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Sample records for intervention trial brain-hit

  1. Frailty Intervention Trial (FIT

    Directory of Open Access Journals (Sweden)

    Lockwood Keri

    2008-10-01

    Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a

  2. Nutrition Intervention Trials in Linxian, China

    Science.gov (United States)

    Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population

  3. 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…

  4. Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial (SPRINT)

    Science.gov (United States)

    Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

    2016-01-01

    Background The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter, randomized clinical trial of 9,361 participants with hypertension who are ≥ 50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal recruitment strategies and lessons learned during recruitment of the SPRINT cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥ 75 years, women, and minorities. Methods In collaboration with the National Institutes of Health Project Office and SPRINT Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began November 8, 2010 and ended March 15, 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Results Recruitment was scheduled to last 24 months to enroll a target of 9,250 participants; in just over 28 months, the trial enrolled 9,361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by SPRINT staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized /number screened) was 64% (9,361 randomized /14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those age ≥ 75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional clinics were included and inclusion criteria were broadened, keeping event rates

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

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    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

  6. Choosing a control intervention for a randomised clinical trial

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    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  7. Feasibility trial of a Spanish-language multimedia educational intervention.

    Science.gov (United States)

    Wells, Kristen J; McIntyre, Jessica; Gonzalez, Luis E; Lee, Ji-Hyun; Fisher, Kate J; Jacobsen, Paul B; Meade, Cathy; Muñoz-Antonia, Teresita; Quinn, Gwendolyn P

    2013-10-01

    Hispanic cancer patients are underrepresented in clinical trials; research suggests lack of knowledge and language barriers contribute to low accrual. Multimedia materials offer advantages to Hispanic populations because they have high acceptability, are easy to disseminate, and can be viewed with family. Hispanic cancer patients and caregivers participated in focus groups to aid in developing a Spanish-language multimedia intervention to educate Hispanic cancer patients about clinical trials. We explored the feasibility of delivering the intervention in medical oncology clinics. A total of 35 patients were randomized to either the multimedia intervention group (n = 18) or a control group (n = 17) who were asked to read the National Cancer Institute's Spanish-language clinical trials brochure. Self-reported data on knowledge about and attitudes toward clinical trials, self-efficacy for participating in a clinical trial, intention to participate in a clinical trial if asked, and receptivity to information about a clinical trial were collected at baseline and 10 days later. Delivery of the multimedia presentation in oncology clinics was feasible. The intervention group had more knowledge about clinical trials at follow-up than the control group; scores for intention to participate in a clinical trial by participants in the intervention group increased from 3.8 to 4.0 of a possible 5, but declined in the control group from 4.5 to 4.1. No statistically significant difference was detected between groups in scores for attitudes or self-efficacy for making a decision to participate in a clinical trial. Our sample size was inadequate to identify differences between the informational methods. Although all patients were asked about their willingness to participate in a clinical trial, this decision was hypothetical. In addition, the study was conducted with a sample of Spanish-speaking Hispanic cancer patients at a comprehensive cancer center in Florida. Thus, the results

  8. European Nicotinamide Diabetes Intervention Trial (ENDIT)

    DEFF Research Database (Denmark)

    Gale, E A M; Bingley, P J; Emmett, C L

    2004-01-01

    to assess whether high dose nicotinamide prevents or delays clinical onset of diabetes in people with a first-degree family history of type 1 diabetes. METHOD: We did a randomised double-blind placebo-controlled trial of nicotinamide in 552 relatives with confirmed islet cell antibody (ICA) levels of 20...... Juvenile Diabetes Federation (JDF) units or more, and a non-diabetic oral glucose tolerance test. Participants were recruited from 18 European countries, Canada, and the USA, and were randomly allocated oral modified release nicotinamide (1.2 g/m2) or placebo for 5 years. Random allocation was done...

  9. European Nicotinamide Diabetes Intervention Trial (ENDIT)

    DEFF Research Database (Denmark)

    Gale, E A M; Bingley, P J; Emmett, C L

    2004-01-01

    Juvenile Diabetes Federation (JDF) units or more, and a non-diabetic oral glucose tolerance test. Participants were recruited from 18 European countries, Canada, and the USA, and were randomly allocated oral modified release nicotinamide (1.2 g/m2) or placebo for 5 years. Random allocation was done......, and number of islet autoantibodies detected was 1.01 (0.73-1.38; p=0.97). Of 168 (30.4%) participants who withdrew from the trial, 83 were on placebo. The number of serious adverse events did not differ between treatment groups. Nicotinamide treatment did not affect growth in children or first-phase insulin...

  10. Simulations for designing and interpreting intervention trials in infectious diseases.

    Science.gov (United States)

    Halloran, M Elizabeth; Auranen, Kari; Baird, Sarah; Basta, Nicole E; Bellan, Steven E; Brookmeyer, Ron; Cooper, Ben S; DeGruttola, Victor; Hughes, James P; Lessler, Justin; Lofgren, Eric T; Longini, Ira M; Onnela, Jukka-Pekka; Özler, Berk; Seage, George R; Smith, Thomas A; Vespignani, Alessandro; Vynnycky, Emilia; Lipsitch, Marc

    2017-12-29

    Interventions in infectious diseases can have both direct effects on individuals who receive the intervention as well as indirect effects in the population. In addition, intervention combinations can have complex interactions at the population level, which are often difficult to adequately assess with standard study designs and analytical methods. Herein, we urge the adoption of a new paradigm for the design and interpretation of intervention trials in infectious diseases, particularly with regard to emerging infectious diseases, one that more accurately reflects the dynamics of the transmission process. In an increasingly complex world, simulations can explicitly represent transmission dynamics, which are critical for proper trial design and interpretation. Certain ethical aspects of a trial can also be quantified using simulations. Further, after a trial has been conducted, simulations can be used to explore the possible explanations for the observed effects. Much is to be gained through a multidisciplinary approach that builds collaborations among experts in infectious disease dynamics, epidemiology, statistical science, economics, simulation methods, and the conduct of clinical trials.

  11. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.

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    Cihoric, Nikola; Tsikkinis, Alexandros; Minniti, Giuseppe; Lagerwaard, Frank J; Herrlinger, Ulrich; Mathier, Etienne; Soldatovic, Ivan; Jeremic, Branislav; Ghadjar, Pirus; Elicin, Olgun; Lössl, Kristina; Aebersold, Daniel M; Belka, Claus; Herrmann, Evelyn; Niyazi, Maximilian

    2017-01-03

    The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.

  12. Prevention and intervention trials for colorectal cancer.

    Science.gov (United States)

    Komiya, Masami; Fujii, Gen; Takahashi, Mami; Iigo, Masaaki; Mutoh, Michihiro

    2013-07-01

    There have been a number of candidates for chemopreventive agents from synthetic drugs and natural compounds suggested to prevent colorectal cancer. However, they have shown modest efficacy in humans. The reason for this could be partly explained by the use of inappropriate models in vitro and in vivo, and the limitation of chemoprevention trials. In Japan, there are no cancer chemopreventive medicines, and few cancer chemoprevention trials to date. In contrast, an increase in the prevalence of colorectal cancer in Japan has forced us to develop more efficient chemopreventive strategies. It is now a good time to review in detail the current status and future prospects for chemoprevention of colorectal cancer with respect to the future development of chemopreventive medicines, particularly using synthetic drugs and natural compounds in Asian populations. The role and mode of action of available synthetic drugs, mainly aspirin and metformin, are reviewed. In addition, the possible impact of natural compounds with anti-inflammatory/immunosuppressive properties, such as ω3 polyunsaturated fatty acid and lactoferrin, are also reviewed.

  13. Nutritional intervention trials for preventing and treating pressure ulcer.

    OpenAIRE

    Bourdel-Marchasson, Isabelle; Rondeau, Virginie

    2001-01-01

    The purpose of this study was to assess the effect of nutritional supplementation on dietary intake and on pressure ulcer development in critically ill older patients. The multi-center trial involved 19 wards stratified according to specialty and recruitment for critically ill older patients; 9 wards were randomly selected for nutritional intervention (nutritional intervention group), consisting of the daily distribution of two oral supplements, with each supplement containg 200 kcal, for 15 ...

  14. Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.

    Science.gov (United States)

    Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

    2015-12-01

    The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools

  15. Core journals that publish clinical trials of physical therapy interventions.

    Science.gov (United States)

    Costa, Leonardo Oliveira Pena; Moseley, Anne M; Sherrington, Catherine; Maher, Christopher G; Herbert, Robert D; Elkins, Mark R

    2010-11-01

    The objective of this study was to identify core journals in physical therapy by identifying those that publish the most randomized controlled trials of physical therapy interventions, provide the highest-quality reports of randomized controlled trials, and have the highest journal impact factors. This study was an audit of a bibliographic database. All trials indexed in the Physiotherapy Evidence Database (PEDro) were analyzed. Journals that had published at least 80 trials were selected. The journals were ranked in 4 ways: number of trials published; mean total PEDro score of the trials published in the journal, regardless of publication year; mean total PEDro score of the trials published in the journal from 2000 to 2009; and 2008 journal impact factor. The top 5 core journals in physical therapy, ranked by the total number of trials published, were Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Spine, British Medical Journal (BMJ), and Chest. When the mean total PEDro score was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, Journal of the American Medical Association (JAMA), Stroke, Spine, and Clinical Rehabilitation. When the mean total PEDro score of the trials published from 2000 to 2009 was used as the ranking criterion, the top 5 journals were Journal of Physiotherapy, JAMA, Lancet, BMJ, and Pain. The most highly ranked physical therapy-specific journals were Physical Therapy (ranked eighth on the basis of the number of trials published) and Journal of Physiotherapy (ranked first on the basis of the quality of trials). Finally, when the 2008 impact factor was used for ranking, the top 5 journals were JAMA, Lancet, BMJ, American Journal of Respiratory and Critical Care Medicine, and Thorax. There were no significant relationships among the rankings on the basis of trial quality, number of trials, or journal impact factor. Physical therapists who are trying to keep up-to-date by reading the best

  16. A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis – trial intervention including physician and treatment characteristics

    OpenAIRE

    Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno

    2014-01-01

    Background In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial’s participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers a...

  17. Motives for (not) participating in a lifestyle intervention trial

    DEFF Research Database (Denmark)

    Lakerveld, J.; IJzelenberg, W.; van Tulder, M.

    2008-01-01

    were used to assess socio-demographic, health-related and lifestyle behavioral variables. Univariate and multivariate logistic regression was used to describe the relationship between explanatory variables and study participation. Furthermore, motives and barriers that underlie study participation were....... The participants consent in order to alter their lifestyle, and/or because they want to improve their health. To minimize non-participation, it is recommended that access to a lifestyle intervention program should be easy and cause no financial restraints. Trial registration. ISRCTN69776211. © 2008 Lakerveld et al......Background. Non-participants can have a considerable influence on the external validity of a study. Therefore, we assessed the socio-demographic, health-related, and lifestyle behavioral differences between participants and non-participants in a comprehensive CVD lifestyle intervention trial...

  18. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of surgical interventions for osteoarthritis.

    Science.gov (United States)

    Katz, J N; Losina, E; Lohmander, L S

    2015-05-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For each challenge raised in the paper, we propose potential solutions. Enrollment poses challenges in maintaining investigator equipoise, managing conflict of interest and anticipating that patient preferences for specific treatments may reduce enrollment. Intervention design and implementation pose challenges relating to obsolescence, fidelity of intervention delivery, and adherence and crossover. Assessment and analysis raise questions regarding blinding and clustering of observations. This paper describes methodological problems in the design and conduct of surgical randomized trials and proposes strategies for addressing these challenges. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  19. Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

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    Huisjes Anjoke JM

    2007-07-01

    Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN

  20. Adaptive Intervention Design in Mobile Health: Intervention Design and Development in the Cell Phone Intervention for You (CITY) Trial

    Science.gov (United States)

    Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

    2015-01-01

    Background/Aims The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this manuscript is to describe the design and development of the intervention tested in the Cell Phone Intervention for You (CITY) study and to highlight the importance of adaptive intervention design (AID) that made it possible. The CITY study was an NHLBI-sponsored, controlled 24-month randomized clinical trial (RCT) comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (BMI ≥ 25 kg/m2) young adults. Methods Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, AID, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The AID strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. AID was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. Results The cellphone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive – providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools for self-tracking and receiving tailored feedback. The intervention changed over two years to

  1. 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 (SpO 2 ), 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.

  2. Screen Time Weight-loss Intervention Targeting Children at Home (SWITCH: process evaluation of a randomised controlled trial intervention

    Directory of Open Access Journals (Sweden)

    Louise Foley

    2016-05-01

    Full Text Available Abstract Background The Screen Time Weight-loss Intervention Targeting Children at Home (SWITCH trial tested a family intervention to reduce screen-based sedentary behaviour in overweight children. The trial found no significant effect of the intervention on children’s screen-based sedentary behaviour. To explore these null findings, we conducted a pre-planned process evaluation, focussing on intervention delivery and uptake. Methods SWITCH was a randomised controlled trial of a 6-month family intervention to reduce screen time in overweight children aged 9–12 years (n = 251. Community workers met with each child’s primary caregiver to deliver the intervention content. Community workers underwent standard training and were monitored once by a member of the research team to assess intervention delivery. The primary caregiver implemented the intervention with their child, and self-reported intervention use at 3 and 6 months. An exploratory analysis determined whether child outcomes at 6 months varied by primary caregiver use of the intervention. Results Monitoring indicated that community workers delivered all core intervention components to primary caregivers. However, two thirds of primary caregivers reported using any intervention component “sometimes” or less frequently at both time points, suggesting that intervention uptake was poor. Additionally, analyses indicated no effect of primary caregiver intervention use on child outcomes at 6 months, suggesting the intervention itself lacked efficacy. Conclusions Poor uptake, and the efficacy of the intervention itself, may have played a role in the null findings of the SWITCH trial on health behaviour and body composition. Trial registration The trial was registered in the Australian and New Zealand Clinical Trials Registry (no. ACTRN12611000164998 ; registration date: 10/02/2011.

  3. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  4. A pragmatic cluster randomised trial evaluating three implementation interventions

    Science.gov (United States)

    2012-01-01

    Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first national randomised

  5. An efficacy trial of brief lifestyle intervention delivered by generalist community nurses (CN SNAP trial

    Directory of Open Access Journals (Sweden)

    Fanaian Mahnaz

    2010-02-01

    Full Text Available Abstract Background Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP are the main behavioural risk factors for chronic disease. Primary health care (PHC has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors. Methods/Design The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1 telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2 nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3 semi-structured interviews/focus with nurses, managers and clients

  6. A psychosocial intervention for the management of functional dysphonia: complex intervention development and pilot randomised trial.

    Science.gov (United States)

    Deary, Vincent; McColl, Elaine; Carding, Paul; Miller, Tracy; Wilson, Janet

    2018-01-01

    Medically unexplained loss or alteration of voice-functional dysphonia-is the commonest presentation to speech and language therapists (SLTs). Besides the impact on personal and work life, functional dysphonia is also associated with increased levels of anxiety and depression and poor general health. Voice therapy delivered by SLTs improves voice but not these associated symptoms. The aims of this research were the systematic development of a complex intervention to improve the treatment of functional dysphonia, and the trialling of this intervention for feasibility and acceptability to SLTs and patients in a randomised pilot study. A theoretical model of medically unexplained symptoms (MUS) was elaborated through literature review and synthesis. This was initially applied as an assessment format in a series of patient interviews. Data from this stage and a small consecutive cohort study were used to design and refine a brief cognitive behavioural therapy (CBT) training intervention for a SLT. This was then implemented in an external pilot patient randomised trial where one SLT delivered standard voice therapy or voice therapy plus CBT to 74 patients. The primary outcomes were of the acceptability of the intervention to patients and the SLT, and the feasibility of changing the SLT's clinical practice through a brief training. This was measured through monitoring treatment flow and through structured analysis of the content of intervention for treatment fidelity and inter-treatment contamination. As measured by treatment flow, the intervention was as acceptable as standard voice therapy to patients. Analysis of treatment content showed that the SLT was able to conduct a complex CBT formulation and deliver novel treatment strategies for fatigue, sleep, anxiety and depression in the majority of patients. On pre-post measures of voice and quality of life, patients in both treatment arms improved. These interventions were acceptable to patients. Emotional

  7. What predicts postpartum pertussis booster vaccination? A controlled intervention trial.

    Science.gov (United States)

    Hayles, Elizabeth Helen; Cooper, Spring Chenoa; Wood, Nicholas; Sinn, John; Skinner, S Rachel

    2015-01-01

    'Cocooning' aims to protect susceptible infants from pertussis via caregiver vaccination. Control trials evaluating educational interventions to promote cocooning are lacking. We evaluated the role of message-framing vs. standard health information in promoting pertussis vaccination. We recruited postpartum women from a maternity hospital in Sydney, Australia (November 2010-July 2012). Participants self-completed a pertussis knowledge and attitudes questionnaire. We then assigned pertussis-susceptible (no pertussis vaccine ≤10 years) participants to receive a gain-framed, loss-framed pamphlet or control (Government Pertussis factsheet) using weekly sequential block allocation. Next, participants were offered a pertussis vaccine (dTpa) and completed a post-questionnaire on discharge. A baseline questionnaire was completed for 96.4% (1433/1486) of postpartum women approached. Missing data was excluded (n=29). Next, participants (1404) were screened for vaccine status: 324 (23%) reported prior pertussis booster vaccine receipt, leaving 1080 participants requiring vaccination. Among susceptible mothers, 70% (754/1080) were vaccinated post-intervention. Rates were similar between 'gain', 'loss' or 'control' pamphlets (69.1% vs. 71.8% vs. 68.8%; p=0.62). Intention to be vaccinated (OR 2.46, pvaccine benefits (OR: 1.61, pvaccine recommendation (OR 1.68; p=0.025; 95% CI: 1.07-2.65) were independent predictors of vaccine uptake. At discharge, overall pertussis vaccine coverage had increased from 23% to 77% among women screened (1078/1404). A cocooning strategy for pertussis vaccination can be highly effective when partially implemented within maternity hospitals, with information accompanied by a funded vaccine. Mothers were highly receptive to vaccination in the postnatal ward: facts about pertussis were as effective as message-framing in promoting a high uptake of 70%. Perceived vaccine benefits, intentions and vaccine recommendation were important predictors of uptake

  8. 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

  9. An efficacy trial of brief lifestyle intervention delivered by generalist community nurses (CN SNAP trial).

    Science.gov (United States)

    Laws, Rachel A; Chan, Bibiana C; Williams, Anna M; Davies, Gawaine Powell; Jayasinghe, Upali W; Fanaian, Mahnaz; Harris, Mark F

    2010-02-23

    Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP) are the main behavioural risk factors for chronic disease. Primary health care (PHC) has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors. The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison) group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1) telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2) nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3) semi-structured interviews/focus with nurses, managers and clients in 'early intervention' sites to explore the

  10. Women, Hypertension, and the Systolic Blood Pressure Intervention Trial.

    Science.gov (United States)

    Wenger, Nanette K; Ferdinand, Keith C; Bairey Merz, C Noel; Walsh, Mary Norine; Gulati, Martha; Pepine, Carl J

    2016-10-01

    Hypertension accounts for approximately 1 in 5 deaths in American women and is the major contributor to many comorbid conditions. Although blood pressure lowering reduces cardiovascular disease outcomes, considerable uncertainty remains on best management in women. Specifically, female blood pressure treatment goals have not been established, particularly among older and African American and Hispanic women, for whom hypertension prevalence, related adverse outcomes, and poor control rates are high. The Systolic Blood Pressure Intervention Trial (SPRINT) planned to clarify optimal blood pressure management in both sexes. Although confirming that a lower blood pressure goal is generally better, because female enrollment and event rates were low and follow-up shortened, outcomes differences in women were not statistically significant. Thus optimal blood pressure goals for women have not been established with the highest evidence. This review addresses SPRINT's significance and key remaining knowledge gaps in optimal blood pressure management to improve women's health. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. 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

  12. Brief telephone interventions for problem gambling: a randomized controlled trial.

    Science.gov (United States)

    Abbott, Max; Hodgins, David C; Bellringer, Maria; Vandal, Alain C; Palmer Du Preez, Katie; Landon, Jason; Sullivan, Sean; Rodda, Simone; Feigin, Valery

    2018-05-01

    Problem gambling is a significant public health issue world-wide. There is substantial investment in publicly funded intervention services, but limited evaluation of effectiveness. This study investigated three brief telephone interventions to determine whether they were more effective than standard helpline treatment in helping people to reduce gambling. Randomized clinical trial. National gambling helpline in New Zealand. A total of 462 adults with problem gambling. INTERVENTIONS AND COMPARATOR: (1) Single motivational interview (MI), (2) single motivational interview plus cognitive-behavioural self-help workbook (MI + W) and (3) single motivational interview plus workbook plus four booster follow-up telephone interviews (MI + W + B). Comparator was helpline standard care [treatment as usual (TAU)]. Blinded follow-up was at 3, 6 and 12 months. Primary outcomes were days gambled, dollars lost per day and treatment goal success. There were no differences across treatment arms, although participants showed large reductions in gambling during the 12-month follow-up period [mean reduction of 5.5 days, confidence interval (CI) = 4.8, 6.2; NZ$38 lost ($32, $44; 80.6%), improved (77.2%, 84.0%)]. Subgroup analysis revealed improved days gambled and dollars lost for MI + W + B over MI or MI + W for a goal of reduction of gambling (versus quitting) and improvement in dollars lost by ethnicity, gambling severity and psychological distress (all P gambling severity than TAU or MI at 12 months and also better for those with higher psychological distress and lower self-efficacy to MI (all P problem gambling in New Zealand, brief telephone interventions are associated with changes in days gambling and dollars lost similar to more intensive interventions, suggesting that more treatment is not necessarily better than less. Some client subgroups, in particular those with greater problem severity and greater distress, achieve better outcomes when they receive more

  13. Reporting quality of social and psychological intervention trials: a systematic review of reporting guidelines and trial publications.

    Directory of Open Access Journals (Sweden)

    Sean P Grant

    Full Text Available BACKGROUND: Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. OBJECTIVE/DESIGN: We conducted a two-part study that reviewed (1 reporting guidelines for and (2 the reporting quality of social and psychological intervention trials. DATA SOURCES: (1 To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2 To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1 Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2 Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. RESULTS: (1 We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2 Our review of trials (n = 239 revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information and abstracts (55%; information about blinding (15%, sequence generation (23%, and allocation concealment (17%; and details about actual delivery of experimental (43% and control interventions (34%, participant uptake (25%, and service environment (28%. Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors." CONCLUSION: Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely

  14. Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications

    Science.gov (United States)

    Grant, Sean P.; Mayo-Wilson, Evan; Melendez-Torres, G. J.; Montgomery, Paul

    2013-01-01

    Background Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. Objective/Design We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. Data Sources (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. Eligibility (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. Results (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in “Instructions to Authors.” Conclusion Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely

  15. "Did the trial kill the intervention?" experiences from the development, implementation and evaluation of a complex intervention

    Directory of Open Access Journals (Sweden)

    Cox Karen

    2011-03-01

    Full Text Available Abstract Background The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.

  16. Many randomized trials of physical therapy interventions are not adequately registered: a survey of 200 published trials.

    Science.gov (United States)

    Pinto, Rafael Zambelli; Elkins, Mark R; Moseley, Anne M; Sherrington, Catherine; Herbert, Robert D; Maher, Christopher G; Ferreira, Paulo H; Ferreira, Manuela L

    2013-03-01

    Clinical trial registration has several putative benefits: prevention of selective reporting, avoidance of duplication, encouragement of participation, and facilitation of reviews. Previous surveys suggest that most trials are registered. However, these surveys examined only trials in journals with high impact factors, which may bias the results. This study examined the completeness of clinical trial registration and the extent of selective reporting of outcomes in a random sample of published randomized trials in physical therapy. This was a retrospective cohort study in which 200 randomized trials of physical therapy interventions were randomly selected from those published in 2009 and indexed in the Physiotherapy Evidence Database (PEDro), regardless of the publishing journal. Evidence of registration was sought for each trial in the study, on clinical trial registers, and by contacting authors. The proportion of randomized trials that were registered was 67/200 (34%). This proportion was significantly lower than among the trials in journals with high impact factors, where the proportion was 75% (odds ratio=7.4, 95% confidence interval=2.6-21.4). Unambiguous primary outcomes (ie, method and time points of measurement clearly defined in the trial registry entry) were registered for 32 trials, and registration was adequate (ie, prospective with unambiguous primary outcomes) for 5/200 (2.5%) trials. Selective outcome reporting occurred in 23 (47%) of the 49 trials in which selective reporting was assessable. The inclusion of only English-language trials prevents generalization of the results to non-English-language trials. Registration of randomized trials of physical therapy interventions is rarely adequate. Consequently, the putative benefits of registration are not being fully realized.

  17. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

    Science.gov (United States)

    Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

    2017-01-01

    Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. 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 lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

  18. Methodology of the Interventional Management of Stroke (IMS) III Trial

    Science.gov (United States)

    Khatri, Pooja; Hill, Michael D.; Palesch, Yuko Y.; Spilker, Judith; Jauch, Edward C.; Carrozzella, Janice A.; Demchuk, Andrew M.; Martin, Renee’; Mauldin, Patrick; Dillon, Catherine; Ryckborst, Karla J.; Janis, Scott; Tomsick, Thomas A; Broderick, Joseph P

    2011-01-01

    SUMMARY RATIONALE The IMS I and II pilot trials demonstrated that the combined intravenous (IV) and intra-arterial (IA) approach to recanalization may be more effective than standard IV rt-PA (Activase®) alone for moderate-to-large (NIHSS ≥10) strokes, and with a similar safety profile. AIMS The primary objective of this NIH-funded, Phase III, randomized, multi-center, open-label clinical trial is to determine whether a combined IV/IA approach to recanalization is superior to standard IV rt-PA alone when initiated within three hours of acute ischemic stroke onset. The IMS III Trial will develop and maintain a network of interventional centers to test the safety, feasibility, and potential efficacy of new FDA-approved catheter devices as part of a combined IV/IA approach to recanalization as the IMS III Study progresses. A secondary objective of the IMS III Trial is to determine the cost-effectiveness of the combined IV/IA approach as compared to standard IV rt-PA. Trial enrollment began in July of 2006. DESIGN A projected 900 subjects with moderate-to-large (NIHSS ≥10) ischemic strokes between ages 18–80 will be enrolled over the next 5 years at 40+ centers in the United States and Canada. Patients must have IV treatment initiated within three hours of stroke onset inn both arms. Subjects will be randomized in a 2:1 ratio with more subjects enrolled in the combined IV/IA group. The IV rt-PA alone group will receive the standard full dose (0.9 mg/kg, 90 mg max [10% as bolus]) of rt-PA intravenously over an hour. The combined IV/IA group will receive a lower dose of IV rt-PA (~ 0.6 mg/kg, 60 mg max) over 40 minutes followed by immediate angiography. If a treatable thrombus is not demonstrated, no IA therapy will be administered. If an appropriate thrombus is identified, treatment will continue with either the Concentric Merci® thrombus-removal device, infusion of rt-PA and delivery of low-intensity ultrasound at the site of the occlusion via the EKOS® Micro

  19. Successful subject recruitment for a prostate cancer behavioral intervention trial.

    Science.gov (United States)

    Heiney, Sue P; Arp Adams, Swann; Drake, Bettina F; Bryant, Lisa H; Bridges, Lynne; Hebert, James R

    2010-08-01

    Inadequate participant recruitment, which may lead to unrepresentative study samples that threaten a study's validity, is often a major challenge in the conduct of research studies. The purpose of this article is to describe the development and implementation of a recruitment plan and evaluate the different recruitment strategies for a prostate cancer behavioral intervention trial. Our recruitment plan was based on a framework (The Heiney-Adams Recruitment Model) that we developed, which combines relationship building and social marketing. We evaluated the success of our model using several different recruitment sources including: mailed letters, physician referral, and self-referral. Recruitment rates ranged from 67% for a support services department mailing to 100% for physician referral. While our original list of contacted patients was comprised of only 13% African American (AA) men, 22% of our recruited participants were AA. One of the strongest barriers to recruitment was strict patient eligibility. Another significant barrier was the lack of electronic records systems to allow for the identification of large numbers of potential participants. In conclusion, our model incorporating social marketing and relationship building was quite successful in recruiting for a prostate cancer behavioral study, particularly AA participants. In developing strategies, future researchers should attend to issues of staffing, financial resources, physician support, and eligibility criteria in the light of study accrual.

  20. A Randomized Trial of a Brief Mental Health Intervention for Primary Care Patients

    Science.gov (United States)

    Lang, Ariel J.; Norman, Gregory J.; Casmar, Pollyanna V.

    2006-01-01

    This randomized trial is a first evaluation of a brief psychotherapeutic intervention for primary care patients. Sixty-two participants were randomly assigned to the intervention or to treatment as usual. As compared with treatment as usual, the intervention led to significant reductions in symptoms of anxiety and depression. The reduction was…

  1. The Use of Deception in Public Health Behavioral Intervention Trials: A Case Study of Three Online Alcohol Trials

    Science.gov (United States)

    McCambridge, Jim; Kypri, Kypros; Bendtsen, Preben; Porter, John

    2013-01-01

    Some public health behavioral intervention research studies involve deception. A methodological imperative to minimize bias can be in conflict with the ethical principle of informed consent. As a case study, we examine the specific forms of deception used in three online randomized controlled trials evaluating brief alcohol interventions. We elaborate our own decision making about the use of deception in these trials, and present our ongoing findings and uncertainties. We discuss the value of the approach of pragmatism for examining these kinds of ethical issues that can arise in research on public health interventions. PMID:24161181

  2. Early-Life Obesity Prevention: Critique of Intervention Trials During the First One Thousand Days.

    Science.gov (United States)

    Reilly, John J; Martin, Anne; Hughes, Adrienne R

    2017-06-01

    To critique the evidence from recent and ongoing obesity prevention interventions in the first 1000 days in order to identify evidence gaps and weaknesses, and to make suggestions for more informative future intervention trials. Completed and ongoing intervention trials have had fairly modest effects, have been limited largely to high-income countries, and have used relatively short-term interventions and outcomes. Comparison of the evidence from completed prevention trials with the evidence from systematic reviews of behavioral risk factors shows that some life-course stages have been neglected (pre-conception and toddlerhood), and that interventions have neglected to target some important behavioral risk factors (maternal smoking during pregnancy, infant and child sleep). Finally, while obesity prevention interventions aim to modify body composition, few intervention trials have used body composition measures as outcomes, and this has limited their sensitivity to detect intervention effects. The new WHO Healthy Lifestyles Trajectory (HeLTI) initiative should address some of these weaknesses. Future early obesity prevention trials should be much more ambitious. They should, ideally: extend their interventions over the first 1000 days; have longer-term (childhood) outcomes, and improved outcome measures (body composition measures in addition to proxies for body composition such as the BMI for age); have greater emphasis on maternal smoking and child sleep; be global.

  3. Reporting of factorial trials of complex interventions in community settings: a systematic review

    Directory of Open Access Journals (Sweden)

    Peters Tim J

    2011-07-01

    Full Text Available Abstract Background Standards for the reporting of factorial randomised trials remain to be established. We aimed to review the quality of reporting of methodological aspects of published factorial trials of complex interventions in community settings. Methods We searched MEDLINE, EMBASE, PsychInfo and the Cochrane Controlled Trials Register to identify factorial randomised trials of complex interventions in community settings from January 2000 to August 2009. We also conducted a citation search of two review papers published in 2003. Data were extracted by two reviewers on 22 items relating to study design, analysis and presentation. Results We identified 5941 unique titles, from which 116 full papers were obtained and 76 were included in the review. The included trials reflected a broad range of target conditions and types of intervention. The median sample size was 400 (interquartile range 191-1001. Most (88% trials employed a 2 × 2 factorial design. Few trials (21% explicitly stated the rationale for using a factorial design. Reporting of aspects of design, analysis or presentation specific to factorial trials was variable, but there was no evidence that reporting of these aspects was different for trials published before or after 2003. However, for CONSORT items that apply generally to the reporting of all trials, there was some evidence that later studies were more likely to report employing an intention-to-treat (ITT approach (78% vs 52%, present appropriate between-group estimates of effect (88% vs 63%, and present standard errors or 95% confidence intervals for such estimates (78% vs 56%. Interactions between interventions and some measure of the precision associated with such effects were reported in only 14 (18% trials. Conclusions Reports of factorial trials of complex interventions in community settings vary in the amount of information they provide regarding important methodological aspects of design and analysis. This variability

  4. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

    DEFF Research Database (Denmark)

    Punthakee, Z; Bosch, J; Dagenais, G

    2012-01-01

    AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...

  5. Outcome reporting across randomised controlled trials evaluating therapeutic interventions for pre-eclampsia.

    Science.gov (United States)

    Duffy, Jmn; Hirsch, M; Kawsar, A; Gale, C; Pealing, L; Plana, M N; Showell, M; Williamson, P R; Khan, K S; Ziebland, S; McManus, R J

    2017-11-01

    Standardising outcome collection and reporting in pre-eclampsia trials requires an appraisal of current outcome reporting. To map maternal and offspring outcome reporting across randomised trials evaluating therapeutic interventions for pre-eclampsia. Randomised trials were identified by searching bibliographical databases from inception to January 2016. Randomised controlled trials. We systematically extracted and categorised outcome reporting. Seventy-nine randomised trials, reporting data from 31 615 maternal participants and 28 172 of their offspring, were included. Fifty-five different interventions were evaluated. Included trials reported 119 different outcomes, including 72 maternal outcomes and 47 offspring outcomes. Maternal outcomes were inconsistently reported across included trials; for example, 11 trials (14%) reported maternal mortality, reporting data from 12 422 participants, and 16 trials (20%) reported cardiovascular morbidity, reporting data from 14 963 maternal participants. Forty-three trials (54%) reported fetal outcomes and 23 trials (29%) reported neonatal outcomes. Twenty-eight trials (35%) reported offspring mortality. There was poor reporting of childhood outcomes: six trials (8%) reported neurodevelopmental outcomes. Less than half of included trials reported any relevant information regarding harms for maternal participants and their offspring. Most randomised trials evaluating interventions for pre-eclampsia are missing information on clinically important outcomes, and in particular have neglected to evaluate efficacy and safety in the offspring of participants. Developing and implementing a minimum data set, known as a core outcome set, in future pre-eclampsia trials could help to address these issues. Future #preeclampsia research requires a core outcome set to reduce #research waste. @coreoutcomes @jamesmnduffy International Prospective Register of Systematic Reviews: CRD42015015529; www.crd

  6. A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics.

    Science.gov (United States)

    Ortiz, Miriam; Witt, Claudia M; Binting, Sylvia; Helmreich, Cornelia; Hummelsberger, Josef; Pfab, Florian; Wullinger, Michael; Irnich, Dominik; Linde, Klaus; Niggemann, Bodo; Willich, Stefan N; Brinkhaus, Benno

    2014-04-06

    In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial's participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians. ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6). The trial interventions were

  7. Harms, benefits, and the nature of interventions in pragmatic clinical trials.

    Science.gov (United States)

    Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

    2015-10-01

    To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems. © The Author(s) 2015.

  8. Microrandomized 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

    2015-12-01

    This article presents an experimental design, the microrandomized 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. Microrandomized 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. The article describes the microrandomized 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. Microrandomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Microrandomized 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. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  9. Intervention Efficacy in Trials Targeting Cannabis Use Disorders in Patients with Comorbid Psychosis

    DEFF Research Database (Denmark)

    Hjorthoj, Carsten Rygaard; Baker, Amanda; Fohlmann, Allan

    2014-01-01

    Introduction: Cannabis use disorders are highly prevalent in patients with schizophrenia and other psychoses, and are probably associated with a range of poor outcomes. Several trials have been conducted on this population, the results of which have been summarized in several systematic reviews...... but never in meta-analyses specifically regarding cannabis use. Methods: PubMed, PsycINFO, EMBASE, and The Cochrane Central Register of Controlled Trials were searched using predefined search terms. We included randomized trials of all types of interventions targeting cannabis use disorders in patients...... with schizophrenia spectrum disorders. We extracted information on intervention types, efficacy, trial characteristics, and risk of bias. Results: There was no evidence of an effect on frequency of cannabis use, but intervention effects of motivational intervention with or without cognitive behavior therapy were...

  10. Improving Discrete Trial Instruction by Paraprofessional Staff Through an Abbreviated Performance Feedback Intervention

    Science.gov (United States)

    Leblanc, Marie-Pierre; Ricciardi, Joseph N.; Luiselli, James K.

    2005-01-01

    We evaluated an abbreviated performance feedback intervention as a training strategy to improve discrete trial instruction of children with autism by three paraprofessional staff (assistant teachers) at a specialized day school. Feedback focused on 10 discrete trial instructional skills demonstrated by the staff during teaching sessions. Following…

  11. Characteristics of cancer patients participating in presurgical lifestyle intervention trials exploring effects on tumor biology

    Directory of Open Access Journals (Sweden)

    John A. Dasher

    2017-12-01

    Conclusion: Similar to other clinical trials, lack of time is a leading barrier to enrollment, and travel/distance appears to be a greater barrier for women in presurgical studies. Larger presurgical lifestyle intervention trials will require tailored strategies to enhance recruitment.

  12. 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

  13. The challenges of control groups, placebos and blinding in clinical trials of dietary interventions.

    Science.gov (United States)

    Staudacher, Heidi M; Irving, Peter M; Lomer, Miranda C E; Whelan, Kevin

    2017-08-01

    High-quality placebo-controlled evidence for food, nutrient or dietary advice interventions is vital for verifying the role of diet in optimising health or for the management of disease. This could be argued to be especially important where the benefits of dietary intervention are coupled with potential risks such as compromising nutrient intake, particularly in the case of exclusion diets. The objective of the present paper is to explore the challenges associated with clinical trials in dietary research, review the types of controls used and present the advantages and disadvantages of each, including issues regarding placebos and blinding. Placebo-controlled trials in nutrient interventions are relatively straightforward, as in general placebos can be easily produced. However, the challenges associated with conducting placebo-controlled food interventions and dietary advice interventions are protean, and this has led to a paucity of placebo-controlled food and dietary advice trials compared with drug trials. This review appraises the types of controls used in dietary intervention trials and provides recommendations and nine essential criteria for the design and development of sham diets for use in studies evaluating the effect of dietary advice, along with practical guidance regarding their evaluation. The rationale for these criteria predominantly relate to avoiding altering the outcome of interest in those delivered the sham intervention in these types of studies, while not compromising blinding.

  14. Clinical trials of health information technology interventions intended for patient use: unique issues and considerations.

    Science.gov (United States)

    DeVito Dabbs, Annette; Song, Mi-Kyung; Myers, Brad; Hawkins, Robert P; Aubrecht, Jill; Begey, Alex; Connolly, Mary; Li, Ruosha; Pilewski, Joseph M; Bermudez, Christian A; Dew, Mary Amanda

    2013-01-01

    Despite the proliferation of health information technology (IT) interventions, descriptions of the unique considerations for conducting randomized trials of health IT interventions intended for patient use are lacking. Our purpose is to describe the protocol to evaluate Pocket PATH (Personal Assistant for Tracking Health), a novel health IT intervention, as an exemplar of how to address issues that may be unique to a randomized controlled trial (RCT) to evaluate health IT intended for patient use. An overview of the study protocol is presented. Unique considerations for health IT intervention trials and strategies are described to maintain equipoise, to monitor data safety and intervention fidelity, and to keep pace with changing technology during such trials. The sovereignty granted to technology, the rapid pace of changes in technology, ubiquitous use in health care, and obligation to maintain the safety of research participants challenge researchers to address these issues in ways that maintain the integrity of intervention trials designed to evaluate the impact of health IT interventions intended for patient use. Our experience evaluating the efficacy of Pocket PATH may provide practical guidance to investigators about how to comply with established procedures for conducting RCTs and include strategies to address the unique issues associated with the evaluation of health IT for patient use.

  15. Influence of trial design, heterogeneity and regulatory environment on the results of clinical trials: An appraisal in the context of recent trials on acute stroke intervention

    Directory of Open Access Journals (Sweden)

    P R Srijithesh

    2014-01-01

    Full Text Available The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.

  16. 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…

  17. A Marginal Structural Model Analysis for Loneliness: Implications for Intervention Trials and Clinical Practice

    Science.gov (United States)

    VanderWeele, Tyler J.; Hawkley, Louise C.; Thisted, Ronald A.; Cacioppo, John T.

    2011-01-01

    Objective: Clinical scientists, policymakers, and individuals must make decisions concerning effective interventions that address health-related issues. We use longitudinal data on loneliness and depressive symptoms and a new class of causal models to illustrate how empirical evidence can be used to inform intervention trial design and clinical…

  18. A Trial of an iPad™ Intervention Targeting Social Communication Skills in Children with Autism

    Science.gov (United States)

    Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O'Hare, Anne; Pain, Helen; McConachie, Helen

    2016-01-01

    This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of…

  19. Review of Randomised Controlled Trials of Internet Interventions for Mental Disorders and Related Conditions

    Science.gov (United States)

    Griffiths, Kathleen M.; Christensen, Helen

    2006-01-01

    Self-help Internet interventions have the potential to enable consumers to play a central role in managing their own health. This paper contains a systematic review of 15 randomised controlled trials of the effectiveness of self-help Internet interventions for mental disorders and related conditions. Conditions addressed by the interventions…

  20. Screening and brief intervention targeting risky drinkers in Danish general practice - a pragmatic controlled trial

    DEFF Research Database (Denmark)

    Beich, A.; Gannik, D.; Saelan, H.

    2007-01-01

    AIMS: Recommendations for routine alcohol screening and brief counselling intervention in primary health care rest on results from intervention efficacy studies. By conducting a pragmatic controlled trial (PCT), we aimed at evaluating the effectiveness of the WHO recommendations for screening......-14 months. Outcome measures focused on patients' acceptance of screening and intervention and their self-reported alcohol consumption. RESULTS: Patient acceptance of screening and intervention -10.3% (N = 794) of the target population (N = 7, 691) explicitly refused screening. All intervention group...

  1. Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi

    Directory of Open Access Journals (Sweden)

    Ndebele Paul M

    2012-11-01

    Full Text Available Abstract Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124 obtained low scores (lower than 75% on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18 and intervention arms (n=18. The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75% during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001. Conclusions

  2. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  3. Effectiveness of nurse-led brief alcohol intervention: a cluster randomized controlled trial.

    Science.gov (United States)

    Lock, Catherine A; Kaner, Eileen; Heather, Nick; Doughty, Julie; Crawshaw, Andrea; McNamee, Paul; Purdy, Sarah; Pearson, Pauline

    2006-05-01

    This paper reports an evaluation of the effectiveness and cost-effectiveness of nurse-led screening and brief intervention in reducing excessive alcohol consumption among patients in primary health care. Excessive alcohol consumption is a major source of social, economic and health problems. However, such consumption is responsive to brief alcohol intervention. To date, brief intervention research in primary health care has focused on general practitioner-led interventions, and there is only circumstantial evidence of effectiveness in nurse-led interventions. However, nurses are increasingly taking a lead in health promotion work in primary care. A pragmatic cluster-randomized controlled trial was carried out between August 2000 and June 2003 to evaluate the effects of a brief intervention compared with standard advice (control condition). A total of 40 general practice clusters (intervention = 21 and control = 19) recruited 127 patients (intervention = 67 and control = 60) to the trial. Excessive consumption was identified opportunistically via the Alcohol Use Disorders Identification Test. After baseline assessment, patients received either a 5-10 minutes brief intervention using the 'Drink-Less' protocol or standard advice (control condition). Follow-up occurred at 6 and 12 months postintervention. Analysis of variance weighted for cluster size revealed no statistically significant differences between intervention and control patients at follow up. A majority of patients in both conditions reduced their alcohol consumption between assessment and subsequent measurement. Economic analysis suggested that the brief intervention led to no statistically significant changes in subsequent health service resource use relative to standard treatment. The brief intervention evaluated in this trial had no effect over standard advice delivered by nurses in primary health care. However, there was a reduction in excessive drinking across both arms of the trial over time. Due to

  4. "Smart" RCTs: Development of a Smartphone App for Fully Automated Nutrition-Labeling Intervention Trials.

    Science.gov (United States)

    Volkova, Ekaterina; Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona

    2016-03-17

    There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled trials (RCTs) in New Zealand and Australia. Two versions of the smartphone app were developed: one for a 5-arm trial (Australian) and the other for a 3-arm trial (New Zealand). The RCT protocols guided requirements for app functionality, that is, obtaining informed consent, two-stage eligibility check, questionnaire administration, randomization, intervention delivery, and outcome assessment. Intervention delivery (nutrition labels) and outcome data collection (individual shopping data) used the smartphone camera technology, where a barcode scanner was used to identify a packaged food and link it with its corresponding match in a food composition database. Scanned products were either recorded in an electronic list (data collection mode) or allocated a nutrition label on screen if matched successfully with an existing product in the database (intervention delivery mode). All recorded data were transmitted to the RCT database hosted on a server. In total approximately 4000 users have downloaded the FLT app to date; 606 (Australia) and 1470 (New Zealand) users met the eligibility criteria and were randomized. Individual shopping data collected by participants currently comprise more than 96,000 (Australia) and 229,000 (New Zealand) packaged food and beverage products. The FLT app is one of the first smartphone apps to enable conducting fully automated RCTs. Preliminary app usage statistics demonstrate large potential of such technology, both for intervention delivery and data collection. Australian

  5. Reporting of interventions in randomised trials: an audit of journal instructions to authors.

    Science.gov (United States)

    Hoffmann, Tammy; English, Thomas; Glasziou, Paul

    2014-01-14

    A complete description of the intervention in a published trial report is necessary for readers to be able to use the intervention, yet the completeness of intervention descriptions in trials is very poor. Low awareness of the issue by authors, reviewers, and editors is part of the cause and providing specific instructions about intervention reporting to authors and encouraging full sharing of intervention materials is important. We assessed the extent to which: 1) journals' Instructions to Authors provide instructions about how interventions that have been evaluated in a randomised controlled trial (RCT) should be reported in the paper; and 2) journals offer the option of authors providing online supplementary materials. We examined the web-based Instructions to Authors of 106 journals (the six leading general medical journals, 50 randomly selected journals from the National Library of Medicine's Core Clinical Journals, and 50 randomly selected journals from the remainder of the journal collection indexed by PubMed). To be eligible, each journal must have published at least one randomised trial involving human participants each year from 2008 to 2012. We extracted all information related to the reporting of interventions, reporting of randomised trials in general, and online supplementary materials. Of the 106 journals' Instructions to Authors, only 15 (14%) specifically mentioned the reporting of interventions and most of these provided non-specific advice such as 'describe essential features'. Just over half (62, 58%) of the journals mentioned the Consolidated Standards of Reporting Trials (CONSORT) statement in their author instructions. Seventy-eight (74%) of the journals' instructions mentioned the option of providing supplementary content online as part of the paper; however, only four of these journals explicitly encouraged or mandated use of this option for providing intervention information or materials. Most journals' Instructions to Authors do not

  6. Detecting Periprocedural Myocardial Infarction in Contemporary Percutaneous Coronary Intervention Trials

    NARCIS (Netherlands)

    Spitzer, Ernest; de Vries, Ton; Cavalcante, Rafael; Tuinman, Marieke; Rademaker-Havinga, Tessa; Alkema, Maaike; Morel, Marie-Angele; Soliman, Osama I.; Onuma, Yoshinobu; van Es, Gerrit-Anne; Tijssen, Jan G. P.; McFadden, Eugene; Serruys, Patrick W.

    2017-01-01

    This study sought to investigate the differences in detecting (e.g., triggering) periprocedural myocardial infarction (PMI) among 3 current definitions. PMI is a frequent component of primary endpoints in coronary device trials. Identification of all potential suspected events is critical for

  7. Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials.

    Science.gov (United States)

    Eggly, Susan; Hamel, Lauren M; Heath, Elisabeth; Manning, Mark A; Albrecht, Terrance L; Barton, Ellen; Wojda, Mark; Foster, Tanina; Carducci, Michael; Lansey, Dina; Wang, Ting; Abdallah, Rehab; Abrahamian, Narineh; Kim, Seongho; Senft, Nicole; Penner, Louis A

    2017-12-02

    Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial. Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the

  8. Description of complex interventions: analysis of changes in reporting in randomised trials since 2002.

    Science.gov (United States)

    Candy, Bridget; Vickerstaff, Victoria; Jones, Louise; King, Michael

    2018-02-22

    Inadequate description of non-pharmacological complex interventions in trial publications means that they cannot be replicated or assessed for generalisability. There are published guidelines on how to describe an intervention, such as those from the CONSORT Group. However, there have been few evaluations of whether intervention reporting is improving. We aimed to assess whether descriptions of multicomponent, non-pharmacological interventions evaluated in randomised trials are improving. To do so, we chose trials of educational and psychotherapeutic interventions to promote adherence to therapy, and compared those published between 2002 and 2007 (Time-1) with those between 2010 and 2015 (Time-2). These time periods were chosen to concord with the publication in 2008 of the CONSORT extension statement of reporting guidelines for non-pharmacological treatment which included items on intervention description. We assessed 19 items, based on the CONSORT Statement and the more recent Template for Intervention Description and Replication Checklist (TIDieR). Two reviewers independently extracted data. We created a quality score of the eight items we considered key information for replication and assessment of generalisability (setting, provider, recipient, comparator, intervention intensity, how it was conducted, existence of a manual or protocol, and detail of whether there was an assessment of fidelity). Score per item was '1' if reported adequately and '0' if not. Of the eligible trials, 42 were published in Time-1 and 134 published in Time-2. The trials included were published in 112 peer-reviewed journals, 52 of these journals currently require authors to follow the CONSORT Statements, while only one recommended adherence to the TIDieR. Most items of CONSORT and TIDieR were reported by more than half of the trials at both time points. Few trials reported fidelity. A large proportion of the trials did not report the existence of a manual or protocol, or what the

  9. Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial: Post-Intervention Results

    Science.gov (United States)

    Fitzgibbon, M. L.; Stolley, M. R.; Schiffer, L.; Braunschweig, C. L.; Gomez, S. L.; Van Horn, L.; Dyer, A.

    2013-01-01

    The preschool years offer an opportunity to interrupt the trajectory toward obesity in black children. The Hip-Hop to Health Jr. Obesity Prevention Effectiveness Trial was a group-randomized controlled trial assessing the feasibility and effectiveness of a teacher-delivered weight control intervention for black preschool children. The 618 participating children were enrolled in 18 schools administered by the Chicago Public Schools. Children enrolled in the 9 schools randomized to the intervention group received a 14-week weight control intervention delivered by their classroom teachers. Children in the 9 control schools received a general health intervention. Height and weight, physical activity, screen time, and diet data were collected at baseline and post-intervention. At post-intervention, children in the intervention schools engaged in more moderate-to vigorous physical activity than children in the control schools (difference between adjusted group means=7.46 min/day, p=.02). Also, children in the intervention group had less total screen time (−27.8 min/day, p=.05). There were no significant differences in BMI, BMI Z score, or dietary intake. It is feasible to adapt an obesity prevention program to be taught by classroom teachers. The intervention showed positive influences on physical activity and screen time, but not diet. Measuring diet and physical activity in preschool children remains a challenge, and interventions delivered by classroom teachers require both intensive initial training and ongoing individualized supervision. PMID:21193852

  10. Preoperative lifestyle intervention in bariatric surgery: a randomized clinical trial.

    Science.gov (United States)

    Kalarchian, Melissa A; Marcus, Marsha D; Courcoulas, Anita P; Cheng, Yu; Levine, Michele D

    2016-01-01

    Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period. Bariatric Center of Excellence at a large, urban medical center. Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual presurgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions, followed by 16 weeks of face-to-face and telephone sessions before surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted 6, 12, and 24 months after surgery. Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average body mass index was 47.5 kg/m(2) at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12-, and 24-month assessments, respectively. Percent weight loss from study enrollment to 6 and 12 months after surgery was comparable for both groups, but at 24 months after surgery, the lifestyle group had significantly smaller percent weight loss compared with the usual care group (26.5% versus 29.5%, respectively, P = .02). Presurgery lifestyle intervention did not improve weight loss at 24 months after surgery. The findings from this study raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  11. Preoperative Lifestyle Intervention in Bariatric Surgery: A Randomized Clinical Trial

    Science.gov (United States)

    Kalarchian, Melissa A.; Marcus, Marsha D.; Courcoulas, Anita P.; Cheng, Yu; Levine, Michele D.

    2015-01-01

    Background Studies of the impact of pre-surgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. Objective To evaluate whether a pre-surgery behavioral lifestyle intervention improves weight loss through 24-months post-surgery. Setting Bariatric Center of Excellence at a large, urban medical center. Methods Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual pre-surgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions followed by 16 weeks of face-to-face and telephone sessions prior to surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted at 6-, 12- and 24-months post-surgery. Results Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average BMI was 47.5 kg/m2 at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12- and 24 month assessments, respectively. Percent weight loss from study enrollment to 6- and 12-months post-surgery was comparable for both groups, but at 24-months post-surgery, the lifestyle group had significantly smaller percent weight loss than the usual care group (26.5% vs. 29.5%, respectively, p = 0.02). Conclusions Pre-surgery lifestyle intervention did not improve weight loss at 24 months post-surgery. Findings raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. PMID:26410538

  12. 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

  13. A novel experience-based internet intervention for smoking cessation: feasibility randomised controlled trial

    Directory of Open Access Journals (Sweden)

    John Powell

    2016-11-01

    Full Text Available Abstract Background The internet is frequently used to share experiences of health and illness, but this phenomenon has not been harnessed as an intervention to achieve health behaviour change. The aim of this study was to determine the feasibility of a randomised trial assessing the effects of a novel, experience-based website as a smoking cessation intervention. The secondary aim was to measure the potential impact on smoking behaviour of both the intervention and a comparator website. Methods A feasibility randomised controlled single-blind trial assessed a novel, experience-based website containing personal accounts of quitting smoking as a cessation intervention, and a comparator website providing factual information. Feasibility measures including recruitment, and usage of the interventions were recorded, and the following participant-reported outcomes were also measured: Smoking Abstinence Self-Efficacy Questionnaire, the single-item Motivation to Stop Scale, self-reported abstinence, quit attempts and health status outcomes. Eligible smokers from two English regions were entered into the trial and given access to their allocated website for two weeks. Results Eighty-seven smokers were randomised, 65 completed follow-up (75 %. Median usage was 15 min for the intervention, and 5 min for the comparator (range 0.5–213 min. Median logins for both sites was 2 (range 1–20. All participant-reported outcomes were similar between groups. Conclusions It was technically feasible to deliver a novel intervention harnessing the online sharing of personal experiences as a tool for smoking cessation, but recruitment was slow and actual use was relatively low, with attrition from the trial. Future work needs to maximize engagement and to understand how best to assess the value of such interventions in everyday use, rather than as an isolated ‘dose of information’. Trial registration ISRCTN29549695 DOI 10.1186/ISRCTN29549695 . Registered 17/05/2013.

  14. The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    Directory of Open Access Journals (Sweden)

    Taylor Stephanie

    2011-02-01

    Full Text Available Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs. It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Method OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or Control group: a depression awareness training session for care home staff. Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Discussion Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. Trial Registration [ISRCTN: ISRCTN43769277

  15. Development of a cancer clinical trials multi-media intervention: clinical trials: are they right for you?

    Science.gov (United States)

    Wells, Kristen J; Quinn, Gwendolyn P; Meade, Cathy D; Fletcher, Michelle; Tyson, Dinorah Martinez; Jim, Heather; Jacobsen, Paul B

    2012-08-01

    To describe processes used to develop a multi-media psycho-educational intervention to prepare patients for a discussion about cancer clinical trials (CTs). Guided by a Steering Committee, formative research was conducted to develop an informative and engaging tool about cancer CTs. Twenty-three patients and caregivers participated in formative in-depth interviews to elicit information about perceptions of cancer CTs to inform production of a new media product. Formative research revealed participants had concerns about experimentation, held beliefs that cancer CTs were for patients who had no other treatment options, and wanted a balance of information about pros and cons of CT participation. The value of physicians as credible spokespersons and the use of patients as role-models were supported. Using iterative processes, the production team infused the results into creation of a multimedia psycho-educational intervention titled Clinical Trials: Are they Right for You? An intervention, developed through an iterative consumer-focused process involving multiple stakeholders and formative research, may result in an engaging informative product. If found to be efficacious, Clinical Trials: Are they Right for You? is a low-cost and easily disseminated multimedia psycho-educational intervention to assist cancer patients with making an informed decision about cancer CTs. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  16. The role of public health authorities, scientific societies and the pharmaceutical industry in planning and conducting intervention trials

    NARCIS (Netherlands)

    van Zwieten, P. A.

    1996-01-01

    BODIES INVOLVED IN CLINICAL TRIALS: Government institutions, academia and associated scientific societies and the pharmaceutical industry are the main entities involved in planning and conducting intervention trials. Funding can only be expected from government institutions and industry, but

  17. DeLLITE Depression in late life: an intervention trial of exercise. Design and recruitment of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Keeling Sally

    2008-05-01

    Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640

  18. The effect of blinding on estimates of mortality in randomised clinical trials of intensive care interventions

    DEFF Research Database (Denmark)

    Anthon, Carl Thomas; Granholm, Anders; Perner, Anders

    2017-01-01

    INTRODUCTION: Evidence exists that unblinded randomised clinical trials (RCTs) overestimate intervention effects compared with blinded RCTs. It has been suggested that this is less pronounced for objective (ie, not subject to interpretation) outcome measures, including mortality. This may not apply......(s). For each intervention, we will compare summary mortality effect estimates in blinded versus unblinded trials. ETHICS AND DISSEMINATION: This research does not require ethical approval as we will use summary data from trials already approved by relevant ethical institutions. We will report the results...... in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement and submit the final paper to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: PROSPERO, registration number: CRD42017056212....

  19. Impact of an Acceptance Facilitating Intervention on Patients' Acceptance of Internet-based Pain Interventions: A Randomized Controlled Trial.

    Science.gov (United States)

    Baumeister, Harald; Seifferth, Holger; Lin, Jiaxi; Nowoczin, Lisa; Lüking, Marianne; Ebert, David

    2015-06-01

    Results from clinical trials indicate that Internet-based psychological pain interventions are effective in treating chronic pain. However, little is known about patients' acceptance of these programs and how to positively influence patients' intention to engage in them. Therefore, the present study aimed (1) to assess patients' acceptance of Internet-based interventions, and (2) to examine whether patients' acceptance can be increased by an acceptance facilitating intervention. A total of 104 patients with chronic pain from 2 pain units were randomly allocated to an intervention group (IG) and a no-intervention control group (CG). The IG was shown a short informational video about Internet-based psychological pain interventions before receiving a questionnaire on patients' acceptance of Internet-based psychological pain interventions and predictors of acceptance (performance expectancy, effort expectancy, social influence, facilitating conditions, Internet usage, and Internet anxiety). The CG filled out the questionnaire immediately. Patients' acceptance was measured with a 4-item scale (sum score ranging from 4 to 20). Baseline acceptance of Internet-based interventions was reported as low (sum-score:4-9) by 53.8%, moderate (10 to 15) by 42.3%, and high (16 to 20) by 3.9% of the patients with chronic pain in the CG. The IG showed a significantly higher acceptance (M = 12.17, SD = 4.22) than the CG (M = 8.94, SD = 3.71) with a standardized mean difference of d = 0.81 (95% CI, 0.41, 1.21). All predictor variables were significantly improved in the IG compared with the CG, except for Internet usage. Patients with chronic pain display a relatively low acceptance of Internet-based psychological pain interventions, which can be substantially increased by a short informational video.

  20. The IDEFICS intervention trial to prevent childhood obesity: design and study methods.

    Science.gov (United States)

    Pigeot, I; Baranowski, T; De Henauw, S

    2015-12-01

    One of the major research dimensions of the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study involved the development, implementation and evaluation of a setting-based community-oriented intervention programme for primary prevention of childhood obesity. In this supplement of Obesity Reviews, a compilation of key results of the IDEFICS intervention is packaged in a series of complementary papers. This paper describes the overall design and methods of the IDEFICS intervention in order to facilitate a comprehensive reading of the supplement. In addition, some 'best practice' examples are described. The IDEFICS intervention trial was conducted to assess whether the IDEFICS intervention prevented obesity in young children aged 2 to 9.9 years. The study was a non-randomized, quasi-experimental trial with one intervention matched to one control region in each of eight participating countries. The intervention was designed following the intervention mapping framework, using a socio-ecological theoretical approach. The intervention was designed to address several key obesity-related behaviours in children, parents, schools and community actors; the primary outcome was the prevalence of overweight/obesity according to the IOTF criteria based on body mass index. The aim was to achieve a reduction of overweight/obesity prevalence in the intervention regions. The intervention was delivered in school and community settings over a 2-year period. Data were collected in the intervention and control cohort regions at baseline and 2 years later. This paper offers an introductory framework for a comprehensive reading of this supplement on IDEFICS intervention key results. © 2015 World Obesity.

  1. Grey literature in meta-analyses of randomized trials of health care interventions.

    Science.gov (United States)

    Hopewell, S; McDonald, S; Clarke, M; Egger, M

    2007-04-18

    The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. To review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials of health care interventions. We searched the Cochrane Methodology Register (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to 20 May 2005), the Science Citation Index (June 2005) and contacted researchers who may have carried out relevant studies. A study was considered eligible for this review if it compared the effect of the inclusion and exclusion of grey literature on the results of a cohort of meta-analyses of randomized trials. Data were extracted from each report independently by two reviewers. The main outcome measure was an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information was also collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality. Five studies met the inclusion criteria. All five studies showed that published trials showed an overall greater treatment effect than grey trials. This difference was statistically significant in one of the five studies. Data could be combined for three of the five studies. This showed that, on average, published trials showed a 9% greater treatment effect than grey trials (ratio of odds ratios for grey versus published trials 1.09; 95% CI 1.03-1.16). Overall there were more published trials included in the meta-analyses than grey trials (median 224 (IQR 108-365) versus 45(IQR 40-102)). Published trials had more participants on average. The most

  2. Evaluation of a Web-based intervention to promote hand hygiene: exploratory randomized controlled trial.

    Science.gov (United States)

    Yardley, Lucy; Miller, Sascha; Schlotz, Wolff; Little, Paul

    2011-12-09

    Hand-washing is regarded as a potentially important behavior for preventing transmission of respiratory infection, particularly during a pandemic. The objective of our study was to evaluate whether a Web-based intervention can encourage more frequent hand-washing in the home, and to examine potential mediators and moderators of outcomes, as a necessary first step before testing effects of the intervention on infection rates in the PRIMIT trial (PRimary care trial of a website based Infection control intervention to Modify Influenza-like illness and respiratory infection Transmission). In a parallel-group pragmatic exploratory trial design, 517 nonblinded adults recruited through primary care were automatically randomly assigned to a fully automated intervention comprising 4 sessions of tailored motivational messages and self-regulation support (n = 324) or to a no-intervention control group (n = 179; ratio 2:1). Hand-washing frequency and theory of planned behavior cognitions relating to hand-washing were assessed by online questionnaires at baseline (in only half of the control participants, to permit evaluation of effects of baseline assessment on effect sizes), at 4 weeks (postintervention; all participants), and at 12 weeks. Hand-washing rates in the intervention group were higher at 4 weeks than in the control group (mean 4.40, n = 285 and mean 4.04, n = 157, respectively; P Hand-washing intentions and positive attitudes toward hand-washing increased more from baseline to 4 weeks in the intervention group than in the control group. Mediation analyses revealed positive indirect effects of the intervention on change in hand-washing via intentions (coefficient = .15, 95% confidence interval [CI], .08-.26) and attitudes (coefficient = 0.16, 95% CI, .09-.26). Moderator analyses confirmed that the intervention was similarly effective for men and women, those of higher and lower socioeconomic status, and those with higher and lower levels of perceived risk. This

  3. Incomplete descriptions of oral nutritional supplement interventions in reports of randomised controlled trials.

    Science.gov (United States)

    Liljeberg, E; Andersson, A; Lövestam, E; Nydahl, M

    2018-02-01

    The effects of oral nutritional supplements (ONS) have been evaluated in several clinical trials and more studies have been requested. To facilitate replication, support accurate evaluations of research results and avoid research waste, high quality reporting of interventions in clinical trials is needed. The aim of this study is to assess the quality of reporting of interventions in publications describing randomised controlled trials of ONS in populations with malnutrition or at nutritional risk. The PubMed database was searched for articles describing ONS trials published between January 2002 and December 2015. The quality of intervention descriptions was evaluated using the Template for Intervention Description and Replication (TIDieR) checklist and guide, which contains twelve items. Articles published before and after 2011 were compared. Of 76 articles identified, only 3% reported all TIDieR items in sufficient detail. The most frequently missing elements were descriptions of the intervention procedures (e.g. how the ONS were to be taken and if participants were given a choice of flavours), which were adequately presented in only 26% of the articles. Less than half of the articles included a description of the intervention provider and sufficient information about the location(s) for the intervention. Information about adherence and mode of delivery was reported in 60-65% of the articles. Most frequently reported, in >70% of the articles, were items regarding the brief name of the intervention, the rationale for the intervention and the materials used (i.e. information about the specific ONS product(s) administered). The reporting quality for two of the items (materials and provider) was higher in articles published after 2011. The quality of reporting of ONS interventions was found to be poor. The descriptions mostly lacked information about intervention procedures, provider and location(s). A moderately higher reporting quality was observed in articles

  4. A novel experience-based internet intervention for smoking cessation: feasibility randomised controlled trial.

    Science.gov (United States)

    Powell, John; Newhouse, Nikki; Martin, Angela; Jawad, Sena; Yu, Ly-Mee; Davoudianfar, Mina; Locock, Louise; Ziebland, Sue

    2016-11-11

    The internet is frequently used to share experiences of health and illness, but this phenomenon has not been harnessed as an intervention to achieve health behaviour change. The aim of this study was to determine the feasibility of a randomised trial assessing the effects of a novel, experience-based website as a smoking cessation intervention. The secondary aim was to measure the potential impact on smoking behaviour of both the intervention and a comparator website. A feasibility randomised controlled single-blind trial assessed a novel, experience-based website containing personal accounts of quitting smoking as a cessation intervention, and a comparator website providing factual information. Feasibility measures including recruitment, and usage of the interventions were recorded, and the following participant-reported outcomes were also measured: Smoking Abstinence Self-Efficacy Questionnaire, the single-item Motivation to Stop Scale, self-reported abstinence, quit attempts and health status outcomes. Eligible smokers from two English regions were entered into the trial and given access to their allocated website for two weeks. Eighty-seven smokers were randomised, 65 completed follow-up (75 %). Median usage was 15 min for the intervention, and 5 min for the comparator (range 0.5-213 min). Median logins for both sites was 2 (range 1-20). All participant-reported outcomes were similar between groups. It was technically feasible to deliver a novel intervention harnessing the online sharing of personal experiences as a tool for smoking cessation, but recruitment was slow and actual use was relatively low, with attrition from the trial. Future work needs to maximize engagement and to understand how best to assess the value of such interventions in everyday use, rather than as an isolated 'dose of information'. ISRCTN29549695 DOI 10.1186/ISRCTN29549695 . Registered 17/05/2013.

  5. 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…

  6. A randomised controlled demonstration trial of multifaceted nutritional intervention and or probiotics: the healthy mums and babies (HUMBA) trial.

    Science.gov (United States)

    Okesene-Gafa, Karaponi; Li, Minglan; Taylor, Rennae S; Thompson, John M D; Crowther, Caroline A; McKinlay, Christopher J D; McCowan, Lesley M E

    2016-11-24

    Maternal obesity is associated with adverse pregnancy outcomes and has lifelong negative implications for offspring health. The Institute of Medicine recommends limited gestational weight gain (GWG) in obese women for optimal maternal and infant outcomes. However, there is a gap regarding an effective and sustainable intervention strategy to achieve this goal. The aim of the healthy mums and babies (HUMBA) demonstration trial is to assess whether a multifaceted nutritional intervention and/or an oral probiotic treatment in obese pregnant women can reduce excessive GWG and optimise pregnancy outcomes. The study is a two by two factorial randomised controlled demonstration trial conducted in Counties Manukau health region, New Zealand, a multi-ethnic region with a high prevalence of obesity. A total of 220 non-diabetic obese women with a singleton pregnancy will be recruited between 12 0 and 17 6  weeks. At recruitment, women are randomised to receive either a culturally tailored multifaceted dietary intervention or routine dietary advice, and either an oral probiotic or placebo capsule. Randomisation is undertaken via a web-based protocol, randomize.net, with a 1:1 ratio using stratification by body mass index (BMI) category (BMI of 30-34.9 or BMI ≥35 kg/m 2 ). The dietary intervention includes 4 customised nutrition education visits by a trained community health worker combined with motivational text messaging. Probiotic capsules consist of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12 at a dose of 7 × 10 9 colony-forming units one per day until birth. Probiotic and placebo capsules are identically pre-packed and labelled by a third party, and are prescribed in a double blinded fashion. Research assessments are conducted at enrolment, 28 weeks, 36 weeks, at birth and at 5 months post-delivery. The primary outcomes for the study are proportion of women with excessive GWG and infant birthweight. The HUMBA demonstration trial will assess the

  7. The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation.

    Science.gov (United States)

    Underwood, Martin; Eldridge, Sandra; Lamb, Sallie; Potter, Rachel; Sheehan, Bartley; Slowther, Anne-Marie; Taylor, Stephanie; Thorogood, Margaret; Weich, Scott

    2011-02-02

    Depression is common in residents of Residential and Nursing homes (RNHs). It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months. INTERVENTION GROUP: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or a depression awareness training session for care home staff.Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. [ISRCTN: ISRCTN43769277].

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

    OpenAIRE

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

    2017-01-01

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

  9. 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

    2017-10-01

    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).

  10. Pragmatic trial of an intervention to increase human papillomavirus vaccination in safety-net clinics

    Directory of Open Access Journals (Sweden)

    Maureen Sanderson

    2017-02-01

    Full Text Available Abstract Background Human papillomavirus (HPV infection has been causally linked to six cancers, and many disproportionately affect minorties. This study reports on the development and effectiveness of an intervention aimed at increasing HPV vaccine uptake among African American and Hispanic pediatric patients in safety-net clinics. Methods Formative research, community engagement, and theory guided development of the intervention. A clustered, non-randomized controlled pragmatic trial was conducted in four clinics providing healthcare for the underserved in Tennessee, U.S., with two intervention sites and two usual care sites. Patients aged 9-18 years (N = 408 and their mothers (N = 305 enrolled, with children clustered within families. The intervention consisted of two provider/staff training sessions and provision of patient education materials, consisting of a video/flyer promoting HPV vaccine. Medical records were reviewed before/after the initial visit and after 12 months. Results At the initial visit, provision of patient education materials and provider recommendation were higher at intervention sites versus usual care sites, and receipt of HPV vaccine was higher at intervention sites (45.4% versus 32.9% but not significantly after adjusting for patient’s age and mother’s education. Provider recommendation, but not education materials, increased the likelihood of vaccine receipt at the initial visit, although over one-third of intervention mothers cited the flyer/video as motivating vaccination. Completion of the 3-dose series at follow-up was lower in the intervention arm. Conclusions Future interventions should combine patient education, intensive provider/staff education, and patient reminders. Research should compare patient education focusing on HPV vaccine only versus all adolescent vaccines. Trial registration Retrospectively registered with ClinicalTrials.gov NCT02808832 , 9/12/16

  11. Statistical methods for analysing Barthel scores in trials of poststroke interventions: a review and computer simulations.

    Science.gov (United States)

    Song, Fujian; Jerosch-Herold, Christina; Holland, Richard; Drachler, Maria de Lourdes; Mares, Kath; Harvey, Ian

    2006-04-01

    Arguments persist as to whether parametric or non-parametric methods should be used to analyse ordinal data in trials. This paper aims to assess methods used for presenting and analysing an ordinal scale, the Barthel Index, in trials of poststroke interventions. All randomized controlled trials (RCTs) of poststroke interventions published from 1995 to 2004 in two journals (Stroke and Clinical Rehabilitation) were scrutinized for methods used to present and analyse Barthel scores. Computer simulations were used to compare the type I errors and the statistical power of different statistical methods under a range of assumed circumstances. One hundred and fifty-six RCTs were identified within the two journals. The central tendency of Barthel scores was measured by the median in 47 trials and by the mean in 35 trials. Non-parametric analyses of Barthel scores were conducted in 47 trials and parametric methods used in 18 trials. The results of computer simulations demonstrate that the t-test has a similar type I error rate and statistical power when compared with the rank sum test. However, when a zero final Barthel score is assigned to patients who have died, the statistical power of the t-test is much reduced. The possible maximal statistical power of dichotomization and ordinal regression is usually much lower than that of the rank sum test. To facilitate comparison and meta-analysis, we recommend that mean values (with standard deviations or standard errors) of Barthel scores should be routinely reported in trials of poststroke interventions. The rank sum test appears the most powerful inferential technique for detecting differences in Barthel scores.

  12. A Randomized Clinical Trial Evaluating a Combined Alcohol Intervention for High-Risk College Students*

    Science.gov (United States)

    Turrisi, Rob; Larimer, Mary E.; Mallett, Kimberly A.; Kilmer, Jason R.; Ray, Anne E.; Mastroleo, Nadine R.; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W.; Montoya, Heidi

    2009-01-01

    Objective: The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Method: Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. Results: The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. Conclusions: The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session. PMID:19515296

  13. A randomized clinical trial evaluating a combined alcohol intervention for high-risk college students.

    Science.gov (United States)

    Turrisi, Rob; Larimer, Mary E; Mallett, Kimberly A; Kilmer, Jason R; Ray, Anne E; Mastroleo, Nadine R; Geisner, Irene Markman; Grossbard, Joel; Tollison, Sean; Lostutter, Ty W; Montoya, Heidi

    2009-07-01

    The current study is a multisite randomized alcohol prevention trial to evaluate the efficacy of both a parenting handbook intervention and the Brief Alcohol Screening and Intervention for College Students (BASICS) intervention, alone and in combination, in reducing alcohol use and consequences among a high-risk population of matriculating college students (i.e., former high school athletes). Students (n = 1,275) completed a series of Web-administered measures at baseline (in the summer before starting college) and follow-up (after 10 months). Students were randomized to one of four conditions: parent intervention only, BASICS only, combined (parent and BASICS), and assessment-only control. Intervention efficacy was tested on a number of outcome measures, including peak blood alcohol concentration, weekly and weekend drinking, and negative consequences. Hypothesized mediators and moderators of intervention effect were tested. The overall results revealed that the combined-intervention group had significantly lower alcohol consumption, high-risk drinking, and consequences at 10-month follow-up, compared with the control group, with changes in descriptive and injunctive peer norms mediating intervention effects. The findings of the present study suggest that the parent intervention delivered to students before they begin college serves to enhance the efficacy of the BASICS intervention, potentially priming students to respond to the subsequent BASICS session.

  14. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  15. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

    NARCIS (Netherlands)

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.

    2015-01-01

    Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was

  16. 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…

  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

  18. 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…

  19. Walking the talk: the need for a trial registry for development interventions

    DEFF Research Database (Denmark)

    Rasmussen, Ole Dahl; Malchow-Møller, Nikolaj; Andersen, Thomas Barnebeck

    2011-01-01

    Recent advances in the use of randomised control trials to evaluate the effect of development interventions promise to enhance our knowledge of what works and why. A core argument supporting randomised studies is the claim that they have high internal validity. The authors argue that this claim...

  20. 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…

  1. Effectiveness of an early intervention for panic symptoms: Randomized controlled trial

    NARCIS (Netherlands)

    Meulenbeek, Petrus Antonius Maria

    2012-01-01

    EFFECTIVENESS OF AN EARLY INTERVENTION FOR PANIC SYMPTOMS: RANDOMIZED CONTROLLED TRIAL Peter Meulenbeek¹,3,4, Godelief Willemse², Filip Smit²,3, Pim Cuijpers²,3 ¹ GGNet, the Netherlands; UTwente ² Trimbos instituut, Netherlands Institute of Mental Health and Addiction ³ Vrije Universiteit van

  2. 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…

  3. Fraction Intervention for Students with Mathematics Difficulties: Lessons Learned from Five Randomized Controlled Trials

    Science.gov (United States)

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

    2017-01-01

    In this article, the authors summarize results from 5 randomized controlled trials assessing the effects of intervention to improve the fraction performance of fourth-grade students at risk for difficulty in learning about fractions. The authors begin by explaining the importance of competence with fractions and why an instructional focus on…

  4. Shifting effects in randomised controlled trials of complex interventions: a new kind of performance bias?

    Science.gov (United States)

    Gold, C; Erkkilä, J; Crawford, M J

    2012-11-01

    Randomised controlled trials (RCTs) aim to provide unbiased estimates of treatment effects. However, the process of implementing trial procedures may have an impact on the performance of complex interventions that rely strongly on the intuition and confidence of therapists. We aimed to examine whether shifting effects over the recruitment period can be observed that might indicate such impact. Three RCTs investigating music therapy vs. standard care were included. The intervention was performed by experienced therapists and based on established methods. We examined outcomes of participants graphically, analysed cumulative effects and tested for differences between first vs. later participants. We tested for potential confounding population shifts through multiple regression models. Cumulative differences suggested trends over the recruitment period. Effect sizes tended to be less favourable among the first participants than later participants. In one study, effects even changed direction. Age, gender and baseline severity did not account for these shifting effects. Some trials of complex interventions have shifting effects over the recruitment period that cannot be explained by therapist experience or shifting demographics. Replication and further research should aim to find out which interventions and trial designs are most vulnerable to this new kind of performance bias. © 2012 John Wiley & Sons A/S.

  5. Reading and language intervention for children at risk of dyslexia: a randomised controlled trial.

    Science.gov (United States)

    Duff, Fiona J; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J; Miles, Jeremy N V; Snowling, Margaret J

    2014-11-01

    Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children identified by research criteria as being at risk of dyslexia (n = 56), and their school-identified peers (n = 89). An Experimental group received two 9-week blocks of daily intervention delivered by trained teaching assistants; the Control group received 9 weeks of typical classroom instruction, followed by 9 weeks of intervention. Following mixed effects regression models and path analyses, small-to-moderate effects were shown on letter knowledge, phoneme awareness and taught vocabulary. However, these were fragile and short lived, and there was no reliable effect on the primary outcome of word-level reading. This new intervention was theoretically motivated and based on previous successful interventions, yet failed to show reliable effects on language and literacy measures following a rigorous evaluation. We suggest that the intervention may have been too short to yield improvements in oral language; and that literacy instruction in and beyond the classroom may have weakened training effects. We argue that reporting of null results makes an important contribution in terms of raising standards both of trial reporting and educational practice. © 2014 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

  6. Protocol for the atWork trial: a randomised controlled trial of a workplace intervention targeting subjective health complaints

    Directory of Open Access Journals (Sweden)

    Tone Langjordet Johnsen

    2016-08-01

    Full Text Available Abstract Background Subjective health complaints, such as musculoskeletal and mental health complaints, have a high prevalence in the general population, and account for a large proportion of sick leave in Norway. It may be difficult to prevent the occurrence of subjective health complaints, but it may be possible to influence employees’ perception and management of these complaints, which in turn may have impact on sick leave and return to work after sick leave. Long term sick leave has many negative health and social consequences, and it is important to gain knowledge about effective interventions to prevent and reduce long term sick leave. Methods/Design This study is a cluster randomised controlled trial to evaluate the effect of the modified atWork intervention, targeting non-specific musculoskeletal complaints and mental health complaints. This intervention will be compared to the original atWork intervention targeting only non-specific musculoskeletal complaints. Kindergartens in Norway are invited to participate in the study and will be randomly assigned to one of the two interventions. Estimated sample size is 100 kindergartens, with a total of approximately 1100 employees. Primary outcome is sick leave at unit level, measured using register data from the Norwegian Labour and Welfare Administration. One kindergarten equals one unit, regardless of number of employees. Secondary outcomes will be measured at the individual level and include coping, health, job satisfaction, social support, and workplace inclusion, collected through questionnaires distributed at baseline and at 12 months follow up. All employees in the included kindergartens are eligible for participating in the survey. Discussion The effect evaluation of the modified atWork intervention is a large and comprehensive project, providing evidence-based information on prevention of long-term sick leave, which may be of considerable benefit both from a societal

  7. 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

  8. A Randomized Trial of a Multicomponent Intervention to Promote Medication Adherence: The Teen Adherence in Kidney Transplant Effectiveness of Intervention Trial (TAKE-IT).

    Science.gov (United States)

    Foster, Bethany J; Pai, Ahna L H; Zelikovsky, Nataliya; Amaral, Sandra; Bell, Lorraine; Dharnidharka, Vikas R; Hebert, Diane; Holly, Crystal; Knauper, Baerbel; Matsell, Douglas; Phan, Veronique; Rogers, Rachel; Smith, Jodi M; Zhao, Huaqing; Furth, Susan L

    2018-03-15

    Poor adherence to immunosuppressive medications is a major cause of premature graft loss among children and young adults. Multicomponent interventions have shown promise but have not been fully evaluated. Unblinded parallel-arm randomized trial to assess the efficacy of a clinic-based adherence-promoting intervention. Prevalent kidney transplant recipients 11 to 24 years of age and 3 or more months posttransplantation at 8 kidney transplantation centers in Canada and the United States (February 2012 to May 2016) were included. Adherence was electronically monitored in all participants during a 3-month run-in, followed by a 12-month intervention. Participants assigned to the TAKE-IT intervention could choose to receive text message, e-mail, and/or visual cue dose reminders and met with a coach at 3-month intervals when adherence data from the prior 3 months were reviewed with the participant. "Action-Focused Problem Solving" was used to address adherence barriers selected as important by the participant. Participants assigned to the control group met with coaches at 3-month intervals but received no feedback about adherence data. The primary outcomes were electronically measured "taking" adherence (the proportion of prescribed doses of immunosuppressive medications taken) and "timing" adherence (the proportion of doses of immunosuppressive medications taken between 1 hour before and 2 hours after the prescribed time of administration) on each day of observation. Secondary outcomes included the standard deviation of tacrolimus trough concentrations, self-reported adherence, acute rejection, and graft failure. 81 patients were assigned to intervention (median age, 15.5 years; 57% male) and 88 to the control group (median age, 15.8 years; 61% male). Electronic adherence data were available for 64 intervention and 74 control participants. Participants in the intervention group had significantly greater odds of taking prescribed medications (OR, 1.66; 95% CI, 1

  9. Worksite Environmental Interventions for Obesity Prevention and Control: Evidence from Group Randomized Trials.

    Science.gov (United States)

    Fernandez, Isabel Diana; Becerra, Adan; Chin, Nancy P

    2014-06-01

    Worksites provide multiple advantages to prevent and treat obesity and to test environmental interventions to tackle its multiple causal factors. We present a literature review of group-randomized and non-randomized trials that tested worksite environmental, multiple component interventions for obesity prevention and control paying particular attention to the conduct of formative research prior to intervention development. The evidence on environmental interventions on measures of obesity appears to be strong since most of the studies have a low (4/8) and unclear (2/8) risk of bias. Among the studies reviewed whose potential risk of bias was low, the magnitude of the effect was modest and sometimes in the unexpected direction. None of the four studies describing an explicit formative research stage with clear integration of findings into the intervention was able to demonstrate an effect on the main outcome of interest. We present alternative explanation for the findings and recommendations for future research.

  10. A randomized control trial of a chronic care intervention for homeless women with alcohol use problems.

    Science.gov (United States)

    Upshur, Carole; Weinreb, Linda; Bharel, Monica; Reed, George; Frisard, Christine

    2015-04-01

    A clinician-randomized trial was conducted using the chronic care model for disease management for alcohol use problems among n = 82 women served in a health care for the homeless clinic. Women with problem alcohol use received either usual care or an intervention consisting of a primary care provider (PCP) brief intervention, referral to addiction services, and on-going support from a care manager (CM) for 6 months. Both groups significantly reduced their alcohol consumption, with a small effect size favoring intervention at 3 months, but there were no significant differences between groups in reductions in drinking or in housing stability, or mental or physical health. However, intervention women had significantly more frequent participation in substance use treatment services. Baseline differences and small sample size limit generalizability, although substantial reductions in drinking for both groups suggest that screening and PCP brief treatment are promising interventions for homeless women with alcohol use problems. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. 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

    The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. College students were randomly assigned to an intervention (n = 64) or a control (n = 65) group. Intervention participants received three 45-minute RCI sessions over subsequent weeks. All participants completed pre- and post-intervention assessments at the beginning of Week 1 and end of Week 3. Student resilience, coping, hope, stress, depression, and anxiety were assessed. RCI participants reported significantly more hope and less stress and depression from Week 1 to Week 3 compared with control participants. Results for resilience also approached statistical significance. Effect sizes were small to moderate. This study found preliminary evidence that RCI is an effective resilience intervention for use with college students.

  12. Effects of superfoods on risk factors of metabolic syndrome: a systematic review of human intervention trials.

    Science.gov (United States)

    van den Driessche, José J; Plat, Jogchum; Mensink, Ronald P

    2018-03-20

    Functional foods can be effective in the prevention of metabolic syndrome and subsequently the onset of cardiovascular diseases and type II diabetes mellitus. More recently, however, another term was introduced to describe foods with additional health benefits: "superfoods", for which, to date, no generally accepted definition exists. Nonetheless, their consumption might contribute to the prevention of metabolic syndrome, for example due to the presence of potentially bioactive compounds. This review provides an overview of controlled human intervention studies with foods described as "superfoods" and their effects on metabolic syndrome parameters. First, an Internet search was performed to identify foods described as superfoods. For these superfoods, controlled human intervention trials were identified until April 2017 investigating the effects of superfood consumption on metabolic syndrome parameters: waist circumference or BMI, blood pressure, or concentrations of HDL cholesterol, triacylglycerol or glucose. Seventeen superfoods were identified, including a total of 113 intervention trials: blueberries (8 studies), cranberries (8), goji berries (3), strawberries (7), chili peppers (3), garlic (21), ginger (10), chia seed (5), flaxseed (22), quinoa (1), cocoa (16), maca (1), spirulina (7), wheatgrass (1), acai berries (0), hemp seed (0) and bee pollen (0). Overall, only limited evidence was found for the effects of the foods described as superfoods on metabolic syndrome parameters, since results were not consistent or the number of controlled intervention trials was limited. The inconsistencies might have been related to intervention-related factors, such as duration or dose. Furthermore, conclusions may be different if other health benefits are considered.

  13. Workplace alcohol harm reduction intervention in Australia: Cluster non-randomised controlled trial.

    Science.gov (United States)

    Pidd, Ken; Roche, Ann; Cameron, Jacqui; Lee, Nicole; Jenner, Linda; Duraisingam, Vinita

    2018-01-18

    The workplace holds substantial potential as an alcohol harm reduction and prevention setting. Few studies have rigorously examined strategies to reduce workplace alcohol-related harm. Hence, an in-situ 3 year trial of a comprehensive alcohol harm reduction intervention in Australian manufacturing workplaces was undertaken. Informed by a gap analysis, a multi-site trial was undertaken. Three manufacturing industry companies, located at four separate worksites, with a minimum of 100 employees were recruited through a local industry network. Based on worksite location, two worksites were allocated to the intervention group and two to the comparison group. The pre-specified primary outcome measure, risky drinking (Alcohol Use Disorders Identification Test, AUDIT-C) and other self-report measures were collected pre-intervention (T1), 12 months (T2) and 24 months post-intervention (T3). No significant intervention effect was observed for the primary outcome measure, risky drinking. Significant intervention effects were observed for increased awareness of alcohol policy and employee assistance. At T3, the odds of intervention group participants being aware of the workplace policy and aware of employee assistance were 48.9% (95% confidence interval 29.3-88.9%) and 79.7% (11.5%, 91.8%), respectively, greater than comparison group participants. Comprehensive tailored workplace interventions can be effective in improving workplace alcohol policy awareness. This is one of few workplace alcohol trials undertaken to-date and the findings make an important contribution to the limited evidence base for workplace alcohol harm prevention initiatives. © 2018 Australasian Professional Society on Alcohol and other Drugs.

  14. A web-based intervention for abused women: the New Zealand isafe randomised controlled trial protocol.

    Science.gov (United States)

    Koziol-McLain, Jane; Vandal, Alain C; Nada-Raja, Shyamala; Wilson, Denise; Glass, Nancy E; Eden, Karen B; McLean, Christine; Dobbs, Terry; Case, James

    2015-01-31

    Intimate partner violence (IPV) and its associated negative mental health consequences are significant for women in New Zealand and internationally. One of the most widely recommended interventions is safety planning. However, few women experiencing violence access specialist services for safety planning. A safety decision aid, weighing the dangers of leaving or staying in an abusive relationship, gives women the opportunity to prioritise, plan and take action to increase safety for themselves and their children. This randomised controlled trial is testing the effectiveness of an innovative, interactive web-based safety decision aid. The trial is an international collaborative concurrent replication of a USA trial (IRIS study NCT01312103), regionalised for the Aotearoa New Zealand culture and offers fully automated online trial recruitment, eligibility screening and consent. In a fully automated web-based trial (isafe) 340 abused women will be randomly assigned in equal numbers to a safety decision aid intervention or usual safety planning control website. Intervention components include: (a) safety priority setting, (b) danger assessment and (c) an individually tailored safety action plan. Self-reported outcome measures are collected at baseline and 3, 6, and 12-months post-baseline. Primary outcomes are depression (measured by Center for Epidemiologic Studies Depression Scale, Revised) and IPV exposure (measured by Severity Violence Against Women Scale) at 12 months post-baseline. Secondary outcomes include PTSD, psychological abuse, decisional conflict, safety behaviors and danger in the relationship. This trial will provide much-needed information on the potential relationships among safety planning, improved mental health, reduced violence as well as decreased decisional conflict related to safety in the abusive relationship. The novel web-based safety decision aid intervention may provide a cost-effective, easily accessed safety-planning resource that can be

  15. A randomized controlled trial of a personalized feedback intervention for problem gamblers.

    Directory of Open Access Journals (Sweden)

    John A Cunningham

    Full Text Available Personalized feedback is a promising self-help for problem gamblers. Such interventions have shown consistently positive results with other addictive behaviours, and our own pilot test of personalized normative feedback materials for gamblers yielded positive findings. The current randomized controlled trial evaluated the effectiveness, and the sustained efficacy, of the personalized feedback intervention materials for problem gamblers.Respondents recruited by a general population telephone screener of Ontario adults included gamblers with moderate and severe gambling problems. Those who agreed to participate were randomly assigned to receive: 1 the full personalized normative feedback intervention; 2 a partial feedback that contained all the feedback information provided to those in condition 1 but without the normative feedback content (i.e., no comparisons provided to general population gambling norms; or 3 a waiting list control condition. The primary hypothesis was that problem gamblers who received the personalized normative feedback intervention would reduce their gambling more than problem gamblers who did not receive any intervention (waiting list control condition by the six-month follow-up.The study found no evidence for the impact of normative personalized feedback. However, participants who received, the partial feedback (without norms reduced the number of days they gambled compared to participants who did not receive the intervention. We concluded that personalized feedback interventions were well received and the materials may be helpful at reducing gambling. Realistically, it can be expected that the personalized feedback intervention may have a limited, short term impact on the severity of participants' problem gambling because the intervention is just a brief screener. An Internet-based version of the personalized feedback intervention tool, however, may offer an easy to access and non-threatening portal that can be used to

  16. A workplace intervention for sick-listed employees with distress: results of a randomised controlled trial.

    Science.gov (United States)

    van Oostrom, Sandra H; van Mechelen, Willem; Terluin, Berend; de Vet, Henrica C W; Knol, Dirk L; Anema, Johannes R

    2010-09-01

    To evaluate the effectiveness of a participatory workplace intervention compared with usual care for sick-listed employees with distress, with regard to return to work (RTW) within the 12-month follow-up. Employees with distress and sick-listed for 2-8 weeks were randomised to a workplace intervention (n=73) or to usual care (n=72). The participatory workplace intervention is a stepwise process involving the sick-listed employee and their supervisor, aimed at reducing obstacles for RTW by reaching consensus about an action plan for RTW. Outcome variables were lasting RTW, cumulative sickness absence and stress-related symptoms. Overall, an HR of 0.99 (95% CI 0.70 to 1.39) indicated no effect of the workplace intervention on lasting RTW. However, the workplace intervention significantly reduced the time until lasting RTW for employees who at baseline intended to return to work despite symptoms with an HR of 2.05 (95% CI 1.22 to 3.45). Employees who intended to return to work despite symptoms returned to work after 55 days in the workplace intervention group and 120 days in the usual care group. No such effect of the intervention was found for employees without baseline intentions to return to work despite symptoms (HR=0.78, 95% CI 0.47 to 1.28). No overall effect of the participatory workplace intervention on lasting RTW was found. The workplace intervention appeared effective on lasting RTW for employees who at baseline intended to return to work despite symptoms. For employees who showed no baseline intention to return to work, the intervention did not have any effect. Other approaches are needed for this subgroup. This trial has been registered at the Dutch National Trial Register ISRCTN92307123.

  17. Moderators of Theory-Based Interventions to Promote Physical Activity in 77 Randomized Controlled Trials.

    Science.gov (United States)

    Bernard, Paquito; Carayol, Marion; Gourlan, Mathieu; Boiché, Julie; Romain, Ahmed Jérôme; Bortolon, Catherine; Lareyre, Olivier; Ninot, Gregory

    2017-04-01

    A meta-analysis of randomized controlled trials (RCTs) has recently showed that theory-based interventions designed to promote physical activity (PA) significantly increased PA behavior. The objective of the present study was to investigate the moderators of the efficacy of these theory-based interventions. Seventy-seven RCTs evaluating theory-based interventions were systematically identified. Sample, intervention, methodology, and theory implementation characteristics were extracted, coded by three duos of independent investigators, and tested as moderators of interventions effect in a multiple-meta-regression model. Three moderators were negatively associated with the efficacy of theory-based interventions on PA behavior: intervention length (≥14 weeks; β = -.22, p = .004), number of experimental patients (β = -.10, p = .002), and global methodological quality score (β = -.08, p = .04). Our findings suggest that the efficacy of theory-based interventions to promote PA could be overestimated consequently due to methodological weaknesses of RCTs and that interventions shorter than 14 weeks could maximize the increase of PA behavior.

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

    Directory of Open Access Journals (Sweden)

    Patrícia Pozas Saboya

    Full Text Available Abstract 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.

  19. A randomized controlled trial of a telehealth parenting intervention: A mixed-disability trial.

    Science.gov (United States)

    Hinton, Sharon; Sheffield, Jeanie; Sanders, Matthew R; Sofronoff, Kate

    2017-06-01

    The quality of parenting a child receives has a major impact on development, wellbeing and future life opportunities. This study examined the efficacy of Triple P Online - Disability (TPOL-D) a telehealth intervention for parents of children with a disability. Ninety-eight parents and carers of children aged 2-12 years diagnosed with a range of developmental, intellectual and physical disabilities were randomly assigned to either the intervention (51) or treatment-as-usual (47) control group. At post-intervention parents receiving the TPOL-D intervention demonstrated significant improvements in parenting practices and parenting self-efficacy, however a significant change in parent-reported child behavioral and emotional problems was not detected. At 3-month follow up intervention gains were maintained and/or enhanced. A significant decrease in parent-reported child behavioral and emotional problems was also detected at this time. The results indicate that TPOL-D is a promising telehealth intervention for a mixed-disability group. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Campbell Karen

    2008-03-01

    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  1. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial.

    Directory of Open Access Journals (Sweden)

    2005-11-01

    Full Text Available BACKGROUND: Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled intervention trial was conducted in a general population of South Africa to test this hypothesis. METHODS AND FINDINGS: A total of 3,274 uncircumcised men, aged 18-24 y, were randomized to a control or an intervention group with follow-up visits at months 3, 12, and 21. Male circumcision was offered to the intervention group immediately after randomization and to the control group at the end of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios (RR of HIV incidence were determined with 95% CI. Protection against HIV infection was calculated as 1 - RR. The trial was stopped at the interim analysis, and the mean (interquartile range follow-up was 18.1 mo (13.0-21.0 when the data were analyzed. There were 20 HIV infections (incidence rate = 0.85 per 100 person-years in the intervention group and 49 (2.1 per 100 person-years in the control group, corresponding to an RR of 0.40 (95% CI: 0.24%-0.68%; p < 0.001. This RR corresponds to a protection of 60% (95% CI: 32%-76%. When controlling for behavioural factors, including sexual behaviour that increased slightly in the intervention group, condom use, and health-seeking behaviour, the protection was of 61% (95% CI: 34%-77%. CONCLUSION: Male circumcision provides a degree of protection against acquiring HIV infection, equivalent to what a vaccine of high efficacy would have achieved. Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa. (Preliminary and partial results were presented at the International AIDS Society 2005 Conference, on 26 July 2005, in Rio de Janeiro, Brazil..

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

    Science.gov (United States)

    McEachan, Rosemary R C; Lawton, Rebecca J; Jackson, Cath; Conner, Mark; Meads, David M; West, Robert M

    2011-04-11

    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. 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. 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. 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. © 2011 McEachan et al; licensee BioMed Central Ltd.

  3. Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial.

    Science.gov (United States)

    Tan, Ai May; LaMontagne, Anthony D; English, Dallas R; Howard, Peter

    2016-08-24

    Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 285.3 to 295.7, p workplace-based intervention substantially improved calcium intake and load-bearing moderate to vigorous physical activity 6 months after the intervention began. Australia New Zealand Clinical Trial Registry ACTRN12616000079448 . Registered 25 January 2016

  4. Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia.

    Science.gov (United States)

    Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

    2014-01-01

    In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health

  5. Randomized trial of four noise-induced hearing loss and tinnitus prevention interventions for children.

    Science.gov (United States)

    Martin, William Hal; Griest, Susan E; Sobel, Judith L; Howarth, Linda C

    2013-02-01

    To evaluate the effectiveness of four NIHL prevention interventions at improving knowledge, attitudes, and intended behaviors regarding sound exposure and appropriate use of hearing protective strategies in children. A randomized trial of the four interventions with a non-intervention comparison group. Questionnaires were completed prior to, immediately after, and three months after each intervention. Interventions included: (1) A classroom presentation by older-peer educators, (2) A classroom presentation by health professionals, (3). Exploration of a museum exhibition, and (4). Exploration of an internet-based virtual museum. A comparison group received no intervention. Fifty-three fourth grade classrooms (1120 students) participated in the study. All interventions produced significant improvements but the number of improvements decreased over time. In terms of effectiveness, the classroom programs were more effective than the internet-based virtual exhibit, which was more effective than the visit to the museum exhibition. Self-reported exposures indicated that as many as 94.5% of participants were at risk for NIHL. Interpersonal, interactive educational interventions such as the classroom program are more effective and have longer impact than self-directed learning experiences for NIHL and tinnitus prevention, however each may have an important role in promoting hearing health in elementary school students.

  6. Childhood obesity prevention interventions in childcare settings: systematic review of randomized and nonrandomized controlled trials.

    Science.gov (United States)

    Zhou, Yuan E; Emerson, Janice S; Levine, Robert S; Kihlberg, Courtney J; Hull, Pamela C

    2014-01-01

    Childcare settings are an opportune location for early intervention programs seeking to prevent childhood obesity. This article reports on a systematic review of controlled trials of obesity prevention interventions in childcare settings. The review was limited to English language articles published in PubMed, Web of Science, and Education Resources Information Center (ERIC) between January 2000 and April 2012. childhood obesity prevention interventions in childcare settings using controlled designs that reported adiposity and behavior outcomes. no interventions, non-childcare settings, clinical weight loss programs, non-English publications. Publications were identified by key word search. Two authors reviewed eligible studies to extract study information and study results. Qualitative synthesis was conducted, including tabulation of information and a narrative summary. Fifteen studies met the eligibility criteria. Seven studies reported improvements in adiposity. Six of the 13 interventions with dietary components reported improved intake or eating behaviors. Eight of the 12 interventions with physical activity components reported improved activity levels or physical fitness. Evidence was mixed for all outcomes. Results should be interpreted cautiously given the high variability in study designs and interventions. Further research needs long-term follow-up, multistrategy interventions that include changes in the nutrition and physical activity environment, reporting of cost data, and consideration of sustainability.

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

    Science.gov (United States)

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

    2017-03-01

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

  8. Feasibility trial of a psychoeducational intervention for parents with personality difficulties: The Helping Families Programme

    Directory of Open Access Journals (Sweden)

    Crispin Day

    2017-12-01

    Full Text Available The Helping Families Programme is a psychoeducational parenting intervention that aims to improve outcomes and engagement for parents affected by clinically significant personality difficulties. This is achieved by working collaboratively with parents to explore ways in which their emotional and relational difficulties impact on parenting and child functioning, and to identify meaningful and realistic goals for change. The intervention is delivered via one-to-one sessions at weekly intervals over a period of 16 weeks. This protocol describes a two-arm parallel RCT in which consenting parents are randomly allocated in a 1:1 ratio to either the Helping Families Programme plus the usual services that the parent may be receiving from their mental health and/or social care providers, or to standard care (usual services plus a brief parenting advice session. The primary clinical outcome will be child behaviour. Secondary clinical outcomes will be child and parental mental health, parenting satisfaction, parenting behaviour and therapeutic alliance. Health economic measures will be collected on quality of life and service use. Outcome measures will be collected at the initial assessment stage, after the intervention is completed and at 6-month follow-up by research staff blind to group allocation. Trial feasibility will be assessed using rates of trial participation at the three time points and intervention uptake, attendance and retention. A parallel process evaluation will use qualitative interviews to ascertain key-workers’ and parent participants' experiences of intervention delivery and trial participation. The results of this feasibility study will determine the appropriateness of proceeding to a full-scale trial.

