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  • 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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Public health
Protocol
Study protocol for the ‘HelpMeDoIt!’ randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity
  1. Lynsay Matthews1,
  2. Juliana Pugmire1,
  3. Laurence Moore1,
  4. Mark Kelson2,
  5. Alex McConnachie3,
  6. Emma McIntosh4,
  7. Sarah Morgan-Trimmer5,
  8. Simon Murphy6,
  9. Kathryn Hughes7,
  10. Elinor Coulman8,
  11. Olga Utkina-Macaskill1,
  12. Sharon Anne Simpson1
  1. 1 MRC/CSO Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
  2. 2 College of Engineering, Mathematics, and Physical Sciences, Data Science Institute, University of Exeter, Exeter, UK
  3. 3 Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
  4. 4 Health Economics and Health Technology Assessment Unit (HEHTA), Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK
  5. 5 Psychology Applied to Health (PAtH) Group, Institute of Health Research, University of Exeter Medical School, Exeter, UK
  6. 6 Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), Cardiff University, Cardiff School of Social Sciences, Cardiff, UK
  7. 7 Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK
  8. 8 Centre for Trials Research (CTR), School of Medicine, Cardiff University, Cardiff, UK
  1. Correspondence to Dr Lynsay Matthews; Lynsay.Matthews{at}glasgow.ac.uk

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.

  • randomised controlled trials
  • feasibility trials
  • behaviour change intervention
  • weight loss
  • digital health
  • social support

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

https://doi.org/10.1136/bmjopen-2017-017159

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    Footnotes

    • Contributors LM is trial manager and responsible for coordinating the HelpMeDoIt! study. LM was involved in finalising the study protocol, implementing study processes and drafting the manuscript. JP was involved in finalising the study protocol, in particular the Social Network Analysis methods and qualitative analyses, and reviewing the manuscript. OU is trial administrator and was involved in finalising the study protocol, in particular in relation to intervention content, and reviewing the manuscript. LMo, EC, KH, SM, was involved in finalising the study protocol and reviewing the manuscript. MK was involved in finalising the study protocol, in particular the statistical considerations, and reviewing the manuscript. SMT were involved in finalising the study protocol, in particular the process evaluation methods, and reviewing the manuscript. AM was involved in finalising the study protocol, in particular the statistical analyses, and reviewing the manuscript. EM was involved in finalising the study protocol, in particular the health economics analysis, and reviewing the manuscript. SS is principal investigator and responsible for overall management of the HelpMeDoIt! study. She led the design of the intervention, the development and finalisation of the protocol and reviewed the manuscript.

    • Funding This work was supported by the National Institute of Health Research (Public Health Research Programme grant number 12/180/20). Additional time on the study was supported by UK Medical Research Council and Chief Scientist Office core funding as part of the MRC/CSO Social and Public Health Sciences Unit ‘Social Relationships and Health Improvement’ programme (MC_UU_12017/11 and SPHSU11) and ‘Complexity in Health Improvement’ programme (MC_UU_12017/14 and SPHSU14). SS was supported by MRC Strategic Award MC_PC_13027.

    • Competing interests None declared.

    • Ethics approval West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108)

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement None.