (66% completed the study. 184/1115 (17% had a casual sexual relationship abroad and overall 46/1115 (4.1% had inconsistently protected sexual relations. Women (adjusted OR 2.7 [95%CI 1.4-5.6] and travelers with a history of past STI (adjusted OR 2.8 [95%CI 1.1-7.4] had more frequent casual sexual relationships without consistent protection. Regarding the effect of our intervention, the prevalence of subjects using condoms inconsistently was 28% (95%CI16-40 in the motivational BI group, 24% (95%CI10-37 in the condoms group and 24% (95%CI14-33 in the control group (p = 0.7. Conclusion This study showed that a motivational brief intervention and/or the provision of free condoms did not modify risky sexual behavior of young travelers. The rate of inconsistently protected sexual relationships during travel was however lower than expected Trial Registration Number ClinicalTrials.gov: NCT01056536

  18. Motivational brief intervention for the prevention of sexually transmitted infections in travelers: a randomized controlled trial.

    Science.gov (United States)

    Senn, Nicolas; de Valliere, Serge; Berdoz, Didier; Genton, Blaise

    2011-11-01

    Sexually transmitted infections (STIs) are among the frequent risks encountered by travelers. Efficient interventions are needed to improve the understanding of the risks of STIs. We investigated the potential benefits of a motivational brief intervention (BI) and the provision of condoms on the engagement in unprotected casual sex. 3-arm randomized controlled trial performed among single travelers aged 18-44 years visiting a travel clinic in Switzerland. The main outcomes were the prevalence of casual unprotected sexual intercourse and their predictors. 5148 eligible travelers were seen from 2006 to 2008. 1681 agreed to participate and 1115 subjects (66%) completed the study. 184/1115 (17%) had a casual sexual relationship abroad and overall 46/1115 (4.1%) had inconsistently protected sexual relations. Women (adjusted OR 2.7 [95%CI 1.4-5.6]) and travelers with a history of past STI (adjusted OR 2.8 [95%CI 1.1-7.4]) had more frequent casual sexual relationships without consistent protection. Regarding the effect of our intervention, the prevalence of subjects using condoms inconsistently was 28% (95%CI16-40) in the motivational BI group, 24% (95%CI10-37) in the condoms group and 24% (95%CI14-33) in the control group (p = 0.7). This study showed that a motivational brief intervention and/or the provision of free condoms did not modify risky sexual behavior of young travelers. The rate of inconsistently protected sexual relationships during travel was however lower than expected ClinicalTrials.gov: NCT01056536.

  19. Randomized Trial of a Cellular Phone-Enhanced Home Visitation Parenting Intervention

    Science.gov (United States)

    Lefever, Jennifer Burke; Bigelow, Kathryn; Borkowski, John; Warren, Steven F.

    2013-01-01

    BACKGROUND AND OBJECTIVES: Although home visiting programs have been documented to improve parenting in high-risk families, their effectiveness is diminished when parents disengage from programs. Cellular phones offer an approach to promoting parent engagement and enhancing parenting outcomes. Our objective was to examine whether mothers in a parenting intervention, Planned Activities Training (PAT), or cellular phone-enhanced version (CPAT) of the intervention would demonstrate greater use of parenting strategies after treatment and at 6 months post-treatment compared with a wait-list control (WLC). METHODS: A sample of 371 low-income mothers and their 3.5- to 5.5-year-old children were randomly assigned to condition and assessed at pre-test, post-intervention, and 6 months post-intervention. Treatment efficacy was evaluated through observations of mother-child interactions as well as maternal interviews about depression, parenting stress, and child behaviors. RESULTS: Mothers receiving PAT and CPAT demonstrated more frequent use of parenting strategies and engaged in more responsive parenting than mothers in the WLC. Mothers receiving CPAT used more PAT parenting strategies than mothers in the other 2 groups and experienced greater reductions in depression and stress. Children of mothers receiving PAT and CPAT demonstrated higher rates of positive engagement, and children of CPAT mothers demonstrated higher levels of adaptive behaviors than children in the WLC. Importantly, changes in parenting, depression, and stress predicted positive child behaviors. CONCLUSIONS: PAT and CPAT conditions improved parenting strategies and child engagement and reduced children’s challenging behaviors. The addition of cellular phones to a home visiting program enhanced maternal responsivity and reduced depression and stress. PMID:24187120

  20. A randomized controlled trial of brief interventions for problem gambling in substance abuse treatment patients.

    Science.gov (United States)

    Petry, Nancy M; Rash, Carla J; Alessi, Sheila M

    2016-10-01

    This study evaluated the efficacy of brief gambling treatments in patients attending substance abuse treatment clinics. Substance abuse treatment patients with gambling problems (N = 217) were randomly assigned to a 10- to 15-min brief psychoeducation gambling intervention; a 10- to 15-min brief advice intervention addressing gambling norms, risk factors, and methods to prevent additional problems; or 4 50-min sessions of motivational enhancement therapy plus cognitive behavior therapy for reducing gambling (MET + CBT). Gambling and related problems were assessed at baseline and throughout 24 months. In the sample as a whole, days and dollars wagered and gambling problems decreased markedly from baseline through Month 5; thereafter, reductions in dollars wagered and gambling problems continued to decrease modestly but significantly, and days gambled remained constant. Brief advice significantly reduced days gambled between baseline and Month 5 relative to brief psychoeducation. The MET + CBT condition engendered no benefit beyond brief advice in terms of days gambled but did lead to more precipitous reductions in dollars gambled and problems experienced in the initial 5 months, and greater clinically significant improvements in gambling in both the short and long term. MET + CBT also resulted in initial decreases in self-reported alcohol use and problems but did not differentially impact self-reported illicit drug use or submission of positive samples. Gambling problems tend to dissipate over time regardless of the intervention applied, but offering MET + CBT was more efficacious in decreasing gambling than providing a brief single session intervention. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  1. Patients' communication with doctors: a randomized control study of a brief patient communication intervention.

