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, Pugmire, Juliana, Moore, Laurence, Kelson, Mark, McConnachie, Alex, McIntosh, Emma, Morgan-Trimmer, Sarah, Murphy, Simon ORCID: https://orcid.org/0000-0003-3589-3681, Hughes, Kathryn ORCID: https://orcid.org/0000-0002-8099-066X, Coulman, Elinor, Utkina-Macaskill, Olga and Simpson, Sharon Anne 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. 10.1136/bmjopen-2017-017159

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Abstract

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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Centre for Trials Research (CNTRR) Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer) Medicine Social Sciences (Includes Criminology and Education)
Publisher:	BMJ Publishing Group
ISSN:	2044-6055
Funders:	NIHR-PHR additional funding from MRC/CSO
Date of First Compliant Deposit:	26 October 2017
Date of Acceptance:	4 August 2017
Last Modified:	05 May 2023 10:11
URI:	https://orca.cardiff.ac.uk/id/eprint/105960

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