Lifestyle and Medication Management to Lower Diabetes Risk in Severe Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 6
- 主要终点
- Lifestyle risk for type 2 diabetes
研究概览
简要总结
The primary aim of the study is to compare the effect of three different interventions on lifestyle risk factors and biological risk factors for type 2 diabetes in depressed Cambodians. The three different interventions are lifestyle, lifestyle plus medication therapy management, and social services.
详细描述
Cambodian Americans have high risk for major depressive disorder and for type 2 diabetes. Depression is a known risk factor for diabetes. Some antidepressants can also increase risk of diabetes by causing weight gain. DREAM will test the effect of lifestyle and medication therapy management (MTM) compared to social services (control) on diabetes risk among depressed Cambodian Americans. Community health workers (CHWs) will deliver the lifestyle intervention and assist pharmacists with MTM. Lifestyle and biological risk factors for diabetes, such as depressive symptoms, HbA1c and insulin sensitivity, will be measured before and after the interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identified as Cambodian or Cambodian-American
- •Khmer speaking
- •Likely major depressive disorder
- •Elevated diabetes risk score per ADA guidelines
- •Ambulatory
- •Competent to give consent.
排除标准
- •Pregnancy or plans to become pregnant in the next 2 years
- •Previous diagnosis of diabetes
- •Seeing or hearing problems that would interfere with group sessions
- •Currently being followed by a physician for major medical problem
- •Serious thinking or memory problems (e.g., schizophrenia or dementia)
- •3 or more days in a psychiatric hospital or self-harm in the past 2 years.
结局指标
主要结局
Lifestyle risk for type 2 diabetes
时间窗: 12 months and 15 months
Change from baseline in depressive symptoms according to the Hopkins Symptom Checklist
Biological risk for type 2 diabetes
时间窗: 12 months and 15 months
Change from baseline in HbA1c and insulin resistance according to logHOMA-IR
次要结局
未报告次要终点
研究者
Julie A. Wagner
Professor
UConn Health