Ahern, AL, Richards, R, Jones, RA et al. (13 more authors) (2022) Acceptability and feasibility of an acceptance and commitment therapy-based guided self-help intervention for weight loss maintenance in adults who have previously completed a behavioural weight loss programme: the SWiM feasibility study protocol. BMJ Open, 12 (4). e058103. ISSN 2044-6055
Abstract
Introduction The cost-effectiveness and long-term health impact of behavioural weight management programmes depends on post-treatment weight-loss maintenance. Growing evidence suggests that interventions using acceptance and commitment therapy (ACT) could improve long-term weight management. We developed an ACT-based, guided self-help intervention to support adults who have recently completed a behavioural weight loss programme. This study will assess the feasibility and acceptability of this type of intervention and findings will inform the development of a full-scale trial.
Methods and analysis This is a pragmatic, randomised, single-blind, parallel group, two-arm, feasibility study with an embedded process evaluation. We will recruit and randomise 60 adults who have recently completed a behavioural weight loss programme to the ACT-based intervention or standard care, using a computer-generated sequence with 2:1 allocation stratified by diabetes status and sex. Baseline and 6-month measurements will be completed using online questionnaires. Qualitative interviews will be conducted with a subsample of participants and coaches about their experiences at 3 (mid-intervention) and 6 (postintervention) months. Feasibility and acceptability of the intervention, and a full-scale trial will be assessed using a number of outcomes, including adherence to, and engagement with the intervention, recruitment and retention rates, proportion of missing data for each outcome measure, participants’ experiences of the intervention and study, and coaches’ experiences of delivering intervention support. Quantitative and qualitative findings will be integrated and summarised to contribute to the interpretation of the main feasibility evaluation findings. Value of information methods will be used to estimate the decision uncertainty associated with the intervention’s cost-effectiveness and determine the value of a definitive trial.
Ethics and dissemination Ethical approval was received from Cambridge South Research Ethics Committee on 15/03/2021 (21/EE/0024). This protocol (V.2) was approved on 19 April 2021. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate.
Trial registration number ISRCTN12685964.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. |
Keywords: | Information technology; Telemedicine; diabetes & endocrinology; Acceptance and Commitment Therapy; Adult; Feasibility Studies; Humans; Pragmatic Clinical Trials as Topic; Randomized Controlled Trials as Topic; Single-Blind Method; Weight Loss; Weight Reduction Programs |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Health Sciences (Leeds) > Academic Unit of Psychiatry and Behavioural Sciences (Leeds) |
Funding Information: | Funder Grant number NIHR National Inst Health Research Not Known |
Depositing User: | Symplectic Publications |
Date Deposited: | 11 May 2022 14:23 |
Last Modified: | 11 May 2022 14:23 |
Status: | Published |
Publisher: | BMJ Publishing Group |
Identification Number: | 10.1136/bmjopen-2021-058103 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:186627 |