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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.)

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., Competing Interests: Competing interests: ALA is principal investigator on another publicly funded trial where JW provided the intervention at no cost but has received no personal fees. SG reports grants from Medical Research Council, personal fees from Eli Lilly and personal fees from Janssen, outside this programme of research. AH reports personal fees from Slimming World and the College of Contemporary Health, outside this programme of research. CH reports informal unpaid advice to Thriva., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Introduction: On average, aspects of mental health improve following behavioural weight management programmes, yet this is not the case for all participants. It is important to identify those at risk of harm to provide more effective psychological support. We aimed to identify participant characteristics associated with changes in depression and anxiety in participants of a behavioural weight management programme., Methods: In the Weight loss Referrals for Adults in Primary care trial, 1,267 adults with body mass index ≥28 kg/m2 were randomized to brief intervention, or WW (formerly weight watchers) for 12-weeks or 52-weeks and followed for 5 years. We used linear and multinomial regression to explore the association between participant characteristics and changes in depression and anxiety (measured by the hospital anxiety and depression scale). Where possible, the impact of missing data was investigated using multiple imputation., Results: Higher baseline anxiety was associated with decreases in anxiety symptoms and increases in depression symptoms from baseline to follow-up. Higher baseline depression was associated with decreases in depression symptoms and increases in anxiety symptoms from baseline to follow-up. The magnitude of the associations was small. No further characteristics were consistently associated with changes in mental health., Discussion: Evidence suggests that baseline depression and anxiety may indicate how depression and anxiety symptoms change during and after attending WW. Measurement of depression and anxiety at the start of a behavioural weight management programme and subsequent monitoring may facilitate timely psychological support if a deterioration in mental health is identified. Further research in large and diverse participant samples is required to clarify the findings., (© 2022 The Author(s). Published by S. Karger AG, Basel.)

Background: Low attendance and engagement in behavioural weight management trials are common. Mental health may play an important role, however previous research exploring this association is limited with inconsistent findings. We aimed to investigate whether mental health was associated with attendance and engagement in a trial of behavioural weight management programmes., Methods: This is a secondary data analysis of the Weight loss referrals for adults in primary care (WRAP) trial, which randomised 1267 adults with overweight or obesity to brief intervention, WW (formerly Weight Watchers) for 12-weeks, or WW for 52-weeks. We used regression analyses to assess the association of baseline mental health (depression and anxiety (by Hospital Anxiety and Depression Scale), quality of life (by EQ5D), satisfaction with life (by Satisfaction with Life Questionnaire)) with programme attendance and engagement in WW groups, and trial attendance in all randomised groups., Results: Every one unit of baseline depression score was associated with a 1% relative reduction in rate of WW session attendance in the first 12 weeks (Incidence rate ratio [IRR] 0.99; 95% CI 0.98, 0.999). Higher baseline anxiety was associated with 4% lower odds to report high engagement with WW digital tools (Odds ratio [OR] 0.96; 95% CI 0.94, 0.99). Every one unit of global quality of life was associated with 69% lower odds of reporting high engagement with the WW mobile app (OR 0.31; 95% CI 0.15, 0.64). Greater symptoms of depression and anxiety and lower satisfaction with life at baseline were consistently associated with lower odds of attending study visits at 3-, 12-, 24-, and 60-months., Conclusions: Participants were less likely to attend programme sessions, engage with resources, and attend study assessments when reporting poorer baseline mental health. Differences in attendance and engagement were small, however changes may still have a meaningful effect on programme effectiveness and trial completion. Future research should investigate strategies to maximise attendance and engagement in those reporting poorer mental health., Trial Registration: The original trial ( ISRCTN82857232 ) and five year follow up ( ISRCTN64986150 ) were prospectively registered with Current Controlled Trials on 15/10/2012 and 01/02/2018., (© 2021. The Author(s).)

