Abstract
BACKGROUND AND OBJECTIVE: The 12-month follow-up effect of the self-efficacy-focused structured education program (SSEP) requires in-depth confirmation. This study aims to verify whether the benefits of SSEP can be maintained in 12 months. MATERIALS AND METHODS: A multicenter randomized controlled trial with 12-month follow-up conducted among 265 type 2 diabetes patients not on insulin from 4 hospitals in mainland China. The intervention group (n = 133) was administrated with SSEP, and the control group (n = 132) received the routine education. The indicators of metabolic and psychosocial aspects of the patients were assessed at baseline and 12 months. RESULTS: As opposed to the control group, the primary outcomes of HbA1c in the intervention group were improved obviously in the 12th month during the 12-month follow-up (-1.13%, P < 0.001). The secondary outcomes (ie, waist circumference, total cholesterol, low-density lipoprotein cholesterol, diabetes self-efficacy, diabetes self-management behaviors, diabetes knowledge and diabetes distress) were improved significantly in the intervention group as compared with the control group in the 12th month during the 12-month follow-up (-3.14 cm, P = 0.001; -0.30 mmol/L, P = 0.032; -0.25 mmol/L, P = 0.008; 0.87, P < 0.001; 10.67, P < 0.001; 3.42, P < 0.001; -4.97, P < 0.001). The non-significant difference in the secondary outcomes (ie, systolic pressure, diastolic pressure, triglycerides and high-density lipoprotein cholesterol) was identified between the two groups in the 12th month during the 12-month follow-up (P > 0.05). CONCLUSION: The SSEP provided sustainable benefits in outcomes of HbA1c, waist circumference, total cholesterol, low-density lipoprotein cholesterol, diabetes knowledge, diabetes distress, diabetes self-efficacy and diabetes self-management behaviors for type 2 diabetes patients not on insulin in the 12th month during the 12-month follow-up. Thus, it will be an effective education model capable of being generalized nationwide, and it can be referenced for the nations and regions under consistent conditions. CLINICAL TRIAL REGISTRY: Chinese Clinical Trial Registry (ChiCTR-IOR-17011007).