Health Literacy and Exercise-Focused Interventions on Clinical Measurements in Chinese Diabetes Patients: A Cluster Randomized Controlled Trial

Background: The diabetes patients in China have low health literacy and low levels of physical activities which may result in the poor glycemic control and other clinical outcomes. This study is designed to evaluate the effectiveness of health literacy and exercise-focused interventions on clinical outcomes among Chinese patients with type 2 diabetes (T2DM). Methods: In this cluster randomized controlled trial, 799 T2DM patients with the most recent A1c ≥ 7·5% (58 mmol/mol, or fasting glucose level ≥10 mmol/L) were recruited from 35 clinics in 8 communities in Shanghai, China, and randomized into one standard care (control) arm and three intervention arms receiving interventions focused on health literacy, exercise or both. A1c (primary outcome), blood pressure and lipids (secondary outcomes) were measured at baseline, 3-, 6-, 12-months of intervention period and 12-months after completion of the interventions. This trial is registered with the International Standard RCT Number Register, number ISRCTN76130594. Findings: The three intervention groups had more reductions in A1c than the control group, with 0·90% reduction in the health literacy, 0·83% in the exercise and 0·54% in the comprehensive group at 12-months (p