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

Matthews, L. et al. (2017) Study protocol for the ‘HelpMeDoIt!’ randomised controlled feasibility trial: an app, web and social support based weight loss intervention for adults with obesity. BMJ Open, 7(10), e017159. (doi:10.1136/bmjopen-2017-017159) (PMID:29074513) (PMCID:PMC5665248)

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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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McConnachie, Dr Alex and Utkina-Macaskill, Mrs Olga and McIntosh, Professor Emma and Matthews, Dr Lynsay and Moore, Professor Laurence and Pugmire, Dr Juliana and Simpson, Professor Sharon
Authors: Matthews, L., Pugmire, J., Moore, L., Kelson, M., McConnachie, A., McIntosh, E., Morgan-Trimmer, S., Murphy, S., Hughes, K., Coulman, E., Utkina-Macaskill, O., and Simpson, S. A.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > MRC/CSO Unit
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:BMJ Open
Publisher:BMJ Publishing Group
ISSN:2044-6055
ISSN (Online):2044-6055
Published Online:25 October 2017
Copyright Holders:Copyright © 2017 The Authors
First Published:First published in BMJ Open 7(10): e017159
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
649131'Helpmedoit!' a web and text based intervention to facilitate social support to achieve and maintain health related behaviour changeSharon SimpsonNational Institute for Health Research (NIHR)12/180/20IHW - MRC/CSO SPHU
727631SPHSU Core Renewal: Relationships & Health Improvement Research ProgrammeLisa McDaidMedical Research Council (MRC)MC_UU_12017/11IHW - MRC/CSO SPHU
727661SPHSU Core Renewal: Complexity in Health Improvement Research ProgrammeLaurence MooreMedical Research Council (MRC)MC_UU_12017/14IHW - MRC/CSO SPHU
620221MRC SPHSU/GU Transfer FellowshipsLaurence MooreMedical Research Council (MRC)MC_PC_13027IHW - MRC/CSO SPHU