Abstract
Background and ObjectiveThe 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 MethodsA 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.ResultsAs 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).ConclusionThe 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 RegistryChinese Clinical Trial Registry (ChiCTR‐IOR‐17011007).
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