  9. Managing Loss and Change: Grief Interventions for Dementia Caregivers in a CBT-Based Trial.

    Science.gov (United States)

    Meichsner, Franziska; Schinköthe, Denise; Wilz, Gabriele

    2016-05-01

    Dementia caregivers often experience loss and grief related to general caregiver burden, physical, and mental health problems. Through qualitative content analysis, this study analyzed intervention strategies applied by therapists in a randomized-controlled trial in Germany to assist caregivers in managing losses and associated emotions. Sequences from 61 therapy sessions that included interventions targeting grief, loss, and change were transcribed and analyzed. A category system was developed deductively, and the intercoder reliability was satisfactory. The identified grief intervention strategies were recognition and acceptance of loss and change,addressing future losses,normalization of grief, and redefinition of the relationship Therapists focused on identifying experienced losses, managing associated feelings, and fostering acceptance of these losses. A variety of cognitive-behavioral therapy-based techniques was applied with each strategy. The findings contribute to understanding how dementia caregivers can be supported in their experience of grief and facilitate the development of a manualized grief intervention. © The Author(s) 2015.

  10. Influencing self-rated health among adolescent girls with dance intervention: a randomized controlled trial.

    Science.gov (United States)

    Duberg, Anna; Hagberg, Lars; Sunvisson, Helena; Möller, Margareta

    2013-01-01

    To investigate whether dance intervention influenced self-rated health for adolescent girls with internalizing problems. Randomized controlled intervention trial with follow-up measures at 8, 12, and 20 months after baseline. A Swedish city with a population of 130 000. Girls aged 13 to 18 years with internalizing problems, ie, stress and psychosomatic symptoms. A total of 59 girls were randomized to the intervention group and 53 were randomized to the control group. The intervention comprised dance classes twice weekly during 8 months. Each dance class lasted 75 minutes and the focus was on the joy of movement, not on performance. Self-rated health was the primary outcome; secondary outcomes were adherence to and experience of the intervention. The dance intervention group improved their self-rated health more than the control group at all follow-ups. At baseline, the mean score on a 5-point scale was 3.32 for the dance intervention group and 3.75 for the control group. The difference in mean change was 0.30 (95% CI, -0.01 to 0.61) at 8 months, 0.62 (95% CI, 0.25 to 0.99) at 12 months, and 0.40 (95% CI, 0.04 to 0.77) at 20 months. Among the girls in the intervention group, 67% had an attendance rate of 50% to 100%. A total of 91% of the girls rated the dance intervention as a positive experience. An 8-month dance intervention can improve self-rated health for adolescent girls with internalizing problems. The improvement remained a year after the intervention.

  11. A typology of practice narratives during the implementation of a preventive, community intervention trial.

    Science.gov (United States)

    Riley, Therese; Hawe, Penelope

    2009-12-14

    Traditional methods of process evaluation encompass what components were delivered, but rarely uncover how practitioners position themselves and act relative to an intervention being tested. This could be crucial for expanding our understanding of implementation and its contribution to intervention effectiveness. We undertook a narrative analysis of in-depth, unstructured field diaries kept by nine community development practitioners for two years. The practitioners were responsible for implementing a multi-component, preventive, community-level intervention for mothers of new babies in eight communities, as part of a cluster randomised community intervention trial. We constructed a narrative typology of approaches to practice, drawing on the phenomenology of Alfred Schutz and Max Weber's Ideal Type theory. Five types of practice emerged, from a highly 'technology-based' type that was faithful to intervention specifications, through to a 'romantic' type that held relationships to be central to daily operations, with intact relationships being the final arbiter of intervention success. The five types also differed in terms of how others involved in the intervention were characterized, the narrative form (e.g., tragedy, satire) and where and how transformative change in communities was best created. This meant that different types traded-off or managed the priorities of the intervention differently, according to the deeply held values of their type. The data set constructed for this analysis is unique. It revealed that practitioners not only exercise their agency within interventions, they do so systematically, that is, according to a pattern. The typology is the first of its kind and, if verified through replication, may have value for anticipating intervention dynamics and explaining implementation variation in community interventions.

  12. A typology of practice narratives during the implementation of a preventive, community intervention trial

    Science.gov (United States)

    2009-01-01

    Background Traditional methods of process evaluation encompass what components were delivered, but rarely uncover how practitioners position themselves and act relative to an intervention being tested. This could be crucial for expanding our understanding of implementation and its contribution to intervention effectiveness. Methods We undertook a narrative analysis of in-depth, unstructured field diaries kept by nine community development practitioners for two years. The practitioners were responsible for implementing a multi-component, preventive, community-level intervention for mothers of new babies in eight communities, as part of a cluster randomised community intervention trial. We constructed a narrative typology of approaches to practice, drawing on the phenomenology of Alfred Schutz and Max Weber's Ideal Type theory. Results Five types of practice emerged, from a highly 'technology-based' type that was faithful to intervention specifications, through to a 'romantic' type that held relationships to be central to daily operations, with intact relationships being the final arbiter of intervention success. The five types also differed in terms of how others involved in the intervention were characterized, the narrative form (e.g., tragedy, satire) and where and how transformative change in communities was best created. This meant that different types traded-off or managed the priorities of the intervention differently, according to the deeply held values of their type. Conclusions The data set constructed for this analysis is unique. It revealed that practitioners not only exercise their agency within interventions, they do so systematically, that is, according to a pattern. The typology is the first of its kind and, if verified through replication, may have value for anticipating intervention dynamics and explaining implementation variation in community interventions. PMID:20003399

  13. Effectiveness of interventions to promote physical activity in children and adolescents: systematic review of controlled trials.

    Science.gov (United States)

    van Sluijs, Esther M F; McMinn, Alison M; Griffin, Simon J

    2007-10-06

    To review the published literature on the effectiveness of interventions to promote physical activity in children and adolescents. Systematic review. Literature search using PubMed, SCOPUS, Psychlit, Ovid Medline, Sportdiscus, and Embase up to December 2006. Review methods Two independent reviewers assessed studies against the following inclusion criteria: controlled trial, comparison of intervention to promote physical activity with no intervention control condition, participants younger than 18 years, and reported statistical analyses of a physical activity outcome measure. Levels of evidence, accounting for methodological quality, were assessed for three types of intervention, five settings, and three target populations. The literature search identified 57 studies: 33 aimed at children and 24 at adolescents. Twenty four studies were of high methodological quality, including 13 studies in children. Interventions that were found to be effective achieved increases ranging from an additional 2.6 minutes of physical education related physical activity to 283 minutes per week of overall physical activity. Among children, limited evidence for an effect was found for interventions targeting children from low socioeconomic populations, and environmental interventions. Strong evidence was found that school based interventions with involvement of the family or community and multicomponent interventions can increase physical activity in adolescents. Some evidence was found for potentially effective strategies to increase children's levels of physical activity. For adolescents, multicomponent interventions and interventions that included both school and family or community involvement have the potential to make important differences to levels of physical activity and should be promoted. A lack of high quality evaluations hampers conclusions concerning effectiveness, especially among children.

  14. 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,

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

    NARCIS (Netherlands)

    Verdurmen, J.E.E.; Koning, I.M.; Vollebergh, W.A.M.; Eijnden, R.J.J.M. van den; Engels, R.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,

  16. Process evaluation of a randomised controlled trial of a diabetes prevention intervention in Dutch primary health care: the SLIMMER study

    NARCIS (Netherlands)

    Dongen, van E.J.I.; Duijzer, G.; Oord-Jansen, van S.J.; Beek, ter J.; Huijg, Johanna M.; Leerlooijer, J.N.; Hiddink, G.J.; Feskens, E.J.M.; Haveman-Nies, A.

    2016-01-01

    Objective To investigate (i) how the SLIMMER intervention was delivered and received in Dutch primary health care and (ii) how this could explain intervention effectiveness.
    Design A randomised controlled trial was conducted and subjects were randomly allocated to the intervention (10-month

  17. 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…

  18. Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial

    Directory of Open Access Journals (Sweden)

    Alison Quinlan

    2017-11-01

    Full Text Available Abstract Background Identifying critical life transitions in people’s physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited, and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. Methods This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum with two assessment points at 6 weeks (3.5 months postpartum and 3 months (5 months postpartum and a final follow-up assessment at 6 months (8 months postpartum. The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. Results A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. Discussion If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform

  19. Augmenting psychoeducation with a mobile intervention for bipolar disorder: a randomized controlled trial.

    Science.gov (United States)

    Depp, Colin A; Ceglowski, Jenni; Wang, Vicki C; Yaghouti, Faraz; Mausbach, Brent T; Thompson, Wesley K; Granholm, Eric L

    2015-03-15

    Psychosocial interventions for bipolar disorder are frequently unavailable and resource intensive. Mobile technology may improve access to evidence-based interventions and may increase their efficacy. We evaluated the feasibility, acceptability and efficacy of an augmentative mobile ecological momentary intervention targeting self-management of mood symptoms. This was a randomized single-blind controlled trial with 82 consumers diagnosed with bipolar disorder who completed a four-session psychoeducational intervention and were assigned to 10 weeks of either: 1) mobile device delivered interactive intervention linking patient-reported mood states with personalized self-management strategies, or 2) paper-and-pencil mood monitoring. Participants were assessed at baseline, 6 weeks (mid-point), 12 weeks (post-treatment), and 24 weeks (follow up) with clinician-rated depression and mania scales and self-reported functioning. Retention at 12 weeks was 93% and both conditions were associated with high satisfaction. Compared to the paper-and-pencil condition, participants in the augmented mobile intervention condition showed significantly greater reductions in depressive symptoms at 6 and 12 weeks (Cohen׳s d for both were d=0.48). However, these effects were not maintained at 24-weeks follow up. Conditions did not differ significantly in the impact on manic symptoms or functional impairment. This was not a definitive trial and was not powered to detect moderators and mediators. Automated mobile-phone intervention is feasible, acceptable, and may enhance the impact of brief psychoeducation on depressive symptoms in bipolar disorder. However, sustainment of gains from symptom self-management mobile interventions, once stopped, may be limited. Published by Elsevier B.V.

  20. Randomized trial of a population-based, home-delivered intervention for preschool language delay.

    Science.gov (United States)

    Wake, Melissa; Tobin, Sherryn; Levickis, Penny; Gold, Lisa; Ukoumunne, Obioha C; Zens, Naomi; Goldfeld, Sharon; Le, Ha; Law, James; Reilly, Sheena

    2013-10-01

    Population approaches to lessen the adverse impacts of preschool language delay remain elusive. We aimed to determine whether systematic ascertainment of language delay at age 4 years, followed by a 10-month, 1-on-1 intervention, improves language and related outcomes at age 5 years. A randomized trial nested within a cross-sectional ascertainment of language delay. Children with expressive and/or receptive language scores more than 1.25 SD below the mean at age 4 years entered the trial. Children randomly allocated to the intervention received 18 1-hour home-based therapy sessions. The primary outcomes were receptive and expressive language (Clinical Evaluation of Language Fundamentals - Preschool, 2(nd) Edition) and secondary outcomes were child phonological skills, letter awareness, pragmatic skills, behavior, and quality of life. A total of 1464 children were assessed for language delay at age 4 years. Of 266 eligible children, 200 (13.6%) entered the trial, with 91 intervention (92% of 99) and 88 control (87% of 101) children retained at age 5 years. At age 5 years, there was weak evidence of benefit to expressive (adjusted mean difference, intervention - control, 2.0; 95% confidence interval [CI] -0.5 to 4.4; P = .12) but not receptive (0.6; 95% CI -2.5 to 3.8; P = .69) language. The intervention improved phonological awareness skills (5.0; 95% CI 2.2 to 7.8; P language intervention was successfully delivered by non-specialist staff, found to be acceptable and feasible, and has the potential to improve long-term consequences of early language delay within a public health framework.

  1. 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.

  2. 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

  3. A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions.

    Science.gov (United States)

    Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

    2011-06-01

    If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

  4. Protocol for the atWork trial: a randomised controlled trial of a workplace intervention targeting subjective health complaints.

    Science.gov (United States)

    Johnsen, Tone Langjordet; Indahl, Aage; Baste, Valborg; Eriksen, Hege Randi; Tveito, Torill Helene

    2016-08-19

    Subjective health complaints, such as musculoskeletal and mental health complaints, have a high prevalence in the general population, and account for a large proportion of sick leave in Norway. It may be difficult to prevent the occurrence of subjective health complaints, but it may be possible to influence employees' perception and management of these complaints, which in turn may have impact on sick leave and return to work after sick leave. Long term sick leave has many negative health and social consequences, and it is important to gain knowledge about effective interventions to prevent and reduce long term sick leave. This study is a cluster randomised controlled trial to evaluate the effect of the modified atWork intervention, targeting non-specific musculoskeletal complaints and mental health complaints. This intervention will be compared to the original atWork intervention targeting only non-specific musculoskeletal complaints. Kindergartens in Norway are invited to participate in the study and will be randomly assigned to one of the two interventions. Estimated sample size is 100 kindergartens, with a total of approximately 1100 employees. Primary outcome is sick leave at unit level, measured using register data from the Norwegian Labour and Welfare Administration. One kindergarten equals one unit, regardless of number of employees. Secondary outcomes will be measured at the individual level and include coping, health, job satisfaction, social support, and workplace inclusion, collected through questionnaires distributed at baseline and at 12 months follow up. All employees in the included kindergartens are eligible for participating in the survey. The effect evaluation of the modified atWork intervention is a large and comprehensive project, providing evidence-based information on prevention of long-term sick leave, which may be of considerable benefit both from a societal, organisational, and individual perspective. Clinicaltrials.gov: NCT02396797

  5. Process and effects of a community intervention on malaria in rural Burkina Faso: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    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

  6. A multicenter, longitudinal, interventional, double blind randomized clinical trial in hematopoietic cell transplant recipients residing in remote areas: Lessons learned from the late cytomegalovirus prevention trial

    Directory of Open Access Journals (Sweden)

    Louise E. Kimball

    2016-12-01

    Conclusion: Complex randomized, double-blind, multicenter interventional trials with treatment decisions made at a central coordinating site can be conducted safely and effectively according to Good Clinical Practice (GCP guidelines over a large geographic area.

  7. Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial.

    Directory of Open Access Journals (Sweden)

    Sarah Cockayne

    Full Text Available Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention.Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness.In the primary analysis were 484 (98.2% intervention and 507 (98.1% control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16. The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05 as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01. There was an increase (p = 0.02 in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY difference 0.0129, 95% CI -0.0050 to 0.0314 and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained.There was a small reduction in falls. The intervention may be cost-effective.ISRCTN ISRCTN68240461.

  8. Cohort Randomised Controlled Trial of a Multifaceted Podiatry Intervention for the Prevention of Falls in Older People (The REFORM Trial).

    Science.gov (United States)

    Cockayne, Sarah; Adamson, Joy; Clarke, Arabella; Corbacho, Belen; Fairhurst, Caroline; Green, Lorraine; Hewitt, Catherine E; Hicks, Kate; Kenan, Anne-Maree; Lamb, Sarah E; McIntosh, Caroline; Menz, Hylton B; Redmond, Anthony C; Richardson, Zoe; Rodgers, Sara; Vernon, Wesley; Watson, Judith; Torgerson, David J

    2017-01-01

    Falls are a major cause of morbidity among older people. A multifaceted podiatry intervention may reduce the risk of falling. This study evaluated such an intervention. Pragmatic cohort randomised controlled trial in England and Ireland. 1010 participants were randomised (493 to the Intervention group and 517 to Usual Care) to either: a podiatry intervention, including foot and ankle exercises, foot orthoses and, if required, new footwear, and a falls prevention leaflet or usual podiatry treatment plus a falls prevention leaflet. The primary outcome was the incidence rate of self-reported falls per participant in the 12 months following randomisation. Secondary outcomes included: proportion of fallers and those reporting multiple falls, time to first fall, fear of falling, Frenchay Activities Index, Geriatric Depression Scale, foot pain, health related quality of life, and cost-effectiveness. In the primary analysis were 484 (98.2%) intervention and 507 (98.1%) control participants. There was a small, non statistically significant reduction in the incidence rate of falls in the intervention group (adjusted incidence rate ratio 0.88, 95% CI 0.73 to 1.05, p = 0.16). The proportion of participants experiencing a fall was lower (49.7 vs 54.9%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00, p = 0.05) as was the proportion experiencing two or more falls (27.6% vs 34.6%, adjusted odds ratio 0.69, 95% CI 0.52 to 0.90, p = 0.01). There was an increase (p = 0.02) in foot pain for the intervention group. There were no statistically significant differences in other outcomes. The intervention was more costly but marginally more beneficial in terms of health-related quality of life (mean quality adjusted life year (QALY) difference 0.0129, 95% CI -0.0050 to 0.0314) and had a 65% probability of being cost-effective at a threshold of £30,000 per QALY gained. There was a small reduction in falls. The intervention may be cost-effective. ISRCTN ISRCTN68240461.

  9. Intervention for children with word-finding difficulties: a parallel group randomised control trial.

    Science.gov (United States)

    Best, Wendy; Hughes, Lucy Mari; Masterson, Jackie; Thomas, Michael; Fedor, Anna; Roncoli, Silvia; Fern-Pollak, Liory; Shepherd, Donna-Lynn; Howard, David; Shobbrook, Kate; Kapikian, Anna

    2017-07-31

    The study investigated the outcome of a word-web intervention for children diagnosed with word-finding difficulties (WFDs). Twenty children age 6-8 years with WFDs confirmed by a discrepancy between comprehension and production on the Test of Word Finding-2, were randomly assigned to intervention (n = 11) and waiting control (n = 9) groups. The intervention group had six sessions of intervention which used word-webs and targeted children's meta-cognitive awareness and word-retrieval. On the treated experimental set (n = 25 items) the intervention group gained on average four times as many items as the waiting control group (d = 2.30). There were also gains on personally chosen items for the intervention group. There was little change on untreated items for either group. The study is the first randomised control trial to demonstrate an effect of word-finding therapy with children with language difficulties in mainstream school. The improvement in word-finding for treated items was obtained following a clinically realistic intervention in terms of approach, intensity and duration.

  10. Efficacy of musical interventions in dementia: evidence from a randomized controlled trial.

    Science.gov (United States)

    Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine

    2014-01-01

    Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress.

  11. The results of a 2-year randomized trial of a worksite weight management intervention.

    Science.gov (United States)

    Williams, Andrew E; Stevens, Victor J; Albright, Cheryl L; Nigg, Claudio R; Meenan, Richard T; Vogt, Thomas M

    2014-01-01

    We assessed the effectiveness of a worksite management intervention (the 3W program) for overweight and obese hotel employees. The program was tested in a 2-year cluster-randomized trial involving 30 hotels that employed nearly 12,000 individuals. All participating hotels were on Oahu, Hawaii. The intervention was implemented within hotel worksites. Participants were included in the analysis if they had an initial body mass index (BMI) ≥ 25, were assessed at least twice, were not missing other data needed for the analysis, and did not switch to employment at a hotel in a different experimental condition. Of the 6519 employees we assessed, data from 1207 individuals (intervention: 598; control: 610) met these criteria and contributed to the analysis. The intervention had two components: (1) group meetings and (2) a workplace environment intervention. Weight and waist to height ratio (WHtR) were measured at three annual assessments. The effect of the intervention on change in BMI and WHtR was estimated in hierarchical mixed regression models using full maximum likelihood to estimate model parameters. The effects on change in BMI and WHtR were in the expected direction but were not statistically significant. The 3W program was not effective. The low intensity of the intervention may have contributed to its ineffectiveness.

  12. Quality and Reporting of Cluster Randomized Controlled Trials Evaluating Occupational Therapy Interventions: A Systematic Review.

    Science.gov (United States)

    Tokolahi, Ema; Hocking, Clare; Kersten, Paula; Vandal, Alain C

    2016-01-01

    Growing use of cluster randomized control trials (RCTs) in health care research requires careful attention to study designs, with implications for the development of an evidence base for practice. The objective of this study is to investigate the characteristics, quality, and reporting of cluster RCTs evaluating occupational therapy interventions to inform future research design. An extensive search of cluster RCTs evaluating occupational therapy was conducted in several databases. Fourteen studies met our inclusion criteria; four were protocols. Eleven (79%) justified the use of a cluster RCT and accounted for clustering in the sample size and analysis. All full studies reported the number of clusters randomized, and five reported intercluster correlation coefficients (50%): Protocols had higher compliance. Risk of bias was most evident in unblinding of participants. Statistician involvement was associated with improved trial quality and reporting. Quality of cluster RCTs of occupational therapy interventions is comparable with those from other areas of health research and needs improvement. © The Author(s) 2015.

  13. Effects of web-based interventions on cancer patients' symptoms: review of randomized trials.

    Science.gov (United States)

    Fridriksdottir, N; Gunnarsdottir, S; Zoëga, S; Ingadottir, B; Hafsteinsdottir, E J G

    2018-02-01

    Symptom management is of high priority in cancer care. Information and communication technology allows interventions to be provided through the internet to enhance the delivery of care. This study aimed to review the effects of web-based interventions on cancer patients' symptoms. MEDLINE, PSychINFO, PubMed, CINAHL, and Cochrane databases were systematically searched. Included were randomized controlled trials (RCTs), pilot RCTs, or quasi-experimental (QE) studies focusing on web-based interventions in adult cancer patients with at least one outcome primary or secondary, in terms of symptoms, treatment side effects, or distress. Data were analyzed study by study. Twenty studies were identified. All web interventions included information, 16 included self-management support, 14 included self-monitoring, 13 included feedback/tailored information, 12 used communication with health-care professionals, and eight used communication with other patients. Overall, 13 studies reported positive symptom outcomes. Psychological distress was reported in eight studies with positive intervention effects in three. Symptoms of anxiety/depression were reported in ten studies with positive intervention effects in five. Somatic symptom severity was reported in ten studies with intervention effects found in six, and symptom distress was reported in six studies with intervention effects found in all. This review shows the promising potential of web-based interventions for cancer symptom management, although it was limited by considerable heterogeneity in the interventions tested and targeted outcomes. The multidimensional nature of symptoms was partly addressed; only one study was guided by a comprehensive theoretical model of cancer symptom management. It can only be speculated which web elements are important for effective symptom outcomes. Further testing is needed for web-based cancer symptom management.

  14. 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

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

    Directory of Open Access Journals (Sweden)

    Marianne J E van der Heijden

    Full Text Available 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.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.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.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.

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

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    Gage Brian F

    2010-11-01

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

  17. Feasibility and acceptability of a multiple risk factor intervention: The Step Up randomized pilot trial

    Directory of Open Access Journals (Sweden)

    Richards Julie

    2011-03-01

    Full Text Available Abstract Background Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52. This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity. Methods Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months. Results The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05 and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004 Conclusions Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field. Trial registration The trial is registered with ClinicalTrials.gov (NCT00644995.

  18. Can early intervention policies improve wellbeing? Evidence from a randomized controlled trial

    OpenAIRE

    Michael Daly; Liam Delaney; Orla Doyle; Nick Fitzpatrick; Christine O'Farrelly

    2014-01-01

    Many authors have proposed incorporating measures of well-being into evaluations of public policy. Yet few evaluations use experimental design or examine multiple aspects of well-being, thus the causal impact of public policies on well-being is largely unknown. In this paper we examine the effect of an intensive early intervention program on maternal well-being in a targeted disadvantaged community. Using a randomized controlled trial design we estimate and compare treatment effects on global...

  19. Can Early Intervention Policies Improve Well-being? Evidence from a randomized controlled trial

    OpenAIRE

    Daly, Michael; Delaney, Liam; Doyle, Orla; Fitzpatrick, Nick; O'Farrelly, Christine

    2014-01-01

    Many authors have proposed incorporating measures of well-being into evaluations of public policy. Yet few evaluations use experimental design or examine multiple aspects of wellbeing, thus the causal impact of public policies on well-being is largely unknown. In this paper we examine the effect of an intensive early intervention program on maternal wellbeing in a targeted disadvantaged community. Using a randomized controlled trial design we estimate and compare treatment effects on global w...

  20. Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

    Science.gov (United States)

    Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D

    2017-09-15

    Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

  1. Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial

    OpenAIRE

    Adamsen, Lis; Quist, Morten; Andersen, Christina; M?ller, Tom; Herrstedt, J?rn; Kronborg, Dorte; Baadsgaard, Marie T; Vistisen, Kirsten; Midtgaard, Julie; Christiansen, Birgitte; Stage, Maria; Kronborg, Morten T; R?rth, Mikael

    2009-01-01

    Objective To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced disease. Design Randomised controlled trial. Setting Two university hospitals in Copenhagen, Denmark. Participants 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing...

  2. The matching quality of experimental and control interventions in blinded pharmacological randomised clinical trials

    DEFF Research Database (Denmark)

    Bello, Segun; Wei, Maoling; Hilden, Jørgen

    2016-01-01

    to systematically identify and analyse studies of matching quality in drug trials. Our primary objective was to assess the proportion of studies that concluded that the matching was inadequate; our secondary objective was to describe mechanisms for inadequate matching. Methods: Systematic review. We searched Pub......Med, Google Scholar and Web of Science Citation Index for studies that assessed whether supposedly indistinguishable interventions (experimental and control) in randomized clinical drug trials could be distinguished based on physical properties (e.g. appearance or smell). Two persons decided on study...... eligibility and extracted data independently. Our primary analysis was based on the conclusions of each study. In supportive analyses, we defined a low and a high threshold for inadequate matching. We summarised results qualitatively. Results: We included studies of 36 trials, of which 28 (78 %) were...

  3. Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial.

    Science.gov (United States)

    Chadi, Nicholas; McMahon, Audrey; Vadnais, Majorie; Malboeuf-Hurtubise, Catherine; Djemli, Anissa; Dobkin, Patricia L; Lacroix, Jacques; Luu, Thuy Mai; Haley, Nancy

    2016-01-01

    To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (padolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain.

  4. Compliance with Sport Injury Prevention Interventions in Randomised Controlled Trials: A Systematic Review.

    Science.gov (United States)

    van Reijen, Miriam; Vriend, Ingrid; van Mechelen, Willem; Finch, Caroline F; Verhagen, Evert A

    2016-08-01

    Sport injury prevention studies vary in the way compliance with an intervention is defined, measured and adjusted for. The objective of this systematic review was to assess the extent to which sport injury prevention randomised controlled trials (RCTs) have defined, measured and adjusted results for compliance with an injury prevention intervention. An electronic search was performed in MEDLINE, PubMed, the Cochrane Center of Controlled Trials, CINAHL (Cumulative Index to Nursing and Allied Health Literature), PEDro (Physiotherapy Evidence Database) and SPORTDiscus. English RCTs, quasi-RCTs and cluster-RCTs were considered eligible. Trials that involved physically active individuals or examined the effects of an intervention aimed at the prevention of sport- or physical activity-related injuries were included. Of the total of 100 studies included, 71.6 % mentioned compliance or a related term, 68.8 % provided details on compliance measurement and 51.4 % provided compliance data. Only 19.3 % analysed the effect of compliance rates on study outcomes. While studies used heterogeneous methods, pooled effects could not be presented. Studies that account for compliance demonstrated that compliance significant affects study outcomes. The way compliance is dealt with in preventions studies is subject to a large degree of heterogeneity. Valid and reliable tools to measure and report compliance are needed and should be matched to a uniform definition of compliance.

  5. 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

  6. Lay Health Worker Intervention Improved Compliance with Hepatitis B Vaccination in Asian Americans: Randomized Controlled Trial.

    Science.gov (United States)

    Juon, Hee-Soon; Strong, Carol; Kim, Frederic; Park, Eunmi; Lee, Sunmin

    2016-01-01

    This study aimed to evaluate the effect of a lay health worker (LHW) telephone intervention on completing a series of hepatitis B virus (HBV) vaccinations among foreign-born Asian Americans in the Baltimore-Washington Metropolitan area. During the period of April 2013 and March 2014, we recruited Asian Americans who were 18 years of age and older in the community-based organizations. Of the 645 eligible participants, 600 (201 Chinese, 198 Korean, 201 Vietnamese) completed a pretest survey and received hepatitis B screening. Based on the screening results, we conducted a randomized controlled trial among those unprotected (HBsAg-/HBsAB-) by assigning them either to an intervention group (n = 124) or control group (n = 108). The intervention group received a list of resources by mails for where to get free vaccinations as well as reminder calls for vaccinations from trained LHWs, while the control group received only list of resources by mail. Seven months after mailing the HBV screening results, trained LHWs followed up with all participants by phone to ask how many of the recommended series of 3 vaccinations they had received: none, 1 or 2, or all 3 (complete). Their self-reported vaccinations were verified with the medical records. Multinomial logistic regressions were used to examine the effect of the LHW intervention. Process evaluation was conducted by asking study participants in the intervention group to evaluate the performance of the LHWs. After seven months, those in the intervention group were more likely to have 1 or more vaccines than the control group, compared to the no vaccination group (OR = 3.04, 95% CI, 1.16, 8.00). Also, those in the intervention group were more likely to complete a series of vaccinations than the control group, compared to the no vaccination group (OR = 7.29, 95% CI 3.39, 15.67). The most important barrier preventing them from seeking hepatitis B vaccinations was lack of time to get the vaccination. The most important promoters

  7. Internet-based early intervention to prevent posttraumatic stress disorder in injury patients: randomized controlled trial.

    Science.gov (United States)

    Mouthaan, Joanne; Sijbrandij, Marit; de Vries, Giel-Jan; Reitsma, Johannes B; van de Schoot, Rens; Goslings, J Carel; Luitse, Jan S K; Bakker, Fred C; Gersons, Berthold P R; Olff, Miranda

    2013-08-13

    -risk individuals who are more likely to benefit from the intervention. International Standard Randomized Controlled Trial Number (ISRCTN): 57754429; http://www.controlled-trials.com/ISRCTN57754429 (Archived by WebCite at http://webcitation.org/6FeJtJJyD).

  8. A systematic review of randomized controlled trials testing the efficacy of psychosocial interventions for gastrointestinal cancers.

    Science.gov (United States)

    Steel, Jennifer L; Bress, Kathryn; Popichak, Lydia; Evans, Jonathan S; Savkova, Alexandra; Biala, Michelle; Ordos, Josh; Carr, Brian I

    2014-06-01

    Psychological morbidity in those diagnosed with cancer has been shown to result in poorer quality of life and increase the risk of mortality. As a result, researchers have designed and tested psychosocial interventions to improve quality of life and survival of patients diagnosed with cancer. A systematic review of the literature was performed to describe the psychosocial interventions that have been tested in patients with gastrointestinal cancers. Databases such as MEDLINE, PsychINFO, PubMed, MedLine, and Cochrane Reviews were searched. The searches were inclusive of studies published in English between 1966 and October 2013. Raters conducted full-text review of the resulting articles for the following eligibility criteria: (1) participants were 18 years or older, (2) the majority of patients in the sample were diagnosed with a gastrointestinal cancer, (3) the trial was testing a psychosocial intervention, and (4) random assignment to one or more interventions versus a usual care, placebo, attention control, or waiting-list control condition. The interventions that were eligible for this review included psychosocial or behavioral intervention (e.g., cognitive behavioral therapy, problem solving, educational, and collaborative care), physical activity, and/or psychopharmacologic treatment (e.g., selective serotonin reuptake inhibitor). Interventions that included dietary changes were not included in the present review. Study quality was also assessed using the Physiotherapy Evidence Database (PEDro) system. The results of the review resulted in a finding of eight studies to have been conducted, testing psychosocial interventions, in patients with gastrointestinal cancers. Findings of these studies suggested that the interventions were effective in reducing psychological and physical symptoms associated with the cancer, improved quality of life, and reduced immune system dysregulation, and one study demonstrated an improvement in survival. Two studies reported no

  9. Lay Health Worker Intervention Improved Compliance with Hepatitis B Vaccination in Asian Americans: Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Hee-Soon Juon

    Full Text Available This study aimed to evaluate the effect of a lay health worker (LHW telephone intervention on completing a series of hepatitis B virus (HBV vaccinations among foreign-born Asian Americans in the Baltimore-Washington Metropolitan area.During the period of April 2013 and March 2014, we recruited Asian Americans who were 18 years of age and older in the community-based organizations. Of the 645 eligible participants, 600 (201 Chinese, 198 Korean, 201 Vietnamese completed a pretest survey and received hepatitis B screening. Based on the screening results, we conducted a randomized controlled trial among those unprotected (HBsAg-/HBsAB- by assigning them either to an intervention group (n = 124 or control group (n = 108. The intervention group received a list of resources by mails for where to get free vaccinations as well as reminder calls for vaccinations from trained LHWs, while the control group received only list of resources by mail. Seven months after mailing the HBV screening results, trained LHWs followed up with all participants by phone to ask how many of the recommended series of 3 vaccinations they had received: none, 1 or 2, or all 3 (complete. Their self-reported vaccinations were verified with the medical records. Multinomial logistic regressions were used to examine the effect of the LHW intervention. Process evaluation was conducted by asking study participants in the intervention group to evaluate the performance of the LHWs.After seven months, those in the intervention group were more likely to have 1 or more vaccines than the control group, compared to the no vaccination group (OR = 3.04, 95% CI, 1.16, 8.00. Also, those in the intervention group were more likely to complete a series of vaccinations than the control group, compared to the no vaccination group (OR = 7.29, 95% CI 3.39, 15.67. The most important barrier preventing them from seeking hepatitis B vaccinations was lack of time to get the vaccination. The most important

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

    Science.gov (United States)

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

    2014-09-10

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

  11. Evaluation of a physical activity intervention for new parents: protocol paper for a randomized trial.

    Science.gov (United States)

    Quinlan, Alison; Rhodes, Ryan E; Beauchamp, Mark R; Symons Downs, Danielle; Warburton, Darren E R; Blanchard, Chris M

    2017-11-09

    Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group. This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity. A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures. If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners. This trial has been

  12. A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions

    Science.gov (United States)

    Ashton, Carol M; Wray, Nelda P; Jarman, Anna F; Kolman, Jacob M; Wenner, Danielle M; Brody, Baruch A

    2013-01-01

    Background If trials of therapeutic interventions are to serve society’s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world’s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial’s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. PMID:21429960

  13. Quality of intervention delivery in a cluster randomised controlled trial: a qualitative observational study with lessons for fidelity.

    Science.gov (United States)

    James, Karen; Quirk, Alan; Patterson, Sue; Brennan, Geoff; Stewart, Duncan

    2017-11-17

    Understanding intervention fidelity is an essential part of the evaluation of complex interventions because fidelity not only affects the validity of trial findings, but also because studies of fidelity can be used to identify barriers and facilitators to successful implementation, and so provide important information about factors likely to impact the uptake of the intervention into clinical practice. Participant observation methods have been identified as being particularly valuable in studies of fidelity, yet are rarely used. This study aimed to use these methods to explore the quality of implementation of a complex intervention (Safewards) on mental health wards during a cluster randomised controlled trial. Specific aims were firstly to describe the different ways in which the intervention was implemented, and secondly to explore the contextual factors moderating the quality of intervention delivery, in order to inform 'real world' implementation of the intervention. Safewards was implemented on 16 mental health wards in England. We used Research Assistants (RAs) trained in participant observation to record qualitative observational data on the quality of intervention delivery (n = 565 observations). At the end of the trial, two focus groups were conducted with RAs, which were used to develop the coding framework. Data were analysed using thematic analysis. There was substantial variation in intervention delivery between wards. We observed modifications to the intervention which were both fidelity consistent and inconsistent, and could enhance or dilute the intervention effects. We used these data to develop a typology which describes the different ways in which the intervention was delivered. This typology could be used as a tool to collect qualitative observational data about fidelity during trials. Moderators of Safewards implementation included systemic, interpersonal, and individual factors and patient responses to the intervention. Our study

  14. 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.

  15. Attenuation of neuropsychiatric symptoms and caregiver burden in Alzheimer's disease by motor intervention: a controlled trial

    Directory of Open Access Journals (Sweden)

    Florindo Stella

    2011-01-01

    Full Text Available OBJECTIVE: To analyze the effects of motor intervention on the neuropsychiatric symptoms of Alzheimer's disease and on the caregivers' burden. DESIGN: This is a controlled trial evaluating the effects of a motor intervention program on the neuropsychiatric symptoms. SETTING: The intervention was performed on community patients from two university centers specializing in physical exercise for the elderly. SUBJECTS: Patients with Alzheimer's disease were divided into two groups: sixteen received the motor intervention and sixteen controls (five controls were excluded because of clinical intercurrences. INTERVENTIONS: Aerobic exercises (flexibility, strength, and agility and functional balance exercises were conducted over six months for 60 minutes three times per week. MAIN MEASURES: Psychopathological features of patients were evaluated with the Neuropsychiatric Inventory and Cornell Scale for Depression in Dementia. Caregivers were evaluated using the Neuropsychiatric Inventory-Distress and Burden Interview. A two-way analysis of variance (ANOVA was applied to observe interactions (pre- vs. post-intervention; participants vs. controls. RESULTS: Patients from the intervention presented a significant reduction in neuropsychiatric conditions when compared to controls (Neuropsychiatric Inventory: F: 11.12; p = 0.01; Cornell Depression scale: F: 11.97; p = 0.01. The burden and stress of caregivers responsible for patients who participated in the intervention significantly decreased when compared to caregivers responsible for controls (Neuropsychiatric Inventory-Distress: F: 9.37; p = 0.01; Burden Interview: F: 11.28; p = 0.01. CONCLUSIONS: Aerobic exercise was associated with a reduction in the neuropsychiatric symptoms and contributed to attenuate the caregivers' burden. However, the researchers were not blinded to the patient's intervention status, which constitutes an important limitation of this study.

  16. Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major

    DEFF Research Database (Denmark)

    Jakobsen, Janus Christian

    2014-01-01

    trial received similar antidepressants as co-interventions. All trials had high risk of bias. Four trials assessed "interpersonal psychotherapy" and one trial "short psychodynamic supportive psychotherapy". Both of these interventions are different forms of psychodynamic therapy. Meta-analysis showed......Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy and psychodynamic therapy may be effective treatment options for major depressive disorder, but the effects have only had limited assessment in systematic...... reviews. The two modern forms of psychotherapy, "third wave" cognitive therapy and mentalization-based treatment, have both gained some ground as treatments of psychiatric disorders. No randomised trial has compared the effects of these two interventions for major depressive disorder. We performed two...

  17. Characteristics of control group participants who increased their physical activity in a cluster-randomized lifestyle intervention trial.

    Science.gov (United States)

    Waters, Lauren A; Reeves, Marina M; Fjeldsoe, Brianna S; Eakin, Elizabeth G

    2011-01-11

    Meaningful improvement in physical activity among control group participants in lifestyle intervention trials is not an uncommon finding, and may be partly explained by participant characteristics. This study investigated which baseline demographic, health and behavioural characteristics were predictive of successful improvement in physical activity in usual care group participants recruited into a telephone-delivered physical activity and diet intervention trial, and descriptively compared these characteristics with those that were predictive of improvement among intervention group participants. Data come from the Logan Healthy Living Program, a primary care-based, cluster-randomized controlled trial of a physical activity and diet intervention. Multivariable logistic regression models examined variables predictive of an improvement of at least 60 minutes per week of moderate-to-vigorous intensity physical activity among usual care (n = 166) and intervention group (n = 175) participants. Baseline variables predictive of a meaningful change in physical activity were different for the usual care and intervention groups. Being retired and completing secondary school (but no further education) were predictive of physical activity improvement for usual care group participants, whereas only baseline level of physical activity was predictive of improvement for intervention group participants. Higher body mass index and being unmarried may also be predictors of physical activity improvement for usual care participants. This is the first study to examine differences in predictors of physical activity improvement between intervention group and control group participants enrolled in a physical activity intervention trial. While further empirical research is necessary to confirm findings, results suggest that participants with certain socio-demographic characteristics may respond favourably to minimal intensity interventions akin to the treatment delivered to participants in

  18. Characteristics of control group participants who increased their physical activity in a cluster-randomized lifestyle intervention trial

    Directory of Open Access Journals (Sweden)

    Fjeldsoe Brianna S

    2011-01-01

    Full Text Available Abstract Background Meaningful improvement in physical activity among control group participants in lifestyle intervention trials is not an uncommon finding, and may be partly explained by participant characteristics. This study investigated which baseline demographic, health and behavioural characteristics were predictive of successful improvement in physical activity in usual care group participants recruited into a telephone-delivered physical activity and diet intervention trial, and descriptively compared these characteristics with those that were predictive of improvement among intervention group participants. Methods Data come from the Logan Healthy Living Program, a primary care-based, cluster-randomized controlled trial of a physical activity and diet intervention. Multivariable logistic regression models examined variables predictive of an improvement of at least 60 minutes per week of moderate-to-vigorous intensity physical activity among usual care (n = 166 and intervention group (n = 175 participants. Results Baseline variables predictive of a meaningful change in physical activity were different for the usual care and intervention groups. Being retired and completing secondary school (but no further education were predictive of physical activity improvement for usual care group participants, whereas only baseline level of physical activity was predictive of improvement for intervention group participants. Higher body mass index and being unmarried may also be predictors of physical activity improvement for usual care participants. Conclusion This is the first study to examine differences in predictors of physical activity improvement between intervention group and control group participants enrolled in a physical activity intervention trial. While further empirical research is necessary to confirm findings, results suggest that participants with certain socio-demographic characteristics may respond favourably to minimal intensity

  19. Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

    Science.gov (United States)

    Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

    2016-01-28

    Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

  20. The HOPE social media intervention for global HIV prevention in Peru: a cluster randomised controlled trial.

    Science.gov (United States)

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

    2015-01-01

    Social media technologies offer new approaches to HIV prevention and promotion of testing. We examined the efficacy of the Harnessing Online Peer Education (HOPE) social media intervention to increase HIV testing among men who have sex with men (MSM) in Peru. In this cluster randomised controlled trial, Peruvian MSM from Greater Lima (including Callao) who had sex with a man in the past 12 months, were 18 years of age or older, were HIV negative or serostatus unknown, and had a Facebook account or were willing to create one (N=556) were randomly assigned (1:1) by concealed allocation to join intervention or control groups on Facebook for 12 weeks. For the intervention, Peruvian MSM were trained and assigned to be HIV prevention mentors (peer-leaders) to participants in Facebook groups. The interventions period lasted 12 weeks. Participants in control groups received an enhanced standard of care, including standard offline HIV prevention available in Peru and 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 also completed questionnaires on HIV risk behaviours and social media use at baseline and 12 week follow-up. The primary outcome was the number of participants who received a free HIV test at a local community clinic. The facebook groups were analysed as clusters to account for intracluster correlations. This trial is registered with ClinicalTrials.gov, number NCT01701206. Of 49 peer-leaders recruited, 34 completed training and were assigned at random to the intervention Facebook groups. 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

  1. A behavioural intervention increases physical activity in people with subacute spinal cord injury: a randomised trial

    Directory of Open Access Journals (Sweden)

    Carla FJ Nooijen

    2016-01-01

    Full Text Available Questions: For people with subacute spinal cord injury, does rehabilitation that is reinforced with the addition of a behavioural intervention to promote physical activity lead to a more active lifestyle than rehabilitation alone? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis, and blinded assessors. Participants: Forty-five adults with subacute spinal cord injury who were undergoing inpatient rehabilitation and were dependent on a manual wheelchair. The spinal cord injuries were characterised as: tetraplegia 33%; motor complete 62%; mean time since injury 150 days (SD 74. Intervention: All participants received regular rehabilitation, including handcycle training. Only the experimental group received a behavioural intervention promoting an active lifestyle after discharge. This intervention involved 13 individual sessions delivered by a coach who was trained in motivational interviewing; it began 2 months before and ended 6 months after discharge from inpatient rehabilitation. Outcome measures: The primary outcome was physical activity, which was objectively measured with an accelerometer-based activity monitor 2 months before discharge, at discharge, and 6 and 12 months after discharge from inpatient rehabilitation. The accelerometry data were analysed as total wheeled physical activity, sedentary time and motility. Self-reported physical activity was a secondary outcome. Results: The behavioural intervention significantly increased wheeled physical activity (overall between-group difference from generalised estimating equation 21 minutes per day, 95% CI 8 to 35. This difference was evident 6 months after discharge (28 minutes per day, 95% CI 8 to 48 and maintained at 12 months after discharge (25 minutes per day, 95% CI 1 to 50. No significant intervention effect was found for sedentary time or motility. Self-reported physical activity also significantly improved. Conclusion: The behavioural

  2. Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services.

    Science.gov (United States)

    Bonell, Chris; Moore, Graham; Warren, Emily; Moore, Laurence

    2018-04-19

    We have previously proposed that trials of social interventions can be done within a "realist" research paradigm. Critics have countered that such trials are irredeemably positivist and asked us to explain our philosophical position. We set out to explore what is meant by positivism and whether trials adhere to its tenets (of necessity or in practice) via a narrative literature review of social science and philosophical discussions of positivism, and of the trials literature and three case studies of trials. The philosophical literature described positivism as asserting: (1) the epistemic primacy of sensory information; (2) the requirement that theoretical terms equate with empirical terms; (3) the aim of developing universal laws; and (4) the unity of method between natural and social sciences. Regarding (1), it seems that rather than embodying the epistemic primacy of sensory data, randomised controlled trials (RCTs) of social interventions in health embrace an anti-positivist approach aiming to test hypotheses derived deductively from prior theory. Considering (2), while some RCTs of social interventions appear to limit theorisation to concepts with empirical analogues, others examine interventions underpinned by theories engaging with mechanisms and contextual contingencies not all of which can be measured. Regarding (3), while some trialists and reviewers in the health field do limit their role to estimating statistical trends as a mechanistic form of generalisation, this is not an inevitable feature of RCT-based research. Trials of social interventions can instead aim to generalise at the level of theory which specifies how mechanisms are contingent on context. In terms of (4), while RCTs are used to examine biomedical as well as social interventions in health, RCTs of social interventions are often distinctive in using qualitative analyses of data on participant accounts to examine questions of meaning and agency not pursued in the natural sciences. We

  3. Economic analysis of a randomized trial of academic detailing interventions to improve use of antihypertensive medications.

    Science.gov (United States)

    Simon, Steven R; Rodriguez, Hector P; Majumdar, Sumit R; Kleinman, Ken; Warner, Cheryl; Salem-Schatz, Susanne; Miroshnik, Irina; Soumerai, Stephen B; Prosser, Lisa A

    2007-01-01

    The authors estimated the costs and cost savings of implementing a program of mailed practice guidelines and single-visit individual and group academic detailing interventions in a randomized controlled trial to improve the use of antihypertensive medications. Analyses took the perspective of the payer. The total costs of the mailed guideline, group detailing, and individual detailing interventions were estimated at 1000 dollars, 5500 dollars, and 7200 dollars, respectively, corresponding to changes in the average daily per person drug costs of -0.0558 dollars (95% confidence interval, -0.1365 dollars to 0.0250 dollars) in the individual detailing intervention and -0.0001 dollars (95% confidence interval, -0.0803 dollars to 0.0801 dollars) in the group detailing intervention, compared with the mailed intervention. For all patients with incident hypertension in the individual detailing arm, the annual total drug cost savings were estimated at 21,711 dollars (95% confidence interval, 53,131 dollars savings to 9709 dollars cost increase). Information on costs of academic detailing could assist with health plan decision making in developing interventions to improve prescribing.

  4. A health advocacy intervention for adolescents with intellectual disability: a cluster randomized controlled trial.

    Science.gov (United States)

    Lennox, Nicholas; McPherson, Lyn; Bain, Chris; O'Callaghan, Michael; Carrington, Suzanne; Ware, Robert S

    2016-12-01

    Adolescents with intellectual disability experience poorer heath than their peers in the general population, partially due to communication barriers and knowledge gaps in their health history. This study aimed to test a health intervention package against usual care for a range of health promotion and disease detection outcomes. A parallel-group cluster randomized controlled trial was conducted with Australian adolescents with intellectual disability living in the community. Randomization occurred at school level. The intervention package consisted of classroom-based health education, a hand-held personalized health record, and a health check. Evidence of health promotion, disease prevention, and case-finding activities were extracted from general practitioners' records for 12 months post-intervention. Clinical data was available for 435 of 592 (73.5%) participants from 85 schools. Adolescents allocated to receive the health intervention were more likely to have their vision (odds ratio [OR] 3.3; 95% confidence interval [CI] 1.8-6.1) and hearing (OR 2.7; 95% CI 1.0-7.3) tested, their blood pressure checked (OR 2.4; 95% CI 1.6-3.7), and weight recorded (OR 4.8; 95% CI 3.1-7.6). There was no difference between health intervention and usual care for identification of new diseases. The school-based intervention package increased healthcare activity in adolescents with intellectual disability living in the community. © 2016 Mac Keith Press.

  5. Intervention based on Transtheoretical Model promotes anthropometric and nutritional improvements - a randomized controlled trial.

    Science.gov (United States)

    Menezes, Mariana Carvalho de; Mingoti, Sueli Aparecida; Cardoso, Clareci Silva; Mendonça, Raquel de Deus; Lopes, Aline Cristine Souza

    2015-04-01

    To analyze the effects of an intervention based on the Transtheoretical Model on anthropometric and dietetic profile among women in the Primary Health Care in Brazil. Randomized controlled trial. The control group participated in physical activity and open group-education regarding nutrition of usual care. The intervention group participated in 10 workshops based on the Transtheoretical Model. Seventy-one women completed the study, with a mean age of 57.9±11.7years. Participants in the intervention group showed an improved body perception, reduced weight and body mass index post-intervention, and lower consumption of calories and foods high in fat. Significant weight reduction in the intervention group was associated with higher per capita income, reduced consumption of protein, reduced consumption of lipids, and the removal of visible fat from red meat and skin from chicken. An intervention based on the Transtheoretical Model promoted reduction in consumption of foods high in calories and fat, with positive effects on weight and body perception. These results provide evidence of the applicability and benefit of the Transtheoretical Model within primary care. Copyright © 2014 Elsevier Ltd. All rights reserved.