    Science.gov (United States)

    Talen, Mary R; Muller-Held, Christine F; Eshleman, Kate Grampp; Stephens, Lorraine

    2011-09-01

    In research on doctor-patient communication, the patient role in the communication process has received little attention. The dynamic interactions of shared decision making and partnership styles which involve active patient communication are becoming a growing area of focus in doctor-patient communication. However, patients rarely know what makes "good communication" with medical providers and even fewer have received coaching in this type of communication. In this study, 180 patients were randomly assigned to either an intervention group using a written communication tool to facilitate doctor-patient communication or to standard care. The goal of this intervention was to assist patients in becoming more effective communicators with their physicians. The physicians and patients both rated the quality of the communication after the office visit based on the patients' knowledge of their health concerns, organizational skills and questions, and attitudes of ownership and partnership. The results supported that patients in the intervention group had significantly better communication with their doctors than patients in the standard care condition. Physicians also rated patients who were in the intervention group as having better overall communication and organizational skills, and a more positive attitude during the office visit. This study supports that helping patients structure their communication using a written format can facilitate doctor-patient communication. Patients can become more adept at describing their health concerns, organizing their needs and questions, and being proactive, which can have a positive effect on the quality of the doctor-patient communication during outpatient office visits. (PsycINFO Database Record (c) 2011 APA, all rights reserved).

  2. 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

  3. Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Ritvo, Paul; Obadia, Maya; Santa Mina, Daniel; Alibhai, Shabbir; Sabiston, Catherine; Oh, Paul; Campbell, Kristin; McCready, David; Auger, Leslie; Jones, Jennifer Michelle

    2017-08-24

    Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors. This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT. We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program. We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly

  4. Randomized controlled trial of web-based alcohol screening and brief intervention in primary care.

    Science.gov (United States)

    Kypri, Kypros; Langley, John D; Saunders, John B; Cashell-Smith, Martine L; Herbison, Peter

    2008-03-10

    There is compelling evidence supporting screening and brief intervention (SBI) for hazardous drinking, yet it remains underused in primary health care. Electronic (computer or Web-based) SBI (e-SBI) offers the prospects of ease and economy of access. We sought to determine whether e-SBI reduces hazardous drinking. We conducted a randomized controlled trial in a university primary health care service. Participants were 975 students (age range, 17-29 years) screened using the Alcohol Use Disorders Identification Test (AUDIT). Of 599 students who scored in the hazardous or harmful range, 576 (300 of whom were women) consented to the trial and were randomized to receive an information pamphlet (control group), a Web-based motivational intervention (single-dose e-SBI group), or a Web-based motivational intervention with further interventions 1 and 6 months later (multidose e-SBI group). Relative to the control group, the single-dose e-SBI group at 6 months reported a lower frequency of drinking (rate ratio [RR], 0.79; 95% confidence interval [CI], 0.68-0.94), less total consumption (RR, 0.77; 95% CI, 0.63-0.95), and fewer academic problems (RR, 0.76; 95% CI, 0.64-0.91). At 12 months, statistically significant differences in total consumption (RR, 0.77; 95% CI, 0.63-0.95 [equivalent to 3.5 standard drinks per week]) and in academic problems (RR, 0.80; 95% CI, 0.66-0.97) remained, and the AUDIT scores were 2.17 (95% CI, -1.10 to -3.24) points lower. Relative to the control group, the multidose e-SBI group at 6 months reported a lower frequency of drinking (RR, 0.85; 95% CI, 0.73-0.98), less total consumption (RR, 0.79; 95% CI, 0.64-0.97 [equivalent to 3.0 standard drinks per week]), reduced episodic heavy drinking (RR, 0.65; 95% CI, 0.45-0.93), and fewer academic problems (RR, 0.78; 95% CI, 0.65-0.93). At 12 months, statistically significant differences in academic problems remained (RR, 0.75; 95% CI, 0.62-0.90), while the AUDIT scores were 2.02 (95% CI, -0.97 to -3

  5. Lay health educators translate a weight-loss intervention in senior centers: a randomized controlled trial.

    Science.gov (United States)

    West, Delia Smith; Bursac, Zoran; Cornell, Carol E; Felix, Holly C; Fausett, Jennifer K; Krukowski, Rebecca A; Lensing, Shelly; Love, Sharhonda J; Prewitt, T Elaine; Beck, Cornelia

