Diabetes Mellitus, Type 2
Conditions
Keywords
health promotion, ethnic minorities, cardiovascular diseases, obesity, hypertension, Migrant health, Ambulatory care-sensitive conditions, Diabetes Mellitus, Type 2
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.
Detailed description
Diabetes mellitus has an unequal impact globally, with 80% of cases occurring in low- and middle-income countries. In particular, social determinants of health, such as education, employment, and living conditions, play a significant role in the unequal impact of diabetes. On the other hand, cultural aspects such as education on healthy behaviors, diet, adherence to drug therapy, self-monitoring of blood glucose, and physical activity, are essential for effective diabetes management. Finally, beliefs about the disease, communication difficulties, limited educational backgrounds, and the inability to understand educational materials and read food labels due to language barriers can pose obstacles to achieving adequate disease awareness and control among ethnic minorities. Large randomized clinical trials conducted over the past decade have examined the effectiveness of behavioral interventions to address these influences among diverse ethnic minorities. These studies, mainly conducted on specific ethnic groups living in the US such as Afro-American and Hispanic populations, reported improvements in glycosylated hemoglobin A1c control at 3- and at 6-months post intervention compared with control groups who received 'usual care', being sustained to a lesser extent at 12- and 24-months post intervention. In Europe, where diabetes disproportionately affects adult populations from ethnic minorities, with higher disease risk and complication and mortality rates compared to European host populations, studies on culturally sensitive diabetes self-management education and support are limited, and their effectiveness remains uncertain. The multicenter randomized clinical trial (DiabEthic trial) was therefore designed to compare the effectiveness of culture-sensitive intervention to that of a usual-care approach to promote diabetes care and to improve compliance to therapeutic protocols in first-generation immigrants with type 2 diabetes. To best transfer this experience into clinical practice, personalized cultural approaches to type 2 diabetes were developed with the support of representatives of ethnic communities living in Italy and the participation of specific cultural mediators. Unlike previous studies, this multicenter study focuses on the diversely represented ethnic communities in different parts of Italy.
Interventions
OTHERHealth promotion
Co-created culture-tailored intervention of health promotion aimed to increase healthy diet, physical activity and compliance with treatment protocols for diabetes.
OTHERUsual care
Health promotion activities routinely performed by Diabetes clinics at the recruiting centres.
Sponsors
Azienda Ospedaliero-Universitaria Careggi
Azienda Ospedaliera Universitaria Renato Dulbecco
AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia
Istituto Nazionale per la promozione della salute delle popolazioni Migranti e per il contrasto delle malattie della Povertà (INMP)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated haemoglobin (HbA1c) | from baseline to follow-up at month 12 | Change in glycated haemoglobin (HbA1c) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Total Cholesterol | from baseline to follow-up at month 12 | Change in Total Cholesterol |
| 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 |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORPietro A Modesti, MD, PhD
Azienda Ospedaliero-Universitaria Careggi
Outcome results
None listed