Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial

Ahern, A. L. et al. (2020) Clinical and cost-effectiveness of a diabetes education and behavioural weight management programme versus a diabetes education programme in adults with a recent diagnosis of type 2 diabetes: study protocol for the Glucose Lowering through Weight management (GLoW) randomised controlled trial. BMJ Open, 10(4), e035020. (doi: 10.1136/bmjopen-2019-035020) (PMID:32350016) (PMCID:PMC7213851)

Abstract

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/m2 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.

• Item Type: Articles
• Additional Information: This study is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research Programme (Reference Number RP-PG-0216-20010). The tailored diabetes education and behavioural weight management programme (Live Well With Diabetes) is provided by WW (formerly Weight Watchers) free of charge for the purposes of this trial. ALA, SS and SJG are supported by the Medical Research Council (grant MC_UU_12015/4).
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Lawlor, Dr Emma
• Authors: Ahern, A. L., Woolston, J., Wells, E., Sharp, S. J., Islam, N., Lawlor, E. R., Duschinsky, R., Hill, A. J., Doble, B., Wilson, E., Morris, S., Hughes, C. A., Brennan, A., Bostock, J., Boothby, C., and Griffin, S. J.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: BMJ Open
• Publisher: BMJ Publishing Group
• ISSN: 2044-6055
• ISSN (Online): 2044-6055
• Published Online: 28 April 2020
• Copyright Holders: Copyright © Author(s) (or their employer(s)) 2020
• First Published: First published in BMJ Open 10(4):e035020
• Publisher Policy: Reproduced under a Creative Commons licence