    2011-10-01

    Older adults have high obesity rates and respond well to evidence-based weight-loss programs, such as the Diabetes Prevention Program (DPP) Lifestyle intervention. The goal of this study was to determine whether a translation of the DPP Lifestyle program delivered by lay health educators and conducted in senior centers is effective in promoting weight loss among older adults. An RCT with older adults nested within senior centers. Senior centers identified lay health educators to receive training and deliver the intervention program at the senior center. Senior centers were randomized to DPP Lifestyle program or an attention control intervention (cognitive training). Senior centers (N=15) located throughout Arkansas. Participants (N=228) were obese (BMI=34.5±4.9) older (aged 71.2±6.6 years) adults able to engage in moderate exercise. Follow-up data were collected at 4 months on 93% of the original cohort between February 2009 and July 2010. A 12-session translation of the Diabetes Prevention Program Lifestyle behavioral weight-control program delivered in group sessions by trained lay health educators. Body weight was assessed by digital scale. Percentage weight loss from baseline and proportion achieving ≥5% and ≥7% weight loss were examined. Analyses were completed in March 2011. Participants attending senior centers randomized to Lifestyle lost a significantly greater percentage of baseline weight (3.8%, 95% CI=2.9%, 4.6%) than those in the control senior centers (0.2%, 95% CI= -0.6%, -0.9%) after adjusting for baseline BMI and gender (psenior centers offering the Lifestyle program, 38% lost ≥5% of baseline weight compared with 5% in the control arm (pLifestyle senior centers lost ≥7% than did control participants (3%, p=0.001). A behavioral lifestyle weight-loss intervention delivered by a lay health educator offers a promising vehicle for translation of evidence-based obesity treatment programs in underserved areas. This study is registered at

  6. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

    Directory of Open Access Journals (Sweden)

    López-García-Franco Alberto

    2012-05-01

    Full Text Available Abstract Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain. The number of patients required is 242 (121 in each arm, all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity

  7. Randomized controlled trial of a self-management intervention in persons with spinal cord injury : design of the HABITS (Healthy Active Behavioural IntervenTion in SCI) study

    NARCIS (Netherlands)

    Kooijmans, H.; Post, M. W. M.; van der Woude, L. H. V.; de Groot, S.; Stam, H. J.; Bussmann, J. B. J.

    2013-01-01

    Purpose: To evaluate the effectiveness of a 16-week self-management intervention on physical activity level and self-management skills (self-efficacy, proactive coping and problem solving skills) in persons with chronic SCI. Method and design: Multicenter randomized controlled trial (RCT). Eighty pe

  8. Randomization to nutritional intervention at home did not improve postoperative function, fatigue or well-being

    DEFF Research Database (Denmark)

    Jensen, Martin Bach; Hessov, Ib

    1997-01-01

    BACKGROUND: Postoperative fatigue and deterioration in functional capacity have been correlated to postoperative weight loss. This suggested that nutritional support to enhance the regain of weight might improve upon the convalescence. METHODS: Patients were allocated randomly at discharge......, gain in body-weight and lean body mass, especially in the legs as shown by dual-energy X-ray absorptiometry. Changes in work capacity, hand grip and pinching strength, fatigue and quality of life were similar in patients in control and intervention groups and had returned to preoperative values 1......-2 months after operation, although fatigue was increased at 2-3 months. CONCLUSIONS: This study did not support the hypothesis that changes in weight were important for the changes in function and fatigue in patients with small to moderate weight loss....

  9. An eight month randomized controlled exercise intervention alters resting state synchrony in overweight children.

    Science.gov (United States)

    Krafft, C E; Pierce, J E; Schwarz, N F; Chi, L; Weinberger, A L; Schaeffer, D J; Rodrigue, A L; Camchong, J; Allison, J D; Yanasak, N E; Liu, T; Davis, C L; McDowell, J E

    2014-01-03

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥85th percentile) children 8-11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional magnetic resonance imaging scans. Independent components analysis identified several networks, with four chosen for between-group analysis: salience, default mode, cognitive control, and motor networks. The default mode, cognitive control, and motor networks showed more spatial refinement over time in the exercise group compared to controls. The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls. Exercise behavior may enhance brain development in children.

  10. Reducing School Mobility: A Randomized Trial of a Relationship-Building Intervention.

    Science.gov (United States)

    Fiel, Jeremy E; Haskins, Anna R; López Turley, Ruth N

    2013-12-01

    Student turnover has many negative consequences for students and schools, and the high mobility rates of disadvantaged students may exacerbate inequality. Scholars have advised schools to reduce mobility by building and improving relationships with and among families, but such efforts are rarely tested rigorously. A cluster-randomized field experiment in 52 predominantly Hispanic elementary schools in San Antonio, TX, and Phoenix, AZ, tested whether student mobility in early elementary school was reduced through Families and Schools Together (FAST), an intervention that builds social capital among families, children, and schools. FAST failed to reduce mobility overall but substantially reduced the mobility of Black students, who were especially likely to change schools. Improved relationships among families help explain this finding.

  11. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    Science.gov (United States)

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2012-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was high, and therapist fidelity was high. A 16% improvement in ASD social impairment (within-group effect size = 1.18) was observed on a parent-reported scale. Although anxiety symptoms declined by 26%, the change was not statistically significant. These findings suggest MASSI is a feasible treatment program and further evaluation is warranted. PMID:22735897

  12. Lifestyle intervention can reduce the risk of gestational diabetes: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Song, C; Li, J; Leng, J; Ma, R C; Yang, X

    2016-10-01

    This study aimed to examine the effect of lifestyle intervention on the risk of gestational diabetes mellitus (GDM). We searched PubMed, Springer and other databases to retrieve articles published in English and Chinese up to 30 September 2015. The inclusion criteria were randomized controlled trials evaluating the effects of lifestyle intervention on risk of GDM. Exclusion criteria were studies with prepregnancy diabetes mellitus or interventions with nutrient supplements. Random-effect and fixed-effect model analyses were used to obtain pooled relative risks and 95% confidence intervals (CIs) of diet and physical activity on the risk of GDM. Subgroup analyses were performed to check the consistency of effect sizes across groups where appropriate. We identified 29 randomized controlled trials with 11,487 pregnant women, addressing the effect of lifestyle intervention on the risk of GDM. In the pooled analysis, either diet or physical activity resulted in an 18% (95%CI 5-30%) reduction in the risk of GDM (P = 0.0091). Subgroup analysis showed that such intervention was effective among women with intervention before the 15th gestational week (relative risk: 0.80, 95%CI 0.66-0.97), but not among women receiving the intervention afterwards. We conclude that lifestyle modification during pregnancy, especially before the 15th gestational week, can reduce the risk of GDM. © 2016 World Obesity.

