A pilot randomised trial of group versus individual education for obese adults with type 2 insulin dependent diabetes

Background: Studies of group versus individual education for T2DM have shown favourable outcomes but evidence to support group-based education for patients affected by obesity and T2DM is scant. Methods: A parallel-group, randomised pilot trial was designed to determine the feasibility and acceptability of group-based education compared to individualised (usual care) education for patients affected by obesity, and T2DM requiring insulin. Adults (>18 years, N = 51) completing the ‘Living Healthy with Diabetes’ education program in a specialist bariatric service, with a body mass index (BMI) of greater than 35 kg/m² and T2DM requiring more than 1u/kg/day of insulin were invited to participate. Program delivery was one-on-one (Control, n = 25) or in group sessions (Intervention, n = 26), face-to-face in clinic, or via telehealth during COVID-19 lockdowns. Feasibility endpoint measures were recruitment, protocol adherence, participation rates, and engagement. Secondary endpoints were depression and anxiety, quality of life, sleepiness, body weight, diabetes distress score, metabolic parameters, and daily insulin dose. Results: Protocol adherence and participation rates indicate group sessions were feasible and acceptable. There were no group differences in anthropometric or biochemical baseline measures, 12-month follow-up was complete. Both groups reduced and sustained weight loss with significant within-group improvements in diabetes distress score and daily dose of Insulin. Improvements in health-related quality of life were evident within and between groups but there was no evidence to indicate a difference in the effectiveness of the two educational approaches on weight loss. Conclusions: Group-based education is feasible and acceptable but efficacy in achieving superior outcomes compared to individual education needs further investigation. Optimising nurse-led education delivery methods could enhance intervention effectiveness for patients affected by obesity and T2DM.