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En_Linea. An online treatment to change lifestyle in overweight and obesity: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Obesity has become a major public health problem. Innovative treatments are necessary. Internet and new technologies have been reported effective results in weight control programs, especially those with personalized feedback. This paper presents the protocol for a randomized controlled trial to test the effectiveness of an online weight control program, called en_línea, comparing with a standard group therapy and a control group. METHODS:This is a randomized controlled trial with three intervention arms: en_línea, standard group therapy and control group. To perform this study, 305 adults (18-65?years) with overweight type II (27-29.9?kg/m2) or obesity type I (30-34.9?kg/m2) will be invited to participate. Interventions will last 17?weeks with follow-ups 1, 3, 6 and 12?months after the post-treatment appointment. The primary outcome will be post-treatment weight loss and the maintenance during the follow-ups. Secondary outcomes will be adherence rates, drop outs and quality of life. Participants will be assessed before randomization and they will be sign an inform consent. DISCUSSION:The future challenge is to design innovative obesity treatments. Internet could be a useful tool to improve traditional weight control programs. This new intervention format is appropriate for patients who prefer not to share their intimate problems with a group, and for the new generations who feel comfortable using new technologies. Besides, Internet allows reaching a large amount of people at the same time, even if they live far away. TRIAL REGISTRATION:ClinicalTrials.gov NCT04127201. Retrospectively registered 15th October 2019.

SUBMITTER: Varela C

PROVIDER: S-EPMC6873678 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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En_Línea. An online treatment to change lifestyle in overweight and obesity: study protocol for a randomized controlled trial.

Varela Carmen C Saldaña Carmina C

BMC public health 20191121 1

<h4>Background</h4>Obesity has become a major public health problem. Innovative treatments are necessary. Internet and new technologies have been reported effective results in weight control programs, especially those with personalized feedback. This paper presents the protocol for a randomized controlled trial to test the effectiveness of an online weight control program, called en_línea, comparing with a standard group therapy and a control group.<h4>Methods</h4>This is a randomized controlled ...[more]

PMID: 31752815

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Project description:Preventive and educational programs directed to former elite athletes in the areas of healthy living are required. This is particularly relevant as obesity and health-related problems are observed in retired athletes, especially in those whose current levels of physical activity are below the recommendations. During their sports career, elite athletes are supported by a multidisciplinary team; upon retirement, no support is provided for the transition to a different lifestyle. So far, no program has been implemented to promote sustained healthy lifestyle behaviors in the post-career transition and evidence is lacking for such an intervention. Firstly, we aim to determine if Champ4life, a 1-year lifestyle intervention targeting inactive former athletes with overweight and obesity, is effective for reducing total and abdominal fat. Secondly, our purpose is to assess the effectiveness of the intervention on the levels of physical activity and sedentary behavior, resting energy expenditure, cardio-metabolic markers, physical fitness, energy balance components, eating self-regulation markers, and quality of life over 12 months. Champ4life is an evidence- and theory-based program using a randomized control trial design (intervention vs. control group) that will be conducted on 94 inactive former elite athletes with overweight and obesity. The first four months of the Champ4Life program include a nutritional appointment and 12 weekly, 90-min sessions. Classroom sessions seek to provide participants with key information and a toolbox of behavior change techniques to initiate and sustain long-term lifestyle changes. Participants will undergo baseline, 4-month, and 12-month measurements of body composition (primary outcomes), resting energy expenditure, physical fitness, metabolic markers, energy balance related-markers, and quality of life (secondary outcome). This trial will provide evidence on the effectiveness of the Champ4life program, a pioneer lifestyle intervention for retired athletes, offering tools for sustained changes in physical activity, sedentary behavior and diet, aiming to improve body composition and overall health-related markers.