  13. Effects of 12-week exercise training on osteocalcin, high-sensitivity C-reactive protein concentrations, and insulin resistance in elderly females with osteoporosis.

    Science.gov (United States)

    Ahn, Nayoung; Kim, Kijin

    2016-08-01

    [Purpose] This study examined the effects of exercise training on bone metabolism markers, inflammatory markers, and physical fitness in patients with osteoporosis from an osteoporosis-related immunological perspective. [Subjects and Methods] Twenty-nine elderly female subjects (age, 74.2 ± 3.2 years) were classified into normal, osteopenia, and osteoporosis groups based on the T-score measured using dual-energy X-ray absorptiometry. The exercise was performed voluntarily by the patients for 1 hour per day, three times per week, for 12 weeks. [Results] The differences between bone mineral content, bone mineral density, and osteocalcin concentrations increased significantly in the osteoporosis group after 12 weeks of exercise and were significantly higher than those in the normal and osteopenia groups. However, the homeostatic model assessment of insulin resistance score decreased significantly in the osteoporosis group after 12 weeks of exercise. High-sensitivity C-reactive protein concentrations tended to decrease in all groups after 12 weeks of exercise and showed an inverse correlation with osteocalcin concentration; however, no statistical significance was observed. [Conclusion] Our findings suggest that an exercise program in patients with osteopenia and osteoporosis effectively reduces the risk of osteoporotic fracture and related diseases since it improves bone density and physical fitness and reduces inflammatory marker levels.

  14. Effects of 12-week exercise training on osteocalcin, high-sensitivity C-reactive protein concentrations, and insulin resistance in elderly females with osteoporosis

    Science.gov (United States)

    Ahn, Nayoung; Kim, Kijin

    2016-01-01

    [Purpose] This study examined the effects of exercise training on bone metabolism markers, inflammatory markers, and physical fitness in patients with osteoporosis from an osteoporosis-related immunological perspective. [Subjects and Methods] Twenty-nine elderly female subjects (age, 74.2 ± 3.2 years) were classified into normal, osteopenia, and osteoporosis groups based on the T-score measured using dual-energy X-ray absorptiometry. The exercise was performed voluntarily by the patients for 1 hour per day, three times per week, for 12 weeks. [Results] The differences between bone mineral content, bone mineral density, and osteocalcin concentrations increased significantly in the osteoporosis group after 12 weeks of exercise and were significantly higher than those in the normal and osteopenia groups. However, the homeostatic model assessment of insulin resistance score decreased significantly in the osteoporosis group after 12 weeks of exercise. High-sensitivity C-reactive protein concentrations tended to decrease in all groups after 12 weeks of exercise and showed an inverse correlation with osteocalcin concentration; however, no statistical significance was observed. [Conclusion] Our findings suggest that an exercise program in patients with osteopenia and osteoporosis effectively reduces the risk of osteoporotic fracture and related diseases since it improves bone density and physical fitness and reduces inflammatory marker levels. PMID:27630402

  15. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR in Treatment-Naive Patients with Hepatitis C Virus (HCV Genotype 1 (GT1.

    Directory of Open Access Journals (Sweden)

    Tarik Asselah

    Full Text Available Shortening duration of peginterferon-based HCV treatment reduces associated burden for patients. Primary objectives of this study were to assess the efficacy against the minimally acceptable response rate 12 weeks post-treatment (SVR12 and safety of simeprevir plus PR in treatment-naïve HCV GT1 patients treated for 12 weeks. Additional objectives included the investigation of potential associations of rapid viral response and baseline factors with SVR12.In this Phase III, open-label study in treatment-naïve HCV GT1 patients with F0-F2 fibrosis, patients with HCV-RNA 12-week regimen.Overall SVR12 rate (66% was below the target of 80%, indicating that shortening of treatment with simeprevir plus PR to 12 weeks based on very early response is not effective. However, baseline factors associated with higher SVR12 rates were identified. Therefore, while Week 2 response alone is insufficient to predict efficacy, GT1 patients with favourable baseline factors may benefit from a shortened simeprevir plus PR regimen.ClinicalTrials.gov NCT01846832.

  16. Residual F-18-FDG-PET Uptake 12 Weeks After Stereotactic Ablative Radiotherapy for Stage I Non-Small-Cell Lung Cancer Predicts Local Control

    NARCIS (Netherlands)

    Bollineni, Vikram Rao; Widder, Joachim; Pruim, Jan; Langendijk, Johannes A.; Wiegman, Erwin M.

    2012-01-01

    Purpose: To investigate the prognostic value of [F-18]fluorodeoxyglucose positron emission tomography (FDG-PET) uptake at 12 weeks after stereotactic ablative radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC). Methods and Materials: From November 2006 to February 2010, 132 medically

  17. A web-based sexual violence bystander intervention for male college students: randomized controlled trial.

    Science.gov (United States)

    Salazar, Laura F; Vivolo-Kantor, Alana; Hardin, James; Berkowitz, Alan

    2014-09-05

    Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact. This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration. A random probability sample of 743 male undergraduate students (aged 18 to 24 years) attending a large, urban university located in the southeastern United States was recruited online and randomized to either RealConsent (n=376) or a Web-based general health promotion program (n=367). Participants were surveyed online at baseline, postintervention, and 6-months postintervention. RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent, communication skills regarding sex, the role of alcohol and male socialization in sexual violence, empathy for rape victims, and bystander education. Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration. Secondary outcomes were theoretical mediators (eg, knowledge, attitudes). At 6-month follow-up RealConsent participants intervened more often (P=.04) and engaged in less sexual violence perpetration (P=.04) compared to controls. In addition, RealConsent participants reported greater legal knowledge of sexual assault (Pinappropriate behaviors (Psexual violence. Clinicaltrials.gov: NCT01903876; http://clinicaltrials.gov/show/NCT01903876 (Archived by WebCite at http://www.webcitation.org/6S1PXxWKt).

