The Health for Hearts United Collaborative
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Participant Reach
研究概览
简要总结
This proposed project will determine the effectiveness of Health for Hearts United Collaborative (HHUC) implementation strategies in relation to process outcomes and reducing cardiovascular disease (CVD) risk in African Americans (AAs),examining two possible strategies.
详细描述
This project will determine the effectiveness of HHUC implementation strategies in relation to process outcomes and reducing CVD risk in AAs, guided by ecological theory, the Consolidated Framework for Implementation Research (CFIR), and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. The HHUC model currently includes three components: governance structure, annual events, and basic support. The investigators propose adding a fourth component that includes one of two possible implementation strategies: 1) an internal champions (IC)-driven strategy that includes two features (leadership development, culturally-tailored planning approaches) or 2) an external change agent (external professionals [EP])-driven strategy without these features. The investigators will pilot and refine the IC and EP-driven implementation strategies using health leaders from four churches in the two-county area by determining feasibility and acceptability. Following the pilot, the investigators will use an effectiveness implementation hybrid Type 3 design to evaluate the IC and EP implementation strategies in relation to process outcomes. The study will be conducted in a two-county area in North Florida, using congregants ((18 years of age and older, n=225) in nine churches: three IC treatment, three EP treatment, and three comparison with delayed comparable activities.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •African American,
- •18 years of age and older,
- •not pregnant in the last six months,
- •not hospitalized or having a clinically significant medical condition in the past six months
排除标准
- •not being African American,
- •under the age of 18,
- •pregnant in the last six months,
- •hospitalized or having a clinically significant medical condition in the past six months.
结局指标
主要结局
Participant Reach
时间窗: 12 months
Percent of participants that are retained in the intervention which will be computed by dividing the number of participants who complete the intervention by the number who enrolled.
Intervention Adoption
时间窗: 12 months
Number of participants who attend intervention sessions which is computed by adding the number of attendees to create total attendance.
Intervention Implementation
时间窗: 12 months
Checklist to be developed by the investigators and completed by staff that monitors church health leaders' planning for health ministry development and delivery of program to participants.
Intervention Maintenance
时间窗: 12 months
Checklist to be developed by investigators regarding whether or not annual plans are submitted. The instrument will include the list of churches and columns for checking yes or no.
次要结局
- Height(12 months)
- Fruit and vegetable intake(12 months)
- Fat intake(12 months)
- Blood pressure(12 months)
- Weight(12 months)
- Food choice(12 months)
- Objective physical activity(12 months)
- Abdomen circumference(12 months)
- Self-report Physical activity(12 months)
- Hip circumference(12 months)
- Waist circumference(12 months)
研究者
Penny Ralston
Professor, Dean Emeritus & Director, Center on Better Health
Florida State University