Cardio-metabolic Diseases in Immigrants and Ethnic Minorities: From Epidemiology to New Prevention Strategies

NCT ID: NCT06131411

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-07
• Study Completion Date: 2025-10-31

Brief Summary

The purpose of this clinical trial is to learn if intervention on health behavior can promote diabetes care and improve compliance to therapeutic protocols in ethnic minorities with type 2 diabetes. To answer this question, researchers will compare the effectiveness of co-created, culture-sensitive intervention to that of a usual-care approach to promote diabetes care 12 months after enrollment in first-generation immigrants with type 2 diabetes.

Detailed Description

Diabetes mellitus has an unequal impact globally, with 80% of cases occurring in low- and middle-income countries. In particular, social determinants of health, such as education, employment, and living conditions, play a significant role in the unequal impact of diabetes. On the other hand, cultural aspects such as education on healthy behaviors, diet, adherence to drug therapy, self-monitoring of blood glucose, and physical activity, are essential for effective diabetes management. Finally, beliefs about the disease, communication difficulties, limited educational backgrounds, and the inability to understand educational materials and read food labels due to language barriers can pose obstacles to achieving adequate disease awareness and control among ethnic minorities. Large randomized clinical trials conducted over the past decade have examined the effectiveness of behavioral interventions to address these influences among diverse ethnic minorities. These studies, mainly conducted on specific ethnic groups living in the US such as Afro-American and Hispanic populations, reported improvements in glycosylated hemoglobin A1c control at 3- and at 6-months post intervention compared with control groups who received 'usual care', being sustained to a lesser extent at 12- and 24-months post intervention. In Europe, where diabetes disproportionately affects adult populations from ethnic minorities, with higher disease risk and complication and mortality rates compared to European host populations, studies on culturally sensitive diabetes self-management education and support are limited, and their effectiveness remains uncertain. The multicenter randomized clinical trial (DiabEthic trial) was therefore designed to compare the effectiveness of culture-sensitive intervention to that of a usual-care approach to promote diabetes care and to improve compliance to therapeutic protocols in first-generation immigrants with type 2 diabetes. To best transfer this experience into clinical practice, personalized cultural approaches to type 2 diabetes were developed with the support of representatives of ethnic communities living in Italy and the participation of specific cultural mediators. Unlike previous studies, this multicenter study focuses on the diversely represented ethnic communities in different parts of Italy.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention

Health promotion intervention

Group Type: EXPERIMENTAL

Health promotion

Intervention Type: OTHER

Co-created culture-tailored intervention of health promotion aimed to increase healthy diet, physical activity and compliance with treatment protocols for diabetes.

Control

Usual care

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: OTHER

Health promotion activities routinely performed by Diabetes clinics at the recruiting centres.

Interventions

Health promotion

Co-created culture-tailored intervention of health promotion aimed to increase healthy diet, physical activity and compliance with treatment protocols for diabetes.

Intervention Type: OTHER

Usual care

Health promotion activities routinely performed by Diabetes clinics at the recruiting centres.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Immigrant status: Self-identification of being born in High migration pressure countries from parents born in high migration pressure countries
• Age ≥ 18 years
• Type 2 diabetes newly diagnosed or with HbA1c > 8% in the last assessment within 24 months before the visit

Exclusion Criteria

• Patients who will not provide the informed consent
• Patients with HbA1c ≤ 8% in the last assessment within 24 months before the visit
• Severe psychiatric disorders
• Pregnant women
• Critical illness
• Impaired cognitive or physical ability that could make the intervention not feasible, as judged by clinical staff members

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Renato Dulbecco

UNKNOWN

Sponsor Role: collaborator

AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia

UNKNOWN

Sponsor Role: collaborator

Istituto Nazionale per la promozione della salute delle popolazioni Migranti e per il contrasto delle malattie della Povertà (INMP)

UNKNOWN

Sponsor Role: collaborator

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pietro A Modesti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria Careggi

Locations

Azienda Ospedaliera Universitaria Renato Dulbecco

Catanzaro, Catanzaro, Italy

Azienda Ospedaliera-Universitaria Careggi

Florence, Florence, Italy

AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia

Reggio Emilia, Reggio Emilia, Italy

Istituto Nazionale per la promozione della salute delle popolazioni Migranti e il contrasto delle malattie della Povertà (INMP)

Rome, Rome, Italy

Countries

Italy

References

Bonvicini L, Venturelli F, Bononi F, Balestra GL, Iorio G, Ghirotto L, Petrelli A, Pierconti S, Laurendi G, Perticone M, Pellegrino A, Boddi M, Modesti PA, Giorgi Rossi P; DIABETHIC Working Group. A randomized trial to evaluate a complex, co-created, culture-sensitive intervention to promote healthy lifestyles and compliance to therapy in immigrants with type 2 diabetes: A protocol of a multicenter Italian study. PLoS One. 2025 Feb 24;20(2):e0317994. doi: 10.1371/journal.pone.0317994. eCollection 2025.

Reference Type: DERIVED

PMID: 39992940 (View on PubMed)

Other Identifiers

DIABETHIC

Identifier Type: -

Identifier Source: org_study_id