  6. A Nutrition Education Intervention Trial for Adolescent Girls in Isfahan: Study Design and Protocol

    Directory of Open Access Journals (Sweden)

    Morvarid Ghasab Shirazi

    2016-11-01

    Full Text Available BackgroundNutrition behaviors of adolescent girls is of serious health concerns. Although nutrition education interventions in Iran have met with some success, most of them could not promote nutrition behavioral changes. The aim of our study is to determine a school-based nutrition education intervention to improve adolescents’ nutrition behaviors and behavioral mediators based on the social cognitive theory (SCT.Materials and MethodsThis study is a single-blind randomized controlled trial. Eligible participants will be all student girls in grade 6 and 7, their parents and teachers in Isfahan governmental schools. This multi com­ponent school-based intervention include adolescents’ nutrition education package, parents’ nutrition massages, participatory homework, parents and teachers nutrition education package, supportive group, and collaboration with decision makers. Changing in nutrition behaviors including breakfast, fruit and vegetable, snack and fast food consumption will be examined, as primary outcome. Secondary outcome will be behavioral mediators such as knowledge, self-efficacy, intention, situation, self-regulation, social support, outcome expectations and expectancies, in adolescent girls. The outcomes will be assessed at baseline, and after 3 and 6-month follow-up.DiscussionThis study evaluates a school-based, guided SCT intervention, designed to improve healthy dietary behaviors, nutrition knowledge of adolescent girls. Few behavioral interventions have targeted this high-risk population in Iran. The intervention seems to be promising and has the potential to bridge the gap of the limited program outcomes of nutrition education in Iranian adolescents.

  7. Work, Weight, and Wellness: the 3W Program: a worksite obesity prevention and intervention trial.

    Science.gov (United States)

    Williams, Andrew E; Vogt, Thomas M; Stevens, Victor J; Albright, Cheryl A; Nigg, Claudio R; Meenan, Richard T; Finucane, Melissa L

    2007-11-01

    In this paper, we describe the aims, intervention, and design of the Work, Weight, and Wellness program, a group-randomized worksite obesity prevention and intervention trial being conducted at 31 hotels with 11,559 employees on the island of Oahu in Hawaii. We report baseline prevalence of overweight and obesity, and the distribution of BMI (kilograms per meter squared) across sex, race, and job categories. We also describe factors that have influenced intervention adoption and employee participation. The study's primary outcome is change in BMI among hotel employees over a 2-year intervention period. The intervention includes environmental and group components that target diet, physical activity, and weight management. Men, Pacific Islanders, and individuals employed in managerial or facility maintenance roles had higher prevalence of obesity and higher mean BMI than women and individuals from other races or in other occupational categories. These results may be helpful in guiding choices about the adoption or design of future worksite and community interventions addressing at-risk ethnically diverse populations and are especially relevant to the hotel industry and similar industries.

  8. Screening and brief intervention for obesity in primary care: a parallel, two-arm, randomised trial.

    Science.gov (United States)

    Aveyard, Paul; Lewis, Amanda; Tearne, Sarah; Hood, Kathryn; Christian-Brown, Anna; Adab, Peymane; Begh, Rachna; Jolly, Kate; Daley, Amanda; Farley, Amanda; Lycett, Deborah; Nickless, Alecia; Yu, Ly-Mee; Retat, Lise; Webber, Laura; Pimpin, Laura; Jebb, Susan A

    2016-11-19

    Obesity is a common cause of non-communicable disease. Guidelines recommend that physicians screen and offer brief advice to motivate weight loss through referral to behavioural weight loss programmes. However, physicians rarely intervene and no trials have been done on the subject. We did this trial to establish whether physician brief intervention is acceptable and effective for reducing bodyweight in patients with obesity. In this parallel, two-arm, randomised trial, patients who consulted 137 primary care physicians in England were screened for obesity. Individuals could be enrolled if they were aged at least 18 years, had a body-mass index of at least 30 kg/m 2 (or at least 25 kg/m 2 if of Asian ethnicity), and had a raised body fat percentage. At the end of the consultation, the physician randomly assigned participants (1:1) to one of two 30 s interventions. Randomisation was done via preprepared randomisation cards labelled with a code representing the allocation, which were placed in opaque sealed envelopes and given to physicians to open at the time of treatment assignment. In the active intervention, the physician offered referral to a weight management group (12 sessions of 1 h each, once per week) and, if the referral was accepted, the physician ensured the patient made an appointment and offered follow-up. In the control intervention, the physician advised the patient that their health would benefit from weight loss. The primary outcome was weight change at 12 months in the intention-to-treat population, which was assessed blinded to treatment allocation. We also assessed asked patients' about their feelings on discussing their weight when they have visited their general practitioner for other reasons. Given the nature of the intervention, we did not anticipate any adverse events in the usual sense, so safety outcomes were not assessed. This trial is registered with the ISRCTN Registry, number ISRCTN26563137. Between June 4, 2013, and Dec 23, 2014, we

  9. Expanding the scope and relevance of health interventions: Moving beyond clinical trials and behavior change models

    Directory of Open Access Journals (Sweden)

    Khary K. Rigg

    2014-07-01

    Full Text Available An overemphasis on clinical trials and behavior change models has narrowed the knowledge base that can be used to design interventions. The overarching point is that the process of overanalyzing variables is impeding the process of gaining insight into the everyday experiences that shape how people define health and seek treatment. This claim is especially important to health decision-making and behavior change because subtle interpretations often influence the decisions that people make. This manuscript provides a critique of traditional approaches to developing health interventions, and theoretically justifies what and why changes are warranted. The limited scope of these models is also discussed, and an argument is made to adopt a strategy that includes the perceptions of people as necessary for understanding health and health-related decision-making. Three practical strategies are suggested to be used with the more standard approaches to assessing the effectiveness and relevance of health interventions.

  10. Parents make the difference: a randomized-controlled trial of a parenting intervention in Liberia.

    Science.gov (United States)

    Puffer, E S; Green, E P; Chase, R M; Sim, A L; Zayzay, J; Friis, E; Garcia-Rolland, E; Boone, L

    2015-01-01

    The objective of this study was to evaluate the impact of a brief parenting intervention, 'Parents Make the Difference'(PMD), on parenting behaviors, quality of parent-child interactions, children's cognitive, emotional, and behavioral wellbeing, and malaria prevention behaviors in rural, post-conflict Liberia. A sample of 270 caregivers of children ages 3-7 were randomized into an immediate treatment group that received a 10-session parent training intervention or a wait-list control condition (1:1 allocation). Interviewers administered baseline and 1-month post-intervention surveys and conducted child-caregiver observations. Intent-to-treat estimates of the average treatment effects were calculated using ordinary least squares regression. This study was pre-registered at ClinicalTrials.gov (NCT01829815). The program led to a 55.5% reduction in caregiver-reported use of harsh punishment practices ( p  parent-child relationships in low-resource settings.

  11. 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...... 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......: 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....

  12. Cost-effectiveness of nutritional intervention in elderly subjects after hip fracture. A randomized controlled trial.

    Science.gov (United States)

    Wyers, C E; Reijven, P L M; Evers, S M A A; Willems, P C; Heyligers, I C; Verburg, A D; van Helden, S; Dagnelie, P C

    2013-01-01

    Hip fracture patients can benefit from nutritional supplementation during their recovery. Up to now, cost-effectiveness evaluation of nutritional intervention in these patients has not been performed. Costs of nutritional intervention are relatively low as compared with medical costs. Cost-effectiveness evaluation shows that nutritional intervention is likely to be cost-effective. Previous research on the effect of nutritional intervention on clinical outcome in hip fracture patients yielded contradictory results. Cost-effectiveness of nutritional intervention in these patients remains unknown. The aim of this study was to evaluate cost-effectiveness of nutritional intervention in elderly subjects after hip fracture from a societal perspective. Open-label, multi-centre randomized controlled trial investigating cost-effectiveness of intensive nutritional intervention comprising regular dietetic counseling and oral nutritional supplementation for 3 months postoperatively. Patients allocated to the control group received care as usual. Costs, weight and quality of life were measured at baseline and at 3 and 6 months postoperatively. Incremental cost-effectiveness ratios (ICERs) were calculated for weight at 3 months and quality adjusted life years (QALYs) at 6 months postoperatively. Of 152 patients enrolled, 73 were randomized to the intervention group and 79 to the control group. Mean costs of the nutritional intervention was 613 Euro. Total costs and subcategories of costs were not significantly different between both groups. Based on bootstrapping of ICERs, the nutritional intervention was likely to be cost-effective for weight as outcome over the 3-month intervention period, regardless of nutritional status at baseline. With QALYs as outcome, the probability for the nutritional intervention being cost-effective was relatively low, except in subjects aged below 75 years. Intensive nutritional intervention in elderly hip fracture patients is likely to be cost

  13. A randomised controlled feasibility trial for an educational school-based mental health intervention: study protocol.

    Science.gov (United States)

    Chisholm, Katharine Elizabeth; Patterson, Paul; Torgerson, Carole; Turner, Erin; Birchwood, Max

    2012-03-22

    With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors' knowledge. If efficacious the intervention could provide a

  14. Statistical design of personalized medicine interventions: the Clarification of Optimal Anticoagulation through Genetics (COAG) trial.

    Science.gov (United States)

    French, Benjamin; Joo, Jungnam; Geller, Nancy L; Kimmel, Stephen E; Rosenberg, Yves; Anderson, Jeffrey L; Gage, Brian F; Johnson, Julie A; Ellenberg, Jonas H

    2010-11-17

    There is currently much interest in pharmacogenetics: determining variation in genes that regulate drug effects, with a particular emphasis on improving drug safety and efficacy. The ability to determine such variation motivates the application of personalized drug therapies that utilize a patient's genetic makeup to determine a safe and effective drug at the correct dose. To ascertain whether a genotype-guided drug therapy improves patient care, a personalized medicine intervention may be evaluated within the framework of a randomized controlled trial. The statistical design of this type of personalized medicine intervention requires special considerations: the distribution of relevant allelic variants in the study population; and whether the pharmacogenetic intervention is equally effective across subpopulations defined by allelic variants. The statistical design of the Clarification of Optimal Anticoagulation through Genetics (COAG) trial serves as an illustrative example of a personalized medicine intervention that uses each subject's genotype information. The COAG trial is a multicenter, double blind, randomized clinical trial that will compare two approaches to initiation of warfarin therapy: genotype-guided dosing, the initiation of warfarin therapy based on algorithms using clinical information and genotypes for polymorphisms in CYP2C9 and VKORC1; and clinical-guided dosing, the initiation of warfarin therapy based on algorithms using only clinical information. We determine an absolute minimum detectable difference of 5.49% based on an assumed 60% population prevalence of zero or multiple genetic variants in either CYP2C9 or VKORC1 and an assumed 15% relative effectiveness of genotype-guided warfarin initiation for those with zero or multiple genetic variants. Thus we calculate a sample size of 1238 to achieve a power level of 80% for the primary outcome. We show that reasonable departures from these assumptions may decrease statistical power to 65%. In a

  15. 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

  16. Frameworks for Proof-of-Concept Clinical Trials of Interventions That Target Fundamental Aging Processes

    Science.gov (United States)

    Justice, Jamie; Miller, Jordan D.; Newman, John C.; Hashmi, Shahrukh K.; Halter, Jeffrey; Austad, Steve N.; Barzilai, Nir

    2016-01-01

    Therapies targeted at fundamental processes of aging may hold great promise for enhancing the health of a wide population by delaying or preventing a range of age-related diseases and conditions—a concept dubbed the “geroscience hypothesis.” Early, proof-of-concept clinical trials will be a key step in the translation of therapies emerging from model organism and preclinical studies into clinical practice. This article summarizes the outcomes of an international meeting partly funded through the NIH R24 Geroscience Network, whose purpose was to generate concepts and frameworks for early, proof-of-concept clinical trials for therapeutic interventions that target fundamental processes of aging. The goals of proof-of-concept trials include generating preliminary signals of efficacy in an aging-related disease or outcome that will reduce the risk of conducting larger trials, contributing data and biological samples to support larger-scale research by strategic networks, and furthering a dialogue with regulatory agencies on appropriate registration indications. We describe three frameworks for proof-of-concept trials that target age-related chronic diseases, geriatric syndromes, or resilience to stressors. We propose strategic infrastructure and shared resources that could accelerate development of therapies that target fundamental aging processes. PMID:27535966

  17. Improving transparency and reproducibility through registration: The status of intervention trials published in clinical psychology journals.

    Science.gov (United States)

    Cybulski, Lukasz; Mayo-Wilson, Evan; Grant, Sean

    2016-09-01

    Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  18. 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

  19. 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

  20. 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

  1. Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial.

    Science.gov (United States)

    Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Bauman, Adrian; Lee, I-Min; Miyachi, Motohiko; Kawachi, Ichiro

    2017-12-07

    Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40-79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78-83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3-3.4%, P ≥ 0.138). Linear dose-response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. The 5-year CWI using the focused social marketing strategy increased the population-level of PA. © The Author 2017. Published by Oxford University Press on behalf of the International Epidemiological Association

  2. 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

  3. Confronting Challenges in Intervention Research with Ethnically Diverse Older Adults: The USC Well Elderly II Trial

    Science.gov (United States)

    Jackson, Jeanne; Mandel, Deborah; Blanchard, Jeanine; Carlson, Mike; Cherry, Barbara; Azen, Stanley; Chou, Chih-Ping; Jordan-Marsh, Maryalice; Forman, Todd; White, Brett; Granger, Douglas; Knight, Bob; Clark, Florence

    2011-01-01

    Background Community-dwelling older adults are at risk for declines in physical health, cognition, and psychosocial well-being. However, their enactment of active and health-promoting lifestyles can reduce such declines. Purpose The purpose of this article is to describe the USC Well Elderly II study, a randomized clinical trial designed to test the effectiveness of a healthy lifestyle program for elders, and document how various methodological challenges were addressed during the course of the trial. Methods In the study, 460 ethnically diverse elders recruited from a variety of sites in the urban Los Angeles area were enrolled in a randomized experiment involving a crossover design component. Within either the first or second six month phase of their study involvement, each elder received a lifestyle intervention designed to improve a variety of aging outcomes. At 4–5 time points over an 18–24 month interval, the research participants were assessed on measures of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the effectiveness of the intervention and document the process mechanisms responsible for its effects. Results The study protocol was successfully implemented, including the enrollment of study sites, the recruitment of 460 older adults, administration of the intervention, adherence to the plan for assessment, and establishment of a large computerized data base. Limitations Methodological challenges were encountered in the areas of site recruitment, participant recruitment, testing, and intervention delivery. Conclusions The completion of clinical trials involving elders from numerous local sites requires careful oversight and anticipation of threats to the study design that stem from: (a) social situations that are particular to specific study sites; and (b) physical, functional, and social challenges pertaining to the elder

  4. A randomised controlled trial of three very brief interventions for physical activity in primary care

    Directory of Open Access Journals (Sweden)

    Sally Pears

    2016-09-01

    Full Text Available Abstract Background Very brief interventions (VBIs for physical activity are promising, but there is uncertainty about their potential effectiveness and cost. We assessed potential efficacy, feasibility, acceptability, and cost of three VBIs in primary care, in order to select the most promising intervention for evaluation in a subsequent large-scale RCT. Methods Three hundred and ninety four adults aged 40–74 years were randomised to a Motivational (n = 83, Pedometer (n = 74, or Combined (n = 80 intervention, delivered immediately after a preventative health check in primary care, or control (Health Check only; n = 157. Potential efficacy was measured as the probability of a positive difference between an intervention arm and the control arm in mean physical activity, measured by accelerometry at 4 weeks. Results For the primary outcome the estimated effect sizes (95 % CI relative to the Control arm for the Motivational, Pedometer and Combined arms were respectively: +20.3 (−45.0, +85.7, +23.5 (−51.3, +98.3, and −3.1 (−69.3, +63.1 counts per minute. There was a73% probability of a positive effect on physical activity for each of the Motivational and Pedometer VBIs relative to control, but only 46 % for the Combined VBI. Only the Pedometer VBI was deliverable within 5 min. All VBIs were acceptable and low cost. Conclusions Based on the four criteria, the Pedometer VBI was selected for evaluation in a large-scale trial. Trial registration Current Controlled Trials ISRCTN02863077 . Retrospectively registered 05/10/2012.

  5. 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

  6. An Internet-based writing intervention for PTSD in veterans: A feasibility and pilot effectiveness trial.

    Science.gov (United States)

    Krupnick, Janice L; Green, Bonnie L; Amdur, Richard; Alaoui, Adil; Belouali, Anas; Roberge, Erika; Cueva, David; Roberts, Miguel; Melnikoff, Elizabeth; Dutton, Mary Ann

    2017-07-01

    [Correction Notice: An Erratum for this article was reported in Vol 9(4) of Psychological Trauma: Theory, Research, Practice, and Policy (see record 2016-54154-001). In the article, the names of authors Adil Alaoui and Anas Belouali were misspelled as Adil Aloui and Anas Beloui respectively. All versions of this article have been corrected.] Objective: Veterans suffering from posttraumatic stress disorder (PTSD) may avoid or fail to follow through with a full course of face-to-face mental health treatment for a variety of reasons. We conducted a pilot effectiveness trial of an online intervention for veterans with current PTSD to determine the feasibility, safety, and preliminary effectiveness of an online writing intervention (i.e., Warriors Internet Recovery & EDucation [WIRED]) as an adjunct to face-to-face psychotherapy. Method: Veterans ( N = 34) who had served in Iraq or Afghanistan with current PTSD subsequent to deployment-related trauma were randomized to Veterans Affairs (VA) mental health treatment as usual (TAU) or to treatment as usual plus the online intervention (TAU + WIRED). All research participants were recruited from the Trauma Services Program, VA Medical Center, Washington, DC. They completed baseline assessments as well as assessments 12 weeks and 24 weeks after the baseline assessment. The online intervention consisted of therapist-guided writing, using principles of prolonged exposure and cognitive therapy. The intervention was adapted from an evidence-based treatment used in The Netherlands and Germany for individuals who had been exposed to nonmilitary traumas. Results: In addition to showing that the online intervention was both feasible to develop and implement, as well as being safe, the results showed preliminary evidence of the effectiveness of the TAU + WIRED intervention in this patient population, with particular evidence in reducing PTSD symptoms of hyperarousal. Conclusion: With minor modifications to enhance the therapeutic

  7. A community intervention trial of multimodal suicide prevention program in Japan: A Novel multimodal Community Intervention program to prevent suicide and suicide attempt in Japan, NOCOMIT-J

    Directory of Open Access Journals (Sweden)

    Suzuki Yuriko

    2008-09-01

    Full Text Available Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals. Discussion The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. Trial registration UMIN Clinical Trials Registry (UMIN-CTR UMIN000000460.

  8. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

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    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

  9. Application of the development stages of a cluster randomized trial to a framework for evaluating complex health interventions

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    Loeb Mark B

    2002-07-01

    Full Text Available Abstract Introduction Trials of complex health interventions often pose difficult methodologic challenges. The objective of this paper is to assess the extent to which the various development steps of a cluster randomized trial to optimize antibiotic use in nursing homes are represented in a recently published framework for the design and evaluation of complex health interventions. In so doing, the utility of the framework for health services researchers is evaluated. Methods Using the five phases of the framework (theoretical, identification of components of the intervention, definition of trial and intervention design, methodological issues for main trial, promoting effective implementation, corresponding stages in the development of the cluster randomized trial using diagnostic and treatment algorithms to optimize the use of antibiotics in nursing homes are identified and described. Results Synthesis of evidence needed to construct the algorithms, survey and qualitative research used to define components of the algorithms, a pilot study to assess the feasibility of delivering the algorithms, methodological issues in the main trial including choice of design, allocation concealment, outcomes, sample size calculation, and analysis are adequately represented using the stages of the framework. Conclusions The framework is a useful resource for researchers planning a randomized clinical trial of a complex intervention.

  10. The effect of educational intervention on intercultural communication: results of a randomised controlled trial.

    Science.gov (United States)

    Harmsen, Hans; Bernsen, Roos; Meeuwesen, Ludwien; Thomas, Siep; Dorrenboom, Govert; Pinto, David; Bruijnzeels, Marc

    2005-05-01

    Due to worldwide migration to Western countries, physicians are increasingly encountering patients with different ethnic backgrounds. Communication problems can arise as a result of differences in cultural backgrounds and poor language proficiency. To assess the effectiveness of an educational intervention on intercultural communication aimed to decrease inequalities in care provided between Western and non-Western patients. A randomised controlled trial with randomisation at the GP level and outcome measurements at the patient level. General practice in Rotterdam. Thirty-eight Dutch GPs in the Rotterdam region, with at least 25% of inhabitants of non-Western origin, and 2407 visiting patients were invited to participate in the study. A total of 986 consultations were finally included. The GPs were educated about cultural differences and trained in intercultural communication. Patients received a videotaped instruction focusing on how to communicate with their GP in a direct way. The primary outcome measure was mutual understanding and the secondary outcomes were patient's satisfaction and perceived quality of care. The intervention effect was assessed for all patients together, for the 'Western' and 'non-Western' patients, and for patients with different cultural backgrounds separately. An intervention effect was seen 6 months after the intervention, as improvement in mutual understanding (and some improvement in perceived quality of care) in consultations with 'non-Western' patients. A double intervention on intercultural communication given to both physician and patient decreases the gap in quality of care between 'Western' and 'non-Western' patients.

  11. Using synchronous distance education to deliver a weight loss intervention: A randomized trial.

    Science.gov (United States)

    Dunn, Carolyn; Olabode-Dada, Olusola; Whetstone, Lauren; Thomas, Cathy; Aggarwal, Surabhi; Nordby, Kelly; Thompson, Samuel; Johnson, Madison; Allison, Christine

    2016-01-01

    To implement a randomized trial to evaluate the effectiveness of a weight loss program delivered using synchronous distance education compared with a wait-list control group with 6-month follow-up. Adults with a body mass index (BMI) ≥25 were randomized to the intervention (n = 42) or wait-list control group (n = 38). The intervention group participated in a synchronous, online, 15-week weight loss program; weight loss was the primary outcome. Secondary measures included height, BMI, and confidence in ability to be physically active and eat healthy. Assessments occurred at three and four time points in the intervention and control group, respectively. Participants who completed the program lost significantly more weight (1.8 kg) than those in the wait-list control group (0.25 kg) at week 15 [F(1,61) = 6.19, P = 0.02] and had a greater reduction in BMI (0.71 vs. 0.14 kg/m(2) ), [F(1,61) = 7.45, P = 0.01]. There were no significant differences between the intervention and the wait-list control groups for change in confidence in ability to be physically active or eat healthy. Weight loss was maintained at 6 months. Use of synchronous distance education is a promising approach for weight loss. The results of this study will help to inform future research that employs Web-based interventions. © 2015 The Obesity Society.

  12. Randomized controlled trial of a brief dyadic cognitive-behavioral intervention designed to prevent PTSD

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    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.

  13. Family-centered brief intervention for reducing obesity and cardiovascular disease risk: A randomized controlled trial.

    Science.gov (United States)

    Duncan, Scott; Goodyear-Smith, Felicity; McPhee, Julia; Zinn, Caryn; Grøntved, Anders; Schofield, Grant

    2016-11-01

    To assess the effects of a family-centered, physical activity and nutrition "brief" intervention (time-limited contact) on body weight and related health outcomes in primary health care patients with an elevated 5-year cardiovascular disease (CVD) risk. This study implemented a cluster randomized controlled trial design with two treatment conditions: a CVD risk assessment and one-time consultation ("usual care" control) and a CVD risk assessment and up to five home sessions that aimed to reduce obesity by encouraging physical activity and healthy eating (intervention). Three hundred and twenty patients aged 35 to 65 years from 16 primary health care clinics in Auckland, New Zealand, participated in the study. Intervention effects on BMI, waist circumference, blood pressure, blood cholesterol, triglycerides, 5-year CVD risk, physical activity, and dietary patterns were assessed using generalized linear mixed models. When compared with the control group, the intervention resulted in a significant but relatively modest decrease in BMI between baseline and the 12-month follow-up (-0.633 kg m -2 , P adj  = 0.048). Significant decreases were also observed for total cholesterol at 4 and 12 months, the total cholesterol to high-density lipoprotein cholesterol ratio at 4 months, 5-year CVD risk at 4 months, and fast food consumption at 12 months. Our findings show that a family-centered brief intervention targeting physical activity and nutrition can generate slightly better obesity-related health outcomes than usual care alone. © 2016 The Obesity Society.

  14. A Web-Based Intervention to Reduce Indoor Tanning Motivations in Adolescents: a Randomized Controlled Trial.

    Science.gov (United States)

    Hillhouse, Joel; Turrisi, Rob; Scaglione, Nichole M; Cleveland, Michael J; Baker, Katie; Florence, L Carter

    2017-02-01

    Youthful indoor tanning as few as ten sessions can increase the risk of melanoma by two to four times with each additional session adding another 2 % to the risk. Recent research estimates that indoor tanning can be linked to approximately 450,000 cases of skin cancer annually in the USA, Europe, and Australia. Despite these risks, indoor tanning remains popular with adolescents. This study tested the efficacy of a web-based skin cancer prevention intervention designed to reduce indoor tanning motivations in adolescent females. A nationally representative sample of 443 female teens was enrolled from an online panel into a two-arm, parallel group design, randomized controlled trial. Treatment participants received an appearance-focused intervention grounded in established health behavior change models. Controls viewed a teen alcohol prevention website. Outcome variables included willingness and intentions to indoor tan, willingness to sunless tan, and measures of indoor tanning attitudes and beliefs. The intervention decreased willingness and intentions to indoor tan and increased sunless tanning willingness relative to controls. We also examined indirect mechanisms of change through intervening variables (e.g., indoor tanning attitudes, norms, positive and negative expectancies) using the product of coefficient approach. The web-based intervention demonstrated efficacy in changing adolescent indoor tanning motivations and improving their orientation toward healthier alternatives. Results from the intervening variable analyses give guidance to future adolescent skin cancer prevention interventions.

  15. An intervention to preschool children for reducing screen time: a randomized controlled trial.

    Science.gov (United States)

    Yilmaz, G; Demirli Caylan, N; Karacan, C D

    2015-05-01

    Screen time, defined as time spent watching television, DVDs, or videos or playing computer or video games, has been related to serious health consequences in children, such as impaired language acquisition, violent behaviour, tobacco smoking and obesity. Our aim was to determine if a simple intervention aimed at preschool-aged children, applied at the health maintenance visits, in the primary care setting, would be effective in reducing screen time. We used a two group randomized controlled trial design. Two- to 6-year-old children and their parents were randomly assigned to receive an intervention to reduce their screen time, BMI and parental report of aggressive behaviour. At the end of the intervention we made home visits at 2, 6 and 9 months and the parents completed questionnaire. Parents in the intervention group reported less screen time and less aggressive behaviour than those in the control group but there were no differences in BMI z scores. This study shows that a preschool-based intervention can lead to reductions in young children's television/video viewing. © 2014 John Wiley & Sons Ltd.

  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. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. 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. (c) 2015 APA, all rights reserved).

  18. Impact of a school-based intervention to promote fruit intake: a cluster randomized controlled trial.

    Science.gov (United States)

    Rosário, R; Araújo, A; Padrão, P; Lopes, O; Moreira, A; Abreu, S; Vale, S; Pereira, B; Moreira, P

    2016-07-01

    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. This is a randomized trial with the schools as the unit of randomisation. A total of 464 children (239 female, 6-12years) from seven elementary schools participated in this cluster randomized controlled trial. Three schools were allocated to the intervention and four to the control group. For the intervention schools, we delivered professional development training to school teachers (12 sessions of 3 h each). The training provided information about nutrition, healthy eating, the importance of drinking water and healthy cooking activities. After each session, teachers were encouraged to develop classroom activities focused on the learned topics. Sociodemographic was assessed at baseline and anthropometric, dietary intake and physical activity assessments were performed at baseline and at the end of the intervention. Dietary intake was evaluated by a 24-h dietary recall and fruit consumption as a dessert was gathered at lunch and dinner. Intervened children reported a significant higher intake in the consumption of fruit compared to the controlled children at lunch (P = 0.001) and at dinner (P = 0.012), after adjusting for confounders. Our study provides further support for the success of intervention programmes aimed at improving the consumption of fruit as a dessert in children. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  19. Effects of a Psychological Intervention in a Primary Health Care Center for Caregivers of Dependent Relatives: A Randomized Trial

    Science.gov (United States)

    Rodriguez-Sanchez, Emiliano; Patino-Alonso, Maria C.; Mora-Simon, Sara; Gomez-Marcos, Manuel A.; Perez-Penaranda, Anibal; Losada-Baltar, Andres; Garcia-Ortiz, Luis

    2013-01-01

    Purpose: To assess, in the context of Primary Health Care (PHC), the effect of a psychological intervention in mental health among caregivers (CGs) of dependent relatives. Design and Methods: Randomized multicenter, controlled clinical trial. The 125 CGs included in the trial were receiving health care in PHC. Inclusion criteria: Identifying…

  20. Associations between ankle-brachial index and cognitive function: results from the Lifestyle Interventions and Independence for Elders trial

    Science.gov (United States)

    OBJECTIVE: The objective of this study was to evaluate cross-sectional and longitudinal associations between ankle-brachial index (ABI) and indicators of cognitive function. DESIGN: Randomized clinical trial (Lifestyle Interventions and Independence for Elders Trial). SETTING: Eight US academic ce...

  1. One year effectiveness of an individualised smoking cessation intervention at the workplace: a randomised controlled trial.

    Science.gov (United States)

    Rodríguez-Artalejo, F; Lafuente Urdinguio, P; Guallar-Castillón, P; Garteizaurrekoa Dublang, P; Sáinz Martínez, O; Díez Azcárate, J I; Foj Alemán, M; Banegas, J R

    2003-05-01

    To assess the effectiveness of a smoking cessation intervention at the workplace. The intervention was adapted to smokers' tobacco dependence, and included minimal structured counselling at the first visit (5-8 minutes), nicotine patches for three months, and three sessions of counselling for reinforcement of abstinence (2-3 minutes) over a three month period. Open randomised trial with two groups: the intervention group, and the control group which was subjected to standard clinical practice, consisting of short (30 seconds to one minute) sporadic sessions of unstructured medical antismoking advice. The trial was carried out among 217 smokers of both sexes, aged 20-63 years, motivated to quit smoking and without contraindications for nicotine patches, who were employees at a public transport company and at two worksites of an electric company. The main outcome measure was self reported tobacco abstinence confirmed by carbon monoxide in expired air workplace is effective to achieve long term smoking cessation. In a setting similar to ours, nine subjects would have to be treated for three months for one to achieve continuous abstinence for 12 months.

  2. trans-Lycopene from tomato juice attenuates inflammatory biomarkers in human plasma samples: An intervention trial.

    Science.gov (United States)

    Colmán-Martínez, Mariel; Martínez-Huélamo, Miriam; Valderas-Martínez, Palmira; Arranz-Martínez, Sara; Almanza-Aguilera, Enrique; Corella, Dolores; Estruch, Ramón; Lamuela-Raventós, Rosa M

    2017-11-01

    The effect of carotenoids from tomato juice (TJ) on inflammatory biomarkers was evaluated by performing a 4-week dose-response nutritional trial in a population at high cardiovascular risk. An open, prospective, randomized, cross-over, and controlled clinical trial was carried out with 28 volunteers (mean age 69.7 ± 3.1 years; mean BMI 31.5 ± 3.6 kg/m 2 ) at high cardiovascular risk, which were assigned to consume daily for 4 weeks in random order: 200 mL (LD) or 400 mL (HD) of TJ, or water as a control (C), with a 21-day wash-out period between each intervention. Blood samples were collected at baseline (B) and after each intervention. Endpoints included significant changes in plasmatic carotenoids, and adhesion molecules ICAM-1, and VCAM-1, as well as a tendency to decrease the chemokine IL-8. Compared to C, concentration of ICAM-1, and VCAM-1 were significantly lower (p ˂ 0.001), after each TJ intervention. Decreases were correlated remarkably with the trans-lycopene, while the other carotenoids present in TJ have presented a minor association or no association with changes in these molecules. trans-Lycopene from TJ may attenuate the risk of cardiovascular disease by reducing the concentration of important inflammatory molecules related to atherosclerosis. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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

    Science.gov (United States)

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

    2014-03-01

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

  4. Obesity and physical frailty in older adults: a scoping review of lifestyle intervention trials.

    Science.gov (United States)

    Porter Starr, Kathryn N; McDonald, Shelley R; Bales, Connie W

    2014-04-01

    Many frail older adults are thin, weak, and undernourished; this component of frailty remains a critical concern in the geriatric field. However, there is also strong evidence that excessive adiposity contributes to frailty by reducing the ability of older adults to perform physical activities and increasing metabolic instability. Our scoping review explores the impact of being obese on physical frailty in older adults by summarizing the state of the science for both clinical markers of physical function and biomarkers for potential underlying causes of obesity-related decline. We used the 5-stage methodological framework of Arksey and O'Malley to conduct a scoping review of randomized trials of weight loss and/or exercise interventions for obesity (body mass index ≥ 30 kg/m(2)) in older adults (aged >60 years), examining the outcomes of inflammation, oxidative stress, and lipid accumulation in muscle, as well as direct measures of physical function. Our initial search yielded 212 articles; exclusion of cross-sectional and observational studies, cell culture and animal studies, disease-specific interventions, and articles published before 2001 led to a final result of 21 articles. Findings of these trials included the following major points. The literature consistently confirmed benefits of lifestyle interventions to physical function assessed at the clinical level. Generally speaking, weight loss alone produced a greater effect than exercise alone, and the best outcomes were achieved with a combination of weight loss and exercise, especially exercise programs that combined aerobic, resistance, and flexibility training. Weight loss interventions tended to reduce markers of inflammation and/or oxidative damage when more robust weight reduction was achieved and maintained over time, whereas exercise did not change markers of inflammation. However, participation in a chronic exercise program did reduce the oxidative stress induced by an acute bout of exercise

  5. Rational prescribing in primary care (RaPP: a cluster randomized trial of a tailored intervention.

    Directory of Open Access Journals (Sweden)

    Atle Fretheim

    2006-06-01

    Full Text Available A gap exists between evidence and practice regarding the management of cardiovascular risk factors. This gap could be narrowed if systematically developed clinical practice guidelines were effectively implemented in clinical practice. We evaluated the effects of a tailored intervention to support the implementation of systematically developed guidelines for the use of antihypertensive and cholesterol-lowering drugs for the primary prevention of cardiovascular disease.We conducted a cluster-randomized trial comparing a tailored intervention to passive dissemination of guidelines in 146 general practices in two geographical areas in Norway. Each practice was randomized to either the tailored intervention (70 practices; 257 physicians or control group (69 practices; 244 physicians. Patients started on medication for hypertension or hypercholesterolemia during the study period and all patients already on treatment that consulted their physician during the trial were included. A multifaceted intervention was tailored to address identified barriers to change. Key components were an educational outreach visit with audit and feedback, and computerized reminders linked to the medical record system. Pharmacists conducted the visits. Outcomes were measured for all eligible patients seen in the participating practices during 1 y before and after the intervention. The main outcomes were the proportions of (1 first-time prescriptions for hypertension where thiazides were prescribed, (2 patients assessed for cardiovascular risk before prescribing antihypertensive or cholesterol-lowering drugs, and (3 patients treated for hypertension or hypercholesterolemia for 3 mo or more who had achieved recommended treatment goals. The intervention led to an increase in adherence to guideline recommendations on choice of antihypertensive drug. Thiazides were prescribed to 17% of patients in the intervention group versus 11% in the control group (relative risk 1.94; 95

  6. 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

  7. Participatory workplace interventions can reduce sedentary time for office workers--a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Sharon Parry

    Full Text Available BACKGROUND: Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes, increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA during work hours. METHODS: A randomised controlled trial (ANZCTR NUMBER: ACTN12612000743864 was conducted using clerical, call centre and data processing workers (n = 62, aged 25-59 years in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: 'Active office' (n = 19, 'Active Workstation' and promotion of incidental office activity; 'Traditional physical activity' (n = 14, pedometer challenge to increase activity between productive work time and 'Office ergonomics' (n = 29, computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. RESULTS: For all participants there was a significant reduction in sedentary time on work days (-1.6%, p = 0.006 and during work hours (-1.7%, p = 0.014 and a significant increase in number of breaks/sedentary hour on work days (0.64, p = 0.005 and during work hours (0.72, p = 0.015; there was a concurrent significant increase in light activity during work hours (1.5%, p = 0.012 and MVPA on work days (0.6%, p = 0.012. CONCLUSIONS: This study explored novel ways to modify work practices to reduce occupational sedentary behaviour

  8. Improving hearing and vision in dementia: protocol for a field trial of a new intervention.

    Science.gov (United States)

    Regan, Jemma; Dawes, Piers; Pye, Annie; Armitage, Christopher J; Hann, Mark; Himmelsbach, Ines; Reeves, David; Simkin, Zoe; Yang, Fan; Leroi, Iracema

    2017-11-28

    Quality of life and other key outcomes may be improved by optimising hearing and vision function in people living with dementia. To date, there is limited research assessing the efficacy of interventions aimed at improving hearing and vision in people with dementia. Here, we outline a protocol to field test a newly developed home-based intervention, designed to optimise sensory functioning in people with dementia in three European sites. The results of this study will inform the design and conduct of a full-scale randomised controlled trial (RCT) in five European sites. In this multisite, single arm, open label, feasibility study, participants with dementia (n=24) will be assessed for hearing and vision impairments and be prescribed a hearing aid and/or glasses. Each participant will have a study partner ('dyads'). A subset of dyads will receive 'sensory support' from a 'sensory support therapist', comprising home visits over 12 weeks. The therapist will offer the following intervention: adherence support for corrective devices; adaptations to the home environment to facilitate sensory function; communication training; and referral to community-based support services. The primary outcomes will be process measures assessing the feasibility, tolerability and acceptability of: (1) the intervention components; (2) the method of implementation of the intervention and (3) the study procedures, including outcome assessment measures. Quantitative data will be collected at baseline and follow-up. Qualitative data using semistructured interviews will be collected postintervention and weekly, using participant diaries. Finally, we will explore a model of cost-effectiveness to apply in the subsequent full-scale trial. This feasibility study is a necessary step in the development of a complex, individualised, psychosocial intervention. The data gathered will allow logistical and theoretical processes to be refined in preparation for a full-scale RCT. Ethical approval was

  9. Improving hearing and vision in dementia: protocol for a field trial of a new intervention

    Science.gov (United States)

    Regan, Jemma; Dawes, Piers; Pye, Annie; Armitage, Christopher J; Hann, Mark; Himmelsbach, Ines; Reeves, David; Simkin, Zoe; Yang, Fan; Leroi, Iracema

    2017-01-01

    Introduction Quality of life and other key outcomes may be improved by optimising hearing and vision function in people living with dementia. To date, there is limited research assessing the efficacy of interventions aimed at improving hearing and vision in people with dementia. Here, we outline a protocol to field test a newly developed home-based intervention, designed to optimise sensory functioning in people with dementia in three European sites. The results of this study will inform the design and conduct of a full-scale randomised controlled trial (RCT) in five European sites. Methods and analysis In this multisite, single arm, open label, feasibility study, participants with dementia (n=24) will be assessed for hearing and vision impairments and be prescribed a hearing aid and/or glasses. Each participant will have a study partner (‘dyads’). A subset of dyads will receive ‘sensory support’ from a ‘sensory support therapist’, comprising home visits over 12 weeks. The therapist will offer the following intervention: adherence support for corrective devices; adaptations to the home environment to facilitate sensory function; communication training; and referral to community-based support services. The primary outcomes will be process measures assessing the feasibility, tolerability and acceptability of: (1) the intervention components; (2) the method of implementation of the intervention and (3) the study procedures, including outcome assessment measures. Quantitative data will be collected at baseline and follow-up. Qualitative data using semistructured interviews will be collected postintervention and weekly, using participant diaries. Finally, we will explore a model of cost-effectiveness to apply in the subsequent full-scale trial. This feasibility study is a necessary step in the development of a complex, individualised, psychosocial intervention. The data gathered will allow logistical and theoretical processes to be refined in preparation for

  10. Pilot Trial of a Disclosure Intervention for HIV+ Mothers: The TRACK Program

    Science.gov (United States)

    Murphy, Debra A.; Armistead, Lisa; Marelich, William D.; Payne, Diana L.; Herbeck, Diane M.

    2011-01-01

    Objective The Teaching, Raising, And Communicating with Kids (TRACK) program was a longitudinal pilot-trial intervention designed to assist mothers living with HIV (MLH) to disclose their serostatus to their young children (age 6 – 12 years). Method MLH and child dyads (N = 80 dyads) were recruited and randomized to intervention or control; the intervention group had three individual sessions and one follow-up phone call. The sessions focused on preparing MLH for disclosure through behavioral exercises utilizing Derlaga’s model of HIV-disclosure. Both MLH and their child were assessed across multiple time-points (baseline, 3-, 6-, and 9-months) regarding disclosure of HIV status, and specific outcome variables (i.e., relationship context, mother’s health, child’s mental health, and family outcomes). Results MLH in the intervention group were six times more likely to disclose their HIV status than those in the control group (O.R. 6.33, 95% C.I.: 1.64 – 24.45), with 33% disclosing in the intervention group compared to 7.3% in the control group. MLHs in the intervention group showed increases in disclosure self-efficacy across time, increased communication with their child, and improvement in emotional functioning. Children of MLHs in the intervention group exhibited reductions in depression and anxiety, and increases in happiness. Conclusions TRACK was found to be successful in helping MLH disclose their HIV status to their children, with positive outcomes noted for both MLH and their children. PMID:21355637

  11. 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.

  12. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial.

    Science.gov (United States)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette; Kroman, Niels; Maibom, Annerikke; Sauerberg, Marie-Louise; Møller, Ann M

    2010-11-01

    Smokers are more prone to develop postoperative complications. Smoking cessation intervention beginning 4-8 weeks prior to surgery improves the postoperative outcome. Cancer patients, however, often undergo surgery less than 4 weeks after diagnosis. The primary objective of this study was therefore to examine if a brief smoking cessation intervention shortly before breast cancer surgery would influence postoperative complications and smoking cessation. A randomized controlled multicentre trial with blinded outcome assessment conducted at 3 hospitals in Denmark. One hundred and thirty patients were randomly assigned to brief smoking intervention (n = 65) or standard care (n = 65). The intervention followed the principles of motivational interviewing and included personalized nicotine replacement therapy aimed at supporting smoking cessation from 2 days before to 10 days after surgery. The overall postoperative complication rate (including seroma requiring aspiration) was 61% in both groups risk ratio (RR) 1.00 (95% CI 0.75-1.33). The wound complication rate was 44% versus 45%. The effect on perioperative smoking cessation was modest, 28% intervention versus 11% control group patients, RR 2.49 (95% CI 1.10-5.60). There was no effect on smoking cessation at 12 months, 13% versus 9%. Brief smoking intervention administered shortly before breast cancer surgery modestly increased self-reported perioperative smoking cessation without having any clinical impact on postoperative complications. The study adds to the body of evidence indicating that brief intervention has no clinical importance for surgical patients in regard to postoperative morbidity. Future studies should be designed to determine the optimal time of smoking cessation before surgery.

  13. Intervention study for smoking cessation in Spanish college students: pragmatic randomized controlled trial.

    Science.gov (United States)

    Pardavila-Belio, Miren I; García-Vivar, Cristina; Pimenta, Adriano Marçal; Canga-Armayor, Ana; Pueyo-Garrigues, Sara; Canga-Armayor, Navidad

    2015-10-01

    To evaluate the effectiveness of a nurse intervention aimed at helping college student smokers quit smoking. Single-blind, pragmatic randomized controlled trial which compares a multi-component intervention, tailored specifically to college students, with a brief advice session with a 6-month follow-up. This study was conducted at the University of Navarra, Spain. A total of 255 college student smokers (age range = 18-24 years) were randomized to an intervention group (n = 133) or to a control group (n = 122). A multi-component intervention based on the Theory of Triadic Influence of Flay was developed. The intervention consisted of a 50-minute motivational interview conducted by a nurse and online self-help material. The follow-up included a reinforcing e-mail and group therapy. The primary outcome was self-reported abstinence, with biochemical verification at 6 months. The secondary outcomes consisted of the mean number of cigarettes smoked per day, self-reported attempts to quit smoking and stage of change at 6 months. At the 6-month follow-up, the smoking cessation incidence was 21.1% in the intervention group compared with 6.6% in the control group (difference = 14.5 confidence interval = 6.1-22.8; relative risk = 3.41, 95% confidence interval = 1.62-7.20). The difference in the mean number of cigarettes at 6 months was significantly different (difference = -2.2, confidence interval = -3.6 to -0.9). A multi-component intervention tailored to college students and managed by a nurse is effective in increasing smoking cessation among college students. © 2015 Society for the Study of Addiction.

  14. Preventing heavy alcohol use in adolescents (PAS): cluster randomized trial of a parent and student intervention offered separately and simultaneously

    NARCIS (Netherlands)

    Koning, I.M.; Vollebergh, W.A.M.; Smit, F.; Verdurmen, J.E.E.; Eijnden, R.J.J.M. van den; Bogt, T.F.M. ter; Stattin, H.; Engels, R.C.M.E.

    2009-01-01

    Aims To evaluate the effectiveness of two preventive interventions to reduce heavy drinking in first- and second-year high school students. Design and setting Cluster randomized controlled trial using four conditions for comparing two active interventions with a control group from 152 classes of 19

  15. Effects of lifestyle intervention in obese pregnant women on gestational weight gain and mental health : A randomized controlled trial

    NARCIS (Netherlands)

    Bogaerts, A.F.L.; Devlieger, R.; Nuyts, E.; Witters, I.; Gyselaers, W.; Van den Bergh, B.R.H.

    2013-01-01

    Objective: Lifestyle intervention could help obese pregnant women to limit their weight gain during pregnancy and improve their psychological comfort, but has not yet been evaluated in randomized controlled trials. We evaluated whether a targeted antenatal lifestyle intervention programme for obese

  16. One Year Effects of a Workplace Integrated Care Intervention for Workers with Rheumatoid Arthritis: Results of a Randomized Controlled Trial

    NARCIS (Netherlands)

    Vilsteren, M. van; Boot, C.R.L.; Twisk, J.W.R.; Steenbeek, R.; Voskuyl, A.E.; Schaardenburg, D. van; Anema, J.R.

    2017-01-01

    Purpose To evaluate the effectiveness of a workplace integrated care intervention on at-work productivity loss in workers with rheumatoid arthritis (RA) compared to usual care. Methods In this randomized controlled trial, 150 workers with RA were randomized into either the intervention or control

  17. Effectiveness of a Web-Based Intervention to Reduce Alcohol Consumption among French Hazardous Drinkers: A Randomized Controlled Trial

    Science.gov (United States)

    Guillemont, Juliette; Cogordan, Chloé; Nalpas, Bertrand; Nguyen-Thanh, Vi?t; Richard, Jean-Baptiste; Arwidson, Pierre

    2017-01-01

    This study aims to evaluate the effectiveness of a web-based intervention to reduce alcohol consumption among hazardous drinkers. A two-group parallel randomized controlled trial was conducted among adults identified as hazardous drinkers according to the Alcohol Use Disorders Identification Test. The intervention delivers personalized normative…

  18. Mathematics Learned by Young Children in An Intervention Based on Learning Trajectories: A Large-Scale Cluster Randomized Trial

    Science.gov (United States)

    Clements, Douglas H.; Sarama, Julie; Spitler, Mary Elaine; Lange, Alissa A.; Wolfe, Christopher B.

    2011-01-01

    This study employed a cluster randomized trial design to evaluate the effectiveness of a research-based intervention for improving the mathematics education of very young children. This intervention includes the "Building Blocks" mathematics curriculum, which is structured in research-based learning trajectories, and congruous…

  19. The Northern Manhattan Caregiver Intervention Project: a randomised trial testing the effectiveness of a dementia caregiver intervention in Hispanics in New York City.

    Science.gov (United States)

    Luchsinger, José; Mittelman, Mary; Mejia, Miriam; Silver, Stephanie; Lucero, Robert J; Ramirez, Mildred; Kong, Jian; Teresi, Jeanne A

    2012-01-01

    Dementia prevalence and its burden on families are increasing. Caregivers of persons with dementia have more depression and stress than the general population. Several interventions have proven efficacy in decreasing depression and stress in selected populations of caregivers. Hispanics in New York City tend to have a higher burden of dementia caregiving compared to non-Hispanic whites (NHW) because Hispanics have a higher prevalence of dementia, tend to have high family involvement, and tend to have higher psychosocial and economic stressors. Thus, we chose to test the effectiveness of a dementia caregiving intervention, the New York University Caregiver Intervention (NYUCI), with demonstrated efficacy in spouse caregivers in Hispanic relative caregivers of persons with dementia. Including the community health worker (CHW) intervention in both arms alleviates general psychosocial stressors and allows the assessment of the effectiveness of the intervention. Compared to two original efficacy studies of the NYUCI, which included only spouse caregivers, our study includes all relative caregivers, including common law spouses, children, siblings, a nephew and nieces. This study will be the first randomised trial to test the effectiveness of the NYUCI in Hispanic caregivers including non-spouses. The design of the study is a randomised controlled trial (RCT). Participants are randomised to two arms: case management by a CHW and an intervention arm including the NYUCI in addition to case management by the CHW. The duration of intervention is 6 months. The main outcomes in the trial are changes in the Geriatric Depression Scale (GDS) and the Zarit Caregiver Burden Scale (ZCBS) from baseline to 6 months. This trial is approved by the Columbia University Medical Center Institutional Review Board (AAAI0022), and funded by the National Institute on Minority Health and Health Disparities. The funding agency has no role in dissemination.  www.ClinicalTrials.gov NCT01306695.

  20. Collaterals at angiography and outcomes in the Interventional Management of Stroke (IMS) III trial.

    Science.gov (United States)

    Liebeskind, David S; Tomsick, Thomas A; Foster, Lydia D; Yeatts, Sharon D; Carrozzella, Janice; Demchuk, Andrew M; Jovin, Tudor G; Khatri, Pooja; von Kummer, Ruediger; Sugg, Rebecca M; Zaidat, Osama O; Hussain, Syed I; Goyal, Mayank; Menon, Bijoy K; Al Ali, Firas; Yan, Bernard; Palesch, Yuko Y; Broderick, Joseph P

    2014-03-01

    Endovascular strategies provide unique opportunity to correlate angiographic measures of collateral circulation at the time of endovascular therapy. We conducted systematic analyses of collaterals at conventional angiography on recanalization, reperfusion, and clinical outcomes in the endovascular treatment arm of the Interventional Management of Stroke (IMS) III trial. Prospective evaluation of angiographic collaterals was conducted via central review of subjects treated with endovascular therapy in IMS III (n=331). Collateral grade before endovascular therapy was assessed with the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology scale, blinded to all other data. Statistical analyses investigated the association between collaterals with baseline clinical variables, angiographic measures of recanalization, reperfusion and clinical outcomes. Adequate views of collateral circulation to the ischemic territory were available in 276 of 331 (83%) subjects. Collateral grade was strongly related to both recanalization of the occluded arterial segment (P=0.0016) and downstream reperfusion (P<0.0001). Multivariable analyses confirmed that robust angiographic collateral grade was a significant predictor of good clinical outcome (modified Rankin Scale score≤2) at 90 days (P=0.0353), adjusted for age, history of diabetes mellitus, National Institutes of Health Stroke Scale strata, and Alberta Stroke Program Early CT Score. The relationship between collateral flow and clinical outcome may depend on the degree of reperfusion. More robust collateral grade was associated with better recanalization, reperfusion, and subsequent better clinical outcomes. These data, from the largest endovascular trial to date, suggest that collaterals are an important consideration in future trial design. http://www.clinicaltrials.gov. Unique identifier: NCT00359424.

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

    Directory of Open Access Journals (Sweden)

    Marc A Adams

    Full Text Available 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.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.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.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.The adaptive intervention outperformed the static intervention for increasing

  2. Protocol for the ENCODE trial: evaluating a novel online depression intervention for persons with epilepsy.

    Science.gov (United States)

    Meyer, Björn; Weiss, Mario; Holtkamp, Martin; Arnold, Stephan; Brückner, Katja; Schröder, Johanna; Scheibe, Franziska; Nestoriuc, Yvonne

    2017-02-07

    Depression is common among persons with epilepsy (PwE), affecting roughly one in three individuals, and its presence is associated with personal suffering, impaired quality of life, and worse prognosis. Despite the availability of effective treatments, depression is often overlooked and treated inadequately in PwE, in part because of assumed concerns over drug interactions or proconvulsant effects of antidepressants. Internet-administered psychological interventions might complement antidepressant medication or psychotherapy, and preliminary evidence suggests that they can be effective. However, no trial has yet examined whether an Internet intervention designed to meet the needs of PwE can achieve sustained reductions in depression and related symptoms, such as anxiety, when offered as adjunct to treatment as usual. This randomized controlled trial will include 200 participants with epilepsy and a current depressive disorder, along with currently at least moderately elevated depression (Patient Health Questionnaire (PHQ-9) sum score of at least 10). Patients will be recruited via epilepsy treatment centers and other sources, including Internet forums, newspaper articles, flyers, posters, and media articles or advertisements, in German-speaking countries. Main inclusion criteria are: self-reported diagnosis of epilepsy and a depressive disorder, as assessed with a phone-administered structured diagnostic interview, none or stable antidepressant medication, no current psychotherapy, no other major psychiatric disorder, no acute suicidality. Participants will be randomly assigned to either (1) a care-as-usual/waitlist (CAU/WL) control group, in which they receive CAU and are given access to the Internet intervention after 3 months (that is, a CAU/WL control group), or (2) a treatment group that may also use CAU and in addition immediately receives six-month access to the novel, Internet-administered intervention. The primary outcome measure is the PHQ-9, collected

  3. Prevention of generalized anxiety disorder using a web intervention, iChill: randomized controlled trial.

    Science.gov (United States)

    Christensen, Helen; Batterham, Philip; Mackinnon, Andrew; Griffiths, Kathleen M; Kalia Hehir, Kanupriya; Kenardy, Justin; Gosling, John; Bennett, Kylie

    2014-09-02

    Generalized Anxiety Disorder (GAD) is a high prevalence, chronic disorder. Web-based interventions are acceptable, engaging, and can be delivered at scale. Few randomized controlled trials evaluate the effectiveness of prevention programs for anxiety, or the factors that improve effectiveness and engagement. The intent of the study was to evaluate the effectiveness of a Web-based program in preventing GAD symptoms in young adults, and to determine the role of telephone and email reminders. A 5-arm randomized controlled trial with 558 Internet users in the community, recruited via the Australian Electoral Roll, was conducted with 6- and 12-month follow-up. Five interventions were offered over a 10-week period. Group 1 (Active website) received a combined intervention of psycho-education, Internet-delivered Cognitive Behavioral Therapy (ICBT) for anxiety, physical activity promotion, and relaxation. Group 2 (Active website with telephone) received the identical Web program plus weekly telephone reminder calls. Group 3 (Active website with email) received the identical Web program plus weekly email reminders. Group 4 (Control) received a placebo website. Group 5 (Control with telephone) received the placebo website plus telephone calls. Main outcome measures were severity of anxiety symptoms as measured by the GAD 7-item scale (GAD-7) (at post-test, 6, and 12 months). Secondary measures were GAD caseness, measured by the Mini International Neuropsychiatric Interview (MINI) at 6 months, Centre for Epidemiologic Studies-Depression scale (CES-D), Anxiety Sensitivity Index (ASI), Penn State Worry Questionnaire (PSWQ), and Days out of Role. GAD-7 symptoms reduced over post-test, 6-month, and 12-month follow-up. There were no significant differences between Group 4 (Control) and Groups 1 (Active website), 2 (Active website with telephone), 3 (Active website with email), or 5 (Control with telephone) at any follow-up. A total of 16 cases of GAD were identified at 6 months

  4. 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. PMID:26366179

  5. 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.

  6. Cost effectiveness of interventions for lateral epicondylitis: results from a randomised controlled trial in primary care

    DEFF Research Database (Denmark)

    Korthals-de Bos, Ingeborg B C; Smidt, Nynke; van Tulder, Maurits W

    2004-01-01

    , compared with euro631 for the wait-and-see policy and euro921 for physiotherapy. After 12 months, the success rate in the physiotherapy group (91%) was significantly higher than in the injection group (69%), but only slightly higher than in the wait-and-see group (83%). The differences in costs and effects......OBJECTIVE: Lateral epicondylitis is a common complaint, with an annual incidence between 1% and 3% in the general population. The Dutch College of General Practitioners in The Netherlands has issued guidelines that recommend a wait-and-see policy. However, these guidelines are not evidence based....... DESIGN AND SETTING: This paper presents the results of an economic evaluation in conjunction with a randomised controlled trial to evaluate the effects of three interventions in primary care for patients with lateral epicondylitis. PATIENTS AND INTERVENTIONS: Patients with pain at the lateral side...

  7. A core outcomes set for clinical trials of interventions for young adults with type 1 diabetes

    DEFF Research Database (Denmark)

    Byrne, Molly; O'Connell, Anthony; Egan, Aoife M

    2017-01-01

    of diabetic ketoacidosis (DKA); objectively measured glycated haemoglobin (HbA1C); level of clinic engagement; and perceived level of control over diabetes. CONCLUSIONS: This study is the first to identify a COS for inclusion in future intervention trials to improve outcomes for young adults with T1DM. Use...... outcomes for young adults with type 1 diabetes (T1DM) is hampered by inconsistent use of outcome measures. This population frequently struggles to manage their condition and reports suboptimal clinical outcomes. Our aim was to conduct an international, e-Delphi consensus study to identify a core outcome...... set (COS) that key stakeholders (young adults with T1DM, diabetes health professionals, diabetes researchers and diabetes policy makers) consider as essential outcomes for future intervention research. METHODS: Using a list of 87 outcomes generated from a published systematic review, we administered...

  8. Effect of a multimodal high intensity exercise intervention in cancer patients undergoing chemotherapy: randomised controlled trial

    DEFF Research Database (Denmark)

    Adamsen, Lis; Quist, Morten; Andersen, Christina

    2009-01-01

    OBJECTIVE: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced...... disease. DESIGN: Randomised controlled trial. SETTING: Two university hospitals in Copenhagen, Denmark. PARTICIPANTS: 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing 21 diagnoses. Main exclusion criteria were brain or bone metastases. 235 patients completed follow......-up. INTERVENTION: Supervised exercise comprising high intensity cardiovascular and resistance training, relaxation and body awareness training, massage, nine hours weekly for six weeks in addition to conventional care, compared with conventional care. MAIN OUTCOME MEASURES: European Organization for Research...

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

    Science.gov (United States)

    Bachman, Jessica L; Raynor, Hollie A

    2012-05-01

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

  10. Barriers to and facilitators of implementing complex workplace dietary interventions: process evaluation results of a cluster controlled trial

    OpenAIRE

    Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J.

    2016-01-01

    Background Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees? dietary intakes, nutri...

  11. Estimating efficacy in the presence of non-ignorable non-trial interventions in the Helsinki Psychotherapy Study.

    Science.gov (United States)

    Härkänen, Tommi; Arjas, Elja; Laaksonen, Maarit A; Lindfors, Olavi; Haukka, Jari; Knekt, Paul

    2016-04-01

    In a randomised clinical trial with a longitudinal outcome, analyses of the efficacy of the study treatments may be complicated by both non-trial interventions, which have not been administered by the researcher, and sparsely measured outcome values. The delay between the change in outcome and the starting of the non-trial intervention may be much shorter than the time intervals between the actual measurements. We propose a model that accounts for the possible dynamic interdependence between the longitudinal outcome and time-to-event data. The model is based on discretising time into short intervals. This results in a missing data problem, which we tackle using Bayesian inference and data augmentation. The method is based on the assumption that decisions to initiate non-trial interventions are not confounded by unobservable factors. The Helsinki Psychotherapy Study data are used as an illustration. Different psychotherapies were compared, and possible episodes of psychotropic medication were viewed as non-trial interventions. Simulation studies suggest that our method provides reasonable estimates of the effects of both the study treatment and the non-trial intervention also showing some robustness against possible latent background factors. An application of marginal structural modelling, however, appeared to underestimate the differences between the treatments. © The Author(s) 2013.

  12. Integrating Behavioral HIV Interventions into Biomedical Prevention Trials with Youth: Lessons from Chicago’s Project PrEPare

    Science.gov (United States)

    Hosek, Sybil G.; Green, Keith R.; Siberry, George; Lally, Michelle; Balthazar, Christopher; Serrano, Pedro A.; Kapogiannis, Bill

    2013-01-01

    On the heels of several trials demonstrating the efficacy of pre-exposure prophylaxis (PrEP) and the recent approval by the FDA of the supplemental indication for Truvada as PrEP, researchers, advocates, and community providers are calling for the investigation of implementation strategies that combine behavioral interventions with biomedical prevention. This paper describes the modification and integration of an evidence-based group-level intervention into a small PrEP pilot trial with young men who have sex with men (YMSM). The behavioral intervention as well as ongoing risk reduction counseling sessions were found to be highly acceptable among a sample of racially diverse YMSM. PMID:24223514

  13. The Maternal Obesity Management (MOM) Trial Protocol: a lifestyle intervention during pregnancy to minimize downstream obesity.

    Science.gov (United States)

    Adamo, Kristi B; Ferraro, Zachary M; Goldfield, Gary; Keely, Erin; Stacey, Dawn; Hadjiyannakis, Stasia; Jean-Philippe, Sonia; Walker, Mark; Barrowman, Nicholas J

    2013-05-01

    Maternal obesity and/or high gestational weight gain (GWG) are associated with downstream child obesity. Pregnancy represents a critical period for prevention as women are highly motivated and more receptive to behavior change. This pilot study was developed to test the feasibility of intervening with the mother, specifically keeping her GWG within the Institute of Medicine (IOM) limits, with the intended target of preventing obesity in her child downstream. We are testing the practicality of delivering a structured physical activity and nutrition intervention to pregnant women during gestation and then following mom and baby to 24 months of age. This study is a two-arm, parallel group, randomized controlled trial being conducted in Ottawa. Pregnant women, with pregravid BMI >18.5, between 12 and 20 weeks gestation are randomized to one of two groups: intervention (n=30) who receive the MOM trial Handbook (guide to healthy gestation) plus a structured physical activity and nutrition program, or a standard clinical care control group (n=30). The intervention lasts 25-28 weeks (6 months) depending on anticipated delivery date, with follow-up assessment on mother and child at 3, 6, 12 and 24 months post-delivery. Pregnancy, a critical time of growth, development and physiological change, provides an opportunity for early lifestyle intervention. The goal of identifying an effective lifestyle program for the gestational period that leads to healthy fetal development and subsequently normal weight offspring, less likely to develop obesity and its co-morbidities, is unique and could possibly attenuate the inter-generational cycle of obesity. Copyright © 2013 Elsevier Inc. All rights reserved.

  14. Brief parenting intervention for parents of NICU graduates: a randomized, clinical trial of Primary Care Triple P.

    Science.gov (United States)

    Schappin, Renske; Wijnroks, Lex; Uniken Venema, Monica; Wijnberg-Williams, Barbara; Veenstra, Ravian; Koopman-Esseboom, Corine; Tollenaer, Susanne Mulder-De; van der Tweel, Ingeborg; Jongmans, Marian

    2013-05-07

    Preterm-born or asphyxiated term-born children who received neonatal intensive care show more emotional and behavioral problems than term-born children without a medical condition. It is uncertain whether regular parenting intervention programs to which the parents of these children are usually referred, are effective in reducing child problem behavior in this specific population. Our objective was to investigate whether a regular, brief parenting intervention, Primary Care Triple P, is effective in decreasing emotional and behavioral problems in preterm-born or asphyxiated term-born preschoolers. For this pragmatic, open randomized clinical trial, participants were recruited from a cohort of infants admitted to the neonatal intensive care units (NICU) of two Dutch hospitals. Children born with a gestational age parents on the CBCL, 6 months after the start of the trial. There was no effect of the intervention on the CBCL at the trial endpoint (t64 = 0.54, P = .30). On secondary measurements of child problem behavior, parenting style, parenting stress, and parent perceived child vulnerability, groups either did not differ significantly or the intervention group showed more problems. In both the intervention and control group there was a significant decrease in emotional and behavioral problems during the trial. Primary Care Triple P, a brief parenting intervention, is not effective in reducing child emotional and behavioral problems in preterm-born children or term-born children with perinatal asphyxia. Netherlands National Trial Register (NTR): NTR2179.

  15. Paediatric emergency department-based carbon monoxide detector intervention: a randomised trial.

    Science.gov (United States)

    McKenzie, Lara B; Roberts, Kristin J; Kaercher, Roxanne M; Collins, Christy L; Comstock, R Dawn; Fernandez, Soledad; Abdel-Rasoul, Mahmoud; Casavant, Marcel J; Mihalov, Leslie

    2017-10-01

    Although non-fire-related carbon monoxide (CO) poisoning is almost entirely preventable, over 400 people die and 20 000 people are injured each year in the USA from unintentional CO poisoning. Thus, there is a critical need for evidence-based interventions for preventing CO poisoning and increasing the proper use and installation of CO detectors. A randomised, controlled trial (Project CODE, a Carbon Monoxide Detector Education intervention) with 2-week and 6-month follow-up home observations was conducted in 299 parents of children aged ≤18 years recruited in the emergency department of a level 1 paediatric trauma centre. The intervention group received an educational tool, a spiral-bound, laminated booklet that resembled a CO detector containing theory-based safety messages based on the precaution adoption process model, a plug-in CO detector and 9 V battery. The control group received a one page flyer on CO poisoning prevention. Although the difference was not statistically significant, mean CO knowledge score increased at a greater rate for the intervention group than the control group. Intervention group parents were more likely to exhibit 'safe' CO detector use than control group parents at the 2-week follow-up (RR: 2.75; 95% CI 2.06 to 3.69) and 6-month follow-up (RR: 2.78; 95% CI 2.06 to 3.76), after adjusting for self-reported CO detector use behaviour at enrolment and annual per capita income. An emergency department-delivered intervention containing a theory-based educational tool paired with a CO detector can be an effective method for increasing knowledge about CO poisoning, for prevention and for appropriate use of a CO detector. NCT00959478. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  16. Acceptability and feasibility of the 'DASH for Asthma' intervention in a randomized controlled trial pilot study.

    Science.gov (United States)

    Blonstein, Andrea C; Lv, Nan; Camargo, Carlos A; Wilson, Sandra R; Buist, A Sonia; Rosas, Lisa G; Strub, Peg; Ma, Jun

    2016-08-01

    'DASH for Asthma' (n 90) was a 6-month randomized controlled trial that demonstrated potential benefits of a DASH (Dietary Approaches to Stop Hypertension) behavioural intervention for improving diet quality and asthma control by comparing intervention to usual care in adults with uncontrolled asthma. The present study examined acceptability and feasibility of the intervention from the perspective of intervention participants and lifestyle coaches. Grounded in Social Cognitive Theory, the 3-month intensive stage, including three individual and eight group sessions, focused on diet modifications and behavioural self-regulation. The 3-month maintenance stage contained telephone consultations. Participants and lifestyle coaches completed surveys including 5-point Likert scales and open-ended questions. We analysed data using descriptive and inductive content analyses. Forty-six intervention participants (survey response rate was 65-72 %) and two lifestyle coaches. Participants and lifestyle coaches were highly satisfied (all mean ratings >4) with individual and group sessions. Participants identified mastery of knowledge and skills (awareness, goal setting, self-monitoring, problem solving), social learning (class members sharing experiences and ideas) and good coaching skills (reflective listening, empathy, motivational counselling) as important contributors to self-efficacy and programme satisfaction. Participants also valued personalized feedback received in individual sessions. Lifestyle coaches viewed participant engagement as a facilitator to effective sessions. Finally, participants and lifestyle coaches identified food tasting as beneficial for observational learning and facilitation of participant engagement. High class attendance and self-monitoring rate also reflected the high engagement among participants. The DASH behavioural intervention was feasible and highly acceptable to participants with uncontrolled asthma and lifestyle coaches.

  17. A food store intervention trial improves caregiver psychosocial factors and children's dietary intake in Hawaii.

    Science.gov (United States)

    Gittelsohn, Joel; Vijayadeva, Vinutha; Davison, Nicola; Ramirez, Vickie; Cheung, Leo W K; Murphy, Suzanne; Novotny, Rachel

    2010-02-01

    Diet-related chronic diseases are at epidemic levels in low-income ethnic minority populations. The purpose of this study is to decrease risk for obesity in children by modifying the food environment and conducting point-of-purchase promotions that will lead to changes in psychosocial factors and behaviors associated with healthier food choices among low-income communities with a preponderance of Native Hawaiians and Pacific Islanders. We implemented an intervention trial over a 9-11-month period in five food stores in two low-income multiethnic communities in Hawaii, targeting both children and their adult caregivers. The Healthy Foods Hawaii (HFH) intervention consisted of an environmental component to increase store stocking of nutritious foods, point-of-purchase promotions, interactive sessions, and involved local producers and distributors. We evaluated the impact of the program on 116 child-caregiver dyads, sampled from two intervention and two comparison areas before and after intervention implementation. Program impacts were evaluated using multivariable linear regression. The HFH program had a significant impact on caregiver knowledge and the perception that healthy foods are convenient. Intervention children significantly increased their Healthy Eating Index (HEI) score for servings of grains, their total consumption of water, and showed an average 8.5 point (out of 90 total, eliminating the 10 points for variety, giving a 9.4% increase) increase in overall HEI score. A food store intervention was effective in improving healthy food knowledge and perception that healthy foods are convenient among caregivers, and increased the consumption of several targeted healthy foods by their children. Greater intensity, sustained food system change, and further targeting for children are needed to show greater and sustained change in food-related behaviors in low-income Native Hawaiian and Pacific Islander communities.

  18. Communication interventions to improve adherence to infection control precautions: a randomised crossover trial.

    Science.gov (United States)

    Ong, Mei-Sing; Magrabi, Farah; Post, Jeffrey; Morris, Sarah; Westbrook, Johanna; Wobcke, Wayne; Calcroft, Ross; Coiera, Enrico

    2013-02-06

    Ineffective communication of infection control requirements during transitions of care is a potential cause of non-compliance with infection control precautions by healthcare personnel. In this study, interventions to enhance communication during inpatient transfers between wards and radiology were implemented, in the attempt to improve adherence to precautions during transfers. Two interventions were implemented, comprising (i) a pre-transfer checklist used by radiology porters to confirm a patient's infectious status; (ii) a coloured cue to highlight written infectious status information in the transfer form. The effectiveness of the interventions in promoting adherence to standard precautions by radiology porters when transporting infectious patients was evaluated using a randomised crossover trial at a teaching hospital in Australia. 300 transfers were observed over a period of 4 months. Compliance with infection control precautions in the intervention groups was significantly improved relative to the control group (p < 0.01). Adherence rate in the control group was 38%. Applying the coloured cue resulted in a compliance rate of 73%. The pre-transfer checklist intervention achieved a comparable compliance rate of 71%. When both interventions were applied, a compliance rate of 74% was attained. Acceptability of the coloured cue was high, but adherence to the checklist was low (40%). Simple measures to enhance communication through the provision of a checklist and the use a coloured cue brought about significant improvement in compliance with infection control precautions by transport personnel during inpatient transfers. The study underscores the importance of effective communication in ensuring compliance with infection control precautions during transitions of care.

  19. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

    Science.gov (United States)

    Verbakel, Natasha J; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-05-01

    A constructive safety culture is essential for the successful implementation of patient safety improvements. To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. A three-arm cluster randomised trial was conducted in a mixed method study, studying the effect of administering a patient safety culture questionnaire (intervention I), the questionnaire complemented with a practice-based workshop (intervention II) and no intervention (control) in 30 general practices in the Netherlands. The primary outcome, the number of reported incidents, was measured with a questionnaire at baseline and a year after. Analysis was performed using a negative binomial model. Secondary outcomes were quality and safety indicators and safety culture. Mixed effects linear regression was used to analyse the culture questionnaires. The number of incidents increased in both intervention groups, to 82 and 224 in intervention I and II respectively. Adjusted for baseline number of incidents, practice size and accreditation status, the study showed that practices that additionally participated in the workshop reported 42 (95% confidence interval [CI] = 9.81 to 177.50) times more incidents compared to the control group. Practices that only completed the questionnaire reported 5 (95% CI = 1.17 to 25.49) times more incidents. There were no statistically significant differences in staff perception of patient safety culture at follow-up between the three study groups. Educating staff and facilitating discussion about patient safety culture in their own practice leads to increased reporting of incidents. It is beneficial to invest in a team-wise effort to improve patient safety. © British Journal of General Practice 2015.

  20. Evaluation of a workplace treadmill desk intervention: a randomized controlled trial.

    Science.gov (United States)

    Schuna, John M; Swift, Damon L; Hendrick, Chelsea A; Duet, Megan T; Johnson, William D; Martin, Corby K; Church, Timothy S; Tudor-Locke, Catrine

    2014-12-01

    To evaluate the effectiveness of a 3-month treadmill desk intervention in eliciting changes in physical activity and sedentary behavior among overweight/obese office workers. A randomized controlled trial was conducted among overweight/obese office workers (n = 41; mean age = 40.1 ± 10.1 years) at a private workplace. Participants were randomly assigned to a shared-treadmill desk intervention (n = 21) or a usual working condition control group (n = 20). Accelerometer-determined physical activity and sedentary behavior were measured before and after the intervention. Compared with the control group, the intervention group increased daily steps (1622 steps/day; P = 0.013) and light physical activity (1.6 minutes/hour; P = 0.008), and decreased sedentary time (-3.6 minutes/hour; P = 0.047) during working hours. Shared-treadmill desks in the workplace can be effective at promoting favorable changes in light physical activity (specifically 40 to 99 steps/minute) and sedentary behavior among overweight/obese office workers.

  1. An Efficacy Trial of an Intervention Program for Children Exposed to Intimate Partner Violence.

    Science.gov (United States)

    Graham-Bermann, Sandra A; Miller-Graff, Laura E; Howell, Kathryn H; Grogan-Kaylor, Andrew

    2015-12-01

    Children exposed to intimate partner violence (IPV) are at high risk for adjustment problems, especially internalizing disorders. Few evidence-based interventions are available to address internalizing behavior problems in this population. An efficacy trial compared outcomes for 4-6 year old children randomly assigned to a program designed to address the effects of exposure to IPV with those allocated to a waitlist comparison condition. Mothers (N = 120) and children from the United States and Canada were assessed at baseline, 5 weeks later (post-intervention) and at 8-month follow-up. The evaluation compared rates of change over time for child internalizing problems. Results were analyzed using both intent-to-treat (ITT) and per-protocol (PP) approaches. ITT analyses indicated the program reduced internalizing problems for girls at follow-up. PP analyses indicated the program reduced internalizing problems for both boys and girls at post-intervention. In this study, child internalizing problems were significantly reduced through an intervention for the mother and the child.

  2. 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.

  3. Economic evaluation of an extended nutritional intervention in older Australian hospitalized patients: a randomized controlled trial.

    Science.gov (United States)

    Sharma, Yogesh; Thompson, Campbell; Miller, Michelle; Shahi, Rashmi; Hakendorf, Paul; Horwood, Chris; Kaambwa, Billingsley

    2018-02-05

    Prevalence of malnutrition in older hospitalized patients is 30%. Malnutrition is associated with poor clinical outcomes in terms of high morbidity and mortality and is costly for hospitals. Extended nutrition interventions improve clinical outcomes but limited studies have investigated whether these interventions are cost-effective. In this randomized controlled trial, 148 malnourished general medical patients ≥60 years were recruited and randomized to receive either an extended nutritional intervention or usual care. Nutrition intervention was individualized and started with 24 h of admission and was continued for 3 months post-discharge with a monthly telephone call whereas control patients received usual care. Nutrition status was confirmed by Patient generated subjective global assessment (PG-SGA) and health-related quality of life (HRQoL) was measured using EuroQoL 5D (EQ-5D-5 L) questionnaire at admission and at 3-months follow-up. A cost-effectiveness analysis was conducted for the primary outcome (incremental costs per unit improvement in PG-SGA) while a cost-utility analysis (CUA) was undertaken for the secondary outcome (incremental costs per quality adjusted life year (QALY) gained). Nutrition status and HRQoL improved in intervention patients. Mean per included patient Australian Medicare costs were lower in intervention group compared to control arm (by $907) but these differences were not statistically significant (95% CI: -$2956 to $4854). The main drivers of higher costs in the control group were higher inpatient ($13,882 versus $13,134) and drug ($838 versus $601) costs. After adjusting outcomes for baseline differences and repeated measures, the intervention was more effective than the control with patients in this arm reporting QALYs gained that were higher by 0.0050 QALYs gained per patient (95% CI: -0.0079 to 0.0199). The probability of the intervention being cost-effective at willingness to pay values as low as $1000 per unit

  4. Screening and brief intervention for drug use in primary care: the ASPIRE randomized clinical trial.

    Science.gov (United States)

    Saitz, Richard; Palfai, Tibor P A; Cheng, Debbie M; Alford, Daniel P; Bernstein, Judith A; Lloyd-Travaglini, Christine A; Meli, Seville M; Chaisson, Christine E; Samet, Jeffrey H

    2014-08-06

    The United States has invested substantially in screening and brief intervention for illicit drug use and prescription drug misuse, based in part on evidence of efficacy for unhealthy alcohol use. However, it is not a recommended universal preventive service in primary care because of lack of evidence of efficacy. To test the efficacy of 2 brief counseling interventions for unhealthy drug use (any illicit drug use or prescription drug misuse)-a brief negotiated interview (BNI) and an adaptation of motivational interviewing (MOTIV)-compared with no brief intervention. This 3-group randomized trial took place at an urban hospital-based primary care internal medicine practice; 528 adult primary care patients with drug use (Alcohol, Smoking, and Substance Involvement Screening Test [ASSIST] substance-specific scores of ≥4) were identified by screening between June 2009 and January 2012 in Boston, Massachusetts. Two interventions were tested: the BNI is a 10- to 15-minute structured interview conducted by health educators; the MOTIV is a 30- to 45-minute intervention based on motivational interviewing with a 20- to 30-minute booster conducted by master's-level counselors. All study participants received a written list of substance use disorder treatment and mutual help resources. Primary outcome was number of days of use in the past 30 days of the self-identified main drug as determined by a validated calendar method at 6 months. Secondary outcomes included other self-reported measures of drug use, drug use according to hair testing, ASSIST scores (severity), drug use consequences, unsafe sex, mutual help meeting attendance, and health care utilization. At baseline, 63% of participants reported their main drug was marijuana, 19% cocaine, and 17% opioids. At 6 months, 98% completed follow-up. Mean adjusted number of days using the main drug at 6 months was 12 for no brief intervention vs 11 for the BNI group (incidence rate ratio [IRR], 0.97; 95% CI, 0.77-1.22) and 12

  5. Frailty measurement and outcomes in interventional studies: protocol for a systematic review of randomised control trials.

    Science.gov (United States)

    Shears, Melissa; McGolrick, Danielle; Waters, Braden; Jakab, Marnie; Boyd, J Gordon; Muscedere, John

    2017-12-26

    Frailty is associated with reduced functional capacity, decreased resistance to stressors and is predictive of a range of adverse health outcomes, including dependency, hospitalisation and mortality. Early identification of frailty may prevent, reduce and postpone adverse health outcomes. However, there is a need for additional evidence to guide decision-making for the care of frail patients since frail persons are frequently excluded from studies, the differential impact of frailty is often not examined in clinical trials and few large-scale clinical trials examining frail cohorts have been conducted. Randomised control trials (RCTs) published to date have used a diverse range of definitions of frailty, as well as a variety of outcome measures. The objective of this systematic review is to comprehensively characterise the frail populations enrolled and the end points reported in frailty RCTs. We will identify all RCTs reporting on the outcome of interventions in adult (age ≥18 years) frail populations as defined by authors, in all settings of care. Databases will include MEDLINE, CINAHL, EMBASE, PsycInfo, Global Health, the Joanna Briggs database and Cochrane Library. Two reviewers will independently determine trial eligibility. For each included trial, we will conduct duplicate independent data extraction, inter-rater reliability, risk of bias assessment and evaluation of the quality of the evidence using the Grading of Recommendations, Assessment, Development and Evaluations approach. This systematic review will comprehensively identify RCTs including frail patients to identify how frailty is measured and which outcomes are reported. The results of this systematic review may inform clinicians caring for persons with frailty, facilitate conduct of future RCTs and inform future efforts to develop common data elements and core outcomes for frailty studies. Our findings will be disseminated through conference presentation and publication in peer-reviewed journals

  6. Podiatry intervention versus usual care to prevent falls in care homes: pilot randomised controlled trial (the PIRFECT study).

    Science.gov (United States)

    Wylie, Gavin; Menz, Hylton B; McFarlane, Sarah; Ogston, Simon; Sullivan, Frank; Williams, Brian; Young, Zoe; Morris, Jacqui

    2017-07-12

    Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents. Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength. 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group. A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised

  7. A systematic review of the inclusion of mechanisms of action in NIH-funded intervention trials to improve medication adherence.

    Science.gov (United States)

    Edmondson, Donald; Falzon, Louise; Sundquist, Kevin J; Julian, Jacob; Meli, Laura; Sumner, Jennifer A; Kronish, Ian M

    2018-02-01

    Medication nonadherence contributes to morbidity/mortality, but adherence interventions yield small and inconsistent effects. Understanding the mechanisms underlying initiation and maintenance of adherence could improve interventions. The National Institutes of Health (NIH) support adherence research, but it is unclear whether existing NIH-funded research incorporates mechanisms. We conducted a systematic review to determine the proportion of NIH-funded adherence trials that have tested hypothesized mechanisms of intervention effects. We included randomized and quasi-randomized NIH-funded trials with medication adherence in adults as the primary outcome. Studies were identified by searching electronic databases from inception to 6/2016, references, and clinicaltrials.gov. Two of 18 (11%) NIH-funded trials tested a hypothesized mechanism of an intervention's effect on medication adherence. Another 44 studies with medication adherence as a secondary outcome were described in protocol form, and are either ongoing or never published results, but none mentioned mechanism tests. Overall, 3% of NIH-funded trials with adherence as an outcome conducted, or plan to conduct, tests of behavior change mechanisms. These results mirror previous findings that very few studies of behavior change interventions actually test the mechanism by which the intervention is hypothesized to improve health behaviors. We must understand mechanisms if we are to improve the effectiveness of interventions. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Development and delivery of a physiotherapist-led exercise intervention in a randomised controlled trial for subacromial impingement syndrome (the SUPPORT trial).

    Science.gov (United States)

    Stevenson, Kay; Jackson, Sue; Shufflebotham, Julie; Roddy, Edward; Foster, Nadine E

    2017-12-01

    This paper describes the development, content and delivery of a physiotherapist- led individualised, supervised and progressed exercise programme for use in a factorial randomised controlled trial testing treatments for subacromial impingement syndrome. To develop the intervention, a survey of community physiotherapists and national guidelines provided the basis for a consensus workshop through which a protocol was developed for the SUPPORT trial physiotherapist-led exercise programme (SUPPORT: SUbacromial impingement syndrome and Pain: a randomised controlled trial Of exeRcise and injection). The protocol included three stages of exercise progression: (1) scapular stability and active exercise with no resistance (2) range of motion exercise with scapular control, isometrics and stretches, and (3) through range resistance exercise. A two day training programme was developed for physiotherapists which included the trial background, current evidence and strategies to improve exercise adherence. Twenty physiotherapists were trained to deliver the exercise intervention. In the SUPPORT trial, 128 participants were randomised to physiotherapist-led exercise. Ninety nine (81%) participants had their first physiotherapy session within 2 to 3 weeks and 71 (56%) received six to eight treatment sessions. Frequently-used exercises were: stage 1 scapular setting with glenohumeral joint (GHJ) flexion to 90°, stage 2 GHJ medial rotation stretch, stage 3 scapular setting through lateral rotation, with resistance bands. We combined clinical and research expertise with national guidance in order to develop a physiotherapist-led, individualised, progressed and supervised exercise intervention for use within a randomised trial. The effectiveness of the intervention is being evaluated within the SUPPORT trial. Trial registration number ISRCTN 42399123. Copyright © 2017 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  9. Participatory workplace interventions can reduce sedentary time for office workers--a randomised controlled trial.

    Science.gov (United States)

    Parry, Sharon; Straker, Leon; Gilson, Nicholas D; Smith, Anne J

    2013-01-01

    Occupational sedentary behaviour is an important contributor to overall sedentary risk. There is limited evidence for effective workplace interventions to reduce occupational sedentary time and increase light activity during work hours. The purpose of the study was to determine if participatory workplace interventions could reduce total sedentary time, sustained sedentary time (bouts >30 minutes), increase the frequency of breaks in sedentary time and promote light intensity activity and moderate/vigorous activity (MVPA) during work hours. A randomised controlled trial (ANZCTR NUMBER: ACTN12612000743864) was conducted using clerical, call centre and data processing workers (n = 62, aged 25-59 years) in 3 large government organisations in Perth, Australia. Three groups developed interventions with a participatory approach: 'Active office' (n = 19), 'Active Workstation' and promotion of incidental office activity; 'Traditional physical activity' (n = 14), pedometer challenge to increase activity between productive work time and 'Office ergonomics' (n = 29), computer workstation design and breaking up computer tasks. Accelerometer (ActiGraph GT3X, 7 days) determined sedentary time, sustained sedentary time, breaks in sedentary time, light intensity activity and MVPA on work days and during work hours were measured before and following a 12 week intervention period. For all participants there was a significant reduction in sedentary time on work days (-1.6%, p = 0.006) and during work hours (-1.7%, p = 0.014) and a significant increase in number of breaks/sedentary hour on work days (0.64, p = 0.005) and during work hours (0.72, p = 0.015); there was a concurrent significant increase in light activity during work hours (1.5%, p = 0.012) and MVPA on work days (0.6%, p = 0.012). This study explored novel ways to modify work practices to reduce occupational sedentary behaviour. Participatory workplace interventions can reduce

  10. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Arija Victoria

    2012-05-01

    view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers’ education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. Trial Registration number Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360775

  11. Mobile phone intervention reduces perinatal mortality in zanzibar: secondary outcomes of a cluster randomized controlled trial.

    Science.gov (United States)

    Lund, Stine; Rasch, Vibeke; Hemed, Maryam; Boas, Ida Marie; Said, Azzah; Said, Khadija; Makundu, Mkoko Hassan; Nielsen, Birgitte Bruun

    2014-03-26

    Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse. We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting. This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text message and voucher component. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality. Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74). Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings. ClinicalTrials

  12. Efficacy of musical interventions in dementia: methodological requirements of nonpharmacological trials.

    Science.gov (United States)

    Samson, Séverine; Clément, Sylvain; Narme, Pauline; Schiaratura, Loris; Ehrlé, Nathalie

    2015-03-01

    The management of patients with Alzheimer's disease is a significant public health problem given the limited effectiveness of pharmacological therapies combined with iatrogenic effects of drug treatments in dementia. Consequently, the development of nondrug care, such as musical interventions, has become a necessity. The experimental rigor of studies in this area, however, is often lacking. It is therefore difficult to determine the impact of musical interventions on patients with dementia. As part of a series of studies, we carried out randomized controlled trials to compare the effectiveness of musical activities to other pleasant activities on various functions in patients with severe Alzheimer's disease. The data obtained in these trials are discussed in light of the methodological constraints and requirements specific to these clinical studies. Although the results demonstrate the power of music on the emotional and behavioral status of patients, they also suggest that other pleasant activities (e.g., cooking) are also effective, leaving open the question about the specific benefits of music in patients with dementia. All these findings highlight the promising potential for nonpharmacological treatments to improve the well-being of patients living in residential care and to reduce caregiver burden. © 2014 New York Academy of Sciences.

  13. 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

  14. Multi-strategic intervention to enhance implementation of healthy canteen policy: a randomised controlled trial.

    Science.gov (United States)

    Wolfenden, Luke; Nathan, Nicole; Janssen, Lisa M; Wiggers, John; Reilly, Kathryn; Delaney, Tessa; Williams, Christopher M; Bell, Colin; Wyse, Rebecca; Sutherland, Rachel; Campbell, Libby; Lecathelinais, Christophe; Oldmeadow, Chris; Freund, Megan; Yoong, Sze Lin

    2017-01-11

    Internationally, governments have implemented school-based nutrition policies to restrict the availability of unhealthy foods from sale. The aim of the trial was to assess the effectiveness of a multi-strategic intervention to increase implementation of a state-wide healthy canteen policy. The impact of the intervention on the energy, total fat, and sodium of children's canteen purchases and on schools' canteen revenue was also assessed. Australian primary schools with a canteen were randomised to receive a 12-14-month, multi-strategic intervention or to a no intervention control group. The intervention sought to increase implementation of a state-wide healthy canteen policy which required schools to remove unhealthy items (classified as 'red' or 'banned') from regular sale and encouraged schools to 'fill the menu' with healthy items (classified as 'green'). The intervention strategies included allocation of a support officer to assist with policy implementation, engagement of school principals and parent committees, consensus processes with canteen managers, training, provision of tools and resources, academic detailing, performance feedback, recognition and marketing initiatives. Data were collected at baseline (April to September, 2013) and at completion of the implementation period (November, 2014 to April, 2015). Seventy schools participated in the trial. Relative to control, at follow-up, intervention schools were significantly more likely to have menus without 'red' or 'banned' items (RR = 21.11; 95% CI 3.30 to 147.28; p ≤ 0.01) and to have at least 50% of menu items classified as 'green' (RR = 3.06; 95% CI 1.64 to 5.68; p ≤ 0.01). At follow-up, student purchases from intervention school canteens were significantly lower in total fat (difference = -1.51 g; 95% CI -2.84 to -0.18; p = 0.028) compared to controls, but not in energy (difference = -132.32 kJ; 95% CI -280.99 to 16.34; p = 0.080) or sodium (difference = -46

  15. The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

    Directory of Open Access Journals (Sweden)

    Dunkley David

    2008-09-01

    Full Text Available Abstract Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues intervention or to an attention control (Care condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will

  16. 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

  17. Internet-Based Intervention for Tinnitus: Outcome of a Single-Group Open Trial.

    Science.gov (United States)

    Beukes, Eldré W; Allen, Peter M; Manchaiah, Vinaya; Baguley, David M; Andersson, Gerhard

    2017-04-01

    Managing chronic tinnitus is challenging, and innovative ways to address the resulting health-care burden are required. Internet-based cognitive behavioral therapy (iCBT) for tinnitus shows promise as a cost-effective treatment option. The feasibility and effectiveness of iCBT in the United Kingdom are yet to be explored. Furthermore, it is not known if iCBT can be supported by an audiologist rather than a psychologist. This study aimed to determine the feasibility of guided iCBT using audiological support on tinnitus distress and tinnitus-related comorbidities. Furthermore, it aimed to establish the feasibility of iCBT for tinnitus distress in the United Kingdom, by determining recruitment, attrition, and compliance rates. Finally, it aimed to identify which aspects of the protocol require refinement for subsequent clinical trials. A single-group open trial design was implemented. This study would serve as a prerequisite study, to identify barriers, before undertaking effectiveness trials. Participants consisted of 37 adults (18 males, 19 females), with an age range of between 50 and 59 yr. The mean preintervention tinnitus severity rating was 56.15 (standard deviation = 18.35), which is categorized as "severe tinnitus" as measured by the Tinnitus Functional Index (TFI). Five participants withdrew during the study, and 29 of the remaining participants completed the postintervention questionnaire. The guided iCBT intervention ran over an eight-week period and consisted of 16 obligatory modules and five optional modules. The intervention was designed to be interactive, interesting, and stimulating. A key element was the provision of support from an audiologist throughout the program. Online questionnaires were used throughout the study. These were administered at baseline and postintervention to determine attrition and compliance rates and to facilitate sample size estimates for further clinical trials. Outcome measures for tinnitus severity, hearing handicap

  18. Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD. TECEPOC: study protocol for a partially randomized controlled trial (preference trial

    Directory of Open Access Journals (Sweden)

    Leiva-Fernández Francisca

    2012-05-01

    Full Text Available Abstract Background Drugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The inability of patients to correctly use their inhaler device may be a direct consequence of insufficient or poor inhaler technique instruction. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD. Methods This study uses both a multicenter patients´ preference trial and a comprehensive cohort design with 495 COPD-diagnosed patients selected by a non-probabilistic method of sampling from seven Primary Care Centers. The participants will be divided into two groups and five arms. The two groups are: 1 the patients´ preference group with two arms and 2 the randomized group with three arms. In the preference group, the two arms correspond to the two educational interventions (Intervention A and Intervention B designed for this study. In the randomized group the three arms comprise: intervention A, intervention B and a control arm. Intervention A is written information (a leaflet describing the correct inhalation techniques. Intervention B is written information about inhalation techniques plus training by an instructor. Every patient in each group will be visited six times during the year of the study at health care center. Discussion Our hypothesis is that the application of two educational interventions in patients with COPD who are treated with inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25 %. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, considering that it will be adequate and feasible within the context of clinical practice. Trial registration Current Controlled Trials ISRTCTN15106246

  19. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    John F. Emerson

    2015-12-01

    , participants had a median of nine total documented contacts with PCMH providers compared to four in the control group. Three intervention and two control participants had controlled diabetes (hemoglobin A1C <9%. Multidisciplinary care that utilizes health coach-facilitated virtual visits is an intervention that could increase access to intensive primary care services in a vulnerable population. The methods tested are feasible and should be tested in a pragmatic randomized controlled trial to evaluate the impact on patient-relevant outcomes across multiple chronic diseases.

  20. The STRIDE weight loss and lifestyle intervention for individuals taking antipsychotic medications: a randomized trial.

    Science.gov (United States)

    Green, Carla A; Yarborough, Bobbi Jo H; Leo, Michael C; Yarborough, Micah T; Stumbo, Scott P; Janoff, Shannon L; Perrin, Nancy A; Nichols, Greg A; Stevens, Victor J

    2015-01-01

    The STRIDE study assessed whether a lifestyle intervention, tailored for individuals with serious mental illnesses, reduced weight and diabetes risk. The authors hypothesized that the STRIDE intervention would be more effective than usual care in reducing weight and improving glucose metabolism. The study design was a multisite, parallel two-arm randomized controlled trial in community settings and an integrated health plan. Participants who met inclusion criteria were ≥18 years old, were taking antipsychotic agents for ≥30 days, and had a body mass index ≥27. Exclusions were significant cognitive impairment, pregnancy/breastfeeding, recent psychiatric hospitalization, bariatric surgery, cancer, heart attack, or stroke. The intervention emphasized moderate caloric reduction, the DASH (Dietary Approaches to Stop Hypertension) diet, and physical activity. Blinded staff collected data at baseline, 6 months, and 12 months. Participants (men, N=56; women, N=144; mean age=47.2 years [SD=10.6]) were randomly assigned to usual care (N=96) or a 6-month weekly group intervention plus six monthly maintenance sessions (N=104). A total of 181 participants (90.5%) completed 6-month assessments, and 170 (85%) completed 12-month assessments, without differential attrition. Participants attended 14.5 of 24 sessions over 6 months. Intent-to-treat analyses revealed that intervention participants lost 4.4 kg more than control participants from baseline to 6 months (95% CI=-6.96 kg to -1.78 kg) and 2.6 kg more than control participants from baseline to 12 months (95% CI=-5.14 kg to -0.07 kg). At 12 months, fasting glucose levels in the control group had increased from 106.0 mg/dL to 109.5 mg/dL and decreased in the intervention group from 106.3 mg/dL to 100.4 mg/dL. No serious adverse events were study-related; medical hospitalizations were reduced in the intervention group (6.7%) compared with the control group (18.8%). Individuals taking antipsychotic medications can lose

  1. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Emerson, John F; Welch, Madelyn; Rossman, Whitney E; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2015-12-22

    median of nine total documented contacts with PCMH providers compared to four in the control group. Three intervention and two control participants had controlled diabetes (hemoglobin A1C <9%). Multidisciplinary care that utilizes health coach-facilitated virtual visits is an intervention that could increase access to intensive primary care services in a vulnerable population. The methods tested are feasible and should be tested in a pragmatic randomized controlled trial to evaluate the impact on patient-relevant outcomes across multiple chronic diseases.

  2. A randomized controlled trial of an intervention for infants' behavioral sleep problems.

    Science.gov (United States)

    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

    2015-11-13

    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. Two hundred thirty five families of six-to-eight month-old infants were randomly allocated to intervention (n = 117) or to control teaching sessions (n = 118) where parents received instruction on infant safety. Outcome measures were observed at baseline and at 6 weeks post intervention. Nightly observation was based on actigraphy and sleep diaries over six days. Secondary outcomes were derived from the Multidimensional Assessment of Fatigue Scale, Center for Epidemiologic Studies Depression Measure, Pittsburgh Sleep Quality Index, and Maternal (parental) Cognitions about Infant Sleep Questionnaire. One hundred eight intervention and 107 control families provided six-week follow-up information with complete actigraphy data for 96 in each group: 96.9% of intervention and 97.9% of control infants had an average of 2 or more nightly wakes, a risk difference of -0.2% (95% CI: -1.32, 0.91). 4% of intervention and 14% of control infants had parent-assessed severe sleep problems: relative risk 0.3, a risk difference of -10% (CI: 0.11, 0.84-16.8 to -2.2). Relative to controls, intervention parents reported improved baseline-adjusted parental depression (CI: -3.7 to -0.4), fatigue (CI: -5.74 to -1.68), sleep quality (CI: -1.5 to -0.2), and sleep cognitions: doubts (CI: -2.0 to -0.6), feeding (CI: - 2.1 to - 0.7), anger (CI: - 1.8 to - 0.4) and setting limits (CI: -3.5 to -1.5). The intervention improved caregivers' assessments of infant sleep problem severity and parental depression, fatigue, sleep

  3. 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

  4. A pilot randomized trial of two cognitive rehabilitation interventions for mild cognitive impairment: caregiver outcomes.

    Science.gov (United States)

    Cuc, Andrea V; Locke, Dona E C; Duncan, Noah; Fields, Julie A; Snyder, Charlene Hoffman; Hanna, Sherrie; Lunde, Angela; Smith, Glenn E; Chandler, Melanie

    2017-12-01

    This study aims to provide effect size estimates of the impact of two cognitive rehabilitation interventions provided to patients with mild cognitive impairment: computerized brain fitness exercise and memory support system on support partners' outcomes of depression, anxiety, quality of life, and partner burden. A randomized controlled pilot trial was performed. At 6 months, the partners from both treatment groups showed stable to improved depression scores, while partners in an untreated control group showed worsening depression over 6 months. There were no statistically significant differences on anxiety, quality of life, or burden outcomes in this small pilot trial; however, effect sizes were moderate, suggesting that the sample sizes in this pilot study were not adequate to detect statistical significance. Either form of cognitive rehabilitation may help partners' mood, compared with providing no treatment. However, effect size estimates related to other partner outcomes (i.e., burden, quality of life, and anxiety) suggest that follow-up efficacy trials will need sample sizes of at least 30-100 people per group to accurately determine significance. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  5. Implementation of physical coordination training and cognitive behavioural training interventions at cleaning workplaces - secondary analyses of a randomised controlled trial

    DEFF Research Database (Denmark)

    Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias

    2012-01-01

    This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12...... intervention effects, more research on implementation is needed. Trial registration: ISRCTN96241850. Practitioner summary: Both physical coordination training and cognitive behavioural training are potential effective workplace interventions among low educated job groups with high physical work demands....... However, thorough consideration should be given to feasibility in the design of interventions. The optimal intervention should be tailored to closely match the implementation context and be robust and flexible to minimise susceptibility to changes in work organisation....

  6. Chronic Stroke Outcome Measures for Motor Function Intervention Trials: Expert Panel Recommendations.

    Science.gov (United States)

    Bushnell, Cheryl; Bettger, Janet Prvu; Cockroft, Kevin M; Cramer, Steven C; Edelen, Maria Orlando; Hanley, Daniel; Katzan, Irene L; Mattke, Soeren; Nilsen, Dawn M; Piquado, Tepring; Skidmore, Elizabeth R; Wing, Kay; Yenokyan, Gayane

    2015-10-01

    About half of survivors with stroke experience severe and significant long-term disability. The purpose of this article is to review the state of the science and to make recommendations for measuring patient-centric outcomes in interventions for motor improvement in the chronic stroke phase. A 9-member expert panel reviewed evidence to identify measures of upper and lower extremity function used to date as outcomes in trials with patients who experienced a stroke ≥6 months before assessment. Outcome measures were screened using StrokEDGE consensus panel recommendations, and evaluated for availability of a published minimal clinically important difference. Measures meeting these criteria were further evaluated with regard to their level of measurement, psychometric properties, and ability of minimal clinically important difference to capture gains associated with improved function and clinical relevance to patients, to arrive at recommendations. A systematic literature review yielded 115 clinical trials of upper and lower extremity function in chronic stroke that used a total of 34 outcome measures. Seven of these had published minimal clinically important differences and were recommended or highly recommended by StrokEDGE. Those are the Fugl-Meyer Upper Extremity and Lower Extremity scales, Wolf Motor Function Test, Action Research Arm Test, Ten-Meter and Six-Minute Walk Tests, and the Stroke Impact Scale. All had evidence for their psychometric performance, although the strength of evidence for validity varied, especially in populations with chronic stroke Fugl-Meyer Upper and Lower Extremity scales showing the strongest evidence for validity. The panel recommends that the Fugl-Meyer Upper and Lower Extremity scales be used as primary outcomes in intervention trials targeting motor function in populations with chronic stroke. The other 6 measures are recommended as secondary outcomes. © 2015 American Heart Association, Inc.

  7. Brief motivational feedback and cognitive behavioral interventions for prevention of disordered gambling: a randomized clinical trial.

    Science.gov (United States)

    Larimer, Mary E; Neighbors, Clayton; Lostutter, Ty W; Whiteside, Ursula; Cronce, Jessica M; Kaysen, Debra; Walker, Denise D

    2012-06-01

    The purpose of the current study was to evaluate feasibility and efficacy of two promising approaches to indicated prevention of disordered gambling in a college population. Randomized clinical trial with assignment to a personalized feedback intervention (PFI), cognitive-behavioral intervention (CBI) or assessment-only control (AOC). PFI was delivered individually in a single session and included feedback regarding gambling behavior, norms, consequences and risk-reduction tips, delivered in a motivational interviewing style. CBI was delivered in small groups over four to six sessions and included functional analysis and brief cognitive correction, as well as identification of and alternatives for responding to gambling triggers. College campus. At-risk or probable pathological gamblers (n = 147; 65.3% male; group assignment: PFI, n = 52; CBI, n = 44; AOC, n = 51). Self-reported gambling quantity, frequency, consequences, psychopathology, normative perceptions and beliefs. Relative to control, results at 6-month follow-up indicated reductions in both interventions for gambling consequences (PFI d = 0.48; CBI d = 0.39) and DSM-IV criteria (PFI d = 0.60; CBI d = 0.48), reductions in frequency for PFI (d = 0.48). CBI was associated with reduced illusions of control, whereas PFI was associated with reduced perceptions of gambling frequency norms. Reductions in perceived gambling frequency norms mediated effects of PFI on gambling frequency. A single-session personalized feedback intervention and a multi-session cognitive-behavioral intervention may be helpful in reducing disordered gambling in US college students. © 2011 The Authors, Addiction © 2011 Society for the Study of Addiction.

  8. Activation and Self-Efficacy in a Randomized Trial of a Depression Self-Care Intervention.

    Science.gov (United States)

    McCusker, Jane; Lambert, Sylvie D; Cole, Martin G; Ciampi, Antonio; Strumpf, Erin; Freeman, Ellen E; Belzile, Eric

    2016-12-01

    In a sample of primary care participants with chronic physical conditions and comorbid depressive symptoms: to describe the cross-sectional and longitudinal associations of activation and self-efficacy with demographic, physical and mental health status, health behaviors, depression self-care, health care utilization, and use of self-care tools; and to examine the effects of a depression self-care coaching intervention on these two outcomes. Design/Study Setting. A secondary analysis of activation and self-efficacy data collected as part of a randomized trial to compare the effects of a telephone-based coached depression self-care intervention with a noncoached intervention. Activation (Patient Activation Measure) was measured at baseline and 6 months. Depression self-care self-efficacy was assessed at baseline, at 3 months, and at 6 months. In multivariable cross-sectional analyses (n = 215), activation and/or self-efficacy were associated with language, birthplace, better physical and mental health, individual exercise, specialist visits, and antidepressant nonuse. In longitudinal analyses (n = 158), an increase in activation was associated with increased medication adherence; an increase in self-efficacy was associated with use of cognitive self-care strategies and increases in social and solitary activities. There were significant improvements from baseline to 6 months in activation and self-efficacy scores both among coached and noncoached groups. The self-care coaching intervention did not affect 6-month activation or self-efficacy but was associated with quicker improvement in self-efficacy. Overall, the results for activation and self-efficacy were similar, although self-efficacy correlated more consistently than activation with depression-specific behaviors and was responsive to a depression self-care coaching intervention. © 2016 Society for Public Health Education.

  9. Protocol for digital intervention for effective health promotion of small children - a cluster randomized trial.

    Science.gov (United States)

    Pakarinen, Anni; Flemmich, Magda; Parisod, Heidi; Selänne, Laura; Hamari, Lotta; Aromaa, Minna; Leppänen, Ville; Löyttyniemi, Eliisa; Smed, Jouni; Salanterä, Sanna

    2018-03-08

    This article introduces the protocol of a study aiming to evaluate the effectiveness of digital WellWe intervention in supporting the participation of families with small children in the promotion of their health. Early childhood is a meaningful period for building a strong base for good health. Parents play a key role in affecting the health behaviour and psychosocial development of their children. A family-centred approach makes it possible to support families' individual health literacy needs and empower them to take actions towards promoting healthier behaviour. However, there are a lack of family-centred digital health interventions intended for parents and their small children. The study is designed as a two-arm cluster, randomized, controlled trial with a four-month follow-up. The data is being collected from 200 families with a four-year old child. Cluster randomization is being performed at the municipality level. Municipalities (N=4) located in Southwest Finland, comprising child health clinics (N=15) with their family clients, were randomly allocated to either an intervention (WellWe intervention) or a control group (usual care). The outcome measures include parental self-efficacy for healthy behaviours, mindfulness in parenting and the family-centred approach of the extensive health examination. Data collection is being performed at baseline, after the intervention and at a four-month follow-up. The results from this study will make it possible to determine whether this new method can be recommended for implementation in child health clinic settings to support the participation of families with small children in promoting their health. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  10. Preventing Adolescent Social Anxiety and Depression and Reducing Peer Victimization: Intervention Development and Open Trial

    Science.gov (United States)

    La Greca, Annette M.; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn

    2016-01-01

    Background Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the development and initial evaluation of a transdiagnostic school-based preventive intervention for adolescents with elevated symptoms of social anxiety and/or depression and elevated peer victimization. We modified Interpersonal Psychotherapy-Adolescent Skills Training for depression, incorporating strategies for dealing with social anxiety and peer victimization. Objective Our open trial assessed the feasibility, acceptability, and preliminary benefit of the modified program (called UTalk) for adolescents at risk for SAD or depression and who also reported peer victimization. Method Adolescents (N=14; 13–18 years; 79% girls; 86% Hispanic) were recruited and completed measures of peer victimization, social anxiety, and depression both pre- and post-intervention and provided ratings of treatment satisfaction. Independent evaluators (IEs) rated youths’ clinical severity. The intervention (3 individual and 10 group sessions) was conducted weekly during school. Results Regarding feasibility, 86% of the adolescents completed the intervention (M attendance=11.58 sessions). Satisfaction ratings were uniformly positive. Intention-to-treat analyses revealed significant declines in adolescent- and IE-rated social anxiety and depression and in reports of peer victimization. Additional secondary benefits were observed. Conclusions Although further evaluation is needed, the UTalk intervention appears feasible to administer in schools, with high satisfaction and preliminary benefit. Implications for research on the prevention of adolescent SAD and depression are discussed. PMID:27857509

  11. The Yale Fitness Intervention Trial in female cancer survivors: Cardiovascular and physiological outcomes.

    Science.gov (United States)

    Knobf, M Tish; Jeon, Sangchoon; Smith, Barbara; Harris, Lyndsay; Thompson, Siobhan; Stacy, Mitchel R; Insogna, Karl; Sinusas, Albert J

    Induced premature menopause and cardio-toxic therapy increase cardiovascular disease risk in female cancer survivors. To compare the effects of a 12 month aerobic-resistance fitness center intervention to home based physical activity on cardiovascular function and metabolic risk factors. Subjects (N = 154) who had completed primary and/or adjuvant chemotherapy (past 3 years) were randomized to a fitness center intervention or a home based group. The fitness center intervention was a structured thrice weekly aerobic (30 min brisk walking treadmill in target heart range) combined with resistance (30 min of lower body strength training) exercise program, supervised for the first 6 months. The home based group received national guidelines for 30 min moderate intensity exercise most days of the week. Fasting serum samples were collected at baseline, 6 and 12 months for insulin, glucose, lipids and hemoglobin A-1C. A graded exercise stress test was also performed at baseline and 6 months. The majority of subjects were white (85.7%), had breast cancer (83.1%) and the average age was 51.9 years. Subjects in the fitness center intervention had significantly improved time on treadmill (p = .039), improved heart rate recovery at 1 min (p = .028), greater MET minutes/week (p ≤ .0001), a trend for improved insulin resistance (p = .067) and stable insulin levels (p = .045) compared to the home based physical activity group. Exercise represents a potential cardiac risk reduction intervention for cancer survivors. CLINICAL TRIALS.GOV: NCT01102985. Copyright © 2017. Published by Elsevier Inc.

  12. Can an Educational Intervention Improve Iodine Nutrition Status in Pregnant Women? A Randomized Controlled Trial.

    Science.gov (United States)

    Amiri, Parisa; Hamzavi Zarghani, Najmeh; Nazeri, Pantea; Ghofranipour, Fazlollah; Karimi, Mehrdad; Amouzegar, Atieh; Mirmiran, Parvin; Azizi, Fereidoun

    2017-03-01

    Because of their increased need for iodine, pregnant women are among the high-risk groups for iodine deficiency. The purpose of this study was to evaluate the effectiveness of an educational program on the iodine nutrition status of pregnant women. In this randomized controlled trial, 100 pregnant women were randomly selected from five healthcare centers in the southern region of Tehran, the capital of Iran. In the intervention group, pregnant women received a four-month educational program, which included two face-to-face educational sessions, using a researcher-designed educational pamphlet in the second and third trimesters, and two follow-up telephone calls. Knowledge, attitude, and practice (KAP) scores, urinary iodine concentration (UIC), and salt iodine content were assessed at baseline and four months after the intervention. At baseline, there were significant associations between knowledge and attitude (r = 0.38, p = 0.03) between practice and UIC (r = 0.28, p = 0.01) and between UIC and iodine content of salt (r = 0.24, p = 0.009). Although a significant difference was found in mean KAP scores between the two groups after the educational intervention, scores were significantly higher in the intervention group compared with controls (p educational intervention increasing KAP among women regarding the importance of iodine and iodized salt consumption during pregnancy, their iodine status did not improve. Considering the main socio-environmental determinants of iodine deficiency, in particular, the monitoring of salt fortification, prescribing iodine containing supplements as well as improving health literacy in pregnant women seem essential strategies.

  13. Social learning theory parenting intervention promotes attachment-based caregiving in young children: randomized clinical trial.

    Science.gov (United States)

    O'Connor, Thomas G; Matias, Carla; Futh, Annabel; Tantam, Grace; Scott, Stephen

    2013-01-01

    Parenting programs for school-aged children are typically based on behavioral principles as applied in social learning theory. It is not yet clear if the benefits of these interventions extend beyond aspects of the parent-child relationship quality conceptualized by social learning theory. The current study examined the extent to which a social learning theory-based treatment promoted change in qualities of parent-child relationship derived from attachment theory. A randomized clinical trial of 174 four- to six-year-olds selected from a high-need urban area and stratified by conduct problems were assigned to a parenting program plus a reading intervention (n = 88) or nonintervention condition (n = 86). In-home observations of parent-child interactions were assessed in three tasks: (a) free play, (b) challenge task, and (c) tidy up. Parenting behavior was coded according to behavior theory using standard count measures of positive and negative parenting, and for attachment theory using measures of sensitive responding and mutuality; children's attachment narratives were also assessed. Compared to the parents in the nonintervention group, parents allocated to the intervention showed increases in the positive behavioral counts and sensitive responding; change in behavioral count measures overlapped modestly with change in attachment-based changes. There was no reliable change in children's attachment narratives associated with the intervention. The findings demonstrate that standard social learning theory-based parenting interventions can change broader aspects of parent-child relationship quality and raise clinical and conceptual questions about the distinctiveness of existing treatment models in parenting research.

  14. Preventing Adolescent Social Anxiety and Depression and Reducing Peer Victimization: Intervention Development and Open Trial.

    Science.gov (United States)

    La Greca, Annette M; Ehrenreich-May, Jill; Mufson, Laura; Chan, Sherilynn

    2016-12-01

    Social anxiety disorder (SAD) and depression are common among adolescents, frequently comorbid, and resistant to change. Prevention programs for adolescent SAD are scant, and depression prevention programs do not fully address peer-risk factors. One critical peer-risk factor for SAD and depression is peer victimization. We describe the development and initial evaluation of a transdiagnostic school-based preventive intervention for adolescents with elevated symptoms of social anxiety and/or depression and elevated peer victimization. We modified Interpersonal Psychotherapy-Adolescent Skills Training for depression, incorporating strategies for dealing with social anxiety and peer victimization. Our open trial assessed the feasibility, acceptability, and preliminary benefit of the modified program (called UTalk) for adolescents at risk for SAD or depression and who also reported peer victimization. Adolescents (N=14; 13-18 years; 79% girls; 86% Hispanic) were recruited and completed measures of peer victimization, social anxiety, and depression both pre- and post-intervention and provided ratings of treatment satisfaction. Independent evaluators (IEs) rated youths' clinical severity. The intervention (3 individual and 10 group sessions) was conducted weekly during school. Regarding feasibility, 86% of the adolescents completed the intervention ( M attendance=11.58 sessions). Satisfaction ratings were uniformly positive. Intention-to-treat analyses revealed significant declines in adolescent- and IE-rated social anxiety and depression and in reports of peer victimization. Additional secondary benefits were observed. Although further evaluation is needed, the UTalk intervention appears feasible to administer in schools, with high satisfaction and preliminary benefit. Implications for research on the prevention of adolescent SAD and depression are discussed.

  15. Intervention on whole grain with healthy balanced diet to manage childhood obesity (GReat-Child™trial): study protocol for a quasi-experimental trial.

    Science.gov (United States)

    Koo, H C; Poh, B K; Ruzita, Abd Talib

    2016-01-01

    The rapid increase in childhood obesity is a serious public health problem, and has led to the development of many interventions. However, no intervention has emphasized whole grains as a strategy to manage childhood obesity. Therefore, this article describes the protocol of a 12-week multi-component, family-based intervention on whole grain, using a healthy balanced diet for managing childhood obesity. The GReat-Child trial utilize a quasi-experimental method in which two schools in Kuala Lumpur are assigned to intervention and control groups. The eligibility criteria are overweight/obese children, aged 9 through 11 years, who has no serious co-morbidities. The children who report consuming whole-grain foods in their 3-day diet-recall during the screening will be excluded. The study sample is characterized by anthropometric measurements (weight, height, percentage of body fat and waist circumference), whole grain and nutrient intakes (3-day 24-h diet recalls), and their knowledge, attitudes and practices towards whole grain. The 12-week intervention is comprised of three components addressing behaviour, personal and environmental factors, based on social cognitive theory: (1) individual diet counselling for the parents; (2) six 30-min nutrition education classes and (3) school delivery of whole-grain foods; The control school does not receive any interventions, however, for ethical purposes, a health talk is conducted after the entire GReat-Child Trial is completed. The GReat-Child trial represents a novel approach to examining the effectiveness of the intervention of whole grain in a healthy balanced diet on managing childhood obesity. We anticipate that this trial will reveal not only whether whole grain intervention will be effective in managing childhood obesity, but also provide greater insights into the acceptance of whole grain among Malaysian children.

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

    Science.gov (United States)

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

    2017-06-01

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

  17. Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial.

    Science.gov (United States)

    Durand, Marie-Anne; Gates, Bob; Parkes, Georgina; Zia, Asif; Friedli, Karin; Barton, Garry; Ring, Howard; Oostendorp, Linda; Wellsted, David

    2014-11-20

    Epilepsy is the most common neurological problem that affects people with learning disabilities. The high seizure frequency, resistance to treatments, associated skills deficit and co-morbidities make the management of epilepsy particularly challenging for people with learning disabilities. The Books Beyond Words booklet for epilepsy uses images to help people with learning disabilities manage their condition and improve quality of life. Our aim is to conduct a randomized controlled feasibility trial exploring key methodological, design and acceptability issues, in order to subsequently undertake a large-scale randomized controlled trial of the Books Beyond Words booklet for epilepsy. We will use a two-arm, single-centre randomized controlled feasibility design, over a 20-month period, across five epilepsy clinics in Hertfordshire, United Kingdom. We will recruit 40 eligible adults with learning disabilities and a confirmed diagnosis of epilepsy and will randomize them to use either the Books Beyond Words booklet plus usual care (intervention group) or to receive routine information and services (control group). We will collect quantitative data about the number of eligible participants, number of recruited participants, demographic data, discontinuation rates, variability of the primary outcome measure (quality of life: Epilepsy and Learning Disabilities Quality of Life scale), seizure severity, seizure control, intervention's patterns of use, use of other epilepsy-related information, resource use and the EQ-5D-5L health questionnaire. We will also gather qualitative data about the feasibility and acceptability of the study procedures and the Books Beyond Words booklet. Ethical approval for this study was granted on 28 April 2014, by the Wales Research Ethics Committee 5. Recruitment began on 1 July 2014. The outcomes of this feasibility study will be used to inform the design and methodology of a definitive study, adequately powered to determine the impact of

  18. Randomized trials of alcohol-use interventions with college students and their parents: lessons from the Transitions Project.

    Science.gov (United States)

    Fernandez, A C; Wood, M D; Laforge, R; Black, J T

    2011-04-01

    Matriculation from high school to college is typified by an increase in alcohol use and related harm for many students. Therefore, this transition period is an ideal time for preventive interventions to target alcohol use and related problems. The purpose of this report is to describe the design and methods used in the Transitions Project, a randomized controlled trial of two interventions designed to prevent and reduce heavy episodic drinking and alcohol-related negative consequences among incoming college students. This study used a 2 × 2 factorial design to investigate the effects of a two-session brief motivational intervention delivered to students and a handbook-based parent intervention. Interventions were administered to students and parents. Follow-up assessment took place at 10- and 22-months post-baseline. The Transitions Project successfully recruited and retained participants across a major transition period (i.e., entering college), administered and compared two distinct but complementary interventions, and collected and analyzed highly skewed data. The application of a factorial design and two-part latent growth curve modeling allowed us to examine main and interactive intervention effects in terms of both initiation and growth in heavy drinking and alcohol-related problems. While we conducted successful tests of our primary and secondary study hypotheses over a lengthy follow-up period, our study design did not permit full interpretation of null findings. We suggest that researchers carefully consider assessment timing, tests of assessment reactivity, and ensure objective tests of intervention efficacy when conducting clinical trials of motivational interventions. The lessons we learned while conducting this trial have the potential to assist other researchers designing and conducting future preventive interventions targeting parents and college students. The data analytic procedures presented can also help guide trials that plan to analyze

  19. The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC: a randomised cluster controlled trial

    Directory of Open Access Journals (Sweden)

    Xu Guifa

    2010-05-01

    Full Text Available Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. Methods/Design The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook and physical activity intervention (Happy 10 program will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device, physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Discussion Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the

  20. Physical micro-environment interventions for healthier eating in the workplace: protocol for a stepped wedge randomised controlled pilot trial.

    Science.gov (United States)

    Vasiljevic, Milica; Cartwright, Emma; Pechey, Rachel; Hollands, Gareth J; Couturier, Dominique-Laurent; Jebb, Susan A; Marteau, Theresa M

    2017-01-01

    An estimated one third of energy is consumed in the workplace. The workplace is therefore an important context in which to reduce energy consumption to tackle the high rates of overweight and obesity in the general population. Altering environmental cues for food selection and consumption-physical micro-environment or 'choice architecture' interventions-has the potential to reduce energy intake. The first aim of this pilot trial is to estimate the potential impact upon energy purchased of three such environmental cues (size of portions, packages and tableware; availability of healthier vs. less healthy options; and energy labelling) in workplace cafeterias. A second aim of this pilot trial is to examine the feasibility of recruiting eligible worksites, and identify barriers to the feasibility and acceptability of implementing the interventions in preparation for a larger trial. Eighteen worksite cafeterias in England will be assigned to one of three intervention groups to assess the impact on energy purchased of altering (a) portion, package and tableware size ( n  = 6); (b) availability of healthier options ( n  = 6); and (c) energy (calorie) labelling ( n  = 6). Using a stepped wedge design, sites will implement allocated interventions at different time periods, as randomised. This pilot trial will examine the feasibility of recruiting eligible worksites, and the feasibility and acceptability of implementing the interventions in preparation for a larger trial. In addition, a series of linear mixed models will be used to estimate the impact of each intervention on total energy (calories) purchased per time frame of analysis (daily or weekly) controlling for the total sales/transactions adjusted for calendar time and with random effects for worksite. These analyses will allow an estimate of an effect size of each of the three proposed interventions, which will form the basis of the sample size calculations necessary for a larger trial. ISRCTN52923504.

  1. Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial.

    Science.gov (United States)

    Lombard, Catherine B; Harrison, Cheryce L; Kozica, Samantha L; Zoungas, Sophia; Keating, Catherine; Teede, Helena J

    2014-06-16

    To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities. Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program. Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies

  2. Screening intervention to identify eligible patients and improve accrual to phase II-IV oncology clinical trials.

    Science.gov (United States)

    Chen, Leo; Grant, Janice; Cheung, Winson Y; Kennecke, Hagen F

    2013-07-01

    Low enrolment rates in clinical trials present a barrier to the development of novel cancer therapies. Currently, only 3% of patients with cancer participate, and many studies fail to achieve necessary enrolment. The objective of this study was to evaluate whether a screening intervention to identify potentially eligible patients (PEPs) would increase accrual rates. Over a 4-month intervention period, PEPs for 21 phase II-IV breast, gastrointestinal, genitourinary, gynecology, and lung cancer trials were identified by a screening coordinator. This individual reviewed the electronic medical records of patients attending outpatient clinics and flagged PEPs for 10 medical oncologists at the BC Cancer Agency. Patients who were already documented to be trial eligible by physicians were not flagged. Oncologists were surveyed regarding the helpfulness and accuracy of the intervention. During the intervention period, 73 patients were enrolled, compared with 61 patients enrolled in the 4 months prior and 51 patients in the 4 months after. A total of 2,098 charts were reviewed, and 120 PEPs were identified during the intervention period, resulting in 19 PEPs who enrolled and four PEPs who declined a clinical trial. Relative accrual rates adjusted for oncologist appointments were 0.85 (P = .15) before and 0.70 (P < .005) after, relative to the intervention period. Oncologist-returned surveys indicated that 67% of flags were helpful, and 70% were accurate. In this study, manually screening patient records increased enrolment to specific clinical trials. A screening intervention process, involving a dedicated screening coordinator, should be considered to improve clinical trial accrual.

  3. Patient perspectives on participation in the ENABLE II randomized controlled trial of a concurrent oncology palliative care intervention: benefits and burdens.

    Science.gov (United States)

    Maloney, Cristine; Lyons, Kathleen Doyle; Li, Zhongze; Hegel, Mark; Ahles, Tim A; Bakitas, Marie

    2013-04-01

    ENABLE (Educate, Nurture, Advise Before Life Ends) II was one of the first randomized controlled trials (RCTs) examining the effects of a concurrent oncology palliative care intervention on quality of life, mood, and symptom control for advanced cancer patients and their caregivers. However, little is known about how participants experience early palliative care and the benefits and burdens of participating in a palliative care clinical trial. To gain a deeper understanding of participants' perspectives of the intervention and palliative care trial participation. A qualitative descriptive study using thematic analysis to determine benefits and burdens of a new palliative care intervention and trial participation. Of the 72 participants who were alive when the study commenced, 53 agreed to complete an in-depth, semi-structured interview regarding the ENABLE II intervention and clinical trial participation. Participants' perceptions of intervention benefits were represented by four themes: enhanced problem-solving skills, better coping, feeling empowered, and feeling supported or reassured. Three themes related to trial participation: helping future patients and contributing to science, gaining insight through completion of questionnaires, and trial/intervention aspects to improve. The benefits of the intervention and the positive aspects of trial participation outweighed trial "burdens". This study raises additional important questions relevant to future trial design and intervention development: when should a palliative care intervention be initiated and what aspects of self-care and healthy living should be offered in addition to palliative content for advanced cancer patients when they are feeling well?

  4. Cardiovascular exercise training extends influenza vaccine seroprotection in sedentary older adults: the immune function intervention trial.

    Science.gov (United States)

    Woods, Jeffrey A; Keylock, K Todd; Lowder, Thomas; Vieira, Victoria J; Zelkovich, William; Dumich, Sara; Colantuano, Kim; Lyons, Kristin; Leifheit, Kurt; Cook, Marc; Chapman-Novakofski, Karen; McAuley, Edward

    2009-12-01

    To determine whether cardiovascular exercise training resulted in improved antibody responses to influenza vaccination in sedentary elderly people who exhibited poor vaccine responses. Single-site randomized parallel-arm 10-month controlled trial. University of Illinois at Urbana-Champaign. One hundred forty-four sedentary, healthy older (69.9 +/- 0.4) adults. Moderate (60-70% maximal oxygen uptake) cardiovascular exercise was compared with flexibility and balance training. The primary outcome was influenza vaccine response, as measured according to hemagglutination inhibition (HI) anti-influenza antibody titer and seroprotective responses (HI titer > or =40). Secondary measures included cardiovascular fitness and body composition. Of the 160 participants enrolled, 144 (90%) completed the 10-month intervention with excellent compliance ( approximately 83%). Cardiovascular, but not flexibility, exercise intervention resulted in improvements in indices of cardiovascular fitness, including maximal oxygen uptake. Although not affecting peak (e.g., 3 and 6 weeks) postvaccine anti-influenza HI titers, cardiovascular exercise resulted in a significant increase in seroprotection 24 weeks after vaccination (30-100% dependent on vaccine variant), whereas flexibility training did not. Participants randomized to cardiovascular exercise experienced improvements in influenza seroprotection throughout the entire influenza season, whereas those in the balance and flexibility intervention did not. Although there were no differences in reported respiratory tract infections, the exercise group exhibited reduced overall illness severity and sleep disturbance. These data support the hypothesis that regular endurance exercise improves influenza vaccine responses.

  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. Using a behaviour change techniques taxonomy to identify active ingredients within trials of implementation interventions for diabetes care.

    Science.gov (United States)

    Presseau, Justin; Ivers, Noah M; Newham, James J; Knittle, Keegan; Danko, Kristin J; Grimshaw, Jeremy M

    2015-04-23

    Methodological guidelines for intervention reporting emphasise describing intervention content in detail. Despite this, systematic reviews of quality improvement (QI) implementation interventions continue to be limited by a lack of clarity and detail regarding the intervention content being evaluated. We aimed to apply the recently developed Behaviour Change Techniques Taxonomy version 1 (BCTTv1) to trials of implementation interventions for managing diabetes to assess the capacity and utility of this taxonomy for characterising active ingredients. Three psychologists independently coded a random sample of 23 trials of healthcare system, provider- and/or patient-focused implementation interventions from a systematic review that included 142 such studies. Intervention content was coded using the BCTTv1, which describes 93 behaviour change techniques (BCTs) grouped within 16 categories. We supplemented the generic coding instructions within the BCTTv1 with decision rules and examples from this literature. Less than a quarter of possible BCTs within the BCTTv1 were identified. For implementation interventions targeting providers, the most commonly identified BCTs included the following: adding objects to the environment, prompts/cues, instruction on how to perform the behaviour, credible source, goal setting (outcome), feedback on outcome of behaviour, and social support (practical). For implementation interventions also targeting patients, the most commonly identified BCTs included the following: prompts/cues, instruction on how to perform the behaviour, information about health consequences, restructuring the social environment, adding objects to the environment, social support (practical), and goal setting (behaviour). The BCTTv1 mapped well onto implementation interventions directly targeting clinicians and patients and could also be used to examine the impact of system-level interventions on clinician and patient behaviour. The BCTTv1 can be used to characterise

  7. Weight-management interventions in primary care: a pilot randomised controlled trial.

    Science.gov (United States)

    Nanchahal, Kiran; Townsend, Joy; Letley, Louise; Haslam, David; Wellings, Kaye; Haines, Andy

    2009-05-01

    There is a paucity of randomised controlled trials of weight management in primary care. To ascertain the feasibility of a full trial of a nurse-led weight-management programme in general practice. Factorial randomised control trial. Primary care, UK. A total of 123 adults (80.3% women, mean age 47.2 years) with body mass index > or =27 kg/m(2), recruited from eight practices, were randomised to receive structured lifestyle support (n = 30), structured lifestyle support plus pedometer (n = 31), usual care (n = 31), or usual care plus pedometer (n = 31) for a 12-week period. A total of 103 participants were successfully followed up. The adjusted mean difference in weight in structured support compared to usual care groups was -2.63 kg (95% confidence interval [CI] = -4.06 to -1.20 kg), and for pedometer compared to no pedometer groups it was -0.11 kg (95% CI = -1.52 to 1.30 kg). One in three participants in the structured-support groups (17/50, 34.0%) lost 5% or more of their initial weight, compared to less than one in five (10/53, 18.9%) in usual-care groups; provision of a pedometer made little difference (14/48, 29.2% pedometer; 13/55, 23.6% no pedometer). Difference in waist circumference change between structured-support and usual-care groups was -1.80 cm (95% CI = -3.39 to -0.20 cm), and between the pedometer and no pedometer groups it was -0.84 cm (95% CI = -2.42 to 0.73 cm). When asked about their experience of study participation, most participants found structured support helpful. The structured lifestyle support package could make substantial contributions to improving weight-management services. A trial of the intervention in general practice is feasible and practicable.

  8. Interventions to increase enrollment in a large multicenter phase 3 trial of carotid stenting vs. endarterectomy.

    Science.gov (United States)

    Longbottom, Mary E; Roberts, Jamie N; Tom, Meelee; Hughes, Susan E; Howard, Virginia J; Sheffet, Alice J; Meschia, James F; Brott, Thomas G

    2012-08-01

    Randomized clinical trials often encounter slow enrollment. Failing to meet sample size requirements has scientific, financial, and ethical implications. We report interventions used to accelerate recruitment in a large multicenter clinical trial that was not meeting prespecified enrollment commitments. The Carotid Revascularization Endarterectomy vs. Stenting Trial began randomization in December 2000. To accelerate enrollment, multiple recruitment tactics were initiated, which included expanding the number of sites, hiring a recruitment director (May 2003), broadening eligibility criteria (April 2005), branding with a study logo, Web site, and recruitment materials, increasing site visits by study leadership, sending e-mails to the site teams after every enrollment, distributing electronic newsletters, and implementing investigator and coordinator conferences. From December 2000 through May 2003, 14 sites became active (54 patients randomized), from June 2003 through April 2005, 44 sites were added (404 patients randomized), and from May 2005 through July 2008, 54 sites were added (2044 patients randomized). During these time intervals, the number of patients enrolled per site per year was 1·5, 3·6, and 5·6. For the single years 2004 to 2008, the mean monthly randomization rates per year were 19·7, 38·1, 56·4, 53·0, and 54·7 (annualized), respectively. Enrollment was highest after recruitment tactics were implemented: 677 patients in 2006, 636 in 2007, and 657 in 2008 (annualized). The prespecified sample size of 2502 patients, 47% asymptomatic, was accomplished on July 2008. Aggressive recruitment tactics and investment in a full-time recruitment director who can lead implementation may be effective in accelerating recruitment in multicenter trials. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

  9. Hair cortisol concentrations in war-affected adolescents: A prospective intervention trial.

    Science.gov (United States)

    Dajani, Rana; Hadfield, Kristin; van Uum, Stan; Greff, Michael; Panter-Brick, Catherine

    2018-03-01

    Temporal examinations of the biological signature of stress or trauma in war-affected populations are seldom undertaken. Moreover, few studies have examined whether stress biomarkers track biological sensitivity to brief interventions targeting the improvement of psychosocial wellbeing. Our study is the first to prospectively examine, in war-affected adolescents, the associations between hair cortisol concentrations (HCC) and self-reports of stress, insecurity, posttraumatic reactions, and lifetime trauma. We conducted a randomized controlled trial to test the impact of an 8-week intervention based on profound stress attunement. We collected data for a gender-balanced sample of 733 Syrian refugee (n = 411) and Jordanian non-refugee (n = 322) adolescents (12-18 years), at three time-points. We used growth mixture models to classify cortisol trajectories, and growth models to evaluate intervention impact on stress physiology. We observed three trajectories of HCC: hypersecretion, medium secretion, and hyposecretion (9.6%, 87.5% and 2.9% of the cohort, respectively). For every one percent increase in levels of insecurity, adolescents were 0.02 times more likely to have a trajectory of hypersecretion (95% CI: 1.00, 1.03, p = 0.01). For each additional symptom of posttraumatic stress reported, they were 0.07 times less likely to show hyposecretion (95% CI: 0.89, 0.98, p = 0.01). Indeed, stronger posttraumatic stress reactions were associated with a pattern of within-individual cortisol dysregulation and medium secretion. Overall, HCC decreased by a third in response to the intervention (95% CI: -0.19, -0.03, p = 0.01). While the intervention decreased HCC for youth with hypersecretion and medium secretion, it increased HCC for youth with hyposecretion (95% CI: 0.22, 1.16, p = 0.004), relative to controls. This suggests a beneficial regularization of cortisol levels, corroborating self-reports of improved psychosocial wellbeing. We did not find

  10. CENTRAL, PEDro, PubMed, and EMBASE are the most comprehensive databases indexing randomized controlled trials of physical therapy interventions.

    Science.gov (United States)

    Michaleff, Zoe A; Costa, Leonardo O P; Moseley, Anne M; Maher, Christopher G; Elkins, Mark R; Herbert, Robert D; Sherrington, Catherine

    2011-02-01

    Many bibliographic databases index research studies evaluating the effects of health care interventions. One study has concluded that the Physiotherapy Evidence Database (PEDro) has the most complete indexing of reports of randomized controlled trials of physical therapy interventions, but the design of that study may have exaggerated estimates of the completeness of indexing by PEDro. The purpose of this study was to compare the completeness of indexing of reports of randomized controlled trials of physical therapy interventions by 8 bibliographic databases. This study was an audit of bibliographic databases. Prespecified criteria were used to identify 400 reports of randomized controlled trials from the reference lists of systematic reviews published in 2008 that evaluated physical therapy interventions. Eight databases (AMED, CENTRAL, CINAHL, EMBASE, Hooked on Evidence, PEDro, PsycINFO, and PubMed) were searched for each trial report. The proportion of the 400 trial reports indexed by each database was calculated. The proportions of the 400 trial reports indexed by the databases were as follows: CENTRAL, 95%; PEDro, 92%; PubMed, 89%; EMBASE, 88%; CINAHL, 53%; AMED, 50%; Hooked on Evidence, 45%; and PsycINFO, 6%. Almost all of the trial reports (99%) were found in at least 1 database, and 88% were indexed by 4 or more databases. Four trial reports were uniquely indexed by a single database only (2 in CENTRAL and 1 each in PEDro and PubMed). The results are only applicable to searching for English-language published reports of randomized controlled trials evaluating physical therapy interventions. The 4 most comprehensive databases of trial reports evaluating physical therapy interventions were CENTRAL, PEDro, PubMed, and EMBASE. Clinicians seeking quick answers to clinical questions could search any of these databases knowing that all are reasonably comprehensive. PEDro, unlike the other 3 most complete databases, is specific to physical therapy, so studies not

  11. Benefits and challenges of using the cohort multiple randomised controlled trial design for testing an intervention for depression.

    Science.gov (United States)

    Viksveen, Petter; Relton, Clare; Nicholl, Jon

    2017-07-06

    Trials which test the effectiveness of interventions compared with the status quo frequently encounter challenges. The cohort multiple randomised controlled trial (cmRCT) design is an innovative approach to the design and conduct of pragmatic trials which seeks to address some of these challenges. In this article, we report our experiences with the first completed randomised controlled trial (RCT) using the cmRCT design. This trial-the Depression in South Yorkshire (DEPSY) trial-involved comparison of treatment as usual (TAU) with TAU plus the offer of an intervention for people with self-reported long-term moderate to severe depression. In the trial, we used an existing large population-based cohort: the Yorkshire Health Study. We discuss our experiences with recruitment, attrition, crossover, data analysis, generalisability of results, and cost. The main challenges in using the cmRCT design were the high crossover to the control group and the lower questionnaire response rate among patients who refused the offer of treatment. However, the design did help facilitate efficient and complete recruitment of the trial population as well as analysable data that were generalisable to the population of interest. Attrition rates were also smaller than those reported in other depression trials. This first completed full trial using the cmRCT design testing an intervention for self-reported depression was associated with a number of important benefits. Further research is required to compare the acceptability and cost effectiveness of standard pragmatic RCT design with the cmRCT design. ISRCTN registry: ISRCTN02484593 . Registered on 7 Jan 2013.

  12. Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial

    Directory of Open Access Journals (Sweden)

    Rajalakshmi Lakshman

    2014-01-01

    Full Text Available Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients and healthcare professionals (intervention deliverers to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

  13. Land- and water-based exercise intervention in women with fibromyalgia: the al-andalus physical activity randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Carbonell-Baeza Ana

    2012-02-01

    Full Text Available Abstract Background The al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome, and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes in women with fibromyalgia. Methods/Design One hundred eighty women with fibromyalgia (age range: 35-65 years will be recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain. Patients will be randomly assigned to a usual care (control group (n = 60, a water-based exercise intervention group (n = 60 or a land-based exercise intervention group (n = 60. Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 min each per week during 24 weeks. Both exercise interventions will consist of aerobic, muscular strength and flexibility exercises. We will also study the effect of a detraining period (i.e., 12 weeks with no exercise intervention on the studied variables. Discussion Our study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. If the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. Results from the al-Andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia. Trial registration ClinicalTrials

  14. A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

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    Schuengel Carlo

    2011-07-01

    Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

  15. Behavioral weight loss and physical activity intervention in obese adults with asthma. A randomized trial.

    Science.gov (United States)

    Ma, Jun; Strub, Peg; Xiao, Lan; Lavori, Philip W; Camargo, Carlos A; Wilson, Sandra R; Gardner, Christopher D; Buist, A Sonia; Haskell, William L; Lv, Nan

    2015-01-01

    The effect of weight loss on asthma in obese adults warrants rigorous investigation. To examine an evidence-based, practical, and comprehensive lifestyle intervention targeting modest weight loss and increased physical activity for asthma control. The trial randomized 330 obese adults with uncontrolled asthma to receive usual care enhanced with a pedometer, a weight scale, information about existing weight management services at the participating clinics, and an asthma education DVD, or with these tools plus the 12-month intervention. The primary outcome was change in Asthma Control Questionnaire (ACQ) scores from baseline to 12 months. Participants (mean [SD] age, 47.6 [12.4] yr) were 70.6% women, 20.0% non-Hispanic black, 20.3% Hispanic/Latino, and 8.2% Asian/Pacific Islander. At baseline, they were obese (mean [SD] body mass index, 37.5 [5.9] kg/m(2)) and had uncontrolled asthma (Asthma Control Test score, 15.1 [3.8]). Compared with control subjects, intervention participants achieved significantly greater mean weight loss (±SE) (intervention, -4.0 ± 0.8 kg vs. control, -2.1 ± 0.8 kg; P = 0.01) and increased leisure-time activity (intervention, 418.2 ± 110.6 metabolic equivalent task-min/wk vs. control, 178.8 ± 109.1 metabolic equivalent task-min/wk; P = 0.05) at 12 months. But between-treatment mean (±SE) differences were not significant for ACQ changes (intervention, -0.3 ± 0.1 vs. control, -0.2 ± 0.1; P = 0.92) from baseline (mean [SD], 1.4 [0.8]), nor for any other clinical asthma outcomes (e.g., spirometric results and asthma exacerbations). Among all participants regardless of treatment assignment, weight loss of 10% or greater was associated with a Cohen d effect of 0.76 and with 3.78 (95% confidence interval, 1.72-8.31) times the odds of achieving clinically significant reductions (i.e., ≥0.5) on ACQ as stable weight (loss or gain from baseline). The effects of other weight change categories were small. Moderately and severely obese adults

  16. Evaluating a Web-Based Social Anxiety Intervention Among University Students: Randomized Controlled Trial.

    Science.gov (United States)

    McCall, Hugh Cameron; Richardson, Chris G; Helgadottir, Fjola Dogg; Chen, Frances S

    2018-03-21

    Treatment rates for social anxiety, a prevalent and potentially debilitating condition, remain among the lowest of all major mental disorders today. Although computer-delivered interventions are well poised to surmount key barriers to the treatment of social anxiety, most are only marginally effective when delivered as stand-alone treatments. A new, Web-based cognitive behavioral therapy (CBT) intervention called Overcome Social Anxiety was recently created to address the limitations of prior computer-delivered interventions. Users of Overcome Social Anxiety are self-directed through various CBT modules incorporating cognitive restructuring and behavioral experiments. The intervention is personalized to each user's symptoms, and automatic email reminders and time limits are used to encourage adherence. The purpose of this study was to conduct a randomized controlled trial to investigate the effectiveness of Overcome Social Anxiety in reducing social anxiety symptoms in a nonclinical sample of university students. As a secondary aim, we also investigated whether Overcome Social Anxiety would increase life satisfaction in this sample. Following eligibility screening, participants were randomly assigned to a treatment condition or a wait-list control condition. Only those assigned to the treatment condition were given access to Overcome Social Anxiety; they were asked to complete the program within 4 months. The social interaction anxiety scale (SIAS), the fear of negative evaluation scale (FNE), and the quality of life enjoyment and satisfaction questionnaire-short form (Q-LES-Q-SF) were administered to participants from both conditions during baseline and 4-month follow-up lab visits. Over the course of the study, participants assigned to the treatment condition experienced a significant reduction in social anxiety (SIAS: Psocial anxiety in the 2 conditions over the course of the study showed that those assigned to the treatment condition experienced significantly

  17. Two exercise interventions for the management of patients with ankylosing spondylitis: a randomized controlled trial.

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    Fernández-de-Las-Peñas, César; Alonso-Blanco, Cristina; Morales-Cabezas, Matilde; Miangolarra-Page, Juan Carlos

    2005-06-01

    The purpose of this clinical trial was to evaluate the impact of a 4-month comprehensive protocol of strengthening and flexibility exercises developed by our research group versus conventional exercises for patients with Ankylosing Spondylitis (AS) on functional and mobility outcomes. Randomized controlled trial. Forty-five patients diagnosed with AS according to the modified criteria of New York were allocated to control or experimental groups using a random numbers table. The control group was treated with a conventional protocol of physical therapy in AS, whereas the experimental group was treated with the protocol suggested by our research group. The conventional intervention consisted of 20 exercises: motion and flexibility exercises of the cervical, thoracic, and lumbar spine; stretching of the shortened muscles; and chest expansion exercises. The experimental protocol is based on the postural affectation of the AS and the treatment of the shortened muscle chains in these patients according to the Global Posture Reeducation (GPR) method. This intervention employs specific strengthening and flexibility exercises in which the shortened muscle chains are stretched and strengthened. The study lasted 4 mos. During this period, patients received a weekly group session managed by an experienced physiotherapist. Each session lasted an hour, and there were 15 total sessions. Changes in activity, mobility, and functional capacity were evaluated by an assessor blinded to the intervention, using the following previously validated scores from the Bath group: BASMI (tragus to wall distance, modified Schober test, cervical rotation, lumbar side flexion, and intermalleolar distance), BASDAI (The Bath Ankylosing Spondylitis Disease Activity Index), and BASFI (The Bath Ankylosing Spondylitis Functional Index). Both groups showed an improvement (prepost scores) in all the outcome measures, mobility measures of the BASMI index, as well as in BASFI and BASDAI indexes. In the

  18. Wordless intervention for people with epilepsy and learning disabilities (WIELD): a randomised controlled feasibility trial.

    Science.gov (United States)

    Mengoni, Silvana E; Gates, Bob; Parkes, Georgina; Wellsted, David; Barton, Garry; Ring, Howard; Khoo, Mary Ellen; Monji-Patel, Deela; Friedli, Karin; Zia, Asif; Irvine, Lisa; Durand, Marie-Anne

    2016-11-10

    To investigate the feasibility of a full-scale randomised controlled trial of a picture booklet to improve quality of life for people with epilepsy and learning disabilities. A randomised controlled feasibility trial. Randomisation was not blinded and was conducted using a centralised secure database and a blocked 1:1 allocation ratio. Epilepsy clinics in 1 English National Health Service (NHS) Trust. Patients with learning disabilities and epilepsy who had: a seizure within the past 12 months, meaningful communication and a carer with sufficient proficiency in English. Participants in the intervention group used a picture booklet with a trained researcher, and a carer present. These participants kept the booklet, and were asked to use it at least twice more over 20 weeks. The control group received treatment as usual, and were provided with a booklet at the end of the study. 7 feasibility criteria were used relating to recruitment, data collection, attrition, potential effect on epilepsy-related quality of life (Epilepsy and Learning Disabilities Quality of Life Scale, ELDQOL) at 4-week, 12-week and 20-week follow-ups, feasibility of methodology, acceptability of the intervention and potential to calculate cost-effectiveness. The recruitment rate of eligible patients was 34% and the target of 40 participants was reached. There was minimal missing data and attrition. An intention-to-treat analysis was performed; data from the outcome measures suggest a benefit from the intervention on the ELDQOL behaviour and mood subscales at 4 and 20 weeks follow-up. The booklet and study methods were positively received, and no adverse events were reported. There was a positive indication of the potential for a cost-effectiveness analysis. All feasibility criteria were fully or partially met, therefore confirming feasibility of a definitive trial. ISRCTN80067039. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence

  19. Evidence of Physiotherapy Interventions for Patients with Chronic Neck Pain: A Systematic Review of Randomised Controlled Trials

    Science.gov (United States)

    Damgaard, Pia; Bartels, Else Marie; Ris, Inge; Christensen, Robin; Juul-Kristensen, Birgit

    2013-01-01

    Chronic neck pain (CNP) is common and costly, and the effect of physiotherapeutic interventions on the condition is unclear. We reviewed the literature for evidence of effect of physiotherapy interventions on patients with CNP. Five bibliographic databases (MEDLINE, EMBASE, CINAHL, Cochrane Library, and PEDro) were systematically searched. Randomised, placebo and active-treatment-controlled trials including physiotherapy interventions for adults with CNP were selected. Data were extracted primary outcome was pain. Risk of bias was appraised. Effect of an intervention was assessed, weighted to risk of bias. 42 trials reporting on randomised comparisons of various physiotherapy interventions and control conditions were eligible for inclusion involving 3919 patients with CNP. Out of these, 23 were unclear or at high risk of bias, and their results were considered moderate- or low-quality evidence. Nineteen were at low risk of bias, and here eight trials found effect on pain of a physiotherapy intervention. Only exercise therapy, focusing on strength and endurance training, and multimodal physiotherapy, cognitive-behavioural interventions, massage, manipulations, laser therapy, and to some extent also TNS appear to have an effect on CNP. However, sufficient evidence for application of a specific physiotherapy modality or aiming at a specific patient subgroup is not available. PMID:27335877

  20. A two-session psychological intervention for siblings of pediatric cancer patients: a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Prchal Alice

    2012-01-01

    Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907

  1. Study protocol: a randomised controlled trial of a theory-based online intervention to improve sun safety among Australian adults

    International Nuclear Information System (INIS)

    Cleary, Cathy M; White, Katherine M; Young, Ross McD; Hawkes, Anna L; Leske, Stuart; Starfelt, Louise C; Wihardjo, Kylie

    2014-01-01

    The effects of exposure to ultraviolet radiation are a significant concern in Australia which has one of the highest incidences of skin cancer in the world. Despite most skin cancers being preventable by encouraging consistent adoption of sun-protective behaviours, incidence rates are not decreasing. There is a dearth of research examining the factors involved in engaging in sun-protective behaviours. Further, online multi-behavioural theory-based interventions have yet to be explored fully as a medium for improving sun-protective behaviour in adults. This paper presents the study protocol of a randomised controlled trial of an online intervention based on the Theory of Planned Behaviour (TPB) that aims to improve sun safety among Australian adults. Approximately 420 adults aged 18 and over and predominantly from Queensland, Australia, will be recruited and randomised to the intervention (n = 200), information only (n = 200) or the control group (n = 20). The intervention focuses on encouraging supportive attitudes and beliefs toward sun-protective behaviour, fostering perceptions of normative support for sun protection, and increasing perceptions of control/self-efficacy over sun protection. The intervention will be delivered online over a single session. Data will be collected immediately prior to the intervention (Time 1), immediately following the intervention (Time 1b), and one week (Time 2) and one month (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun-protective behaviour. Secondary outcomes are the participants’ attitudes toward sun protection, perceptions of normative support for sun protection (i.e. subjective norms, group norms, personal norms and image norms) and perceptions of control/self-efficacy toward sun protection. The study will contribute to an understanding of the effectiveness of a TPB-based online intervention to improve Australian adults’ sun-protective behaviour. Australian and New Zealand Trials

  2. Online interventions for problem gamblers with and without co-occurring mental health symptoms: Protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    John A. Cunningham

    2016-07-01

    Full Text Available Abstract Background Comorbidity between problem gambling and depression or anxiety is common. Further, the treatment needs of people with co-occurring gambling and mental health symptoms may be different from those of problem gamblers who do not have a co-occurring mental health concern. The current randomized controlled trial (RCT will evaluate whether there is a benefit to providing access to mental health Internet interventions (G + MH intervention in addition to an Internet intervention for problem gambling (G-only intervention in participants with gambling problems who do or do not have co-occurring mental health symptoms. Methods Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. As part of the baseline screening process, measures of current depression and anxiety will be assessed. Eligible participants agreeing (N = 280 to take part in the study will be randomized to one of two versions of an online intervention for gamblers – an intervention that just targets gambling issues (G-only versus a website that contains interventions for depression and anxiety in addition to an intervention for gamblers (G + MH. It is predicted that problem gamblers who do not have co-occurring mental health symptoms will display no significant difference between intervention conditions at a six-month follow-up. However, for those with co-occurring mental health symptoms, it is predicted that participants receiving access to the G + MH website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with G-only website. Discussion The trial will produce information on the best means of providing online help to gamblers with and without co-occurring mental health symptoms. Trial registration ClinicalTrials.gov NCT02800096 ; Registration date: June 14, 2016.

  3. Type 2 Diabetes and Depression: A Pilot Trial of an Integrated Self-management Intervention for Latino Immigrants.

    Science.gov (United States)

    Kaltman, Stacey; Serrano, Adriana; Talisman, Nicholas; Magee, Michelle F; Cabassa, Leopoldo J; Pulgar-Vidal, Olga; Peraza, Dorys

    2016-02-01

    The purpose of the current study was to determine the feasibility, acceptability, and preliminary effectiveness of an integrated self-management intervention that simultaneously targets diabetes and depression self-management in a primary care clinic that serves the Latino immigrant community. The integrated intervention included behavioral activation and motivational interviewing techniques. It was developed with patient, family member, and provider stakeholders, and it comprised 6 individual sessions, followed by 2 monthly booster sessions. Eighteen Latino immigrants participated in an open trial of the intervention. A1C levels were examined at baseline and postintervention. Participants also completed measures of depression, diabetes self-management behaviors, patient activation, and diabetes-related self-efficacy and gave open-ended feedback about the intervention. Feasibility of delivering the intervention in the primary care setting and acceptability to the target population were demonstrated. Among participants completing the intervention, A1C levels decreased significantly from baseline. A significant reduction in depressive symptoms and an improvement in diabetes self-management behaviors, patient activation, and diabetes-related self-efficacy were observed. Qualitative responses from participants indicated unilateral positive responses to the intervention and endorsed its continuation in the clinic. This pilot trial demonstrated the feasibility and acceptability of an integrated self-management intervention for diabetes and depression. In addition, preliminary data suggest that the intervention may have a positive impact on diabetes and depression-related outcomes. Further evaluation is warranted. © 2015 The Author(s).