Project description:BackgroundThe effect of computer- or human-delivered personalized feedback on the effectivess of web-based behavior change platforms for weight loss is unclear.ObjectiveWe aimed to compare the effectiveness of a web-based behavior change intervention personalized through either computerized or human-delivered feedback with a nonpersonalized intervention in promoting weight loss in community-based adults with overweight or obesity.MethodsThis pragmatic, 3-group, parallel-arm, randomized trial recruited students and staff in a Brazilian public university who were aged 18 to 60 years, had a BMI of ≥25 kg/m2, and were not pregnant. Participants were allocated to one of 3 groups: platform only (24-week behavior change program delivered using a web platform with personalized computer-delivered feedback), platform plus coaching (same 24-week web-based behavior change program plus 12 weeks of personalized feedback delivered online by a dietitian), or waiting list (nonpersonalized dietary and physical activity recommendations delivered through an e-booklet and videos). Self-reported weight at 24 weeks was the primary outcome. Changes in dietary and physical activity habits within 24 weeks were secondary outcomes.ResultsAmong the 1298 participants, 375 (28.89%) were lost to follow-up. In the intention-to-treat analysis, the platform-only and platform plus coaching groups had greater mean weight loss than the waiting-list group at 24 weeks (-1.08 kg, 95% CI -1.41 to -0.75 vs -1.57 kg, 95% CI -1.92 to -1.22 vs -0.66 kg, 95% CI -0.98 to -0.34, respectively). The platform-only and platform plus coaching groups, compared with the waiting list group, had a greater increase in the consumption of vegetables (3%, 95% CI 1% to 6% vs 5%, 95% CI 2% to 8% vs -3%, 95% CI -5% to 0%) and fruits (9%, 95% CI 6% to 12% vs 6%, 95% CI 2% to 9% vs 2%, 95% CI 0% to 6%) and a larger reduction in ultraprocessed food intake (-18%, 95% CI -23% to -13% vs -25%, 95% CI -30% to -20% vs -12%, 95% CI -16% to -8%). Changes in physical activity did not differ across the groups. Engagement was higher in the platform plus coaching group than in the platform-only group (7.6 vs 5.2 completed sessions; P=.007). Longer usage of the platform was associated with clinically meaningful (≥5%) weight loss (odds ratio 1.02, 95% CI 1.01 to 1.04).ConclusionsThe web-based behavior change programs with computer- and human-delivered personalized feedback led to greater, albeit small-magnitude, weight loss within 24 weeks. Improvement in multiple dietary habits, but not physical activity, were also greater in the personalized programs compared with the nonpersonalized one. The human-delivered personalized feedback by the online dietitian coach increased user engagement with the program and was associated with a significantly higher chance of clinically meaningful weight loss.Trial registrationClinicalTrials.gov NCT03435445; https://clinicaltrials.gov/ct2/show/NCT03435445.International registered report identifier (irrid)RR2-10.2196/10.1186/s12889-018-5882-y.

Project description:BackgroundThe nutrigenomics, overweight/obesity and weight management trial (NOW Trial) is a pragmatic randomized controlled trial of community-dwelling adults recruited from the Group Lifestyle Balance™ (GLB™) Program. The GLB™ Program (formerly referred to as the Diabetes Prevention Program) is an evidence-based, intensive weight management program, which was offered to overweight/obese patients (BMI ≥ 25.0 kg/m2) in a rural Ontario community.MethodsPatients enrolled in the GLB™ Program were invited to participate in this study. GLB™ groups were randomized 1:1 to receive either the standard GLB™ program + population-based lifestyle advice for weight management, or a modified GLB™ program + personalized, genetic-based lifestyle advice for weight management. The purpose of this study is to determine if the provision of genetic-based lifestyle guidelines is superior to the provision of population-based guidelines in a pragmatic clinical setting to promote changes in: body composition, weight, body mass index, dietary and physical activity habits, as well as attitudes, subjective norms, and behavioural control. The 12-month intervention protocol consists of 23 group-based sessions and 4 one-on-one sessions. Data collection time points include baseline in addition to 3, 6, and 12-month follow up. The comprehensive study design is described in the present manuscript, using both the extended CONSORT checklist for reporting pragmatic trials and the SPIRIT checklist as guidance during manuscript development.DiscussionOverall, this study seeks to pragmatically determine if the provision of DNA-based lifestyle advice leads to improved health and lifestyle outcomes compared to the provision of standard, population-based lifestyle advice. The results of this trial can be used to inform clinical and community nutrition practice guidelines.Trial registrationThis study was registered with clinicaltrials.gov : NCT03015012 on January 9, 2017.

