Document is current

Article History

Received: 18 July 2024

Accepted: 29 October 2024

First Online: 23 January 2025

Acknowledgements

: We thank all staff from the MRC Epidemiology Unit Functional Group Team, particularly with regard to study coordination, anthropometry measurement, physical activity measurement, laboratory sample collection and analysis, data management, IT, business operations and research governance. We thank NIHR CRN Eastern Primary Care research delivery colleagues, regional primary care stakeholders and Cambridgeshire and Peterborough CCG Research Team for their input to the protocol and operational aspects of the study. Thank you for the support of our Trial Steering Committee (L. Yardley, A. Farmer, E. Doherty, T. Fanshawe, G. Rhodes, H. Patel and N. Scullion). We would also like to thank our patient user panel (F. Amrani, H. Anderson, R. Bentley, R. Clifton, T. Morris, G. Pountain, I. Smith, N. Timmings, M. Willis) for all their input to the trial, and also all the GLoW participants for taking part. WW provided the intervention for this trial at no cost but had no role in the design, data collection, data analysis, data interpretation or writing of the report. Some of the data were presented as an abstract at the 52nd Annual Scientific Meeting of the SAPC, Bristol, July 2024, at Obesity Week in Dallas, November 2023, and at the Diabetes UK Professional Conference in London, April 2024.

: The dataset analysed during the current study is not publicly available. Participant consent allows for data to be shared in future analyses with appropriate ethical approval, and the host institution has an access policy () so that interested parties can obtain the data for replication or other research purposes that are ethically approved. Data access is available upon reasonable request (datasharing@mrc-epid.cam.ac.uk) and the data dictionary is available at . Study documents (study protocol, statistical analysis plan, informed consent form, participant information sheet, analytic code) are available at or on request. The fully executable code, simulated individuals and simulated parameters used to conduct the economic analyses are available under a GPL version 2 or later licence at:

: This work was supported by the National Institute for Health and Care Research (NIHR) under its Programme Grants for Applied Research Programme (RP-PG-0216-20010), the Medical Research Council (MC_UU_00006/6) and the NIHR Cambridge Biomedical Research Centre (NIHR203312). The views expressed are those of the authors and not necessarily those of the MRC, NIHR or the Department of Health and Social Care. The University of Cambridge has received salary support in respect of SJG from the NHS in the East of England through the Clinical Academic Reserve. The funders of the study had no role in the design, data collection, data analysis, data interpretation, or writing of the report.

: All authors have completed the Unified Competing Interest form (available on request from the corresponding author) and declare: FF, FW, PB, KP, JW, EL, MS, RD, SJS, SM, NI, SEB, CEB, NI, AB and JB declare that there are no relationships or activities that might bias, or be perceived to bias, their work. AJH has consulted for Slimming World UK. CAH reports consulting fees, payment or honoraria or support for attending meetings and/or travel from Ethicon and Novo Nordisk. JM is a former Trustee and current member of the Operations Committee for the Association of the Study of Obesity (unpaid role) and has organised educational events funded by Boehringer Ingelheim Ltd and Rhythm Pharmaceuticals. Since the completion of the trial analyses, RAJ has commenced employment for WW. ALA is a member of the Scientific Advisory Board for WW (payment to institution). SJG has received honoraria from Astra Zeneca and Eli Lilly for contributing to postgraduate educational meetings and is a Trustee for the Novo Nordisk UK Research Foundation. DP worked on the Hypo-RESOLVE project, which received in kind support from Novo Nordisk, Eli Lilly, Sanofi, Abbott and Medtronic, and has received personal payments from Novo Nordisk.

: ALA led the conceptualisation and design of the study, led funding acquisition and is the principal investigator of the trial. SJG is joint principal investigator and contributed to the conceptualisation and design of the study and co-led funding acquisition. AJH, CAH, PB, SM, AB and RD are co-investigators on the trial and contributed to study design and conceptualisation and funding acquisition. JM, PB, KP, FF and SM performed the data analyses. JM, PB, ALA, SM and FF wrote the first draft of the manuscript. FW, RAJ, JW, EL and MS were responsible for trial operations and management. SJS supervised the data analysis (clinical effectiveness). NI contributed to the analysis and interpretation of data. JB chaired the Patient and Public Involvement group. SEB and DP contributed to code development and development of the analysis plan for the lifetime cost effectiveness analysis. CEB was responsible for data curation and management. All authors provided critical review for intellectual content before submission and approved the final manuscript. ALA is the guarantor.