Clinical trial NCT06131411: Cardio-metabolic Diseases in Immigrants and Ethnic Minorities: From Epidemiology to New Prevention Strategies
Official title: Cardio-metabolic Diseases in Immigrants and Ethnic Minorities: From Epidemiology to New Prevention Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: migrants
health promotion
ethnic minorities
cardiovascular diseases
obesity
hypertension
diabetes
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Renato Dulbecco
name: AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia
name: Istituto Nazionale per la promozione della salute delle popolazioni Migranti e per il contrasto delle malattie della Povertà (INMP)
First posted: 2023-11-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Glycated haemoglobin (HbA1c)
timeFrame: from baseline to follow-up at month 12
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: from baseline to follow-up at month 12
measure: Diastolic Blood Pressure
timeFrame: from baseline to follow-up at month 12
measure: Total Cholesterol
timeFrame: from baseline to follow-up at month 12
measure: LDL Cholesterol
timeFrame: from baseline to follow-up at month 12
measure: HDL Cholesterol
timeFrame: from baseline to follow-up at month 12
measure: Triglycerides
timeFrame: from baseline to follow-up at month 12
measure: Body Mass Index (BMI)
timeFrame: from baseline to follow-up at month 12
measure: Waist circumference
timeFrame: from baseline to follow-up at month 12
measure: Physical activity
timeFrame: from baseline to follow-up at month 12
measure: Adherence to Mediterranean Diet
timeFrame: from baseline to follow-up at month 12
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Universitaria Renato Dulbecco
city: Florence
country: Italy
facility: Azienda Ospedaliera-Universitaria Careggi
city: Reggio Emilia
country: Italy
facility: AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia
city: Rome
country: Italy
facility: Istituto Nazionale per la promozione della salute delle popolazioni Migranti e il contrasto delle malattie della Povertà (INMP)
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Careggi
name: Pietro A Modesti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: