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Health Literacy and Exercise-Focused Interventions on Clinical Measurements in Chinese Diabetes Patients: A Cluster Randomized Controlled Trial
43 Pages Posted: 4 May 2019
More...Abstract
Background: The diabetes patients in China have low health literacy and lack 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 were recruited from 40 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. Outcomes were A1c, blood pressure and lipids measured at baseline, 3-, 6-, 12-months of intervention period and 12-months after completion of the interventions.
Findings: The three intervention groups had significant lower A1c at each follow-up visit than at baseline, whereas the control group did not change significantly. The significant improvements in A1c relative to the control arm remained even after a 1-year follow-up period post intervention. The exercise only group was more likely to achieve a goal systolic blood pressure (≤130 mmHg) at 3-months (adjusted risk ratio: 0·65, 95%CI: 0·43-0·99) and 12-months (adjusted risk ratio: 0·64, 95%CI: 0·42-0·96), and showed an average of 0·46 mmol/L decrease in LDL at 24-months among participants with suboptimal clinical measurements (p<0·0001). However, no significant benefits in blood pressure and lipids control were observed from the interventions compared to the usual care.
Interpretation: The health literacy and exercise interventions result in significant improvements in A1c. Exercise also improved blood pressure and lipids compared to baseline levels, but not compared to the standard group. These effective interventions may have potential of scaling up in China and other countries.
Trial Registration Information: This trial is registered with the International Standard RCT Number Register, number ISRCTN76130594.
Funding Statement: 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).
Declaration of Interests: The authors declare that we have no competing interests.
Ethics Approval Statement: Ethics approval was obtained from the Medical Ethics Committee of Fudan University (IRB00002408 & FWA00002399) before recruiting study participants (registration number: 2013-06-0451). All local medical ethics committees agreed with this approval.
Keywords: Type 2 diabetes, Health literacy, Exercise, Intervention, Trial
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