Résumé
Objective: To evaluate the effect of health literacy and exercise-focused interventions on glycemic control in patients with type 2 diabetes (T2DM) in China. Methods: In this cluster randomized controlled trial, a total of 799 T2DM patients with most recent hemoglobin A1c (HbA1c) ≥ 7.5% (or fasting plasma glucose level ≥10 mmol/L) were recruited from 8 communities in Minhang and Changning districts of Shanghai, and randomized into a health literacy intervention group, an exercise intervention group, a comprehensive intervention group and a control group. After baseline survey and examination, a one-year intervention and 3 times (at 3(rd), 6(th), and 12(th) month) follow-up surveys were conducted. Results: The follow-up rates for all the subjects were 99.4%, 98.4% and 95.2%, respectively, at 3(rd), 6(th) and 12(th) month. Patients in intervention groups were more likely to achieve a goal HbA1c level (HbA1c <7.0%) than those in control group, with the highest glycemic control rate (25.3%) observed in comprehensive intervention group at 3(rd) month and then in exercise intervention group (25.3% and 34.6%) respectively, at 6(th) month and 12(th) month. The average levels of HbA1c in three intervention groups were lower at each follow-up time point than those at baseline survey. However, the decreases in HbA1c were obvious only at 6(th) month (P<0.001), with ls-mean (95%CI) of -0.48% (-0.71%, -0.25%), -0.33% (-0.55%, -0.11%) and -0.70% (-0.92%, -0.48%), respectively, in comprehensive, health literacy and exercise intervention groups, but it increased slightly by 0.03% (-0.19%, 0.25%) in control group. Compared with control group, the interventions were significantly associated with the decrease of HbA1c level, with the most improvement observed in comprehensive group (β=-0.47, 95% CI: -0.73, -0.20) at 3(rd) month, and in exercise intervention group at 6(th) month (β=-0.73, 95%CI: -0.98, -0.47) and at 12(th) month (β=-0.75, 95%CI: -1.05, -0.45) of follow-up. Stratified analyses showed that patients with lower health literacy level could benefit from any intervention, while those with higher numeracy skill benefited more from exercise intervention. Conclusion: Both health literacy and exercise-focused interventions may decrease HbA1c level in patients with T2DM, which would be helpful in reducing the risks of complications and deaths in diabetes patients.