Article Text
Abstract
Introduction Patients with diabetes in China have low health literacy, which likely leads to poor clinical outcomes. This study aimed to assess the effectiveness of health literacy and exercise interventions on clinical measurements in Chinese adults with type 2 diabetes mellitus (T2DM).
Research design and methods A cluster randomized controlled trial was conducted from February 2015 through April 2017 in Shanghai, China. 799 patients with T2DM aged 18 years or older recruited from eight Community Healthcare Centers were randomized into one control arm and three intervention arms receiving 1-year health literacy intervention, exercise intervention or both as the comprehensive intervention. Propensity score matching was employed to minimize potential imbalance in randomization. The intervention-attributable effects on main clinical outcomes were estimated using a difference-in-difference regression approach.
Results After propensity score matching, 634 patients were included in the analysis. The three intervention groups had decreased hemoglobin A1c (A1c) level after 12 months of intervention. The largest adjusted decrease was observed in the health literacy group (−0.95%, 95% CI: −1.30 to −0.59), followed by the exercise group (−0.81%, 95% CI: −1.17 to −0.45). However, A1c was observed to increase in the health literacy and the comprehensive groups from 12 to 24 months. No obvious changes were observed for other measurements including high-density and low-density lipoprotein cholesterols, and systolic and diastolic blood pressures.
Conclusions Health literacy and exercise-focused interventions improve glycemic control in Chinese patients with diabetes after 12 months of intervention, and the health literacy intervention shows the greatest effect. Our results suggest that the interventions may have the potential to improve diabetes self-management and reduce diabetes burden in China.
Trial registration number ISRCTN76130594.
- adult diabetes
- intervention trials
- health literacy
- exercise
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Footnotes
Presented at Selected content was presented as a poster at the Lancet-CAMS Health Summit, Beijing, China, October 12–14, 2017.
Contributors YW drafted the manuscript. XL, JM and LW contributed to subject recruitment, data collection and quality control. YZ, YC and YW contributed to statistical analysis and data interpretation. WX and LS involved in the conception and design of the study, data interpretation and statistical analysis. WX and RR contributed to the design of the trial. All authors critically reviewed the manuscript and have approved the publication of this final version of the manuscript. WX is the guarantor of this work and had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
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).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval Ethics approval was obtained from the Medical Ethics Committee of Fudan University (IRB00002408 & FWA00002399, approval no. 2013-06-0451). All participants provided written informed consent.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. De-identified data collected for this study and a data dictionary are available from the corresponding author on reasonable request.
Author note Reference to prior publication of study: Liu X, Fang H, Xia Q, Cheng Y, Zhou P, Yan Y, Gao J, Jiang Y, Yao B, Rothman RL, Xu WH. Effect of health literacy and exercise interventions on glycated haemoglobin levels in Chinese patients with type 2 diabetes: a cluster-randomised controlled trial. Lancet, 2017;390:S92 (Conference Abstract). Wang L, Fang H, Xia Q, Liu X, Chen Y, Zhou P, Yan Y, Yao B, Wei Y, Jiang Y, Rothman RL, Xu W. Health literacy and exercise-focused interventions on clinical measurements in Chinese diabetes patients: a cluster randomized controlled trial. EClinicalMedicine. 2019 Nov 19;17:100-211. doi: 10.1016/j.eclinm.2019.11.004. eCollection 2019 Dec.