FELLAShip to Better Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change From Baseline in Life's Essential 8 Overall Score
研究概览
简要总结
The goal of this clinical trial is to evaluate the implementation and effectiveness of the FELLAship program-a church-based cardiovascular health (CVH) intervention-in Black men aged 35-70 who are at risk for heart disease, diabetes, obesity, and related conditions. The main questions this study aims to answer are:
- Does participation in the FELLAship program improve cardiovascular health metrics (e.g., blood pressure, cholesterol, blood sugar) and health behaviors among Black men at The Worship Center Christian Church (TWC)?
- What factors influence the adoption, delivery, and sustainability of the FELLAship program in a faith-based setting? Researchers will compare an immediate-start intervention group and a delayed-start (waitlist control) group to assess both short-term health outcomes and program implementation factors.
Participants will:
- Attend a 90-minute weekly session for 24 weeks, including 45 minutes of physical activity led by a certified trainer and 45 minutes of health education delivered by trained coaches.
- Receive one-on-one support from a community health worker to reduce barriers to care and engage with primary care.
- Complete biometric health screenings and surveys at baseline, 12 weeks, and 24 weeks to assess clinical and behavioral outcomes.
- Use a smartwatch, blood pressure cuff, and other tools to track progress in real time.
- Participate in exit focus groups or interviews to share feedback about the intervention.
- A subset of TWC leaders and interventionists (N=15) will also be interviewed to assess implementation, resource needs, and sustainability.
This study uses the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance, and aims to inform scalable strategies for improving CVH among Black men in trusted community settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Self-identified Black men
- •Age 18 or older
- •LE8 (Life's Essential 8) score (threshold not specified, but implies "less than ideal" CVH)
- •English speaking
- •Resides in the Metropolitan Birmingham, Alabama area
- •No physical activity restrictions imposed by a healthcare provider
排除标准
- •Not identifying as Black and male
- •Under age 18
- •Non-English speakers
- •Not living in the Birmingham, Alabama metro area
- •Having a healthcare provider-imposed restriction on physical activity
- •Ideal CVH (i.e., LE8 (Life's Essential 8) score above inclusion threshold)
研究组 & 干预措施
Waitlist Control
Individuals in the waitlist control arm will not receive the intervention during the evaluation period. They will have access to the intervention post-evaluation period.
FELLAship
FELLAship intervention participants will receive the 24-week intervention according to the curriculum, to be delivered by a health coach, personal trainer, and community health worker.
干预措施: FELLAship (Behavioral)
结局指标
主要结局
Change From Baseline in Life's Essential 8 Overall Score
时间窗: 24 Weeks
Change from baseline in the Life's Essential 8 overall cardiovascular health score (range 0-100, higher scores indicate better cardiovascular health), assessed at 12 and 24 weeks.
次要结局
- Change From Baseline in Life's Essential 8 Blood Lipids Score(24)
- Change From Baseline in Life's Essential 8 Blood Pressure Score(24 Weeks)
- Change From Baseline in Life's Essential 8 Body Mass Index Score(24 Weeks)
- Change From Baseline in Perceived Stress Score(24 Weeks)
- Change in Life's Essential 8 Physical Activity (Accelerometry)(24 Weeks)
- Change From Baseline in Patient Activation Measure (PAM) Score(24 Weeks)
- RE-AIM Adoption, Implementation, and Maintenance Indicators(156 Weeks)
- Change in Life's Essential 8 Diet (subjective)(24 Weeks)
- Change in Life's Essential 8 Physical Activity (Self Reported)(24 Weeks)
- Change From Baseline in Life's Essential 8 Blood Glucose Score(24 Weeks)
- Change From Baseline in Life's Essential 8 Nicotine Exposure Score(24 Weeks)
- Change From Baseline in Life's Essential 8 Sleep Health Score(24 Weeks)
- Change From Baseline in Health-Related Social Needs Score(24 weeks)
研究者
Nashira Brown
Associate Professor
University of Alabama at Birmingham
