The effect of individual and mixed rewards on diabetes management: A feasibility randomized controlled trial [version 3; referees: 2 approved]

Background: Incentives play a role in introducing health-related benefits, but no interventions using mixed incentives, i.e. a combination of individual and group incentives, have been tested in individuals with type 2 diabetes mellitus (T2DM). We evaluated the feasibility of implementing individual- and mixed-incentives, with and without a supportive partner, on glycated haemoglobin (HbA1c) control and weight loss among patients with T2DM. Methods: This is a feasibility, sex-stratified, single-blinded, randomized controlled study in individuals with T2DM. All participants received diabetes education and tailored goal setting for weight and glycated haemoglobin (HbA1c). Participants were randomly assigned into three arms: individual incentives (Arm 1), mixed incentives-altruism (Arm 2), and mixed incentives-cooperation (Arm 3). Participants were accompanied by a diabetes educator every other week to monitor targets, and the intervention period lasted 3 months. The primary outcome was the change in HbA1c at 3 months from baseline. Weight and change body mass index (BMI) were considered as secondary outcomes. Results: Out of 783 patients screened, a total of 54 participants, 18 per study arm, were enrolled and 44 (82%) completed the 3-month follow-up. Mean baseline HbA1c values were 8.5%, 7.9% and 8.2% in Arm 1, Arm 2, and Arm 3, respectively. At 3 months, participants in all three study arms showed reductions in HbA1c ranging from -0.9% in Arm 2 to -1.4% in Arm 1. Weight and BMI also showed reductions. Conclusions: Individual and mixed cash incentives show important reductions in HbA1c, weight and BMI in patients with type 2 diabetes mellitus after 3 months. Recruitment and uptake of the intervention were successfully accomplished demonstrating feasibility to conduct larger effectiveness studies to test individual and mixed economic incentives for diabetes management. Registration: ClinicalTrials.gov Identifier NCT0289138