While many behavioural weight management programmes are effective in the short-term, post-programme weight regain is common. Overcoming "lapses" and preventing "relapse" has been highlighted as important in weight-loss maintenance, but little is known on how this is achieved. This study aimed to compare the cognitive and behavioural strategies employed to overcome "lapses" and prevent "relapse" by people who had regained weight or maintained weight-loss after participating in a weight management programme. By investigating differences between groups, we intended to identify strategies associated with better weight-loss maintenance. Semi-structured interviews were conducted with 26 participants (58% female) recruited from the 5-year follow-up of the Weight Loss Referrals for Adults in Primary Care (WRAP) trial (evaluation of a commercial weight-loss programme). Participants who had lost ≥5% baseline weight during the active intervention were purposively sampled according to 5-year weight trajectories (n = 16 'Regainers', n = 10 'Maintainers'). Interviews were audio-recorded, transcribed verbatim, and analysed thematically. Key differences in strategies were that Maintainers continued to pay attention to their dietary intake, anticipated and planned for potential lapses in high-risk situations, and managed impulses using distraction techniques. Regainers did not report making plans, used relaxed dietary monitoring, found distraction techniques to be ineffective and appeared to have difficulty navigating food within interpersonal relationships. This study is one of the longest qualitative follow-ups of a weight loss trial to date, offering unique insights into long-term maintenance. Future programmes should emphasize strategies focusing on self-monitoring, planning and managing interpersonal relationships to help participants successfully maintain weight-loss in the longer-term., (© 2020 The Authors. Clinical Obesity published by John Wiley & Sons Ltd on behalf of World Obesity Federation.)

Introduction: People with type 2 diabetes (T2D) can improve glycaemic control or even achieve remission through weight loss and reduce their use of medication and risk of cardiovascular disease. The Glucose Lowering through Weight management (GLoW) trial will evaluate whether a tailored diabetes education and behavioural weight management programme (DEW) is more effective and cost-effective than a diabetes education (DE) programme in helping people with overweight or obesity and a recent diagnosis of T2D to lower their blood glucose, lose weight and improve other markers of cardiovascular risk., Methods and Analysis: This study is a pragmatic, randomised, single-blind, parallel group, two-arm, superiority trial. We will recruit 576 adults with body mass index>25 kg/m 2 and diagnosis of T2D in the past 3 years and randomise them to a tailored DEW or a DE programme. Participants will attend measurement appointments at a local general practitioner practice or research centre at baseline, 6 and 12 months. The primary outcome is 12-month change in glycated haemoglobin. The effect of the intervention on the primary outcome will be estimated and tested using a linear regression model (analysis of covariance) including randomisation group and adjusted for baseline value of the outcome and the randomisation stratifiers. Participants will be included in the group to which they were randomised, under the intention-to-treat principle. Secondary outcomes include 6-month and 12-month changes in body weight, body fat percentage, systolic and diastolic blood pressure and lipid profile; probability of achieving good glycaemic control; probability of achieving remission from diabetes; probability of losing 5% and 10% body weight and modelled cardiovascular risk (UKPDS). An intention-to-treat within-trial cost-effectiveness analysis will be conducted from NHS and societal perspectives using participant-level data. Qualitative interviews will be conducted with participants to understand why and how the programme achieved its results and how participants manage their weight after the programme ends., Ethics and Dissemination: Ethical approval was received from East of Scotland Research Ethics Service on 15 May 2018 (18/ES/0048). This protocol (V.3) was approved on 19 June 2019. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate., Trial Registration Number: ISRCTN18399564., Competing Interests: Competing interests: ALA is principal investigator on another publically funded trial where WW provided the intervention at no cost but has received no personal fees. SJG reports grants from Medical Research Council, personal fees from Eli Lilly and personal fees from Janssen, outside this programme of research. AH reports personal fees from Slimming World and the College of Contemporary Health, outside this programme of research. CH reports informal unpaid advice to Thriva. Other Investigators report no conflicts of interest., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)