Cardio-metabolic Diseases in Immigrants and Ethnic Minorities: From Epidemiology to New Prevention Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 4
- 主要终点
- Glycated haemoglobin (HbA1c)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention
Health promotion intervention
干预措施: Health promotion (Other)
Control
Usual care
干预措施: Usual care (Other)
结局指标
主要结局
Glycated haemoglobin (HbA1c)
时间窗: from baseline to follow-up at month 12
Change in glycated haemoglobin (HbA1c)
次要结局
- Systolic Blood Pressure(from baseline to follow-up at month 12)
- Diastolic Blood Pressure(from baseline to follow-up at month 12)
- Total Cholesterol(from baseline to follow-up at month 12)
- LDL Cholesterol(from baseline to follow-up at month 12)
- HDL Cholesterol(from baseline to follow-up at month 12)
- Triglycerides(from baseline to follow-up at month 12)
- Body Mass Index (BMI)(from baseline to follow-up at month 12)
- Waist circumference(from baseline to follow-up at month 12)
- Physical activity(from baseline to follow-up at month 12)
- Adherence to Mediterranean Diet(from baseline to follow-up at month 12)
