Ahern AL, Breeze P, Fusco F, Sharp SJ, Islam N, Wheeler GM, Hill AJ, Hughes CA, Duschinsky R, Thomas C, Bates S, Woolston J, Stubbings M, Whittle F, Boothby C, Bostock J, Jebb S, Aveyard P, Boyland E, Halford JCG, Morris S, Brennan A, and Griffin SJ
Background: There is evidence that commercially available behavioural weight management programmes can lead to short-term weight loss and reductions in glycaemia. Here, we aimed to provide the 5-year impact and cost-effectiveness of these interventions compared with a brief intervention., Methods: WRAP was a non-blinded, parallel-group randomised controlled trial (RCT). We recruited from primary care practices in England and randomly assigned participants to one of three interventions (brief intervention, 12-week open-group behavioural programme [WW, formerly Weight Watchers], or a 52-week open-group WW behavioural programme) in an uneven (2:5:5) allocation. Participants were followed up 5 years after randomisation using data from measurement visits at primary care practices or a research centre, review of primary care electronic medical notes, and self-report questionnaires. The primary outcome was change in weight at 5 years follow-up, assessed using analysis of covariance. We also estimated cost-effectiveness of the intervention. This study is registered at Current Controlled Trials, ISRCTN64986150., Findings: Between Oct 18, 2012, and Feb 10, 2014, we recruited 1269 eligible participants (two participants were randomly assigned but not eligible and therefore excluded) and 1040 (82%) consented to be approached about additional follow-up and to have their medical notes reviewed at 5 years. The primary outcome (weight) was ascertained for 871 (69%) of 1267 eligible participants. Mean duration of follow-up was 5·1 (SD 0·3) years. Mean weight change from baseline to 5 years was -0·46 (SD 8·31) kg in the brief intervention group, -1·95 (9·55) kg in the 12-week programme group, and -2·67 (9·81) kg in the 52-week programme. The adjusted difference in weight change was -1·76 (95% CI -3·68 to 0·17) kg between the 52-week programme and the brief intervention; -0·80 (-2·13 to 0·54) kg between the 52-week and the 12-week programme; and -0·96 (-2·90 to 0·97) kg between the 12-week programme and the brief intervention. During the trial, the 12-week programme incurred the lowest cost and produced the highest quality-adjusted life-years (QALY). Simulations beyond 5 years suggested that the 52-week programme would deliver the highest QALYs at the lowest cost and would be the most cost-effective. No participants reported adverse events related to the intervention., Interpretation: Although the difference in weight change between groups was not statistically significant, some weight loss was maintained at 5 years after an open-group behavioural weight management programme. Health economic modelling suggests that this could have important implications to reduce the incidence of weight-related disease and these interventions might be cost-saving., Funding: The UK National Institute for Health and Care Research Programme Grants for Applied Research and the Medical Research Council., Competing Interests: Declaration of interests ALA reports research grants from the UK National Institute for Health and Care Research (NIHR), UK Medical Research Council (MRC) and the European Association for the Study of Obesity and membership of the Scientific Advisory Board for WW (all payments to her institution). PB reports research grants to her institution from NIHR and consultancy fees from Genomics. NI reports grants from the UK Office for National Statistics, Canadian Institutes of Health Research, Health Data Research UK, and NIHR; is an advisory board member of the WHO-UN Technical Advisory Board, The BMJ Research Forum and BMJ Medicine; and has received consultancy fees and payments from The BMJ. GMW reports grants from MRC and Innovate UK; has received payment from AstraZeneca and support for meeting attendance from Eli Lilly; and is a committee member of the NIHR Statistics Group Early Stage Trials Section, UK National Cancer Research Institute Teenage and Young Adult and Germ Cell Therapies subgroup, and the MRC Experimental Medicine Funding Panel. AJH reports grants to his institution from NIHR and payment for advice from Slimming World. CAH reports consultancy fees from Novo Nordisk; payments or honoraria for presentations; manuscript writing or educational events from Novo Nordisk, Ethicon, Alva Health and International Medical Press; and is an Advisory Board Member for Novo Nordisk. RD reports research grants from NIHR and the Wellcome Trust. SB reports research grants from the Wellcome Trust and NIHR; consultancy fees from the UK Office for Health Improvement and Disparities and Dark Peak Analytics; and is on the Editorial Board of the Journal of Medical Decision Making. SJ has received grants from NIHR and is Chair of the UK Food Standards Agency. PA reports research grants to his institution from NIHR, British Heart Foundation and Nestle Life Sciences, and materials or services from Nestle Life Sciences. EB reports grants to her institution from NIHR, Public Health England, and WHO, and consultancy fees from WHO. JCGH has received grants from Novo Nordisk and the American Beverage Association; consulting fees from Novo Nordisk, Dupont, Boheim Inhelheim, and Mars; support for meeting attendance from Novo Nordisk; and is an Advisory Board Member for Dupont (all payments to his institution). SM and AB report grant funding to their institution from NIHR. SJG reports grants to his institution from NIHR and MRC; consultancy fees to his institution from Genomics; payments for educational events from AstraZeneca; and unpaid membership of the Board of Trustees for the Novo Nordisk UK Research Foundation. FF, SJS CC, CT, JW, MS, FW, and CB report no competing interests beyond funding to their institutions for the current project., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)