Article Text
Abstract
Introduction Previous trials finding an effect of self-monitoring on weight loss have considered the effect to be mediated by self-regulatory processes. However, a qualitative think-aloud study asking people to record thoughts and feelings during weighing showed that self-regulation occurs only rarely without further instruction. The aim of this trial is to test a novel intervention guiding people through the self-regulatory processes to see whether it facilitates weight loss.
Methods and analyses A parallel group, randomised controlled trial will be conducted to test the concept that a self-regulation intervention for weight loss increases weight loss compared with daily self-weighing without further support. One hundred participants with a body mass index ≥30 kg/m2 will be randomised to either the control or intervention group. The control group will be asked to weigh themselves daily for 8 weeks, the intervention group will be encouraged to follow the self-regulation intervention. They will be prompted to weigh daily, track their weight using an app, plan daily actions for weight loss and reflect on their action plans on a weekly basis. This self-regulation cycle will allow them to experiment with different weight loss strategies and identify effective and sustainable actions. Primary and process outcomes will be measured at baseline and 8 weeks’ follow-up. Linear regression analysis of the primary outcome, weight change, will assess the early effectiveness of the intervention. The process outcomes liking, perceived effectiveness, as well as usage and barriers with regard to the self-regulation intervention, will be assessed through qualitative analysis of follow-up interviews and quantitative analysis of adherence rates and responses to a final questionnaire.
Ethics and dissemination This trial was reviewed and approved by the NHS National Research Ethics Committee and the Health Research Authority (reference number: 18/SC/0482). The findings of the trial will be published in peer reviewed journals and presented at conferences.
Trial registration number ISRCTN14148239, prerecruitment.
Protocol version Version 1.1, 7 December 2018.
- self-regulation
- self-monitoring
- self-experimentation
- weight loss
- obesity
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Footnotes
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Contributors KF, JHB, SJ and PA contributed to the design of the intervention and this study. KF led the preparation of the trial. All authors commented and worked on this paper. The sponsor has reviewed all participant-facing documents as part of the ethics application.
Funding This research is funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford (CLAHRC) at Oxford Health NHS Foundation Trust. KF’s time on this project is funded by NIHR CLAHRC Oxford at Oxford Health NHS Foundation Trust, Wolfson College, University of Oxford (Oxford-Wolfson Marriott-Primary Care Graduate Scholarship), and NIHR School for Primary Care Research (NIHR SPCR). JHB’s, SJ’s and PA’s time on this project is funded by the NIHR Oxford Biomedical Research Centre (BRC) and Oxford CLAHRC. PA and SJ are NIHR senior investigators.
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, the Wellcome Trust or the Department of Health and Social Care. The sponsor is not involved in the collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication of the study.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This trial was reviewed and approved by the NHS National Research Ethics Committee and the Health Research Authority (reference number: 18/SC/0482).
Provenance and peer review Not commissioned; externally peer reviewed.