  18. A randomized controlled trial of the effect of a brief cognitive-behavioral intervention on dental fear

    DEFF Research Database (Denmark)

    Spindler, Helle; Staugaard, Søren Risløv; Nicolaisen, Camilla;

    2015-01-01

    The objective of this study was to examine the effect of a brief cognitive-behavioral intervention for patients with dental fear in a private dental clinic. Patients presenting with subjectively reported dental fear were randomly assigned to either an immediate intervention (n = 53) or a waiting...... list (n = 51) group. Both groups received an identical intervention, but delayed by 4-6 weeks in the waiting list group. Participants were asked to fill out two self-report questionnaires of dental fear at pre- and post-intervention, and again at a 2-year follow-up assessment. Analysis of variance...... showed that dental fear was significantly reduced in the immediate intervention group (d = 1.5-2.2), compared with the waiting list group (d = 0.3-0.4). Additionally, all participants showed a significant reduction of dental fear following the brief intervention, and in the subgroup available for follow...

  19. Time-Based Physical Activity Interventions for Weight Loss: A Randomized Trial

    Science.gov (United States)

    Jakicic, John M.; Rickman, Amy D.; Lang, Wei; Davis, Kelliann K.; Gibbs, Bethany Barone; Neiberg, Rebecca; Marcus, Marsha D.

    2014-01-01

    Purpose To examine whether enhancing standard behavior weight loss interventions (SBWP) with additional strategies at the initiation of the intervention (ADOPT) or providing the additional strategies at predetermined times over the intervention period (MAINTAIN) enhances 18 month weight loss. Methods This was a clinical trial with participants (n=195; age= 43.2±8.6 yrs; BMI= 33.0±3.4 kg/m2) randomized to SBWP, ADOPT, or MAINTAIN. All were prescribed an energy restricted diet and physical activity, with group intervention sessions delivered over 18 months. ADOPT received additional phone contact (months 1–3), supervised exercise (months 1–6), and behavior campaigns (months 4–9). MAINTAIN received additional phone contact (months 4–6), supervised exercise (months 7–12), and behavior campaigns (months 13–18). Results There was a significant Group X Time interaction for weight loss (p=0.0032). SBWP lost 9.3±0.9, 7.8±1.1, and 5.9±1.2 kg at 6, 12, and 18 months, respectively. ADOPT lost 8.9±0.9, 7.6±1.2, and 5.8±1.2 kg, and MAINTAIN lost 9.7±0.9, 11.0±1.2, and 9.0±1.2 kg at 6, 12, and 18 months, respectively. The Group X Time interaction for SBWP vs. MAINTAIN (p=0.0033) and ADOPT vs. MAINTAIN (p=0.0075) was significant. There was a significant Group X Time interaction for change in fitness (p=0.0060). The Group X Time interaction for MAINTAIN vs. ADOPT (p=0.0018) was significant with a trend for MAINTAIN vs. SBWP (p=0.0525). Conclusions MAINTAIN improved 18-month weight loss compared to SBWP and ADOPT, with statistical trends that MAINTAIN resulted in greater improvements in fitness. These results suggest that time-based strategies emphasizing physical activity conferred greater benefits when delivered later and over the full course of intervention. This provides valuable information for the implementation of time-based strategies to improve long-term weight loss and fitness in overweight and obese adults. PMID:25160843

  20. Results of a large-scale randomized behavior change intervention on road safety in Kenya.

    Science.gov (United States)

    Habyarimana, James; Jack, William

    2015-08-25

    Road accidents kill 1.3 million people each year, most in the developing world. We test the efficacy of evocative messages, delivered on stickers placed inside Kenyan matatus, or minibuses, in reducing road accidents. We randomize the intervention, which nudges passengers to complain to their drivers directly, across 12,000 vehicles and find that on average it reduces insurance claims rates of matatus by between one-quarter and one-third and is associated with 140 fewer road accidents per year than predicted. Messages promoting collective action are especially effective, and evocative images are an important motivator. Average maximum speeds and average moving speeds are 1-2 km/h lower in vehicles assigned to treatment. We cannot reject the null hypothesis of no placebo effect. We were unable to discern any impact of a complementary radio campaign on insurance claims. Finally, the sticker intervention is inexpensive: we estimate the cost-effectiveness of the most impactful stickers to be between $10 and $45 per disability-adjusted life-year saved.

