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Completed

NCT Number: NCT06131411

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera Universitaria Renato Dulbecco, Catanzaro, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Promotion

Other

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

Usual Care

Other

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

Primary outcomes

  1. Glycated haemoglobin (HbA1c)

    Time frame: from baseline to follow-up at month 12

    Change in glycated haemoglobin (HbA1c)

Secondary outcomes

  1. Systolic Blood Pressure

    Time frame: from baseline to follow-up at month 12

    Change in Systolic Blood Pressure

  2. Diastolic Blood Pressure

    Time frame: from baseline to follow-up at month 12

    Change in Diastolic Blood Pressure

  3. Total Cholesterol

    Time frame: from baseline to follow-up at month 12

    Change in Total Cholesterol

  4. LDL Cholesterol

    Time frame: from baseline to follow-up at month 12

    Change in LDL Cholesterol

  5. HDL Cholesterol

    Time frame: from baseline to follow-up at month 12

    Change in HDL Cholesterol

  6. Triglycerides

    Time frame: from baseline to follow-up at month 12

    Change in triglycerides

  7. Body Mass Index (BMI)

    Time frame: from baseline to follow-up at month 12

    Change in Body Mass Index (BMI)

  8. Waist circumference

    Time frame: from baseline to follow-up at month 12

    Change in Waist circumference

  9. Physical activity

    Time frame: from baseline to follow-up at month 12

    Change in compliance with World Health Organization recommended exercise goals

  10. Adherence to Mediterranean Diet

    Time frame: from baseline to follow-up at month 12

    Change in Adherence to Mediterranean Diet

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Collaborators

  • AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia
  • Azienda Ospedaliera Universitaria Renato Dulbecco
  • Istituto Nazionale per la promozione della salute delle popolazioni Migranti e per il contrasto delle malattie della Povertà (INMP)

Registry information

Acronym: DIABETHIC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2023
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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