  4. Improving the Dictation in Attention Deficit Hyperactivity Disorder by Using Computer Based Interventions: A Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mahdi Tehranidoost

    2006-07-01

    Full Text Available Objective: The aim of the current study was to assess the impact of computer games and computer-assisted type instruction on dictation scores of elementary school children with attention deficit – hyperactivity disorder (ADHD. Method: In this single-blind clinical trial, 37 elementary school children with ADHD, selected by convenience sampling and divided into group I (n=17 and group II (n=20, underwent eight one-hour sessions (3 sessions per week of intervention by computer games versus computer-assisted type instruction, respectively. 12 school dictation scores were considered: 4 scores preintervention, 4 scores during interventions, and 4 scores post-intervention. Dictation test was taken during each session. Data was analyzed using repeated measure ANOVA. Results: Two groups were matched for age, gender, school grade, medication, IQ, parent’s and teacher’s Conners’ scale scores, having computer at home, history of working with computer, and mean dictation scores. There was no significant difference in dictation scores before and after interventions and also between the study groups. The improvement in school dictation scores had no significant correlation with age, gender, Ritalin use, owning a computer at home and past history of computer work, baseline dictation scores, Ritalin dose, educational status, IQ, and the total score of parent’s and teacher’s Conners’ rating scale. Conclusion: Absence of significant improvement in dictation scores in study groups may be due to the confounding effect of other variables with known impact on dictation scores. Further studies in this field should also assess the change of attention and memory.

  5. Community mothers' programme: randomised controlled trial of non-professional intervention in parenting.

    Science.gov (United States)

    Johnson, Z; Howell, F; Molloy, B

    1993-05-29

    To see whether non-professional volunteer community mothers could deliver a child development programme to disadvantaged first time mothers for children aged up to 1 year. Randomised controlled trial. A regional health authority in Dublin. 262 first time mothers who were delivered during six months in 1989 and who lived in a deprived area of Dublin; 30 experienced mothers from the same community recruited as community mothers. All the first time mothers received standard support from the public health nurse. In addition, those in the intervention group received the services of a community mother, who was scheduled to visit monthly during the first year of the child's life. 232 (89%) first time mothers completed the study--127 in the intervention group, 105 controls. At the end of the study children in the intervention group were more likely to have received all of their primary immunisations, to be read to, and to be read to daily, played more cognitive games; and were exposed to more nursery rhymes. They were less likely to begin cows' milk before 26 weeks and to receive an inappropriate energy intake and inappropriate amounts of animal protein, non-animal protein, wholefoods, vegetables, fruit, and milk. Mothers in the intervention group also had a better diet than controls. At the end of the study they were less likely to be tired, feel miserable, and want to stay indoors; had more positive feelings; and were less likely to display negative feelings. Non-professionals can deliver a health promotion programme on child development effectively. Whether they can do so as effectively as professionals requires further study.

  6. Can Early Intervention Improve Maternal Well-Being? Evidence from a Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Orla Doyle

    Full Text Available 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.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.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.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.

  7. 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

    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. 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. 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. 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.

  8. Educational intervention on cardiovascular parameters in perimenopausal women with a cardiovascular risk factor. Randomised clinical trial.

    Science.gov (United States)

    Soto Rodríguez, Anxela; García Soidán, José Luís; Arias Gómez, María Jesús; Del Álamo Alonso, Alberto; Leirós Rodríguez, Raquel; Pérez Fernández, María Reyes

    2018-03-09

    Randomised clinical trial performed in two urban health centres in Spain. To evaluate if educational intervention in women of perimenopausal age with hypertension, diabetes mellitus and/or dyslipidaemia could achieve significant changes in the reduction of biochemical and haemodynamic risk parameters. The study included 320 women aged between 45 and 60 years old who were diagnosed with hypertension, diabetes mellitus and/or dyslipidaemia. They were randomly assigned to the experimental group (n=160) and the control group (n=160). The intervention group received three educational sessions and the control group received an informative leaflet sent by mail. Haemodynamic and biochemical variables were evaluated at baseline and one year later in both groups. Women in the intervention group showed a decrease in low density lipoprotein (P=.034), (-5.89±29.8; 95% CI: -13.1/0.27) and an increase in high density lipoprotein (P=.013), (2.71±10.6; 95% CI: -1.36/6.20), as well as improvements in systolic blood pressure (P=.016), (-2.16±11.8; 95% CI: -4.4/0.01) and frequency (P=.003), (-1.46±10.3; 95% CI: -3.34/0.42) compared to women in the control group. Women in the control group significantly increased glucose (P=.04), (4.84±15.5; 95% CI: -0.75/31.3) and gamma-glutamyltranspeptidase (P=.031), (3.61±14.7; 95% CI: 0.87/6.36) levels more than those in the experimental group. An educational intervention can be an effective method of reducing the parameters associated with an increased likelihood of cardiovascular disease in women at perimenopausal age with hypertension, diabetes mellitus and/or dyslipidaemia. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  9. Randomized controlled trial of a family intervention for children bullied by peers.

    Science.gov (United States)

    Healy, Karyn L; Sanders, Matthew R

    2014-11-01

    This study examined the effects of a family intervention on victimization and emotional distress of children bullied by peers. The intervention, Resilience Triple P, combined facilitative parenting and teaching children social and emotional skills relevant to developing strong peer relationships and addressing problems with peers. Facilitative parenting is parenting that supports the development of children's peer relationship skills. A randomized controlled trial was conducted with 111 families who reported chronic bullying of children aged 6 to 12 years. Families were randomly allocated to either an immediate start to Resilience Triple P (RTP) or an assessment control (AC) condition. Assessments involving children, parents, teachers, and observational measures were conducted at 0 (pre), 3 (post) and 9 months follow-up. RTP families had significantly greater improvements than AC families on measures of victimization, child distress, child peer and family relationships, including teacher reports of overt victimization (d=0.56), child internalizing feelings (d=0.59), depressive symptoms (d=0.56), child overt aggression towards peers (d=0.51), acceptance by same sex and opposite sex peers (d=0.46/ 0.60), and child liking school (d=0.65). Families in both conditions showed significant improvements on most variables over time including child reports of bullying in the last week reducing to a near zero and indistinguishable from the normative sample. The intervention combining facilitative parenting and social and emotional skills training for children produced better results than the comparison assessment control condition. This study demonstrated that family interventions can reduce victimization and distress and strengthen school efforts to address bullying. Copyright © 2014. Published by Elsevier Ltd.

  10. 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. © the American Music Therapy Association 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  11. The effectiveness of a healthy lifestyle intervention, for chronic low back pain: a randomised controlled trial.

    Science.gov (United States)

    Williams, Amanda; Wiggers, John; O'Brien, Kate M; Wolfenden, Luke; Yoong, Sze Lin; Hodder, Rebecca K; Lee, Hopin; Robson, Emma K; McAuley, James H; Haskins, Robin; Kamper, Steven J; Rissel, Chris; Williams, Christopher M

    2018-03-08

    We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial (RCT), embedded within a cohort multiple RCT of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and BMI ≥27kg/m and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks and monthly for 6 months. Data analysis was by intention-to-treat according to a pre-published analysis plan. Between May 13 and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference= 6.5, 95%CI -8.0 to 21.0; p=0.38) or any secondary outcome. In the intervention group 41% (n=32) of participants reported an adverse event compared with 56% (n=45) in the control group. Our findings show providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared to usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

  12. Clinic and Home-Based Behavioral Intervention for Obesity in Preschoolers: A Randomized Trial.

    Science.gov (United States)

    Stark, Lori J; Spear Filigno, Stephanie; Bolling, Christopher; Ratcliff, Megan B; Kichler, Jessica C; Robson, Shannon M; Simon, Stacey L; McCullough, Mary Beth; Clifford, Lisa M; Odar Stough, Cathleen; Zion, Cynthia; Ittenbach, Richard F

    2018-01-01

    To test the hypotheses that an innovative skills-based behavioral family clinic and home-based intervention (LAUNCH) would reduce body mass index z score (BMIz) compared with motivational interviewing and to standard care in preschool-aged children with obesity. Randomized controlled trial with children between the ages of 2 and 5 years above the 95 th percentile for body mass index for age and sex recruited from 27 pediatrician offices across 10 recruitment cycles between March 12, 2012 and June 8, 2015. Children were randomized to LAUNCH (an 18-session clinic and home-based behavioral intervention), motivational interviewing (delivered at the same frequency as LAUNCH), or standard care (no formal intervention). Weight and height were measured by assessors blinded to participant assignment. The primary outcome, BMIz at month 6 after adjusting for baseline BMIz, was tested separately comparing LAUNCH with motivational interviewing and LAUNCH with standard care using regression-based analysis of covariance models. A total of 151 of the 167 children randomized met intent-to-treat criteria and 92% completed the study. Children were 76% White and 57% female, with an average age of 55 months and BMI percentile of 98.57, with no demographic differences between the groups. LAUNCH participants demonstrated a significantly greater decrease in BMIz (mean = -0.32, SD = ±0.33) compared with motivational interviewing (mean = -0.05, SD = ±0.27), P age children, an intensive 6-month behavioral skills-based intervention is necessary to reduce obesity. Clinicaltrials.gov NCT01546727. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. A randomized trial of an optimism training intervention in patients with heart disease.

    Science.gov (United States)

    Mohammadi, Narges; Aghayousefi, Alireza; Nikrahan, Gholam Reza; Adams, Caitlin N; Alipour, Ahmad; Sadeghi, Masoumeh; Roohafza, Hamidreza; Celano, Christopher M; Huffman, Jeff C

    2017-12-19

    Optimism is prospectively and independently associated with superior cardiac outcomes, but there has been minimal study of optimism-specific interventions in persons with cardiovascular illness. We aimed to examine the feasibility and impact of an optimism-promoting program among patients with heart disease in a randomized controlled trial. Participants (N=61) were outpatients, age 35-60, with coronary artery disease who were randomized to an 8-week in-person group-based optimism training intervention or an attention-matched educational control condition. Feasibility was assessed via rates of session attendance and exercise completion, and acceptability was assessed via weekly participant ratings of exercise ease, utility, and likelihood of continuation. The impact of the intervention was assessed via between-group differences in change from baseline optimism (Life Orientation Test-Revised [LOT-R]) and other psychological self-report outcomes at 8weeks (primary time point) and 16weeks, using random effects regression models. Participants completed a mean of 6.8 (SD 1.2) sessions and 13.9 (SD 2.4) exercises, with mean ratings all >3.5/5 on measures of acceptability. The intervention was associated with greater improvement in optimism at 8weeks (β=5.13; 95% confidence interval [CI]=3.55, 6.70; pintervention was also associated with greater improvements in life satisfaction, hope, and anxiety at both time points, though not with positive or negative affect. A group-based optimism training program was feasible, acceptable, and associated with improvements in optimism and other psychological measures in cardiac patients. Future larger studies should examine effects on major clinical outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI): protocol for a cluster-randomised clinical trial of a complex intervention.

    Science.gov (United States)

    Richards-Belle, Alvin; Mouncey, Paul R; Wade, Dorothy; Brewin, Chris R; Emerson, Lydia M; Grieve, Richard; Harrison, David A; Harvey, Sheila; Howell, David; Mythen, Monty; Sadique, Zia; Smyth, Deborah; Weinman, John; Welch, John; Rowan, Kathryn M

    2018-02-08

    Acute psychological stress, as well as unusual experiences including hallucinations and delusions, are common in critical care unit patients and have been linked to post-critical care psychological morbidity such as post-traumatic stress disorder (PTSD), depression and anxiety. Little high-quality research has been conducted to evaluate psychological interventions that could alleviate longer-term psychological morbidity in the critical care unit setting. Our research team developed and piloted a nurse-led psychological intervention, aimed at reducing patient-reported PTSD symptom severity and other adverse psychological outcomes at 6 months, for evaluation in the POPPI trial. This is a multicentre, parallel group, cluster-randomised clinical trial with a staggered roll-out of the intervention. The trial is being carried out at 24 (12 intervention, 12 control) NHS adult, general, critical care units in the UK and is evaluating the clinical effectiveness and cost-effectiveness of a nurse-led preventative psychological intervention in reducing patient-reported PTSD symptom severity and other psychological morbidity at 6 months. All sites deliver usual care for 5 months (baseline period). Intervention group sites are then trained to carry out the POPPI intervention, and transition to delivering the intervention for the rest of the recruitment period. Control group sites deliver usual care for the duration of the recruitment period. The trial also includes a process evaluation conducted independently of the trial team. This protocol was reviewed and approved by the National Research Ethics Service South Central - Oxford B Research Ethics Committee (reference: 15/SC/0287). The first patient was recruited in September 2015 and results will be disseminated in 2018. The results will be presented at national and international conferences and published in peer reviewed medical journals. ISRCTN53448131; Pre-results. © Article author(s) (or their employer(s) unless

  15. A randomized controlled trial of a videoconferencing smoking cessation intervention for Korean American women: preliminary findings

    Directory of Open Access Journals (Sweden)

    Kim SS

    2016-09-01

    Full Text Available Sun S Kim,1 Somporn Sitthisongkram,1 Kunsook Bernstein,2 Hua Fang,3 Won S Choi,4 Douglas Ziedonis5 1Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 2Hunter-Bellevue School of Nursing, Hunter College, City University of New York, New York, NY, 3Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, 4Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, KS, 5Department of Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA Introduction: Korean women are reluctant to pursue in-person smoking cessation treatment due to stigma attached to women smokers and prefer treatment such as telephone and online smoking cessation programs that they can access secretively at home. However, there is some evidence that face-to-face interaction is the most helpful intervention component for them to quit smoking.Methods: This study is a pilot clinical trial that examined the acceptability and feasibility of a videoconferencing smoking cessation intervention for Korean American women and compared its preliminary efficacy with a telephone-based intervention. Women of Korean ethnicity were recruited nationwide in the United States and randomly assigned at a ratio of 1:1 to either a video arm or a telephone arm. Both arms received eight 30-minute weekly individualized counseling sessions of a deep cultural smoking cessation intervention and nicotine patches for 8 weeks. Participants were followed over 3 months from the quit day. Results: The videoconferencing intervention was acceptable and feasible for Korean women aged <50 years, whereas it was not for older women. Self-reported abstinence was high at 67% and 48% for the video and telephone arm at 1 month post-quit, respectively. The rates declined to 33% for the video arm and 28% for the telephone arm at 3 months post-quit when salivary

  16. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial.

    Science.gov (United States)

    Arija, Victoria; Martín, Núria; Canela, Teresa; Anguera, Carme; Castelao, Ana I; García-Barco, Montserrat; García-Campo, Antoni; González-Bravo, Ana I; Lucena, Carme; Martínez, Teresa; Fernández-Barrés, Silvia; Pedret, Roser; Badia, Waleska; Basora, Josep

    2012-05-24

    nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers' education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360775.

  17. 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.

  18. Guided self-help concreteness training as an intervention for major depression in primary care: a Phase II randomized controlled trial

    DEFF Research Database (Denmark)

    Watkins, E R; Taylor, R S; Baeyens, C

    2012-01-01

    Background The development of widely accessible, effective psychological interventions for depression is a priority. This randomized trial provides the first controlled data on an innovative cognitive bias modification (CBM) training guided self-help intervention for depression. Method One hundre...

  19. Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation.

    Science.gov (United States)

    Lloyd, Jenny; Dean, Sarah; Creanor, Siobhan; Abraham, Charles; Hillsdon, Melvyn; Ryan, Emma; Wyatt, Katrina M

    2017-11-28

    The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. Our trial shows that it is possible to

  20. Community-based intervention for blood pressure reduction in Nepal (COBIN trial)

    DEFF Research Database (Denmark)

    Neupane, Dinesh; McLachlan, Craig S; Christensen, Bo

    2016-01-01

    BACKGROUND: Hypertension contributes to a significant burden of cardiovascular disease in low- and middle-income countries; however, responses are inadequate because of a lack of conclusive evidence on population-based approaches to hypertension control. METHODS/DESIGN: The objective of the present...... study is to determine the effect of family-based home health education and blood pressure monitoring by trained female community health volunteers. The primary outcome is change in mean systolic blood pressure. A community-based, open-masked, two-armed, cluster-randomized trial will be conducted...... in Lekhnath Municipality of Nepal. The municipality is divided into 15 administrative clusters. Randomization will be conducted for 14 clusters: 7 for the intervention arm and 7 for the control arm. The participants were recruited from a prevalence study conducted earlier. On the basis of population...

  1. Insulin resistance and progression to type 1 diabetes in the European Nicotinamide Diabetes Intervention Trial (ENDIT)

    DEFF Research Database (Denmark)

    Bingley, Polly J; Mahon, Jeffrey L; Gale, Edwin A M

    2008-01-01

    OBJECTIVE: Insulin resistance can modulate progression to type 1 diabetes in individuals with ongoing islet autoimmunity. We wanted to see whether measures of insulin resistance improved risk assessment in islet cell antibody (ICA)-positive relatives when added to other immune and metabolic markers....... RESEARCH DESIGN AND METHODS: The retrospective cohort analysis included 213 family members participating in the European Nicotinamide Diabetes Intervention Trial. All were aged or=20 Juvenile Diabetes Foundation units. Median length of follow......-up was 4.21 years, and 105 individuals developed diabetes. Oral and intravenous glucose tolerance tests were performed at baseline; antibodies to GAD, IA-2, and insulin were determined by radioimmunoassay; and insulin resistance was estimated by homeostasis model assessment. Risk was assessed by Cox...

  2. Protocol for a cluster randomised controlled trial on information technology-enabled nutrition intervention among urban adults in Chandigarh (India): SMART eating trial.

    Science.gov (United States)

    Kaur, Jasvir; Kaur, Manmeet; Webster, Jacqui; Kumar, Rajesh

    2018-01-01

    Nutrition is an important determinant of health. At present, nutrition programs in India mainly emphasize improving maternal and child nutrition. Adult nutrition has not received due attention, though diseases like hypertension and diabetes are largely preventable through changes in dietary and physical activity behaviour. Little is known about the best approaches to improve dietary behaviours, especially the role of modern information technology (IT) in health education. We describe the protocol of the SMART Eating (Small, Measurable and Achievable dietary changes by Reducing fat, sugar and salt consumption and Trying different fruits and vegetables) health promotion intervention. A Cluster Randomised Controlled Trial will evaluate the effect of an IT-enabled intervention on nutrition behaviour among urban adults of Chandigarh, India. Formative research using a qualitative exploratory approach was undertaken to inform the intervention. The IT-enabled intervention programme includes website development, Short Message Service (SMS), e-mail reminders and interactive help by mobile and landline phones. The IT-enabled intervention will be compared to the traditional nutrition education program of distributing pamphlets in the control group. The primary outcome will be the percentage of study participants meeting the dietary intake guidelines of the National Institute of Nutrition, Hyderabad, India and the change in intake of fat, sugar, salt, fruit and vegetables after the intervention. The difference in differences method will be used to determine the net change in dietary intakes resulting from the interventions. Measurements will be made at baseline and at 6 months post-intervention, using a food frequency questionnaire. The formative research led to the development of a comprehensive intervention, focusing on five dietary components and using multi-channel communication approach including the use of IT to target urban North Indians from diverse socio

  3. Promoting Recruitment using Information Management Efficiently (PRIME): a stepped-wedge, cluster randomised trial of a complex recruitment intervention embedded within the REstart or Stop Antithrombotics Randomised Trial.

    Science.gov (United States)

    Maxwell, Amy E; Parker, Richard A; Drever, Jonathan; Rudd, Anthony; Dennis, Martin S; Weir, Christopher J; Al-Shahi Salman, Rustam

    2017-12-28

    Few interventions are proven to increase recruitment in clinical trials. Recruitment to RESTART, a randomised controlled trial of secondary prevention after stroke due to intracerebral haemorrhage, has been slower than expected. Therefore, we sought to investigate an intervention to boost recruitment to RESTART. We conducted a stepped-wedge, cluster randomised trial of a complex intervention to increase recruitment, embedded within the RESTART trial. The primary objective was to investigate if the PRIME complex intervention (a recruitment co-ordinator who conducts a recruitment review, provides access to bespoke stroke audit data exports, and conducts a follow-up review after 6 months) increases the recruitment rate to RESTART. We included 72 hospital sites located in England, Wales, or Scotland that were active in RESTART in June 2015. All sites began in the control state and were allocated using block randomisation stratified by hospital location (Scotland versus England/Wales) to start the complex intervention in one of 12 different months. The primary outcome was the number of patients randomised into RESTART per month per site. We quantified the effect of the complex intervention on the primary outcome using a negative binomial, mixed model adjusting for site, December/January months, site location, and background time trends in recruitment rate. We recruited and randomised 72 sites and recorded their monthly recruitment to RESTART over 24 months (March 2015 to February 2017 inclusive), providing 1728 site-months of observations for the primary analysis. The adjusted rate ratio for the number of patients randomised per month after allocation to the PRIME complex intervention versus control time before allocation to the PRIME complex intervention was 1.06 (95% confidence interval 0.55 to 2.03, p = 0.87). Although two thirds of respondents to the 6-month follow-up questionnaire agreed that the audit reports were useful, only six patients were reported to

  4. Non-pharmacological interventions for restless legs syndrome: a systematic review of randomised controlled trials.

    Science.gov (United States)

    Harrison, Eloise G; Keating, Jennifer L; Morgan, Prue E

    2018-03-21

    Restless legs syndrome (RLS) is a sensorimotor disorder characterised by an uncomfortable urge to move the legs. Management is primarily pharmacological. Effects for non-pharmacological, non-surgical options are published but lack systematic examination. To synthesise results of non-pharmacological/non-surgical treatment compared to no-treatment controls or alternative treatment for RLS on any relevant outcome. Databases and reference lists of reviews were searched for randomised controlled trials (RCTs) comparing non-pharmacological treatment to alternative or no treatment controls for idiopathic RLS. Search results were independently screened for inclusion by two researchers; disagreements regarding eligibility were resolved with discussion. Outcomes were summarised, and pooled where possible in meta-analysis. The search yielded 442 articles. Eleven trials met inclusion criteria. Repetitive transcranial magnetic stimulation, exercise, compression devices, counterstrain manipulation, infrared therapy, and standard acupuncture were significantly more effective for RLS severity than control conditions. Vibration pads, cryotherapy, and transcranial direct current stimulation were ineffective in reducing RLS severity. Vibration pads, cryotherapy, yoga, compression devices, and acupuncture significantly improved some sleep-related outcomes. Few studies were identified and quality of evidence was not high. Some non-pharmacological interventions may be beneficial for reducing RLS severity and enhancing sleep. Implications for Rehabilitation The current management of restless leg syndrome is primarily pharmacological, and medications can have unwanted side effects. Repetitive transcranial magnetic stimulation, exercise, compression devices, counterstrain manipulation, infrared therapy, and standard acupuncture may reduce restless leg syndrome severity. Vibration pads, cryotherapy, yoga, compression devices, and acupuncture may improve some sleep-related outcomes in

  5. An Internet-Based Intervention to Promote Mental Fitness for Mildly Depressed Adults: Randomized Controlled Trial

    Science.gov (United States)

    Haverman, Merel; Kramer, Jeannet; Westerhof, Gerben J; Riper, Heleen; Walburg, Jan A; Boon, Brigitte; Bohlmeijer, Ernst

    2013-01-01

    Background Depression is a worldwide problem warranting global solutions to tackle it. Enhancing well-being has benefits in its own right and could be a good strategy for preventing depression. Providing well-being interventions via the Internet may have synergetic effects. Objective Psyfit (“mental fitness online”) is a fully automated self-help intervention to improve well-being based on positive psychology. This study examines the clinical effects of this intervention. Methods We conducted a 2-armed randomized controlled trial that compared the effects of access to Psyfit for 2 months (n=143) to a waiting-list control condition (n=141). Mild to moderately depressed adults in the general population seeking self-help were recruited. Primary outcome was well-being measured by Mental Health Continuum-Short Form (MHC-SF) and WHO Well-being Index (WHO-5); secondary outcomes were depressive symptoms, anxiety, vitality, and general health measured by Center for Epidemiological Studies Depression Scale (CES-D), Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and Medical Outcomes Study-Short Form (MOS-SF) vitality and general health subscales, respectively. Online measurements were taken at baseline, 2 months, and 6 months after baseline. Results The dropout rate was 37.8% in the Psyfit group and 22.7% in the control group. At 2-month follow-up, Psyfit tended to be more effective in enhancing well-being (nonsignificantly for MHC-SF: Cohen’s d=0.27, P=.06; significantly for WHO-5: Cohen’s d=0.31, P=.01), compared to the waiting-list control group. For the secondary outcomes, small but significant effects were found for general health (Cohen’s d=0.14, P=.01), vitality (d=0.22, P=.02), anxiety symptoms (Cohen’s d=0.32, P=.001), and depressive symptoms (Cohen’s d=0.36, P=.02). At 6-month follow-up, there were no significant effects on well-being (MHC-SF: Cohen’s d=0.01, P=.90; WHO-5: Cohen’s d=0.26, P=.11), whereas depressive symptoms

  6. LONG-TERM EFFECTS OF CHLORTHALIDONE VS HYDROCHLOROTHIAZIDE ON ELECTROCARDIOGRAPHIC LEFT VENTRICULAR HYPERTROPHY IN THE MULTIPLE RISK FACTOR INTERVENTION TRIAL

    OpenAIRE

    Ernst, Michael E.; Neaton, James D.; Grimm, Richard H.; Collins, Gary; Thomas, William; Soliman, Elsayed Z.; Prineas, Ronald J.

    2011-01-01

    Chlorthalidone (CTD) reduces 24-hour blood pressure more effectively than hydrochlorothiazide (HCTZ), but whether this influences electrocardiographic left ventricular hypertrophy (LVH) is uncertain. One source of comparative data is the Multiple Risk Factor Intervention Trial (MRFIT), which randomly assigned 8,012 hypertensive men to special intervention (SI) or usual care (UC). SI participants could use CTD or HCTZ initially; previous analyses have grouped clinics by their main diuretic use...

  7. Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials.

    Directory of Open Access Journals (Sweden)

    Jim McCambridge

    Full Text Available Participant reports of their own behaviour are critical for the provision and evaluation of behavioural interventions. Recent developments in brief alcohol intervention trials provide an opportunity to evaluate longstanding concerns that answering questions on behaviour as part of research assessments may inadvertently influence it and produce bias. The study objective was to evaluate the size and nature of effects observed in randomized manipulations of the effects of answering questions on drinking behaviour in brief intervention trials.Multiple methods were used to identify primary studies. Between-group differences in total weekly alcohol consumption, quantity per drinking day and AUDIT scores were evaluated in random effects meta-analyses. Ten trials were included in this review, of which two did not provide findings for quantitative study, in which three outcomes were evaluated. Between-group differences were of the magnitude of 13.7 (-0.17 to 27.6 grams of alcohol per week (approximately 1.5 U.K. units or 1 standard U.S. drink and 1 point (0.1 to 1.9 in AUDIT score. There was no difference in quantity per drinking day.Answering questions on drinking in brief intervention trials appears to alter subsequent self-reported behaviour. This potentially generates bias by exposing non-intervention control groups to an integral component of the intervention. The effects of brief alcohol interventions may thus have been consistently under-estimated. These findings are relevant to evaluations of any interventions to alter behaviours which involve participant self-report.

  8. Effectiveness of recruitment to a smartphone-delivered nutrition intervention in New Zealand: analysis of a randomised controlled trial

    OpenAIRE

    Volkova, Ekaterina; Michie, Jo; Corrigan, Callie; Sundborn, Gerhard; Eyles, Helen; Jiang, Yannan; Mhurchu, Cliona Ni

    2017-01-01

    Objectives Delivery of interventions via smartphone is a relatively new initiative in public health, and limited evidence exists regarding optimal strategies for recruitment. We describe the effectiveness of approaches used to recruit participants to a smartphone-enabled nutrition intervention trial. Methods Internet and social media advertising, mainstream media advertising and research team networks were used to recruit New Zealand adults to a fully automated smartphone-delivered nutrition ...

  9. Cardioprotective effects of cocoa: clinical evidence from randomized clinical intervention trials in humans.

    Science.gov (United States)

    Arranz, Sara; Valderas-Martinez, Palmira; Chiva-Blanch, Gemma; Casas, Rosa; Urpi-Sarda, Mireia; Lamuela-Raventos, Rosa M; Estruch, Ramon

    2013-06-01

    Cocoa is an important source of polyphenols, which comprise 12-18% of its total dry weight. The major phenolic compounds in cocoa and cocoa products are mainly flavonoids such as epicatechin, catechin, and proanthocyanidins. These products contain higher amounts of flavonoids than other polyphenol-rich foods. However, the bioavailability of these compounds depends on other food constituents and their interactions with the food matrix. Many epidemiological and clinical intervention trials have concluded that the ingestion of flavonoids reduces the risk factors of developing cardiovascular disease. This review summarizes the new findings regarding the effects of cocoa and chocolate consumption on cardiovascular risk factors. The mechanisms involved in the cardioprotective effects of cocoa flavonoids include reduction of oxidative stress, inhibition of low-density lipoproteins oxidation and platelet aggregation, vasodilatation of blood vessels, inhibition of the adherence of monocytes to vascular endothelium, promotion of fibrinolysis, and immunomodulatory and anti-inflammatory activity. Scientific evidence supports a cause and effect relationship between consumption of cocoa flavonoids and the maintenance of normal endothelium-dependent vasodilation, which contributes to normal blood flow. However, larger randomized trials are required to definitively establish the impact of cocoa and cocoa products consumption on hard cardiovascular outcomes. © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  10. An individually-tailored multifactorial intervention program for older fallers in a middle-income developing country: Malaysian Falls Assessment and Intervention Trial (MyFAIT)

    Science.gov (United States)

    2014-01-01

    Background In line with a rapidly ageing global population, the rise in the frequency of falls will lead to increased healthcare and social care costs. This study will be one of the few randomized controlled trials evaluating a multifaceted falls intervention in a low-middle income, culturally-diverse older Asian community. The primary objective of our paper is to evaluate whether individually tailored multifactorial interventions will successfully reduce the number of falls among older adults. Methods Three hundred community-dwelling older Malaysian adults with a history of (i) two or more falls, or (ii) one injurious fall in the past 12 months will be recruited. Baseline assessment will include cardiovascular, frailty, fracture risk, psychological factors, gait and balance, activities of daily living and visual assessments. Fallers will be randomized into 2 groups: to receive tailored multifactorial interventions (intervention group); or given lifestyle advice with continued conventional care (control group). Multifactorial interventions will target 6 specific risk factors. All participants will be re-assessed after 12 months. The primary outcome measure will be fall recurrence, measured with monthly falls diaries. Secondary outcomes include falls risk factors; and psychological measures including fear of falling, and quality of life. Discussion Previous studies evaluating multifactorial interventions in falls have reported variable outcomes. Given likely cultural, personal, lifestyle and health service differences in Asian countries, it is vital that individually-tailored multifaceted interventions are evaluated in an Asian population to determine applicability of these interventions in our setting. If successful, these approaches have the potential for widespread application in geriatric healthcare services, will reduce the projected escalation of falls and fall-related injuries, and improve the quality of life of our older community. Trial registration

  11. Impact and change of attitudes toward Internet interventions within a randomized controlled trial on individuals with depression symptoms.

    Science.gov (United States)

    Schröder, Johanna; Berger, Thomas; Meyer, Björn; Lutz, Wolfgang; Späth, Christina; Michel, Pia; Rose, Matthias; Hautzinger, Martin; Hohagen, Fritz; Klein, Jan Philipp; Moritz, Steffen

    2018-02-28

    Most individuals with depression do not receive adequate treatment. Internet interventions may help to bridge this gap. Research on attitudes toward Internet interventions might facilitate the dissemination of such interventions by identifying factors that help or hinder uptake and implementation, and by clarifying who is likely to benefit. This study examined whether attitudes toward Internet interventions moderate the effects of a depression-focused Internet intervention, and how attitudes change over the course of treatment among those who do or do not benefit. We recruited 1,004 adults with mild-to-moderate depression symptoms and investigated how attitudes toward Internet interventions are associated with the efficacy of the program deprexis, and how attitudes in the intervention group change from pre to post over a 3 months intervention period, compared to a control group (care as usual). This study consists of a subgroup analysis of the randomized controlled EVIDENT trial. Positive initial attitudes toward Internet interventions were associated with greater efficacy (η 2 p  = .014) independent of usage time, whereas a negative attitude (perceived lack of personal contact) was associated with reduced efficacy (η 2 p  = .012). Users' attitudes changed during the trial, and both the magnitude and direction of attitude change were associated with the efficacy of the program over time (η 2 p  = .030). Internet interventions may be the most beneficial for individuals with positive attitudes toward them. Informing potential users about evidence-based Internet interventions might instill positive attitudes and thereby optimize the benefits such interventions can provide. Assessing attitudes prior to treatment might help identify suitable users. © 2018 Wiley Periodicals, Inc.

  12. Comprehensive school-based intervention to control overweight and obesity in China: a cluster randomized controlled trial.

    Science.gov (United States)

    Xu, Haiquan; Li, Yanping; Zhang, Qian; Hu, Xiaoqi L; Liu, Ailing; Du, Songming; Li, Tingyu; Guo, Hongwei; Li, Ying; Xu, Guifa; Liu, Weijia; Ma, Jun; Ma, Guansheng

    2017-01-01

    With prevalence of childhood obesity increasing rapidly, developing of effective and sustainable intervention strategies is becoming more and more important for the prevention of childhood obesity in China. A trial was developed to evaluate the effect of comprehensive school-based intervention on childhood obesity. A multi-center cluster randomized controlled trial was conducted among urban children (n=9,867) aged 6-13 years in 38 primary schools from six large cities. Comprehensive intervention, nutrition education and physical activity interventions were carried out among children. Nutrition education was also targeted towards teachers, parents and health workers in intervention schools. The program was implemented for 2 semesters from May 2009 to May 2010. The combined prevalence of overweight and obesity increased by 1.5 percent (22.7% vs 24.2%, pintervention group (23.6% vs 23.8%, p=0.954) after intervention (p=0.067). The effect was significantly stronger among girls than boys (-1.4% vs -0.9%, p=0.028). A significant intervention effect was found on BMI for -0.3 kg/m2 (95% confidence interval (CI): -0.4, -0.2; pobesity, BMI, BMI z scores, waist circumference, percentage body fat, glucose and lipid for a comprehensive school-based intervention of childhood obesity in China.

  13. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention

    Directory of Open Access Journals (Sweden)

    Michele R. Sgambato

    2016-08-01

    Full Text Available Abstract Background The prevalence of childhood obesity is increasing at a high rate in Brazil, making prevention a health priority. Schools are the central focus of interventions aiming the prevention and treatment of childhood obesity, however, randomized trials and cohort studies have not yet provided clear evidence of strategies to reduce prevalence of obesity. The aim of this study is to present a protocol to evaluate the efficacy of combining school and household level interventions to reduce excessive weight gain among students. Methods The intervention target fifth and sixth graders from 18 public schools (9 interventions and 9 controls in the municipality of Duque de Caxias, metropolitan area of Rio de Janeiro, Brazil. A sample size of 2500 students will be evaluated at school for their weight status and those from the intervention group who are overweight or obese will be followed monthly at home by community health agents. Demographic, socioeconomic, anthropometric, eating behavior and food consumption data will be collected at school using a standardized questionnaire programmed in personal digital assistant. At school, all students from the intervention group will be encouraged to change eating habits and food consumption and to increase physical activity and reducing sedentary behavior. Discussion This study will provide evidence whether integration of school with primary health care can prevent excessive weight gain among adolescents. Positive results will inform a sustainable strategy to be disseminated in the health care system in Brazil. Trial registration ClinicalTrials.gov, NCT02711488 . Date of registration: March 11, 2016.

  14. Maintaining Treatment Fidelity of Mindfulness-Based Relapse Prevention Intervention for Alcohol Dependence: A Randomized Controlled Trial Experience

    Directory of Open Access Journals (Sweden)

    Aleksandra E. Zgierska

    2017-01-01

    Full Text Available Background. Treatment fidelity is essential to methodological rigor of clinical trials evaluating behavioral interventions such as Mindfulness Meditation (MM. However, procedures for monitoring and maintenance of treatment fidelity are inconsistently applied, limiting the strength of such research. Objective. To describe the implementation and findings related to fidelity monitoring of the Mindfulness-Based Relapse Prevention for Alcohol Dependence (MBRP-A intervention in a 26-week randomized controlled trial. Methods. 123 alcohol dependent adults were randomly assigned to MM (MBRP-A and home practice, adjunctive to usual care; N=64 or control (usual care alone; N=59. Treatment fidelity assessment strategies recommended by the National Institutes of Health Behavior Change Consortium for study/intervention design, therapist training, intervention delivery, and treatment receipt and enactment were applied. Results. Ten 8-session interventions were delivered. Therapist adherence and competence, assessed using the modified MBRP Adherence and Competence Scale, were high. Among the MM group participants, 46 attended ≥4 sessions; over 90% reported at-home MM practice at 8 weeks and 72% at 26 weeks. They also reported satisfaction with and usefulness of MM for maintaining sobriety. No adverse events were reported. Conclusions. A systematic approach to assessment of treatment fidelity in behavioral clinical trials allows determination of the degree of consistency between intended and actual delivery and receipt of intervention.

  15. The quality assessment of the interventional radiology publications in Chinese journal of radiology using the randomized controlled trials

    International Nuclear Information System (INIS)

    Gao Xiangtao; Xu Guohui; He Hong; Yan Yaiying; Mao Bing

    2007-01-01

    Objective: To assess the quality of reporting randomized controlled trials published in Chinese journal of radiology from 2000 to 2005. Methods: A manual search was performed and 22 checklists of CONSORT statements and other self-established criteria were applied. Results: Six volumes and 72 issues were investigated. There were total trials of 236 in 2186 literatures, and finally 3 randomized controlled trials (RCTs) (1.27%) were identified. In the 3 RCTs, there were 3 trials with methods of randomization, 1 with endpoints measurement, 1 with multi-centre, but without the prior calculation of sample size, blind methods, statistically probability, participant flow, compliance and negative results. Conclusion: The quality of reporting randomized controlled trials of interventional radiology has been improved, but it did not meet fully the CONSORT statement. (authors)

  16. Evaluating an audit and feedback intervention for reducing antibiotic prescribing behaviour in general dental practice (the RAPiD trial): a partial factorial cluster randomised trial protocol.

    Science.gov (United States)

    Prior, Maria; Elouafkaoui, Paula; Elders, Andrew; Young, Linda; Duncan, Eilidh M; Newlands, Rumana; Clarkson, Jan E; Ramsay, Craig R

    2014-04-24

    Antibiotic prescribing in dentistry accounts for 9% of total antibiotic prescriptions in Scottish primary care. The Scottish Dental Clinical Effectiveness Programme (SDCEP) published guidance in April 2008 (2nd edition, August 2011) for Drug Prescribing in Dentistry, which aims to assist dentists to make evidence-based antibiotic prescribing decisions. However, wide variation in prescribing persists and the overall use of antibiotics is increasing. RAPiD is a 12-month partial factorial cluster randomised trial conducted in NHS General Dental Practices across Scotland. Its aim is to compare the effectiveness of individualised audit and feedback (A&F) strategies for the translation into practice of SDCEP recommendations on antibiotic prescribing. The trial uses routinely collected electronic healthcare data in five aspects of its design in order to: identify the study population; apply eligibility criteria; carry out stratified randomisation; generate the trial intervention; analyse trial outcomes. Eligibility was determined on contract status and a minimum level of recent NHS treatment provision. All eligible dental practices in Scotland were simultaneously randomised at baseline either to current audit practice or to an intervention group. Randomisation was stratified by single-handed/multi-handed practices. General dental practitioners (GDPs) working at intervention practices will receive individualised graphical representations of their antibiotic prescribing rate from the previous 14 months at baseline and an update at six months. GDPs could not be blinded to their practice allocation. Intervention practices were further randomised using a factorial design to receive feedback with or without: a health board comparator; a supplementary text-based intervention; additional feedback at nine months. The primary outcome is the total antibiotic prescribing rate per 100 courses of treatment over the year following delivery of the baseline intervention. A concurrent

  17. Translating a Fall Prevention Intervention Into Practice: A Randomized Community Trial.

    Science.gov (United States)

    Guse, Clare E; Peterson, Donna J; Christiansen, Ann L; Mahoney, Jane; Laud, Purushottam; Layde, Peter M

    2015-07-01

    We examined whether community translation of an effective evidence-based fall prevention program via standard monetary support can produce a community-wide reduction in fall injuries in older adults and evaluated whether an enhanced version with added technical support and capacity building amplified the fall reduction effect. We completed a randomized controlled community trial among adults aged 65 and older in (1) 10 control communities receiving no special resources or guidance on fall prevention, (2) 5 standard support communities receiving modest funding to implement Stepping On, and (3) 5 enhanced support communities receiving funding and technical support. The primary outcome was hospital inpatient and emergency department discharges for falls, examined with Poisson regression. Compared with control communities, standard and enhanced support communities showed significantly higher community-wide reductions (9% and 8%, respectively) in fall injuries from baseline (2007-2008) to follow-up (2010-2011). No significant difference was found between enhanced and standard support communities. Population-based fall prevention interventions can be effective when implemented in community settings. More research is needed to identify the barriers and facilitators that influence the successful adoption and implementation of fall prevention interventions into broad community practice.

  18. Integration of occupation based intervention in hand injury rehabilitation: A Randomized Controlled Trial.

    Science.gov (United States)

    Che Daud, Ahmad Zamir; Yau, Matthew K; Barnett, Fiona; Judd, Jenni; Jones, Rhondda E; Muhammad Nawawi, Rashdeen Fazwi

    2016-01-01

    Randomized Controlled Trial (RCT). Engagement in daily occupations and day to day activities helps to restore function in individuals with injured hands and provides a platform to practise selected occupations. The purpose of this study was to investigate the effectiveness of a combination of Occupation Based Intervention (OBI) and Therapeutic Exercise (TE) compared to TE alone for the rehabilitation of hand injuries. A single center RCT, parallel group was conducted at the Kuala Lumpur General Hospital (KLGH), Malaysia. Forty-six adult clients with hand injuries who consented to participate were randomly allocated to either the OBI + TE group or to the TE group. Following a ten week intervention program, statistical significance differences were found in DASH score (TE = 18.64 ± 14.84 vs OBI + TE = 9.50 ± 9.14, p = 0.02); total active motion (TE = 1035.85 ± 179.84 vs OBI + TE = 1203.65 ± 133.60, p = 0.01); neuropathic pain (TE = 2.90 ± 2.79 vs OBI + TE = 1.05 ± 2.01, p = 0.02); COPM performance (TE = 7.62 ± 2.03 vs OBI + TE = 9.53 ± 0.64, p hand injury rehabilitation improved outcomes for clients. Copyright © 2016 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

  19. 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.

  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 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.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.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;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.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 intensive hospital-based wellness programs have potential for

  1. Effect of the Goals of Care Intervention for Advanced Dementia: A Randomized Clinical Trial.

    Science.gov (United States)

    Hanson, Laura C; Zimmerman, Sheryl; Song, Mi-Kyung; Lin, Feng-Chang; Rosemond, Cherie; Carey, Timothy S; Mitchell, Susan L

    2017-01-01

    In advanced dementia, goals of care decisions are challenging and medical care is often more intensive than desired. To test a goals of care (GOC) decision aid intervention to improve quality of communication and palliative care for nursing home residents with advanced dementia. A single-blind cluster randomized clinical trial, including 302 residents with advanced dementia and their family decision makers in 22 nursing homes. A GOC video decision aid plus a structured discussion with nursing home health care providers; attention control with an informational video and usual care planning. Primary outcomes at 3 months were quality of communication (QOC, questionnaire scored 0-10 with higher ratings indicating better quality), family report of concordance with clinicians on the primary goal of care (endorsing same goal as the "best goal to guide care and medical treatment," and clinicians' "top priority for care and medical treatment"), and treatment consistent with preferences (Advance Care Planning Problem score). Secondary outcomes at 9 months were family ratings of symptom management and care, palliative care domains in care plans, Medical Orders for Scope of Treatment (MOST) completion, and hospital transfers. Resident-family dyads were the primary unit of analysis, and all analyses used intention-to-treat assignment. Residents' mean age was 86.5 years, 39 (12.9%) were African American, and 246 (81.5%) were women. With the GOC intervention, family decision makers reported better quality of communication (QOC, 6.0 vs 5.6; P = .05) and better end-of-life communication (QOC end-of-life subscale, 3.7 vs 3.0; P = .02). Goal concordance did not differ at 3 months, but family decision makers with the intervention reported greater concordance by 9 months or death (133 [88.4%] vs 108 [71.2%], P = .001). Family ratings of treatment consistent with preferences, symptom management, and quality of care did not differ. Residents in the intervention group had more

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

    Science.gov (United States)

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

    2016-02-01

    Circulating amino acids, such as branched-chain amino acids (BCAAs) and aromatic amino acids (AAAs), have been associated with diabetes risk; however, little is known about how a long-term dietary intervention for weight loss affects circulating amino acids. We examined the effects of weight-loss diets on long-term changes in plasma amino acids and the associations of these changes with weight loss and the improvement of insulin resistance. We repeatedly measured plasma amino acid profiles over 2 y in overweight or obese participants from 2 randomized, dietary intervention, weight-loss trials [774 subjects from the POUNDS LOST (Preventing Overweight Using Novel Dietary Strategies Trial) and 318 subjects from the DIRECT (Dietary Intervention Randomized Controlled Trial)]. Intervention diets consistently lowered most of the amino acid concentrations, including BCAAs and AAAs, in both trials. In the POUNDS LOST, average-protein diets (15% of daily energy) showed stronger effects than did high-protein diets (25% of daily energy) on reducing concentrations of the diabetes-associated BCAA valine at 6 mo independent of the weight change. In both trials, weight loss was directly related to the concurrent reduction of the BCAAs leucine and isoleucine, the AAAs tyrosine and phenylalanine, and 4 other amino acids. For example, per kilogram of weight loss, there was a 0.04-SD decrease in log tyrosine (∼0.6 μmol/L) in both trials. In addition, we showed that reductions in alanine and the AAA tyrosine were significantly related to improved insulin resistance (measured with the use of the homeostasis model assessment of insulin resistance), independent of weight loss, in both trials (both P diabetes risk-enhancing amino acid concentrations) along with and beyond weight loss. The POUNDS LOST and the DIRECT were registered at clinicaltrials.gov as NCT00072995 and NCT00160108, respectively. © 2016 American Society for Nutrition.

  3. Using Mechanical Turk to recruit participants for internet intervention research: experience from recruitment for four trials targeting hazardous alcohol consumption

    Directory of Open Access Journals (Sweden)

    John A. Cunningham

    2017-12-01

    Full Text Available Abstract Background Mechanical Turk (MTurk is an online portal operated by Amazon where ‘requesters’ (individuals or businesses can submit jobs for ‘workers.’ MTurk is used extensively by academics as a quick and cheap means of collecting questionnaire data, including information on alcohol consumption, from a diverse sample of participants. We tested the feasibility of recruiting for alcohol Internet intervention trials through MTurk. Methods Participants, 18 years or older, who drank at least weekly were recruited for four intervention trials (combined sample size, N = 11,107. The same basic recruitment strategy was employed for each trial – invite participants to complete a survey about alcohol consumption (less than 15 min in length, US$1.50 payment, identify eligible participants who drank in a hazardous fashion, invite those eligible to complete a follow-up survey ($10 payment, randomize participants to be sent or not sent information to access an online intervention for hazardous alcohol use. Procedures where put in place to optimize the chances that participants could only complete the baseline survey once. Results There was a substantially slower rate of recruitment by the fourth trial compared to the earlier trials. Demographic characteristics also varied across trials (age, sex, employment and marital status. Patterns of alcohol consumption, while displaying some differences, did not appear to vary in a linear fashion between trials. Conclusions It is possible to recruit large (but not inexhaustible numbers of people who drink in a hazardous fashion. Issues for online intervention research when employing this sample are discussed.

  4. Explaining high and low performers in complex intervention trials: a new model based on diffusion of innovations theory.

    Science.gov (United States)

    McMullen, Heather; Griffiths, Chris; Leber, Werner; Greenhalgh, Trisha

    2015-05-31

    Complex intervention trials may require health care organisations to implement new service models. In a recent cluster randomised controlled trial, some participating organisations achieved high recruitment, whereas others found it difficult to assimilate the intervention and were low recruiters. We sought to explain this variation and develop a model to inform organisational participation in future complex intervention trials. The trial included 40 general practices in a London borough with high HIV prevalence. The intervention was offering a rapid HIV test as part of the New Patient Health Check. The primary outcome was mean CD4 cell count at diagnosis. The process evaluation consisted of several hundred hours of ethnographic observation, 21 semi-structured interviews and analysis of routine documents (e.g., patient leaflets, clinical protocols) and trial documents (e.g., inclusion criteria, recruitment statistics). Qualitative data were analysed thematically using--and, where necessary, extending--Greenhalgh et al.'s model of diffusion of innovations. Narrative synthesis was used to prepare case studies of four practices representing maximum variety in clinicians' interest in HIV (assessed by level of serological testing prior to the trial) and performance in the trial (high vs. low recruiters). High-recruiting practices were, in general though not invariably, also innovative practices. They were characterised by strong leadership, good managerial relations, readiness for change, a culture of staff training and available staff time ('slack resources'). Their front-line staff believed that patients might benefit from the rapid HIV test ('relative advantage'), were emotionally comfortable administering it ('compatibility'), skilled in performing it ('task issues') and made creative adaptations to embed the test in local working practices ('reinvention'). Early experience of a positive HIV test ('observability') appeared to reinforce staff commitment to recruiting

  5. On-line randomized controlled trial of an internet based psychologically enhanced intervention for people with hazardous alcohol consumption.

