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

NCT06131411 | Completed

• 1 other identifier: DIABETHIC
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 4

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

health promotion; ethnic minorities; cardiovascular diseases; obesity; hypertension; Migrant health; Ambulatory care-sensitive conditions; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Glycated haemoglobin (HbA1c)

  Change in glycated haemoglobin (HbA1c)

  from baseline to follow-up at month 12

Secondary Outcomes (10)

• Systolic Blood Pressure

  from baseline to follow-up at month 12

• Diastolic Blood Pressure

  from baseline to follow-up at month 12

• Total Cholesterol

  from baseline to follow-up at month 12

• LDL Cholesterol

  from baseline to follow-up at month 12

• HDL Cholesterol

  from baseline to follow-up at month 12

Study Arms (2)

Intervention

EXPERIMENTAL

Health promotion intervention

Other: Health promotion

Control

PLACEBO COMPARATOR

Usual care

Other: Usual care

Interventions

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.

Intervention

Usual care OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

Azienda Ospedaliera Universitaria Renato Dulbecco

Catanzaro, Catanzaro, 88100, Italy

Location

Azienda Ospedaliera-Universitaria Careggi

Florence, Florence, 50134, Italy

Location

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

Reggio Emilia, Reggio Emilia, 42122, Italy

Location

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

Rome, Rome, 00153, Italy

Location

Related Publications (1)

• 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.

  PMID: 39992940 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Obesity; Hypertension; Ambulatory Care Sensitive Conditions

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pietro A Modesti, MD, PhD

  Azienda Ospedaliero-Universitaria Careggi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: November 7, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)