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Diabetes research and clinical practice · 2026

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

СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Pellegrino Alessio, Bonvicini Laura, Petrelli Alessio, Perticone Maria, Baccari Cecilia, Boddi Maria, Bononi Francesca, Calabrese Maria, Rossi Paolo Giorgi, Manicardi Elisa, Pierconti Silvia, Vacirca Irene, Venturelli Francesco, Modesti Pietro Amedeo, DIABETHIC Working Group

Аннотация

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).

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты