A Pilot Randomized Diabetes Intervention Among Inner-city African American and Latino Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The objectives of the proposed study are to determine whether culturally diverse community residents with diabetes are willing to participate in our community health worker intervention using randomized controlled trial (RCT) methods and to explore and document effective processes and protocols for RCT methods in these communities. The investigators will examine retention rates, identify reasons for attrition through interviews and focus groups, and determine strategies for improving recruitment, retention, and intervention methods. As a secondary objective, the investigators will explore the potential impacts of the intervention for improving healthy lifestyles, diabetes self-management, and selected health outcomes of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •At least 18 years of age
- •Had physician-diagnosed type 2 diabetes
- •Self-identified as African American or Latino/Hispanic
- •Lived in the targeted zip codes.
排除标准
- •Individuals who already had serious diabetes-related complications, such as blindness, amputated limbs, and kidney failure
研究组 & 干预措施
Information on community resources
Participants received information about free and publicly available community resources on healthy lifestyle activities
Community Health Worker services
干预措施: Community Health Worker (CHW) services (Behavioral)
结局指标
主要结局
Hemoglobin A1c
时间窗: 6 months
次要结局
- LDL cholesterol(6 months)
- Blood pressure(6 months)
- Diabetes self-management knowledge(6 months)
- Diabetes Self Management and Self Care Activities (physical activity, healthy eating, glucose testing, medication taking, required screening tests/exams)(6 months)
- Diabetes specific emotional distress(6 months)