  1. The Efficacy and Safety of Add-on Ginko TD (Ginkgo Biloba Treatment for PTSD: Results of a 12-Week Double-Blind Placebo-Controlled Study

    Directory of Open Access Journals (Sweden)

    Laleh Koohi Habibi

    2007-06-01

    Full Text Available "nObjective: Exposure to traumatic stressors lead to activation of arousal responses mediated by serotonergic and noradrenergic systems and it may cause a change in numerous neurotransmitters and neuroendocrine systems. There is ample experimental and clinical evidence to suggest that Ginkgo biloba extract is neuroprotective and has antioxidant properties and can restore stress-induced elevation in brain levels of catecholamines, 5-HT and plasma corticosterone to normal level. "nMethod: In a 12-week, double-blind, placebo-controlled study, the efficacy and safety of adding-on a fixed-dose (200mg of Ginkgo TD to the previous treatment regime of adults with PTSD were examined. Subjects were forty male and female outpatients from a public-owned psychiatric clinic who met criteria for PTSD seven month after a 6.3 Richter earthquake in Bam city on December 26, 2003. The changes in five symptom domains including posttraumatic stress, anxiety and affective symptoms, general health and subjective stress after trauma were ssessed at weeks 0, 12 and 16 to examine effectiveness of the added-on Ginkgo TD and stability of its effects. "nResults: Ginkgo TD was associated with a significantly greater improvement than placebo in PTSD patients as measured by five symptom domain scales including: GHQ-28; Watson PTSD Scale; HAM-D; HAM-A and IES (p= 0.02, 0.01, 0.001, 0.01, 0.02 respectively Four weeks after the discontinuation of intervention, no significant difference was determined between the two groups in the five outcome measures (p= 0.005, 0.01, 0.004, 0.005, 0.01 respectively. No significant difference was observed between the two groups in terms of side effects. "nConclusions: We found Ginkgo TD to be superior to placebo as an adding-on in the treatment of PTSD. Although we did not examine the comparative efficacy of Ginkgo TD on the three main elements of PTSD, beneficial effects both on specific PTSD symptomatology and general conditions including

  2. Effect of a diet intervention during pregnancy on dietary behavior in the randomized controlled Norwegian Fit for Delivery study.

    Science.gov (United States)

    Hillesund, E R; Bere, E; Sagedal, L R; Vistad, I; Øverby, N C

    2016-10-01

    A mother's diet during pregnancy has the potential to influence both her own and her child's short- and long-term health. This paper reports the effects of a randomized controlled diet intervention during pregnancy on dietary behavior post-intervention as reported in late pregnancy. The diet intervention was part of a lifestyle intervention targeting both diet and physical activity behaviors among nulliparous women participating in the randomized controlled Norwegian Fit for Delivery study (NFFD). Eligible women were enrolled in early pregnancy from eight healthcare clinics in southern Norway between 2009 and 2013. The diet intervention was based on 10 dietary recommendations that were conveyed during two counseling sessions by phone and in a pamphlet describing the recommendations and their simplified rationale. A diet score was constructed from a 43-item food frequency questionnaire (FFQ) and used to assess intervention effect on dietary behavior (score range 0-10). Between-group dietary differences post-intervention were estimated with analysis of covariance, with adjustment for baseline diet. A total of 508 women completed the FFQ both at baseline and post-intervention. There were no between-group differences in diet score and subscales at baseline. Post-intervention, the intervention group had higher overall diet score (control: 4.61, intervention: 5.04, P=0.013) and favorable dietary behavior in seven of the 10 dietary domains: 'consumption of water relative to total beverage consumption' (P=0.002), 'having vegetables with dinner' (P=0.027), 'choosing fruits and vegetables for between-meal snacks' (P=0.023), 'buying small portion sizes of unhealthy foods' (P=0.010), 'limiting sugar intake' (P=0.005), 'avoiding eating beyond satiety' (P=0.009) and 'reading food labels' (P=0.011). The NFFD diet intervention improved dietary behavior. Potential long-term clinical influence in mother and child will be investigated in further studies.

  3. Increased protected sex and abstinence among Namibian youth following a HIV risk-reduction intervention: a randomized, longitudinal study.

    Science.gov (United States)

    Stanton, B F; Li, X; Kahihuata, J; Fitzgerald, A M; Neumbo, S; Kanduuombe, G; Ricardo, I B; Galbraith, J S; Terreri, N; Guevara, I; Shipena, H; Strijdom, J; Clemens, R; Zimba, R F

    1998-12-24

    To evaluate an HIV risk-reduction intervention among Namibian adolescents. A randomized trial of a 14-session face-to-face intervention emphasizing abstinence and safer sexual practices conducted among 515 youths (median age 17 years and median grade 11) attending 10 secondary schools located in two districts in Namibia. Youths were randomly assigned to the intervention or control condition at the level of the individual. HIV risk behaviours, intentions and perceptions were assessed at baseline, immediately post-intervention and at 6 and 12 months post-intervention. Among all 515 youths who enrolled in the programme, rates of either abstinence or sex with a condom were not different between control and intervention youths at baseline or in the follow-up period. However, analyses conducted among the subset of youths who were sexually inexperienced at baseline (n = 255) revealed that a higher percentage of intervention youths (17%) than control youths (9%, P<0.05) remained sexually inexperienced one year later. Moreover, in the immediate post-intervention period, among baseline virgins who subsequently initiated sex, intervention youths were more likely than control youths to use a condom (18 versus 10%, P<0.05). Additional HIV-related risk behaviours (failure to discuss previous HIV risk exposure with one's sexual partner and alcohol use), intentions to use condoms, and perceptions of the ability to use condoms were positively affected by the intervention. There is evidence that the 'My Future is My Choice' (MFMC) intervention is reducing HIV risk behaviours among sexually inexperienced participants aged 15-18. Related risk behaviours and perceptions are also positively impacted by the intervention.

