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.
目的： 评估健康素养及运动干预降低2型糖尿病（T2DM）患者血糖水平的效果。 方法： 以上海市闵行区和长宁区799名最近一次糖化血红蛋白（HbA1c）≥ 7.5%（或FPG≥10 mmol/L）的T2DM患者为研究对象，采用整群随机分组方法分为健康素养干预组、运动干预组、综合干预组（健康素养+运动干预）和对照组，每组各约200人。基线调查、身体测量及生化检测完成后，各干预组分别接受为期1年的干预。第3、6和12个月时，对所有患者进行问卷调查随访、身体测量和HbA1c检测。 结果： 3、6和12个月时患者的总应答率分别为99.4%、98.4%和95.2%。干预满3个月时，综合干预组HbA1c达标率（HbA1c<7.0%）最高，为25.3%，6和12个月时运动干预组达标率最高，分别为25.3%和34.6%。与基线时相比，各干预组HbA1c值在不同随访时段均有下降，以6个月时最明显，综合干预组平均下降0.48%（95%CI：-0.71%~-0.25%），健康素养干预组下降0.33%（95%CI：-0.55%~-0.11%），运动干预组下降0.70%（95%CI：-0.92%~-0.48%），而对照组略升高0.03%（95%CI：-0.19%~0.25%），差异有统计学意义（P<0.001）。以对照组为参比，调整可能的混杂因素后，3个月时综合干预组HbA1c效果最佳（β=-0.47，95%CI：-0.73~-0.20）；随后运动干预的效果逐渐凸现，6和12个月时HbA1c降幅分别达-0.73（95%CI：-0.98~-0.47）和-0.75（95% CI：-1.05~-0.45）。分层分析显示，在健康素养较低的患者中3种干预手段均有效，而在算术能力高者中运动干预更为有效。 结论： 健康素养及运动干预均可有效降低上海市社区T2DM患者的HbA1c水平，这将有助于降低患者并发症的发生和早死风险。.
Keywords: Diabetes, type 2; Exercise; Health literacy; Hemoglobin A1c; Intervention.