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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Health promotion
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Health promotion intervention | Other: Health promotion<br>* Co-created culture-tailored intervention of health promotion aimed to increase healthy diet, physical activity and compliance with treatment protocols for diabetes.<br>|
| Placebo Comparator: Control<br>Usual care | Other: Usual care<br>* Health promotion activities routinely performed by Diabetes clinics at the recruiting centres.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated haemoglobin (HbA1c) | Change in glycated haemoglobin (HbA1c) | from baseline to follow-up at month 12 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migrants, health promotion, ethnic minorities, cardiovascular diseases, obesity, hypertension, diabetes