  4. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Pierre-Marie Roy

    Full Text Available Misuse of thromboprophylaxis may increase preventable complications for hospitalized medical patients.To assess the net clinical benefit of a multifaceted intervention in emergency wards (educational lectures, posters, pocket cards, computerized clinical decision support systems and, where feasible, electronic reminders for the prevention of venous thromboembolism.Prospective cluster-randomized trial in 27 hospitals. After a pre-intervention period, centers were randomized as either intervention (n = 13 or control (n = 14. All patients over 40 years old, admitted to the emergency room, and hospitalized in a medical ward were included, totaling 1,402 (712 intervention and 690 control and 15,351 (8,359 intervention and 6,992 control in the pre-intervention and intervention periods, respectively.Symptomatic venous thromboembolism or major bleeding (primary outcome occurred at 3 months in 3.1% and 3.2% of patients in the intervention and control groups, respectively (adjusted odds ratio: 1.02 [95% confidence interval: 0.78-1.34]. The rates of thromboembolism (1.9% vs. 1.9%, major bleedings (1.2% vs. 1.3%, and mortality (11.3% vs. 11.1% did not differ between the groups. Between the pre-intervention and intervention periods, the proportion of patients who received prophylactic anticoagulant treatment more steeply increased in the intervention group (from 35.0% to 48.2%: +13.2% than the control (40.7% to 44.1%: +3.4%, while the rate of adequate thromboprophylaxis remained stable in both groups (52.4% to 50.9%: -1.5%; 49.1% to 48.8%: -0.3%.Our intervention neither improved adequate prophylaxis nor reduced the rates of clinical events. New strategies are required to improve thromboembolism prevention for hospitalized medical patients.ClinicalTrials.gov NCT01212393.

  5. Facemasks, hand hygiene, and influenza among young adults: a randomized intervention trial.

    Directory of Open Access Journals (Sweden)

    Allison E Aiello

    Full Text Available Limited vaccine availability and the potential for resistance to antiviral medications have led to calls for establishing the efficacy of non-pharmaceutical measures for mitigating pandemic influenza. Our objective was to examine if the use of face masks and hand hygiene reduced rates of influenza-like illness (ILI and laboratory-confirmed influenza in the natural setting. A cluster-randomized intervention trial was designed involving 1,178 young adults living in 37 residence houses in 5 university residence halls during the 2007-2008 influenza season. Participants were assigned to face mask and hand hygiene, face mask only, or control group during the study. Discrete-time survival models using generalized estimating equations to estimate intervention effects on ILI and confirmed influenza A/B infection over a 6-week study period were examined. A significant reduction in the rate of ILI was observed in weeks 3 through 6 of the study, with a maximum reduction of 75% during the final study week (rate ratio [RR] = 0.25, [95% CI, 0.07 to 0.87]. Both intervention groups compared to the control showed cumulative reductions in rates of influenza over the study period, although results did not reach statistical significance. Generalizability limited to similar settings and age groups. Face masks and hand hygiene combined may reduce the rate of ILI and confirmed influenza in community settings. These non-pharmaceutical measures should be recommended in crowded settings at the start of an influenza pandemic.[corrected] Clinicaltrials.gov NCT00490633.

  6. Web-based Weight Loss in Primary Care: A Randomized Controlled Trial

    OpenAIRE

    Bennett, Gary G.; Herring, Sharon J.; Puleo, Elaine; Stein, Evelyn K.; Emmons, Karen M; Gillman, Matthew W.

    2009-01-01

    Evidence is lacking regarding effective and sustainable weight loss approaches for use in the primary care setting. We conducted a 12-week randomized controlled trial to evaluate the short-term efficacy of a web-based weight loss intervention among 101 primary care patients with obesity and hypertension. Patients had access to a comprehensive website that used a moderate-intensity weight loss approach designed specifically for web-based implementation. Patients also participated in four (two ...

  7. The Effects of 12 Weeks Regular Aerobic Exercise on Brain-derived Neurotrophic Factor and Inflammatory Factors in Juvenile Obesity and Type 2 Diabetes Mellitus

    Science.gov (United States)

    Lee, Sung Soo; Yoo, Jae Ho; Kang, Sung; Woo, Jin Hee; Shin, Ki Ok; Kim, Kwi Beak; Cho, Su Youn; Roh, Hee Tae; Kim, Young Il

    2014-01-01

    [Purpose] The purpose of this study was to investigate the effects of 12 weeks regular aerobic exercise on brain-derived neurotrophic factor (BDNF) and inflammatory factors in juvenile obesity and type 2 diabetes mellitus (T2DM). Obesity and T2DM, typically common among adults, have recently become more prevalent in the Korean juvenile population, affecting not only their lipid profiles and oxidant stress levels, but also their BDNF and inflammatory factor levels. [Subjects] This study enrolled 26 juveniles (boys = 15, girls = 9) who were assigned to a control group (CG, n = 11), obesity group (OG, n = 8), or T2DM group (TG, n = 7). [Methods] The outcome of a 40–60-minute aerobic exercise session that took place three times per week for 12 weeks at a maximum oxygen intake (VO2max) of 50~60% was investigated. [Results] The exercise resulted in a significant reduction in the resting serum BDNF and TrkB levels (baseline) among juveniles in the OG and TG as compared to those in the CG. Additionally, the 12 weeks of regular aerobic exercise led to significant reductions in body weight, body fat percentage, and body mass index in the OG and a significant increase of VO2max in the OG and TG. However, no significant differences in serum NGF or inflammatory factors were found among the three groups. There was a significant increase in resting serum BDNF levels following the 12 weeks regular exercise only in the OG. [Conclusion] While 12 weeks of regular aerobic exercise had a positive effect on body composition, and increased BDNF levels of juveniles in the OG, it did not affect the inflammatory factor levels and had no effect on the TG. PMID:25202180

  8. The Effects of 12 Weeks Regular Aerobic Exercise on Brain-derived Neurotrophic Factor and Inflammatory Factors in Juvenile Obesity and Type 2 Diabetes Mellitus.