Project description:BackgroundAim2Be is a gamified lifestyle app designed to promote lifestyle behavior changes among Canadian adolescents and their families.ObjectiveThe primary aim was to test the efficacy of the Aim2Be app with support from a live coach to reduce weight outcomes (BMI Z score [zBMI]) and improve lifestyle behaviors among adolescents with overweight and obesity and their parents versus a waitlist control group over 3 months. The secondary aim was to compare health trajectories among waitlist control participants over 6 months (before and after receiving access to the app), assess whether support from a live coach enhanced intervention impact, and evaluate whether the app use influenced changes among intervention participants.MethodsA 2-arm parallel randomized controlled trial was conducted from November 2018 to June 2020. Adolescents aged 10 to 17 years with overweight or obesity and their parents were randomized into an intervention group (Aim2Be with a live coach for 6 months) or a waitlist control group (Aim2Be with no live coach; accessed after 3 months). Adolescents' assessments at baseline and at 3 and 6 months included measured height and weight, 24-hour dietary recalls, and daily step counts measured with a Fitbit. Data on self-reported physical activity, screen time, fruit and vegetable intake, and sugary beverage intake of adolescents and parents were also collected.ResultsA total of 214 parent-child participants were randomized. In our primary analyses, there were no significant differences in zBMI or any of the health behaviors between the intervention and control groups at 3 months. In our secondary analyses, among waitlist control participants, zBMI (P=.02), discretionary calories (P=.03), and physical activity outside of school (P=.001) declined, whereas daily screen time increased (P<.001) after receiving access to the app compared with before receiving app access. Adolescents randomized to Aim2Be with live coaching reported more time being active outside of school compared with adolescents who used Aim2Be with no coaching over 3 months (P=.001). App use did not modify any changes in outcomes among adolescents in the intervention group.ConclusionsThe Aim2Be intervention did not improve zBMI and lifestyle behaviors in adolescents with overweight and obesity compared with the waitlist control group over 3 months. Future studies should explore the potential mediators of changes in zBMI and lifestyle behaviors as well as predictors of engagement.Trial registrationClinicalTrials.gov NCT03651284; https://clinicaltrials.gov/ct2/show/study/NCT03651284.International registered report identifier (irrid)RR2-10.1186/s13063-020-4080-2.

Project description:BACKGROUND:The prevalence of overweight and obesity remains high in Canada, and the current standard for the treatment of childhood obesity is in-person, family-based, multidisciplinary interventions that target lifestyle behaviors (e.g., diet, physical activity, and sedentary behaviors). These programs are costly to operate, have limited success, and report recruitment and retention challenges. With recent advances in technology, mobile health or mHealth has been presented as a viable alternative to in-person interventions for behavior change, especially with teens. PURPOSE:The primary aim of this study is to test the efficacy of Aim2Be, a gamified app based on behavior change theory with health coaching to improve weight outcomes (i.e., decrease in standardized body mass index (zBMI)) and lifestyle behaviors (i.e., improve dietary quality, increase fruit and vegetable intake, reduce sugar-sweetened beverage intake, increase physical activity, and reduce screen time) among children 10- to 17-years old with overweight or obesity versus their peers randomized into a waitlist control condition. The secondary aims of this study are to 1) test whether supplementing the Aim2Be program with health coaching increases adherence and 2) examine the mediators and moderators of adherence to the Aim2Be intervention. METHODS:We will employ a randomized controlled trial design and recruit 200 child and parent dyads to participate in the study (2019-2020). Participants will be recruited from Canadian pediatric weight management clinics and through online advertisements. Child participants must be between the ages of 10 and 17 years, have overweight or obesity, be able to read English at least at a grade 5 level, and have a mobile phone or home computer with internet access. Following baseline data collection, participants will be randomized into intervention and waitlist control groups. Intervention participants will receive access to Aim2Be, with access to health coaching. After having their data collected for 3 months, the control group will gain access to Aim2Be, with no access to health coaching. Participants will control their frequency and duration of app usage to promote autonomy. DISCUSSION:Findings from this study will determine the efficacy of using Aim2Be in improving child weight outcomes and lifestyle behaviors and guide future mHealth interventions for pediatric weight management. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03651284. Registered 29 August 2018.

