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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Usual care; Other: Health promotion

• Registration Number: NCT06131411
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief Summary

The aim of the study is to evaluate the efficacy of the co-created, culture-sensitive intervention to promote healthy diet, physical activity, and to improve compliance to therapeutic protocols in immigrants with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-07
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-14
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2025-03-31
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Usual care	Usual care
Intervention	Health promotion	Health promotion intervention

Primary Outcome Measures

Name	Time	Method
Glycated haemoglobin (HbA1c)	from baseline to follow-up at month 12	Change in glycated haemoglobin (HbA1c)

Secondary Outcome Measures

Name	Time	Method
Total Cholesterol	from baseline to follow-up at month 12	Change in Total Cholesterol
Systolic Blood Pressure	from baseline to follow-up at month 12	Change in Systolic Blood Pressure
Diastolic Blood Pressure	from baseline to follow-up at month 12	Change in Diastolic Blood Pressure
LDL Cholesterol	from baseline to follow-up at month 12	Change in LDL Cholesterol
HDL Cholesterol	from baseline to follow-up at month 12	Change in HDL Cholesterol
Triglycerides	from baseline to follow-up at month 12	Change in triglycerides
Body Mass Index (BMI)	from baseline to follow-up at month 12	Change in Body Mass Index (BMI)
Waist circumference	from baseline to follow-up at month 12	Change in Waist circumference
Physical activity	from baseline to follow-up at month 12	Change in compliance with World Health Organization recommended exercise goals
Adherence to Mediterranean Diet	from baseline to follow-up at month 12	Change in Adherence to Mediterranean Diet

Trial Locations

Locations (4)

Azienda Ospedaliera Universitaria Renato Dulbecco; 🇮🇹 Catanzaro, Italy

Azienda Ospedaliera-Universitaria Careggi; 🇮🇹 Florence, Italy

AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

Istituto Nazionale per la promozione della salute delle popolazioni Migranti e il contrasto delle malattie della Povertà (INMP); 🇮🇹 Rome, Italy