Dataset Information

Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

ABSTRACT:

Introduction

HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s).

Aim

To test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals.

Methods and analysis

12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)> 30?kg/m² and smartphone users. The intervention group will use the app/website for 12?months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12?months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention.

Ethics and dissemination

The protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations.

Trial registration number

ISRCTN85615983.

SUBMITTER: Matthews L

PROVIDER: S-EPMC5665248 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

Matthews Lynsay L Pugmire Juliana J Moore Laurence L Kelson Mark M McConnachie Alex A McIntosh Emma E Morgan-Trimmer Sarah S Murphy Simon S Hughes Kathryn K Coulman Elinor E Utkina-Macaskill Olga O Simpson Sharon Anne SA

BMJ open 20171025 10

<h4>Introduction</h4>HelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite 'helpers' from their social circle to help them achieve their goal(s).<h4>Aim</h4>To test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals ...[more]

PMID: 29074513

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Project description:Background:Social support has an important role in successful weight loss. The aim of this study was to assess the feasibility and acceptability of an app-, web- and social support-based intervention in supporting adults with obesity to achieve weight loss. Methods:The intervention and evaluation methods were tested in a feasibility randomised controlled trial. Adults in the Greater Glasgow and Clyde Health Board area of Scotland with a body mass index ??30?kg/m2 were recruited and randomised 2:1 (intervention to control). The feasibility and acceptability of the intervention and trial methods were assessed against pre-specified progression criteria, via process, economic and outcome evaluation. Three primary outcomes were explored: BMI, diet and physical activity, as well as a number of secondary outcomes. The intervention group had access to the HelpMeDoIt! intervention for 12?months. This encouraged them to (i) set goals, (ii) monitor progress and (iii) harness social support by inviting 'helpers' from their existing social network. The control group received a healthy lifestyle leaflet. Results:One hundred and nine participants were recruited, with 84 participants (77%) followed-up at 12?months. The intervention and trial methods were feasible and acceptable. Participants and helpers were generally positive. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it. Interview data indicated that HelpMeDoIt! promoted social support from existing social networks to support weight loss. This support was often given outside of the app.Outcomes were compared using linear regression models, with randomised group, the baseline measurement of the outcome, age and gender as predictor variables. These analyses were exploratory and underpowered to detect effects. However, all pre-specified primary outcome effects (BMI, diet and physical activity) had wide confidence intervals and were therefore consistent with clinically relevant benefits. Objective physical activity measures perhaps showed most potential (daily step count (p = 0.098; 1187 steps [-?180, 2555])) and sedentary time (p = 0.022; -?60.8?min [-?110.5, -?11.0]). However, these outcomes were poorly completed. Conclusions:The study demonstrated that a novel social support intervention involving support from participants' close social networks, delivered via app and website, has potential to promote weight loss and is feasible and acceptable. Trial registration:ISRCTN, ISRCTN85615983. Registered 25 September 2014.

Project description:BackgroundBy 2022, it is estimated that the rate of female obesity (78%) in Saudi Arabia will almost double that of males (41%). Despite being mainly attributed to poor diet, sedentary lifestyle, and a lack of health awareness, behavioral modification interventions are relatively new to the population; bariatric surgery continues to be the treatment of choice for comorbidities. However, neither pre nor postoperative diet and exercise are promoted. Evidence-informed mobile health (mHealth) weight loss apps and interventions may be an effective tool for delivering a culturally relevant intervention.ObjectiveThis study aimed to determine the feasibility of a weight loss intervention that tests the effectiveness of Twazon, an originally designed Arabic weight-loss app that promotes lifestyle modification specific to Arab populations.MethodsA pre-post single-arm pilot study was carried out among a sample of 240 overweight volunteer Saudi women residing in Riyadh, Saudi Arabia who used the Twazon app over a 4-month period. Anthropometric, diet, and physical activity measures were assessed 3 times: baseline, 2-months and 4-months; frequency of app use and system usability were evaluated during the 2 latter data collection periods. Repeated measures analysis of variance was used to identify changes over time.ResultsA total of 40 participants completed the 4-month intervention with an attrition rate of 83%. An evaluation of the frequency of app use fostered 2 groups: engaged users (65%) and unengaged users (35%). At 4 months, the engaged users experienced more successful outcomes; body weight was lowered on average by 1.3 (SD 0.6) kg (P=.18), waist circumference (WC) was reduced by 4.9 (SD 1.1) cm (P<.001), and daily energy consumption was decreased by >600 calories (P=.002). Unengaged users experienced minor changes in body weight, WC, and reduced energy intake.ConclusionsThe findings have demonstrated that engagement with the Twazon app renders positive changes in body weight, WC, and energy intake. mHealth weight loss apps and interventions have the potential to be effective in promoting weight loss and healthy lifestyle modification in Saudi Arabia and similar populations.

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Dataset Information

Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

Introduction

Aim

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Study protocol for the 'HelpMeDoIt!' randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity.

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