Project description:BACKGROUND:Online social networks may be a promising modality to deliver lifestyle interventions by reducing cost and burden. Although online social networks have been integrated as one component of multimodality lifestyle interventions, no randomized trials to date have compared a lifestyle intervention delivered entirely via online social network with a traditional clinic-delivered intervention. OBJECTIVE:This paper describes the design and methods of a noninferiority randomized controlled trial, testing (1) whether a lifestyle intervention delivered entirely through an online social network would produce weight loss that would not be appreciably worse than that induced by a traditional clinic-based lifestyle intervention among overweight and obese adults and (2) whether the former would do so at a lower cost. METHODS:Adults with body mass index (BMI) between 27 and 45 kg/m2 (N=328) will be recruited from the communities in central Massachusetts. These overweight or obese adults will be randomized to two conditions: a lifestyle intervention delivered entirely via the online social network Twitter (Get Social condition) and an in-person group-based lifestyle intervention (Traditional condition) among overweight and obese adults. Measures will be obtained at baseline, 6 months, and 12 months after randomization. The primary noninferiority outcome is percentage weight loss at 12 months. Secondary noninferiority outcomes include dietary intake and moderate intensity physical activity at 12 months. Our secondary aim is to compare the conditions on cost. Exploratory outcomes include treatment retention, acceptability, and burden. Finally, we will explore predictors of weight loss in the online social network condition. RESULTS:The final wave of data collection is expected to conclude in June 2019. Data analysis will take place in the months following and is expected to be complete in September 2019. CONCLUSIONS:Findings will extend the literature by revealing whether delivering a lifestyle intervention via an online social network is an effective alternative to the traditional modality of clinic visits, given the former might be more scalable and feasible to implement in settings that cannot support clinic-based models. TRIAL REGISTRATION:ClinicalTrials.gov NCT02646618; https://clinicaltrials.gov/ct2/show/NCT02646618 (Archived by WebCite at http://www.webcitation.org/6v20waTFW).

Project description:BACKGROUND:Obesity is a major health problem in Brazil affecting 19% of Brazilian adults with a rising incidence over the last 10 years. Moreover, low fruit/vegetables consumption and high sweetened beverage intake are major issues. Facing the challenge of universal healthcare access, internet-based programs have the potential to reach a large number of inhabitants, be widely accessible and cost effective. Our aim is to to assess the efficacy of a web-based platform to promote weight loss and diet and physical activity habits change in a Brazilian adult population. METHODS:We designed a three-arm parallel randomized controlled trial including 18-60 years university students or employees with 25 kg/m2 minimum body mass index (BMI). Pregnancy, conditions with specific dietary requirements and participation in other weight loss programs are exclusion criteria. Participants are allocated to one of three groups: (1) waitlist with minimal intervention, (2) web-based platform, (3) web-based platform plus online dietician assistance. Assessors are blinded. Weight and BMI loss are the primary outcomes. Diet and physical activity behaviours, health perception and online activity features are secondary outcomes. The intervention comprises recommendations of diet and physical activity habits tailored to the Brazilian population and principles of behaviour change. The web-based platform has online social network and gamification features. Analysis will be on an intention-to-treat basis at 12 and 24 weeks after baseline. Differences in weight loss between groups will be performed by analysis of covariate. Linear regression will be used to assess whether treatment group allocation is an independent predictor of weight loss. The study was approved by the Federal University of Minas Gerais (UFMG) Ethics Research Committee. All participants signed an informed consent form prior to recruitment. DISCUSSION:We present the study protocol of a three arm parallel randomized controlled trial which aims to test the efficacy of an online platform to promote weight loss for adults with overweight and obesity. We anticipate that the adoption of healthy lifestyle habits and weight loss will be more important in participants randomized to the online platform group. TRIAL REGISTRATION:NCT03435445 on February 16th, 2018.

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En_Linea. An online treatment to change lifestyle in overweight and obesity: study protocol for a randomized controlled trial.

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En_Línea. An online treatment to change lifestyle in overweight and obesity: study protocol for a randomized controlled trial.

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