Promotora Intervention for Metabolic and Mental Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Body Weight
研究概览
简要总结
Evidence-based programs to prevent diabetes among high-risk individuals are less effective among those who also have mental health needs. This study involves developing and pilot testing the first adaptation of the landmark Diabetes Prevention Program lifestyle intervention to simultaneously treat prediabetes and elevated mental health symptoms. This project has large potential to impact public health, given that more than half of the U.S. adult population has either of these conditions, and is at risk for developing comorbid diabetes and mental illness.
详细描述
The overall goal of this study is to develop an effective and potentially scalable intervention to prevent diabetes in people with elevated mental health symptoms (EMS) and prediabetes. This study focuses on Latinos, a demographic group at particularly high risk for these related conditions. Experience from the Diabetes Prevention Program (DPP), and related translational studies, suggests that the evidence-based DPP lifestyle intervention is less effective among depressed individuals. The proposed Promotora Intervention for Metabolic and Mental Health (PRIME2) will be the first adaptation of the DPP lifestyle intervention to simultaneously address mental health and prediabetes in a program delivered by promotoras, or community health workers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Latino ethnicity
- •Spanish fluency
- •Age ≥18 years
- •BMI ≥25 kg/m2
- •And "increased risk of diabetes" (ADA Diabetes Risk Score ≥5 as determined by 7-item questionnaire and/or hemoglobin A1C ≥ 5.7%)
排除标准
- •Hemoglobin A1C ≥ 6.5%
- •Current or planned pregnancy during the study period
- •Chronic conditions that could affect potential participants' ability to participate (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily bronchodilator use, and severe psychiatric disease)
- •Medical comorbidities that could influence weight loss or weight gain (thyroid disease, cancer, and HIV)
- •Medications that could affect weight or glucose metabolism (thiazide diuretics, β-blockers, and systemic glucocorticoids).
研究组 & 干预措施
Promotora-led intervention (PLI)
PLI -DPP protocol was developed from original DPP materials and culturally tailored for the target population based on formative research. The core PL-DPP curriculum includes 14 group sessions of 90 minutes duration. One promotora will lead each session in Spanish using behavioral strategies to discuss lifestyle behaviors, exploring such topics as being active, low-fat diets, portion control, self monitoring, problem solving and life-style changes.
干预措施: Promotora-led Intervention (PLI) (Behavioral)
Usual care (UC)
UC participants will receive standard educational materials in Spanish discussing mental health and diabetes prevention. UC participants will be encouraged to continue all routine medical care during the study.
干预措施: Usual care (UC) (Behavioral)
结局指标
主要结局
Body Weight
时间窗: 3 months
Weight change from baseline.
次要结局
- Cardiometabolic marker - A1C(3 months)
- Cardiometabolic marker - waist circumference(3 months)
- Perceived Stress(3 months)
- Beck Depression Inventory(3 months)
研究者
Matthew J O'Brien
Assistant Professor of Medicine and Preventive Medicine
Northwestern University