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临床试验/NCT06131411
NCT06131411已完成不适用

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

Azienda Ospedaliero-Universitaria Careggi4 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2023年11月7日最近更新:
适应症
干预措施

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

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

Experimental

Health promotion intervention

干预措施: Health promotion (Other)

Control

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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