Efficacy of co-created, culturally-sensitive intervention for type 2 diabetes self-management education in immigrants in Italy: The DiabEthic randomized clinical trial

AIMS: DiabEthic trial examined the effectiveness of a culturally sensitive intervention on diabetes care delivered by dieticians and cultural mediators, targeting knowledge, attitudes, and self-management behaviours in a multi-ethnic cohort of immigrants in Italy. METHODS: A total of 202 adult first-generation immigrants with type 2 diabetes newly diagnosed or with HbA1c > 8% were randomized 1:1 to intervention (cultural-sensitive help, with multidisciplinary and co-creative approaches) or standard care approach (guidelines based) in a multicentric, randomized, parallel-controlled, clinical trial. The primary outcome was HbA1c change at 12-month follow-up. Secondary outcomes included blood pressure, lipids, anthropometric measures, diet, physical activity, and adherence to therapy. Mixed-effects models and an intention-to-treat approach were applied. Structural equation modelling investigated mediating pathways. RESULTS: The intervention group showed a greater improvement in HbA1c [-0.70%, 95% confidence interval(CI): -1.31 to -0.09;P = 0.026] at 12-month follow-up, compared with the control group. A significant intervention effect was evident for waist circumference, triglycerides, total cholesterol, non-refined cereals servings/week, and adherence to therapy but not for blood pressure, body mass index, LDL, and physical activity. At mediation analysis, changes in non-refined cereals consumption and waist circumference indirectly mediated 40% of intervention effect on HbA1c changes. CONCLUSIONS: A culturally-tailored self-management intervention led to a greater HbA1c reduction in immigrants and ethnic minorities (https://clinicaltrials.gov/study/NCT06131411).