Promoting health in immigrants with type 2 diabetes
Cardio-metabolic Diseases in Immigrants and Ethnic Minorities: From Epidemiology to New Prevention Strategies
This study tests a new health program designed to help immigrants with type 2 diabetes improve their diet, exercise, and treatment habits in a way that fits their cultural needs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria Careggi Academic / other |
| Locations | 4 sites (Catanzaro and 3 other locations) |
| Trial ID | NCT06131411 on ClinicalTrials.gov |
What this trial studies
This study evaluates a culture-sensitive intervention aimed at improving diet, physical activity, and adherence to treatment protocols among immigrants diagnosed with type 2 diabetes. The intervention is co-created with the target population to ensure it meets their specific cultural needs. Participants will receive health promotion alongside usual care to enhance their overall health outcomes. The study focuses on immigrants from high migration pressure countries, addressing the unique challenges they face in managing diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are immigrants aged 18 and older who have been newly diagnosed with type 2 diabetes or have an HbA1c greater than 8% within the last 24 months.
Not a fit: Patients who have an HbA1c of 8% or lower, severe psychiatric disorders, or those who are pregnant or critically ill may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve health outcomes for immigrants with type 2 diabetes by promoting healthier lifestyles and better treatment adherence.
How similar studies have performed: Other studies have shown success with culturally tailored interventions for diabetes management, indicating a promising approach for this population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Catanzaro and 3 other locations
- Azienda Ospedaliera Universitaria Renato Dulbecco — Catanzaro, Italy (Not_yet_recruiting)
- Azienda Ospedaliera-Universitaria Careggi — Florence, Italy (Recruiting)
- AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia — Reggio Emilia, Italy (Recruiting)
- Istituto Nazionale per la promozione della salute delle popolazioni Migranti e il contrasto delle malattie della Povertà (INMP) — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Pietro A Modesti, MD, PhD — Azienda Ospedaliero-Universitaria Careggi
- Study coordinator: Pietro A Modesti, MD, PhD
- Email: pa.modesti@unifi.it
- Phone: 055 7949376
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.