Abstract
AIMS/HYPOTHESIS: UK standard care for type 2 diabetes is structured diabetes education, with no effects on HbA(1c), small, short-term effects on weight and low uptake. We evaluated whether remotely delivered tailored diabetes education combined with commercial behavioural weight management is cost-effective compared with current standard care in helping people with type 2 diabetes to lower their blood glucose, lose weight, achieve remission and improve cardiovascular risk factors. METHODS: We conducted a pragmatic, randomised, parallel two-group trial. Participants were adults (≥18 years) with overweight or obesity (BMI≥25 kg/m(2)) and recently diagnosed with type 2 diabetes (≤3 years), recruited from 159 primary care practices in England. We randomised participants to a tailored diabetes education and behavioural weight management programme (DEW; delivered by Weight Watchers) or to current standard care diabetes education (DE; Diabetes Education and Self Management for Ongoing and Newly Diagnosed [DESMOND] programme), using a computer-generated randomisation sequence in a 1:1 allocation stratified by gender and diabetes duration, unknown to those collecting and analysing the data. Participants could not be blinded due to the nature of the interventions. Participants completed assessments at 0, 6 and 12 months. The primary outcome was 12 month change from baseline in HbA(1c). We also assessed bodyweight, blood pressure, cholesterol (total, HDL, LDL), glucose-lowering medication, behavioural measures (physical activity, food intake), psychosocial measures (eating behaviour, diabetes-related quality of life, wellbeing) and within-trial and modelled lifetime cost effectiveness. RESULTS: We randomised 577 participants (DEW: 289, DE: 288); 398 (69%) completed 12 month follow-up. We found no evidence for an intervention effect on change in HbA(1c) from baseline to 12 months (difference: -0.84 [95% CI -2.99, 1.31] mmol/mol, p=0.44) or 6 months (-1.83 [-4.05, 0.40] mmol/mol). We found an intervention effect on weight at 6 (-1.77 [-2.86, -0.67] kg) and 12 months (-1.38 [-2.56, -0.19] kg). Participants in DEW had a higher likelihood of achieving diabetes remission than participants in DE (6 months: RR 2.10 [95% CI 1.03, 4.47]; 12 months: RR 2.53 [1.30, 5.16]). DEW was cost-effective compared with DE in within-trial and lifetime analyses, in the latter generating an incremental cost effectiveness ratio of £2290 per quality-adjusted life year gained. CONCLUSIONS/INTERPRETATION: A commercial behavioural weight management programme combined with remote dietary counselling after diagnosis of type 2 diabetes did not improve HbA(1c) up to 12 months post intervention in this trial. The intervention could help people achieve weight loss and be cost-effective compared with current standard National Health Service care. TRIAL REGISTRATION: ISRCTN 18399564 FUNDING: National Institute for Health and Care Research (NIHR; RP-PG-0216-20010), Medical Research Council (MC_UU_00006/6), NIHR Cambridge Biomedical Research Centre (NIHR203312).