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<0·001) and these improvements remained even after a 1-year follow-up period post intervention. The risk of suboptimal A1c (≥7·0% or 53 mmol/mol) was also significantly lower in three intervention groups than control group at each follow-up visit, with adjusted risk ratios (RR) ranging from 0.06 to 0.16. However, the control group has greater reductions in low-density lipoprotein (LDL) than the health literacy group from baseline to 12-months (β=0·55, p<0·0001) and from baseline to 24-months (β=0·62, p<0·0001). A higher risk of abnormal LDL was also observed for the health literacy group at 12-months [adjusted risk ratio (RR): 2·22, 95%CI: 1·11-4·44] and 24-months [adjusted risk ratio (RR): 2·37, 95%CI: 1·16-4·87] compared to the control group. No significant benefits in systolic blood pressure (SBP), diastolic blood pressure (DBP) and low-density lipoprotein (HDL) were observed from the interventions compared to the usual care. INTERPRETATION: The health literacy and exercise interventions result in significant improvements in A1c. However, no significant benefits in blood pressure and lipids control were observed. These effective interventions may have potential of scaling up in China and other countries to help diabetes patients manage their blood glucose levels. FUNDING: This Study was supported by the China Medical Board (CMB) Open Competition Project (No.13-159) and the Social Science Fund of China National Ministry of Education (No.14YJAZH092).