    Science.gov (United States)

    Lee, Sung Soo; Yoo, Jae Ho; Kang, Sung; Woo, Jin Hee; Shin, Ki Ok; Kim, Kwi Beak; Cho, Su Youn; Roh, Hee Tae; Kim, Young Il

    2014-08-01

    [Purpose] The purpose of this study was to investigate the effects of 12 weeks regular aerobic exercise on brain-derived neurotrophic factor (BDNF) and inflammatory factors in juvenile obesity and type 2 diabetes mellitus (T2DM). Obesity and T2DM, typically common among adults, have recently become more prevalent in the Korean juvenile population, affecting not only their lipid profiles and oxidant stress levels, but also their BDNF and inflammatory factor levels. [Subjects] This study enrolled 26 juveniles (boys = 15, girls = 9) who were assigned to a control group (CG, n = 11), obesity group (OG, n = 8), or T2DM group (TG, n = 7). [Methods] The outcome of a 40-60-minute aerobic exercise session that took place three times per week for 12 weeks at a maximum oxygen intake (VO2max) of 50~60% was investigated. [Results] The exercise resulted in a significant reduction in the resting serum BDNF and TrkB levels (baseline) among juveniles in the OG and TG as compared to those in the CG. Additionally, the 12 weeks of regular aerobic exercise led to significant reductions in body weight, body fat percentage, and body mass index in the OG and a significant increase of VO2max in the OG and TG. However, no significant differences in serum NGF or inflammatory factors were found among the three groups. There was a significant increase in resting serum BDNF levels following the 12 weeks regular exercise only in the OG. [Conclusion] While 12 weeks of regular aerobic exercise had a positive effect on body composition, and increased BDNF levels of juveniles in the OG, it did not affect the inflammatory factor levels and had no effect on the TG.

  9. Efeito de 12 semanas de treinamento com pesos sobre a força muscular, composição corporal e triglicérides em homens sedentários 12-week resistance training effect on muscular strength, body composition and triglycerides in sedentary men

    Directory of Open Access Journals (Sweden)

    Marcos Doederlein Polito

    2010-02-01

    Full Text Available O objetivo do presente estudo foi verificar o efeito de 12 semanas de treinamento com pesos (TP sobre a força muscular, composição corporal e triglicérides em homens sedentários. Para tanto, 14 homens saudáveis e sedentários foram separados aleatoriamente, de forma balanceada, em grupo experimental (GE = 29 ± 1 anos; 180,0 ± 3,0cm; 80,5 ± 1,8kg e grupo controle (GC = 27 ± 1 anos; 170,0 ± 2,0cm; 76,2 ± 0,9kg. O GE foi submetido a um protocolo de TP durante 12 semanas, com frequência de três vezes por semana. O programa de TP foi composto por 10 exercícios executados em duas séries de 10-20 repetições. Medidas de massa corporal, estatura, espessura de dobras cutâneas e triglicérides foram realizadas antes e após o período de intervenção. Adicionalmente, o teste de uma repetição máxima (1RM foi aplicado nos exercícios supino em banco horizontal e mesa extensora, nos período pré, após seis e 12 semanas de acompanhamento. Foram encontradas diferenças significativas (P The purpose of this study was to investigate the effect of 12 weeks of resistance training on muscle strength, body composition and triglycerides in sedentary men. Fourteen healthy men were randomly divided into experimental (EG = 29 ± 1 yrs; 180.0 ± 3.0 cm; 80.5 ± 1.8 kg and control (CG = 27 ± 1 yrs; 170.0 ± 2.0 cm; 76.2 ± 0.9 kg groups. The EG subjects participated in a resistance training protocol during 12 weeks, three times per week. The program of resistance training included 10 exercises performed in two sets of 10-20 repetitions. Body mass, height, skinfold thickness and triglycerides were measured before and after the 12 weeks of intervention. One maximal repetition test (1RM was done to measure muscle strength. Significant differences (P<0.05 were observed on the sum of skinfolds only in EG after the resistance training, while body mass and triglycerides did not change in neither groups. Muscle strength increased (P<0.05 in both exercises

  10. A prospective randomized study of the efficacy of "Turning Point," an inpatient violence intervention program.

    Science.gov (United States)

    Loveland-Jones, Catherine; Ferrer, Lucas; Charles, Scott; Ramsey, Frederick; van Zandt, Andrea; Volgraf, Jill; Santora, Thomas; Pathak, Abhijit; Dujon, Jay; Sjoholm, Lars; Rappold, Joseph; Goldberg, Amy

    2016-11-01

    From 2002 to 2011, there were more than 17,000 shootings in Philadelphia. "Turning Point," Temple University Hospital's inpatient violence intervention program, takes advantage of the teachable moment that occurs after violent injury. In addition to receiving traditional social work services, Turning Point patients watch their trauma bay resuscitation video and a movie about violence, meet with a gunshot wound survivor and an outpatient case manager, and also undergo psychiatric assessment. The purpose of this study was to determine the efficacy of Turning Point in changing attitudes toward guns and violence among victims of penetrating trauma. This prospective randomized study was conducted from January 2012 to January 2014. Patients who sustained a gunshot or stab wound were randomized to standard of care, which involved traditional social work services only, or Turning Point. The Attitudes Toward Guns and Violence Questionnaire was administered to assess attitude change. Analysis was perfo