    Directory of Open Access Journals (Sweden)

    Paul Wallace

    2011-03-01

    Full Text Available Interventions delivered via the Internet have the potential to address the problem of hazardous alcohol consumption at minimal incremental cost, with potentially major public health implications. It was hypothesised that providing access to a psychologically enhanced website would result in greater reductions in drinking and related problems than giving access to a typical alcohol website simply providing information on potential harms of alcohol. DYD-RCT Trial registration: ISRCTN 31070347.A two-arm randomised controlled trial was conducted entirely on-line through the Down Your Drink (DYD website. A total of 7935 individuals who screened positive for hazardous alcohol consumption were recruited and randomized. At entry to the trial, the geometric mean reported past week alcohol consumption was 46.0 (SD 31.2 units. Consumption levels reduced substantially in both groups at the principal 3 month assessment point to an average of 26.0 (SD 22.3 units. Similar changes were reported at 1 month and 12 months. There were no significant differences between the groups for either alcohol consumption at 3 months (intervention: control ratio of geometric means 1.03, 95% CI 0.97 to 1.10 or for this outcome and the main secondary outcomes at any of the assessments. The results were not materially changed following imputation of missing values, nor was there any evidence that the impact of the intervention varied with baseline measures or level of exposure to the intervention.Findings did not provide support for the hypothesis that access to a psychologically enhanced website confers additional benefit over standard practice and indicate the need for further research to optimise the effectiveness of Internet-based behavioural interventions. The trial demonstrates a widespread and potentially sustainable demand for Internet based interventions for people with hazardous alcohol consumption, which could be delivered internationally.Controlled-Trials.com ISRCTN

  6. On-line randomized controlled trial of an internet based psychologically enhanced intervention for people with hazardous alcohol consumption.

    Science.gov (United States)

    Wallace, Paul; Murray, Elizabeth; McCambridge, Jim; Khadjesari, Zarnie; White, Ian R; Thompson, Simon G; Kalaitzaki, Eleftheria; Godfrey, Christine; Linke, Stuart

    2011-03-09

    Interventions delivered via the Internet have the potential to address the problem of hazardous alcohol consumption at minimal incremental cost, with potentially major public health implications. It was hypothesised that providing access to a psychologically enhanced website would result in greater reductions in drinking and related problems than giving access to a typical alcohol website simply providing information on potential harms of alcohol. DYD-RCT Trial registration: ISRCTN 31070347. A two-arm randomised controlled trial was conducted entirely on-line through the Down Your Drink (DYD) website. A total of 7935 individuals who screened positive for hazardous alcohol consumption were recruited and randomized. At entry to the trial, the geometric mean reported past week alcohol consumption was 46.0 (SD 31.2) units. Consumption levels reduced substantially in both groups at the principal 3 month assessment point to an average of 26.0 (SD 22.3) units. Similar changes were reported at 1 month and 12 months. There were no significant differences between the groups for either alcohol consumption at 3 months (intervention: control ratio of geometric means 1.03, 95% CI 0.97 to 1.10) or for this outcome and the main secondary outcomes at any of the assessments. The results were not materially changed following imputation of missing values, nor was there any evidence that the impact of the intervention varied with baseline measures or level of exposure to the intervention. Findings did not provide support for the hypothesis that access to a psychologically enhanced website confers additional benefit over standard practice and indicate the need for further research to optimise the effectiveness of Internet-based behavioural interventions. The trial demonstrates a widespread and potentially sustainable demand for Internet based interventions for people with hazardous alcohol consumption, which could be delivered internationally. Controlled-Trials.com ISRCTN31070347.

  7. All-Wales licensed premises intervention (AWLPI): a randomised controlled trial to reduce alcohol-related violence

    Science.gov (United States)

    2014-01-01

    Background Alcohol-related violence in and in the vicinity of licensed premises continues to place a considerable burden on the United Kingdom’s (UK) health services. Robust interventions targeted at licensed premises are therefore required to reduce the costs of alcohol-related harm. Previous evaluations of interventions in licensed premises have a number of methodological limitations and none have been conducted in the UK. The aim of the trial was to determine the effectiveness of the Safety Management in Licensed Environments intervention designed to reduce alcohol-related violence in licensed premises, delivered by Environmental Health Officers, under their statutory authority to intervene in cases of violence in the workplace. Methods/Design A national randomised controlled trial, with licensed premises as the unit of allocation. Premises were identified from all 22 Local Authorities in Wales. Eligible premises were those with identifiable violent incidents on premises, using police recorded violence data. Premises were allocated to intervention or control by optimally balancing by Environmental Health Officer capacity in each Local Authority, number of violent incidents in the 12 months leading up to the start of the project and opening hours. The primary outcome measure is the difference in frequency of violence between intervention and control premises over a 12 month follow-up period, based on a recurrent event model. The trial incorporates an embedded process evaluation to assess intervention implementation, fidelity, reach and reception, and to interpret outcome effects, as well as investigate its economic impact. Discussion The results of the trial will be applicable to all statutory authorities directly involved with managing violence in the night time economy and will provide the first formal test of Health and Safety policy in this environment. If successful, opportunities for replication and generalisation will be considered. Trial registration

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

    Directory of Open Access Journals (Sweden)

    Tsai Midi

    2011-06-01

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

  9. Negotiating Ethical Paradoxes in Conducting a Randomized Controlled Trial: Aligning Intervention Science with Participatory Values.

    Science.gov (United States)

    Javdani, Shabnam; Singh, Sukhmani; Sichel, Corianna E

    2017-12-01

    In this article, we describe ethical tensions we have faced in the context of our work as intervention scientists, where we aim to promote social justice and change systems that impact girls involved in the juvenile legal system. These ethical tensions are, at their core, about resisting collusion with systems of control while simultaneously collaborating with them. Over the course of designing and implementing a randomized controlled trial (RCT) of an ecological advocacy intervention for girls, called ROSES, ethical paradoxes crystalized and prompted us to engage in critical reflection and action toward the aim of moving away from conducting research on legal-system-involved girls and moving toward a more democratic, participatory process of inquiry with girls. Our experience revealed two intertwined paradoxes that ultimately served generative purposes. First, in collaborating with legal system stakeholders, we observed a single story of girls' pathology narrated for girls, without girls, and ultimately internalized by girls. Second, in reflecting critically on the ethical implications of our study design, it became clear that the design was grounded in a medical model of inquiry although the intervention we sought to evaluate was based, in part, on resistance to the medical model. We describe emergent ethical tensions and the solutions we sought, which center on creating counternarratives and counterspaces that leverage, extend, and disrupt our existing RCT. We detail these solutions, focusing on how we restructured our research team to enhance structural competence, shifted the subject of inquiry to include the systems in which youth are embedded, and created new opportunities for former research participants to become co-researchers through formal roles on an advisory board. © Society for Community Research and Action 2017.

  10. Evaluation of a transdiagnostic psychodynamic online intervention to support return to work: A randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Rüdiger Zwerenz

    Full Text Available Given their flexibility, online interventions may be useful as an outpatient treatment option to support vocational reintegration after inpatient rehabilitation. To that purpose we devised a transdiagnostic psychodynamic online intervention to facilitate return to work, focusing on interpersonal conflicts at the workplace often responsible for work-related stress.In a randomized controlled trial, we included employed patients from cardiologic, psychosomatic and orthopedic rehabilitation with work-related stress or need for support at intake to inpatient rehabilitation after they had given written consent to take part in the study. Following discharge, maladaptive interpersonal interactions at the workplace were identified via weekly blogs and processed by written therapeutic comments over 12 weeks in the intervention group (IG. The control group (CG received an augmented treatment as usual condition. The main outcome, subjective prognosis of gainful employment (SPE, and secondary outcomes (psychological complaints were assessed by means of online questionnaires before, at the end of aftercare (3 months and at follow-up (12 months. We used ITT analyses controlling for baseline scores and medical group.N = 319 patients were enrolled into IG and N = 345 into CG. 77% of the IG logged in to the webpage (CG 74% and 65% of the IG wrote blogs. Compared to the CG, the IG reported a significantly more positive SPE at follow-up. Measures of depression, anxiety and psychosocial stressors decreased from baseline to follow-up, whereas the corresponding scores increased in the CG. Correspondingly, somatization and psychological quality of life improved in the IG.Psychodynamic online aftercare was effective to enhance subjective prognosis of future employment and improved psychological complaints across a variety of chronic physical and psychological conditions, albeit with small effect sizes.

  11. Benefits of Individualized Feedback in Internet-Based Interventions for Depression: A Randomized Controlled Trial.

    Science.gov (United States)

    Zagorscak, Pavle; Heinrich, Manuel; Sommer, Daniel; Wagner, Birgit; Knaevelsrud, Christine

    2018-01-01

    Even though there is an increasing number of studies on the efficacy of Internet-based interventions (IBI) for depression, experimental trials on the benefits of added guidance by clinicians are scarce and inconsistent. This study compared the efficacy of semistandardized feedback provided by psychologists with fully standardized feedback in IBI. Participants with mild-to-moderate depression (n = 1,089, 66% female) from the client pool of a health insurance company participated in a cognitive-behavioral IBI targeting depression over 6 weeks. Individuals were randomized to weekly semistandardized e-mail feedback from psychologists (individual counseling; IC) or to automated, standardized feedback where a psychologist could be contacted on demand (CoD). The contents and tasks were identical across conditions. The primary outcome was depression; secondary outcomes included anxiety, rumination, and well-being. Outcomes were assessed before and after the intervention and 3, 6, and 12 months later. Changes in outcomes were evaluated using latent change score modeling. Both interventions yielded large pre-post effects on depression (Beck Depression Inventory-II: dIC = 1.53, dCoD = 1.37; Patient Health Questionnaire-9: dIC = 1.20, dCoD = 1.04), as well as significant improvements of all other outcome measures. The effects remained significant after 3, 6, and 12 months. The groups differed with regard to attrition (IC: 17.3%, CoD: 25.8%, p = 0.001). Between-group effects were statistically nonsignificant across outcomes and measurement occasions. Adding semistandardized guidance in IBI for depression did not prove to be more effective than fully standardized feedback on primary and secondary outcomes, but it had positive effects on attrition. © 2018 S. Karger AG, Basel.

  12. A noninferiority trial of a problem-solving intervention for hospice caregivers: in person versus videophone.

    Science.gov (United States)

    Demiris, George; Parker Oliver, Debra; Wittenberg-Lyles, Elaine; Washington, Karla; Doorenbos, Ardith; Rue, Tessa; Berry, Donna

    2012-06-01

    Problem-solving therapy (PST) has been found effective when delivered to informal caregivers of patients with various conditions. In hospice, however, its translation to practice is impeded by the increased resources needed for its delivery. The study purpose was to compare the effectiveness of a PST intervention delivered face-to-face with one delivered via videophone to hospice primary caregivers. The study design was a randomized noninferiority trial with two groups, Group 1 in which caregivers received PST face-to-face, and Group 2 in which caregivers received PST via videophone. Family hospice caregivers were recruited from two urban hospice agencies and received the PST intervention (in three visits for Group 1 or three video-calls in Group 2) in an approximate period of 20 days after hospice admission. Standard caregiver demographic data were collected. Psychometric instruments administered to caregivers at baseline and at study completion included the CQLI-R (Caregiver Quality of Life Index-Revised), the STAI (State-Trait Anxiety Inventory), and the PSI (Problem-Solving Inventory). One hundred twenty-six caregivers were recruited in the study; 77 were randomly assigned to Group 1 and 49 to Group 2. PST delivered via video was not inferior to face-to-face delivery. The observed changes in scores were similar for each group. Caregiver quality of life improved and state anxiety decreased under both conditions. The delivery of PST via videophone was not inferior to face-to-face. Audiovisual feedback captured by technology may be sufficient, providing a solution to the geographic barriers that often inhibit the delivery of these types of interventions to older adults in hospice.

  13. Effect of a System-Oriented Intervention on Compliance Problems in Schizophrenia: A Pragmatic Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hanne Skarsholm

    2014-01-01

    Full Text Available Background. Numerous studies have been conducted with a view to developing strategies for improvement of medical compliance in patients with schizophrenia. All of the studies conducted so far have had an individual approach to compliance based on the assumption that noncompliance is determined individually due to inappropriate behavior in the patient. We conducted a pragmatic controlled trial with a system-oriented approach, to provide a new perspective on compliance and test the efficacy of a multifactorial intervention at the system level in a routine clinical setting, an approach that has not previously been used for the improvement of compliance. Methods. 30 patients were allocated to the system-oriented therapy and 40 patients were allocated to the reference intervention, which consisted of individually based compliance therapy. The follow-up period was six months. Primary endpoint was improvement in compliance, measured by improvement in a compliance scale specifically developed for the project. Results. When accounting for missing values with a multiple imputation approach, we found a tendency toward a difference in both the compliance scale and PANSS favoring the system-oriented therapy, although it did not reach statistical significance. A significant difference in incidence of adverse events and time to first readmission was found. Attrition rates were significantly higher in the reference group and nonsignificant among individuals with lower compliance, which may have diluted effect estimates. This was reflected by significant differences found in an analysis based on a last observation carried forward approach. Conclusion. This study suggests that compliance problems are better solved by a multifactorial intervention at the system level than at the individual level.

  14. In-session processes of brief motivational interventions in two trials with mandated college students.

    Science.gov (United States)

    Borsari, Brian; Apodaca, Timothy R; Jackson, Kristina M; Mastroleo, Nadine R; Magill, Molly; Barnett, Nancy P; Carey, Kate B

    2015-02-01

    Each year, thousands of college students receive mandated intervention as a sanction for alcohol use or alcohol-related behavior. For these mandated students, brief motivational interventions (BMIs) are currently the most efficacious individual intervention. However, little is known about how the technical (therapist behaviors) and relational (e.g., global ratings of therapist empathy) components of BMIs influence client language as well as subsequent change in alcohol use and consequences. This study used the Motivational Interviewing Skills Code (MISC 2.0; Miller, Moyers, Ernst, & Amrhein, 2003) to code BMI sessions from 2 randomized clinical trials that facilitated significant reductions in alcohol use (Study 1, n = 91) and alcohol-related consequences (Study 2, n = 158) in mandated students. There were significant relationships among therapist behaviors, global scores, and client language both for and against change, yet there were no links between in-session client language and subsequent changes in alcohol use or problems. In contrast, relational aspects of motivational interviewing (MI; global ratings of therapist MI Spirit and client self-exploration) were most predictive of postsession alcohol use. Mediation models incorporating both technical and relational components revealed that higher levels of client self-exploration mediated the relationship between higher therapist ratings of MI Spirit and reduced drinking at follow-up. Findings highlight the importance of considering how both technical and relational components of MI may influence alcohol use in mandated college students and also suggest more exact analyses to better understand this complex relationship. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  15. 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.

  16. Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Patricia Bourgault

    Full Text Available This study evaluated the efficacy of the PASSAGE Program, a structured multicomponent interdisciplinary group intervention for the self-management of FMS.A mixed-methods randomized controlled trial (intervention (INT vs. waitlist (WL was conducted with patients suffering from FMS. Data were collected at baseline (T0, at the end of the intervention (T1, and 3 months later (T2. The primary outcome was change in pain intensity (0-10. Secondary outcomes were fibromyalgia severity, pain interference, sleep quality, pain coping strategies, depression, health-related quality of life, patient global impression of change (PGIC, and perceived pain relief. Qualitative group interviews with a subset of patients were also conducted. Complete data from T0 to T2 were available for 43 patients.The intervention had a statistically significant impact on the three PGIC measures. At the end of the PASSAGE Program, the percentages of patients who perceived overall improvement in their pain levels, functioning and quality of life were significantly higher in the INT Group (73%, 55%, 77% respectively than in the WL Group (8%, 12%, 20%. The same differences were observed 3 months post-intervention (Intervention group: 62%, 43%, 38% vs Waitlist Group: 13%, 13%, 9%. The proportion of patients who reported ≥ 50% pain relief was also significantly higher in the INT Group at the end of the intervention (36% vs 12% and 3 months post-intervention (33% vs 4%. Results of the qualitative analysis were in line with the quantitative findings regarding the efficacy of the intervention. The improvement, however, was not reflected in the primary outcome and other secondary outcome measures.The PASSAGE Program was effective in helping FMS patients gain a sense of control over their symptoms. We suggest including PGIC in future clinical trials on FMS as they appear to capture important aspects of the patients' experience.International Standard Randomized Controlled Trial Number

  17. Screening and brief intervention delivery in the workplace to reduce alcohol-related harm: a pilot randomized controlled trial.

    Science.gov (United States)

    Watson, Hazel; Godfrey, Christine; McFadyen, Angus; McArthur, Katherine; Stevenson, Marisa; Holloway, Aisha

    2015-01-01

    To explore the feasibility and cost effectiveness of screening and delivery of a brief intervention for hazardous drinking employees. A pilot randomised controlled trial of a brief intervention delivered by an Occupational Health nurse versus no delivery of brief intervention (control group) conducted in a Local Authority Council (LCA) in the United Kingdom. Changes in quality of life and economic indicators were measured by the EQ-5D. 627 employees were screened of whom 163 (26.01%) fulfilled the inclusion criteria with a total of 57 (35%) agreeing to participate. No significant differences were found between the groups for baseline demographics or levels/patterns of alcohol consumption. A statistically significant effect was found in the mean AUDIT scores over time (F=8.96, p=0.004) but not for group (F=0.017, p=0.896), and no significant interaction was found (F=0.148, p=0.702). The cost of each intervention was calculated at £12.48, the difference in service costs was calculated at £344.50 per person; that is there was a net saving of health and other care costs in the intervention group compared to the control group. The QALYs fell in both intervention and control groups, the difference -0.002-(-0.010) yields a net advantage of the intervention of 0.008 QALYs. The main results from this pilot study suggest that alcohol brief interventions delivered in the workplace may offer the potential to reduce alcohol-related harm and save public sector resources. A fully powered multi-centre trial is warranted to contribute to the current evidence base and explore further the potential of alcohol brief interventions in the workplace. In a full trial the recruitment method may need to be re-considered. Copyright © 2014 Elsevier Ltd. All rights reserved.

  18. Online interventions for problem gamblers with and without co-occurring mental health symptoms: Protocol for a randomized controlled trial.

    Science.gov (United States)

    Cunningham, John A; Hodgins, David C; Bennett, Kylie; Bennett, Anthony; Talevski, Marina; Mackenzie, Corey S; Hendershot, Christian S

    2016-07-22

    Comorbidity between problem gambling and depression or anxiety is common. Further, the treatment needs of people with co-occurring gambling and mental health symptoms may be different from those of problem gamblers who do not have a co-occurring mental health concern. The current randomized controlled trial (RCT) will evaluate whether there is a benefit to providing access to mental health Internet interventions (G + MH intervention) in addition to an Internet intervention for problem gambling (G-only intervention) in participants with gambling problems who do or do not have co-occurring mental health symptoms. Potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. As part of the baseline screening process, measures of current depression and anxiety will be assessed. Eligible participants agreeing (N = 280) to take part in the study will be randomized to one of two versions of an online intervention for gamblers - an intervention that just targets gambling issues (G-only) versus a website that contains interventions for depression and anxiety in addition to an intervention for gamblers (G + MH). It is predicted that problem gamblers who do not have co-occurring mental health symptoms will display no significant difference between intervention conditions at a six-month follow-up. However, for those with co-occurring mental health symptoms, it is predicted that participants receiving access to the G + MH website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with G-only website. The trial will produce information on the best means of providing online help to gamblers with and without co-occurring mental health symptoms. ClinicalTrials.gov NCT02800096 ; Registration date: June 14, 2016.

  19. 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.

  20. A Positive Psychology Intervention for Patients with an Acute Coronary Syndrome: Treatment Development and Proof-of-Concept Trial.

    Science.gov (United States)

    Huffman, Jeff C; Millstein, Rachel A; Mastromauro, Carol A; Moore, Shannon V; Celano, Christopher M; Bedoya, C Andres; Suarez, Laura; Boehm, Julia K; Januzzi, James L

    2016-10-01

    Positive psychological constructs are associated with superior outcomes in cardiac patients, but there has been minimal study of positive psychology (PP) interventions in this population. Our objective was to describe the intervention development and pilot testing of an 8-week phone-based PP intervention for patients following an acute coronary syndrome (ACS). Initial intervention development and single-arm proof-of-concept trial, plus comparison of the PP intervention to a subsequently-recruited treatment as usual (TAU) cohort. PP development utilized existing literature, expert input, and qualitative interview data in ACS patients. In the proof-of-concept trial, the primary outcomes were feasibility and acceptability, measured by rates of exercise completion and participant ratings of exercise ease/utility. Secondary outcomes were pre-post changes in psychological outcomes and TAU comparisons, measured using effect sizes (Cohen's d ). The PP intervention and treatment manual were successfully created. In the proof-of-concept trial, 17/23 PP participants (74 %) completed at least 5 of 8 exercises. Participants rated the ease ( M = 7.4/10; SD = 2.1) and utility ( M = 8.1/10, SD = 1.6) of PP exercises highly. There were moderate pre-post improvements ( d s = .46-.69) in positive affect, anxiety, and depression, but minimal effects on dispositional optimism ( d = .08). Compared to TAU participants ( n = 22), PP participants demonstrated greater improvements in positive affect, anxiety, and depression ( d s = . 47-.71), but not optimism. A PP intervention was feasible, well-accepted, and associated with improvements in most psychological measures among cardiac patients. These results provide support for a larger trial focusing on behavioral outcomes.

  1. Two fully automated web-based interventions for risky alcohol use: randomized controlled trial.

    Science.gov (United States)

    Tensil, Marc-Dennan; Jonas, Benjamin; Strüber, Evelin

    2013-06-06

    Excessive alcohol use is a widespread problem in many countries, especially among young people. To reach more people engaging in high-risk drinking behaviors, a number of online programs have been developed in recent years. Change Your Drinking is a German, diary-based, fully automated alcohol intervention. In 2010, a revised version of the program was developed. It is more strongly oriented to concepts of relapse prevention than the previous version, includes more feedback, and offers more possibilities to interact with the program. Moreover, the program duration was extended from 10 to 14 days. This paper examines whether the revised version of Change Your Drinking is more effective in reducing alcohol consumption than the original version. The effectiveness of both program versions was compared in a Web-based, open, randomized controlled trial with follow-up surveys 6 weeks and 3 months after registration. Participants were recruited online and were randomly assigned to either the original or the revised version of Change Your Drinking. The following self-assessed outcomes were used: alcohol use days, alcohol intake in grams, the occurrence of binge drinking and risky drinking (all referring to the past 7 days prior to each survey), and the number of alcohol-related problems. A total of 595 participants were included in the trial. Follow-up rates were 58.0% after 6 weeks and 49.6% after 3 months. No significant group differences were found in any of the outcomes. However, the revised version was used by more participants (80.7%) than the original version (55.7%). A significant time effect was detected in all outcomes (alcohol use days: P=.002; alcohol intake in grams: Preducing alcohol consumption. However, differences in program usage between the versions suggest the revised version was more attractive to participants. International Standard Randomized Controlled Trial Number (ISRCTN): 31586428; http://www.controlled-trials.com/ISRCTN31586428/ (Archived by Web

  2. The Dutch Obesity Intervention in Teenagers (DOiT) cluster controlled implementation trial: intervention effects and mediators and moderators of adiposity and energy balance-related behaviours.

    Science.gov (United States)

    van Nassau, Femke; Singh, Amika S; Cerin, Ester; Salmon, Jo; van Mechelen, Willem; Brug, Johannes; Chinapaw, Mai Jm

    2014-12-24

    The Dutch Obesity Intervention in Teenagers (DOiT) programme is an evidence-based obesity prevention programme tailored to adolescents attending the first two years of prevocational education in the Netherlands. The initial programme showed promising results during an effectiveness trial. The programme was adapted and prepared for nationwide dissemination. To gain more insight into the process of translating evidence-based approaches into 'real world' (i.e., 'natural') conditions, our research aims were to evaluate the impact of the DOiT-implementation programme on adolescents' adiposity and energy balance-related behaviours during natural dissemination and to explore the mediating and moderating factors underlying the DOiT intervention effects. We conducted a cluster-controlled implementation trial with 20 voluntary intervention schools (n=1002 adolescents) and 9 comparable control schools (n = 484 adolescents). We measured adolescents' body height and weight, skinfold thicknesses, and waist circumference. We assessed adolescents' dietary and physical activity behaviours by means of self-report. Data were collected at baseline and at 20-months follow-up. We used multivariable multilevel linear or logistic regression analyses to evaluate the intervention effects and to test the hypothesised behavioural mediating factors. We checked for potential effect modification by gender, ethnicity and education level. We found no significant intervention effects on any of the adiposity measures or behavioural outcomes. Furthermore, we found no mediating effects by any of the hypothesised behavioural mediators. Stratified analyses for gender showed that the intervention was effective in reducing sugar-containing beverage consumption in girls (B = -188.2 ml/day; 95% CI = -344.0; -32.3). In boys, we found a significant positive intervention effect on breakfast frequency (B = 0.29 days/week; 95% CI = 0.01; 0.58). Stratified analyses for education level showed

  3. Using Trial-Based Functional Analysis to Design Effective Interventions for Students Diagnosed with Autism Spectrum Disorder

    Science.gov (United States)

    Larkin, Wallace; Hawkins, Renee O.; Collins, Tai

    2016-01-01

    Functional behavior assessments and function-based interventions are effective methods for addressing the challenging behaviors of children; however, traditional functional analysis has limitations that impact usability in applied settings. Trial-based functional analysis addresses concerns relating to the length of time, level of expertise…

  4. A Preliminary Randomized Controlled Trial of Multifaceted Educational Intervention for Mild Cognitive Impairment Among Elderly Malays in Kuala Lumpur

    Directory of Open Access Journals (Sweden)

    Sa’ida Munira Johari

    2014-06-01

    Conclusion: A 12-month educational intervention on nutritional, lifestyle, and cognitive exercise significantly improved nutritional status, knowledge, and attitude score. The study lacked power to demonstrate a statistically significant positive effect on cognitive functioning; thus, the preliminary findings should be confirmed in a larger trial.

  5. Progression to type 1 diabetes in islet cell antibody-positive relatives in the European Nicotinamide Diabetes Intervention Trial

    DEFF Research Database (Denmark)

    Bingley, P J; Gale, E A M; Reimers, Jesper Irving

    2006-01-01

    AIMS/HYPOTHESIS: To examine the role of additional immune, genetic and metabolic risk markers in determining risk of diabetes in islet cell antibody (ICA)-positive individuals with a family history of type 1 diabetes recruited into the European Nicotinamide Diabetes Intervention Trial. METHODS...

  6. Randomized Trial Outcomes of a TTM-Tailored Condom Use and Smoking Intervention in Urban Adolescent Females

    Science.gov (United States)

    Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.

    2015-01-01

    Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females…

  7. An Open Trial of the Anxiety Action Plan ("AxAP"): A Brief Pediatrician-Delivered Intervention for Anxious Youth

    Science.gov (United States)

    Ginsburg, Golda S.; Drake, Kelly L.; Winegrad, Heather; Fothergill, Kate; Wissow, Lawrence S.

    2016-01-01

    Background: Anxiety disorders in youth are among the most common psychiatric disorders, yet the majority of affected youth do not receive treatment. One approach to improving access to care is identification and intervention within the primary care setting. Objective: This manuscript presents data from a single group pre-post open trial of the…

  8. High School Students with Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention

    Science.gov (United States)

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G.; Fall, Anna-Mária; Schnakenberg, Jennifer B.

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state…

  9. A Randomised Controlled Trial to Determine the Effectiveness of an Early Psychological Intervention with Children Involved in Road Traffic Accidents

    Science.gov (United States)

    Stallard, Paul; Velleman, Richard; Salter, Emma; Howse, Imogen; Yule, William; Taylor, Gordon

    2006-01-01

    Objective: To determine whether an early intervention using a psychological debriefing format is effective in preventing psychological distress in child road traffic accident survivors. Design: Randomised controlled trial. Setting: Accident and Emergency Department, Royal United Hospital, Bath. Subjects: 158 children aged 7-18. Follow-up…

  10. Pre-trial Intervention: The Manhattan Court Employment Project of the Vera Institute of Justice. Final Report.

    Science.gov (United States)

    Vera Inst. of Justice, New York, NY.

    The final report of an experimental pre-trial intervention program of intensive manpower services (individual and group counseling and job, training, or academic placement with the help of career developers) for selected defendants in Manhattan covers the period November 1967 through October 1970. After three years and 1,300 participants,…

  11. A Randomized Trial Investigating the Effect of a Brief Lifestyle Intervention on Freshman-Year Weight Gain

    Science.gov (United States)

    Middleton, Kathryn R.; Perri, Michael G.

    2014-01-01

    Objective: The current study was a randomized controlled trial investigating the effect of an innovative, short-term lifestyle intervention on weight gain in female freshman college students. Participants: Ninety-five freshmen were recruited from a large public university in the United States. Methods: Participants completed baseline assessments…

  12. The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation

    OpenAIRE

    Underwood, M.; Eldridge, S.; Lamb, S.; Potter, R.; Sheehan, B.; Slowther, A.-M.; Taylor, S.; Thorogood, M.; Weich, S.

    2011-01-01

    Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs). It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to est...

  13. Which neural mechanisms mediate the effects of a parenting intervention program on parenting behavior: design of a randomized controlled trial.

    Science.gov (United States)

    Kolijn, Laura; Euser, Saskia; van den Bulk, Bianca G; Huffmeijer, Renske; van IJzendoorn, Marinus H; Bakermans-Kranenburg, Marian J

    2017-03-21

    The Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) has proven effective in increasing parental sensitivity. However, the mechanisms involved are largely unknown. In a randomized controlled trial we examine parental neurocognitive factors that may mediate the intervention effects on parenting behavior. Our aims are to (1) examine whether the intervention influences parents' neural processing of children's emotional expressions and the neural precursors of response inhibition and to (2) test whether neural changes mediate intervention effects on parenting behavior. We will test 100 mothers of 4-6 year old same-sex twins. A random half of the mothers will receive the VIPP-SD Twins (i.e. VIPP-SD adapted for twin families), consisting of 5 home visits in a 3-months period; the other half will receive a dummy intervention. Neurocognitive measures are acquired approximately 2 weeks before and 2 weeks after the intervention. Mothers' electroencephalographic (EEG) activity is measured while performing a stop signal task and in response to children's facial expressions. To obtain a complementary behavioral measure, mothers also perform an emotion recognition task. Parenting behavior will be assessed during parent-child interactions at pre and post intervention lab visits. Our results will shed light on the neurocognitive factors underlying changes in parenting behavior after a parenting support program, which may benefit the development of such programs. Dutch Trial Register: NTR5312 ; Date registered: January 3, 2017.

  14. A cluster randomized control field trial of the ABRACADABRA web-based literacy intervention: Replication and extension of basic findings.

    Directory of Open Access Journals (Sweden)

    Noella Angele Piquette

    2014-12-01

    Full Text Available The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA, an evidence-based and web-based literacy intervention (http://abralite.concordia.ca with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10-12 hours of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d = +.66, phonological blending (d = +.52, and word reading (d = +.52, over effect sizes for regular teaching. It is concluded that regular teaching with ABRA technology adds significantly to literacy in the early elementary years.

  15. A sense of security: Spouses’ experiences of participating in an orthopaedic case management intervention (the SICAM-trial)

    DEFF Research Database (Denmark)

    Bøttcher Berthelsen, Connie; Kristensson, Jimmie

    2017-01-01

    The aim of the study was to explore and describe spouses' experiences of participating in a case management intervention during older patients' fast-track programme having total hip replacement as well as which intervention elements they found useful. Data were collected through qualitative...... interviews with 10 spouses from the intervention group of the SICAM-trial, directed by predetermined codes based on elements of the intervention. Data were analysed by both authors using directed content analysis. The results showed that the spouses were very pleased about being a part of the case management...... intervention. They enjoyed being active participants even though problems sometimes occurred such as coordination difficulties between the case manager and other healthcare professionals and their feeling of being burdened. The spouses experienced the contact with the case manager as the most meaningful part...

  16. Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major

    DEFF Research Database (Denmark)

    Jakobsen, Janus Christian

    2014-01-01

    reviews. The two modern forms of psychotherapy, "third wave" cognitive therapy and mentalization-based treatment, have both gained some ground as treatments of psychiatric disorders. No randomised trial has compared the effects of these two interventions for major depressive disorder. We performed two...... (systematic error) and low risks of random errors ("play of chance") examining the effects of third wave' cognitive therapy versus mentalization-based treatment for major depressive disorder. We conducted a randomised trial according to good clinical practice examining the effects of "third wave" cognitive...... trial with low risks of bias and low risks of random errors examining the effects of "third wave" cognitive therapy versus mentalization-based therapy in a setting in the Danish healthcare system. It turned out to be much more difficult to recruit participants in the randomised trial than expected. We...

  17. Assessment of the content reporting for therapeutic exercise interventions among existing randomized controlled trials on knee osteoarthritis.

    Science.gov (United States)

    O'Neil, Jennifer; McEwen, Daniel; Del Bel, Michael J; Jo, Donguk; Thevenot, Odette; MacKiddie, Olivia S; Brosseau, Lucie

    2018-03-01

    Purpose/Rationale: Physical exercise interventions for the management of knee osteoarthritis are well known to be effective and accessible forms of rehabilitation and symptom management. However, without adequate reporting of these interventions, accurate replication and clinical use is negatively impacted. The main objective of this article was to assess content reporting using The Consensus on Exercise Reporting Template list and 2016 American College of Sports Medicine guidelines among moderate- to high-quality exercise interventions randomized controlled trials (total score of ≥6/10 on the PEDro scale) involving individuals with knee osteoarthritis. The Consensus on Exercise Reporting Template mean total score for all 47 included randomized controlled trials was 4.42 out of 19, demonstrating generally low quality of reporting. The Consensus on Exercise Reporting Template list and the 2016 American College of Sports Medicine guidelines scores were moderately correlated (based on 95% confidence interval, intraclass correlation coefficient = 0.508) for aerobic interventions only. The content analysis of exercise interventions in knee osteoarthritis demonstrated low scores for moderate- to high-quality trials. Improved standardized reporting is recommended to ensure knowledge transfer and replication of effective exercise programs for individuals with knee osteoarthritis.

  18. A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Rachel Pritchett

    2013-01-01

    Full Text Available Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child’s neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510.

  19. A Conceptual Framework for Barriers to the Recruitment and Retention of Rural CVD Participants in Behavior Intervention Trials.

    Science.gov (United States)

    Young, Lufei; Montgomery, Melody; Barnason, Sue; Schmidt, Cindy; Do, Van

    2015-08-01

    Rural residents diagnosed with cardiovascular disease (CVD) or with CVD-related risks are underrepresented in behavioral intervention trials based on an extensive review of published studies. The low participation rate of rural residents weakens both the internal and external validity of published studies. Moreover, compared to urban residents, limited research exists to describe the unique barriers that limit the participation of rural residents in behavioral intervention trials. The purpose of this review is to identify a conceptual framework (CF) underpinning common barriers faced by rural CVD patients to enroll in behavioral intervention trials. We conducted a literature review using several electronic databases to obtain a representative sample of research articles, synthesized the evidence, and developed a CF to explain the barriers that may affect the research participation rate of rural residents with CVD or related risks. We found our evidence-based CF well explained the barriers for rural CVD patients to take part in behavioral intervention trials. Besides contextual factors (i.e. patient, community and research levels), other common factors impacting rural patients' intent to enroll are lack of awareness and understanding about behavioral trials, limited support from their healthcare providers and social circles, unfavorable attitudes, and the lack of opportunity to participating research. The findings demonstrate the evidence-based model consisting of interlinked multi-level factors may help our understanding of the barriers encountered by rural CVD patients participating interventions to promote behavioral change. The implication for researchers is that identifying and developing strategies to overcome the barriers precedes conducting studies in rural communities.

  20. Poor uptake of an online intervention in a cluster randomised controlled trial of online diabetes education for rural general practitioners.

    Science.gov (United States)

    Paul, Christine L; Piterman, Leon; Shaw, Jonathan E; Kirby, Catherine; Forshaw, Kristy L; Robinson, Jennifer; Thepwongsa, Isaraporn; Sanson-Fisher, Robert W

    2017-03-23

    In Australia, rural and remote communities have high rates of diabetes-related death and hospitalisation. General practitioners (GPs) play a major role in diabetes detection and management. Education of GPs could optimise diabetes management and improve patient outcomes at a population level. The study aimed to describe the uptake of a continuing medical education intervention for rural GPs and its impact on the viability of a cluster randomised controlled trial of the effects of continuing medical education on whole-town diabetes monitoring and control. Trial design: the cluster randomised controlled trial involved towns as the unit of allocation and analysis with outcomes assessed by de-identified pathology data (not reported here). The intervention programme consisted of an online active learning module, direct electronic access to specialist advice and performance feedback. Multiple rounds of invitation were used to engage GPs with the online intervention content. Evidence-based strategies (e.g. pre-notification, rewards, incentives) were incorporated into the invitations to enrol in the programme. Recruitment to the programme was electronically monitored through the hosting software package during the study intervention period. Eleven matched pairs of towns were included in the study. There were 146 GPs in the 11 intervention towns, of whom 34 (23.3%) enrolled in the programme, and 8 (5.5%) completed the online learning module. No town had more than 10% of the resident GPs complete the learning module. There were no contacts made by GPs regarding requests for specialist advice. Consequently, the trial was discontinued. There is an ongoing need to engage primary care physicians in improving diabetes monitoring and management in rural areas. Online training options, while notionally attractive and accessible, are not likely to have high levels of uptake, even when evidence-based recruitment strategies are implemented. Australian New Zealand Clinical Trials

  1. Impact of a primary care based intervention on breast cancer knowledge, risk perception and concern: A randomized, controlled trial

    Science.gov (United States)

    Livaudais-Toman, Jennifer; Karliner, Leah S.; Tice, Jeffrey A.; Kerlikowske, Karla; Gregorich, Steven; Pérez-Stable, Eliseo J.; Pasick, Rena J.; Chen, Alice; Quinn, Jessica; Kaplan, Celia P.

    2015-01-01

    Purpose To estimate the effects of a tablet-based, breast cancer risk education intervention for use in primary care settings (BreastCARE) on patients' breast cancer knowledge, risk perception and concern. Methods From June 2011–August 2012, we enrolled women from two clinics, aged 40–74 years with no personal breast cancer history, and randomized them to the BreastCARE intervention group or to the control group. All patients completed a baseline telephone survey and risk assessment (via telephone for controls, via tablet computer in clinic waiting room prior to visit for intervention). All women were categorized as high or average risk based on the Referral Screening Tool, the Gail model or the Breast Cancer Surveillance Consortium model. Intervention patients and their physicians received an individualized risk report to discuss during the visit. All women completed a follow-up telephone survey 1–2 weeks after risk assessment. Post-test comparisons estimated differences at follow-up in breast cancer knowledge, risk perception and concern. Results 580 intervention and 655 control women completed follow-up interviews. Mean age was 56 years (SD = 9). At follow-up, 73% of controls and 71% of intervention women correctly perceived their breast cancer risk and 22% of controls and 24% of intervention women were very concerned about breast cancer. Intervention patients had greater knowledge (≥75% correct answers) of breast cancer risk factors at follow-up (24% vs. 16%; p = 0.002). In multivariable analysis, there were no differences in correct risk perception or concern, but intervention patients had greater knowledge ([OR] = 1.62; 95% [CI] = 1.19–2.23). Conclusions A simple, practical intervention involving physicians at the point of care can improve knowledge of breast cancer without increasing concern. Trial Registration ClinicalTrials.gov identifier NCT01830933. PMID:26476466

  2. Toward mHealth Brief Contact Interventions in Suicide Prevention: Case Series From the Suicide Intervention Assisted by Messages (SIAM) Randomized Controlled Trial.

    Science.gov (United States)

    Berrouiguet, Sofian; Larsen, Mark Erik; Mesmeur, Catherine; Gravey, Michel; Billot, Romain; Walter, Michel; Lemey, Christophe; Lenca, Philippe

    2018-01-10

    Research indicates that maintaining contact either via letter or postcard with at-risk adults following discharge from care services after a suicide attempt (SA) can reduce reattempt risk. Pilot studies have demonstrated that interventions using mobile health (mHealth) technologies are feasible in a suicide prevention setting. The aim of this study was to report three cases of patients recruited in the Suicide Intervention Assisted by Messages (SIAM) study to describe how a mobile intervention may influence follow-up. SIAM is a 2-year, multicenter randomized controlled trial conducted by the Brest University Hospital, France. Participants in the intervention group receive SIAM text messages 48 hours after discharge, then at day 8 and day 15, and months 1, 2, 3, 4, 5, and 6. The study includes participants aged 18 years or older, who have attended a participating hospital for an SA, and have been discharged from the emergency department (ED) or a psychiatric unit (PU) for a stay of less than 7 days. Eligible participants are randomized between the SIAM intervention messages and a control group. In this study, we present three cases from the ongoing SIAM study that demonstrate the capability of a mobile-based brief contact intervention for triggering patient-initiated contact with a crisis support team at various time points throughout the mobile-based follow-up period. Out of the 244 patients recruited in the SIAM randomized controlled trial, three cases were selected to illustrate the impact of mHealth on suicide risk management. Participants initiated contact with the emergency crisis support service after receiving text messages up to 6 months following discharge from the hospital. Contact was initiated immediately following receipt of a text message or up to 6 days following a message. This text message-based brief contact intervention has demonstrated the potential to reconnect suicidal individuals with crisis support services while they are experiencing

  3. The Healthy Toddlers Trial Protocol: An Intervention to Reduce Risk Factors for Childhood Obesity in Economically and Educationally Disadvantaged Populations

    Directory of Open Access Journals (Sweden)

    Auld Garry

    2011-07-01

    Full Text Available Abstract Background The number of overweight children in America has doubled to an estimated 10 million in the past 20 years. Establishing healthy dietary behaviors must begin early in childhood and include parents. The Healthy Toddlers intervention focuses on promoting healthy eating habits in 1- to 3-year-old children utilizing the Social Cognitive Theory and a learner-centered approach using Adult Learning principles. This Healthy Toddlers Trial aims to determine the efficacy of a community-based randomized controlled trial of an in-home intervention with economically and educationally disadvantaged mothers of toddlers. The intervention focuses on: (a promoting healthy eating behaviors in toddlers while dietary habits are forming; and (b providing initial evidence for the potential of Healthy Toddlers as a feasible intervention within existing community-based programs. Methods/Design This describes the study protocol for a randomized control trial, a multi-state project in Colorado, Michigan, and Wisconsin with economically and educationally disadvantaged mother-toddler dyads; toddlers are between 12 and 36 months. The Healthy Toddlers intervention consists of eight in-home lessons and four reinforcement telephone contacts, focusing on fruit, vegetable, and sweetened beverage consumption and parental behaviors, taught by paraprofessional instructors. Healthy Toddlers uses a randomized, experimental, short-term longitudinal design with intervention and control groups. In-home data collection (anthropometric measurements, feeding observations, questionnaires, 3-day dietary records occurs at baseline, immediately following the intervention, and 6 months after the intervention. Main toddler outcomes include: a increased fruit and vegetable consumption and decreased sweetened beverage consumption; and b improved toddler-eating skills (self-feeding and self-serving. Main parent outcomes include: a improved psychosocial attributes (knowledge

  4. Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Wilkinson, Esther L; O'Mahen, Heather A; Fearon, Pasco; Halligan, Sarah; King, Dorothy X; Greenfield, Geva; Dunkley-Bent, Jacqueline; Ericksen, Jennifer; Milgrom, Jeannette; Ramchandani, Paul G

    2016-03-22

    National guidelines in the UK, United States of America, Canada, and Australia have recently stressed the importance of identifying and treating antenatal anxiety and depression. However, there is little research into the most effective and acceptable ways of helping women manage their symptoms of anxiety and stress during pregnancy. Research indicates the necessity to consider the unique needs and concerns of perinatal populations to ensure treatment engagement, highlighting the need to develop specialised treatments which could be integrated within routine antenatal healthcare services. This trial aims to develop a brief intervention for antenatal anxiety, with a focus on embedding the delivery of the treatment within routine antenatal care. This study is a two-phase feasibility trial. In phase 1 we will develop and pilot a brief intervention for antenatal anxiety, blended with group support, to be led by midwives. This intervention will draw on cognitive behavioural principles and wider learning from existing interventions that have been used to reduce anxiety in expectant mothers. The intervention will then be tested in a pilot randomised controlled trial in phase 2. The following outcomes will be assessed: (1) number of participants meeting eligibility criteria, (2) number of participants consenting to the study, (3) number of participants randomised, (4) number of sessions completed by those in the intervention arm, and (5) number of participants completing the post-intervention outcome measures. Secondary outcomes comprise: detailed feedback on acceptability, which will guide further development of the intervention; and outcome data on symptoms of maternal and paternal anxiety and depression, maternal quality of life, quality of couple relationship, mother-child bonding, infant temperament and infant sleep. The study will provide important data to inform the design of a future full-scale randomised controlled trial of a brief intervention for anxiety during

  5. [Gold standards for scientific proof of efficacy and effectiveness as prerequisites for the dissemination of intervention programs in the field of early intervention. Randomized controlled trials].

    Science.gov (United States)

    Lengning, A

    2010-10-01

    The necessity of early intervention is recognized both nationally and internationally. This however goes hand in hand with the legitimate request for proving the efficacy and effectiveness of prevention and intervention programs. There are many international studies on this. Some of these exhibit a number of problems, which often restricts the validity of the studies' results. A scientific evaluation of programs in Germany, on the other hand, is often missing entirely or the studies and evaluations are currently in progress. The article at hand using the example of the randomized controlled trial (RCT) gives an overview of which gold standards of evaluation are desirable or should be scientifically demanded to prove efficacy and effectiveness of prevention/intervention in the field of early intervention. Standards for efficacy refer to 1) specification of the program's efficacy, 2) program documentation, 3) evaluating the quality of how the program was carried out, 4) recording and evaluating expected changes, as well as 5) conclusions concerning the causality of results and generalizations. Standards for efficiency refer to 1) description of the intervention, 2) evaluation in real-life contexts and 3) cost-benefit analysis. Based on a presentation of these standards, recommendations are made for the dissemination of prevention and intervention programs.

  6. A School Support Intervention and Educational Outcomes Among Orphaned Adolescents: Results of a Cluster Randomized Controlled Trial in Kenya.

    Science.gov (United States)

    Cho, Hyunsan; Catherine Ryberg, Renee; Hwang, Karam; Pearce, Lisa D; Iritani, Bonita J

    2017-11-01

    Globally, significant progress has been made in primary school enrollment. However, there are millions of adolescents-including orphans in sub-Saharan Africa-who still experience barriers to remaining in school. We conducted a 4-year cluster randomized controlled trial (cRCT) (N = 835) in a high HIV prevalence area in western Kenya to test whether providing orphaned adolescents with a school support intervention improves their educational outcomes. The school support intervention consisted of directly paying tuition, exam fees, and uniform costs to primary and secondary schools for those students who remained enrolled. In addition, research staff monitored intervention participants' school attendance and helped to address barriers to staying in school. This school support intervention had significant positive impacts on educational outcomes for orphaned adolescents. Over the course of the study, school absence remained stable for intervention group participants but increased in frequency for control group participants. Intervention group participants were less likely to drop out of school compared to the control group. Furthermore, the intervention participants were more likely to make age-appropriate progression in grade, matriculate into secondary school, and achieve higher levels of education by the end of the study. The intervention also increased students' expectations of graduating from college in the future. However, we found no significant intervention impact on primary and secondary school test scores. Results from this cRCT suggest that directly covering school-related expenses for male and female orphaned adolescents in western Kenya can improve their educational outcomes.

  7. Effects of a short behavioural intervention for dental flossing: randomized-controlled trial on planning when, where and how.

    Science.gov (United States)

    Schüz, Benjamin; Wiedemann, Amelie U; Mallach, Natalie; Scholz, Urte

    2009-06-01

    Regular dental flossing has been widely recommended to prevent periodontal diseases. Nevertheless, compliance is below a desirable level. This study evaluates the effects of a brief behavioural intervention on dental flossing and determines whether the effects of such an intervention are stronger in a specific subgroup of individuals (those intending to floss regularly=implemental mindset). Behavioural intervention (planning when, where and how to floss) trial was conducting with 194 participants assigned to an intervention or a control group by a random time schedule; the primary outcome was validated self-report of flossing behaviour. Follow-up data were collected 2 and 8 weeks post-intervention. Individuals receiving the planning intervention significantly outperformed those in the control condition at both the 2- and the 8-week follow-up (4.24 times flossing/week versus 3.9 at 2 weeks; 4.02 versus 2.98 at 8 weeks). Intervention effects were stronger in individuals in the implemental mindset. Dropout rates were higher for participants who received the planning intervention but were not in the implemental mindset. Planning interventions are an economic and effective way to change oral self-care behaviour, and are more effective in individuals in an implemental mindset.

  8. Telephone-delivered psychoeducational intervention for Hong Kong Chinese dementia caregivers: a single-blinded randomized controlled trial.

    Science.gov (United States)

    Kwok, Timothy; Wong, Bel; Ip, Isaac; Chui, Kenny; Young, Daniel; Ho, Florence

    2013-01-01

    Many family caregivers of persons with dementia (PWD) are unable to participate in community center-based caregiver support services because of logistical constraints. This study evaluated the effectiveness of a telephone-delivered psychoeducational intervention for family caregivers of PWD in alleviating caregiver burden and enhancing caregiving self-efficacy. In a single-blinded randomized controlled trial, 38 family caregivers of PWD were randomly allocated into an intervention group or a control group. The intervention group received psychoeducation from a registered social worker over the phone for 12 sessions. Caregivers in the control group were given a DVD containing educational information about dementia caregiving. Outcomes of the intervention were measured by the Chinese versions of the Zarit Burden Interview and the Revised Scale for Caregiving Self-efficacy. Mann-Whitney U tests were used to compare the differences between the intervention and control groups. The level of burden of caregivers in the intervention group reduced significantly compared with caregivers in the control group. Caregivers in the intervention group also reported significantly more gain in self-efficacy in obtaining respite than the control group. A structured telephone intervention can benefit dementia caregivers in terms of self-efficacy and caregiving burden. The limitations of the research and recommendations for intervention are discussed.

  9. Walk Well: a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol.

    Science.gov (United States)

    Mitchell, Fiona; Melville, Craig; Stalker, Kirsten; Matthews, Lynsay; McConnachie, Alex; Murray, Heather; Walker, Andrew; Mutrie, Nanette

    2013-07-01

    Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme.A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities. ISRCTN50494254.

  10. A benefit-finding intervention for family caregivers of persons with Alzheimer disease: study protocol of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cheng Sheung-Tak

    2012-07-01

    Full Text Available Abstract Background Caregivers of relatives with Alzheimer’s disease are highly stressed and at risk for physical and psychiatric conditions. Interventions are usually focused on providing caregivers with knowledge of dementia, skills, and/or support, to help them cope with the stress. This model, though true to a certain extent, ignores how caregiver stress is construed in the first place. Besides burden, caregivers also report rewards, uplifts, and gains, such as a sense of purpose and personal growth. Finding benefits through positive reappraisal may offset the effect of caregiving on caregiver outcomes. Design Two randomized controlled trials are planned. They are essentially the same except that Trial 1 is a cluster trial (that is, randomization based on groups of participants whereas in Trial 2, randomization is based on individuals. Participants are randomized into three groups - benefit finding, psychoeducation, and simpli