Health Impact 360: Advancing Physical, Social, and Mental Health Toward Cardiovascular Disease Prevention in Community Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 328
- 试验地点
- 7
- 主要终点
- Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8)
研究概览
简要总结
The purpose of this clinical trial is to evaluate an evidence-based intervention, Health Impact 360, toward the promotion of cardiovascular health (CVH), including physical, mental, and social health outcomes, among adults living in marginalized communities.
Study hypotheses include:
- Participants in the Health Impact 360 intervention arm will have better CVH (i.e., a higher overall LE8 score) at the 16-week endpoint compared to the control.
- Participants in the Health Impact 360 intervention arm will report better mental health (i.e., a lower perceived stress score) at the 16-week endpoint compared to the control.
- Participants in the Health Impact 360 intervention arm will report better social support and well-being (i.e., higher emotional support and instrumental support scores and reduced social isolation) at the 16-week endpoint compared to control.
- Participants with greater intervention engagement (e.g., better session attendance) will experience greater intervention impacts across all primary and secondary outcomes relative to the minimally engaged peers.
Researchers will compare outcomes among intervention participants to outcomes among delayed intervention control participants who will be invited to participate in Health Impact 360 once all endpoint measures are collected.
Participants will:
- Engage in group-based programming twice per week for 8 weeks
- Engage in group-based programming once per week for 8 weeks
- Participate in survey-based and biometric data collection at two timepoints: baseline and 16-week endpoint
- Self-monitor their physical activity via a study-provided pedometer
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 (Outcomes Assessor)
盲法说明
Statisticians will be blinded to arm assignment during analysis.
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
- •English or Spanish speaking
- •Able to participate in group-based programming
排除标准
- •- All pregnant persons to prevent pregnancy-related biometric changes from biasing outcome analyses
研究组 & 干预措施
Health Impact 360
16-week, group-based comprehensive health program that covers all behavioral and clinical dimensions of heart health: healthy eating, physical activity, quality sleep, tobacco cessation, blood pressure, cholesterol, Hemoglobin A1c, and Body Mass Index.
干预措施: Health Impact 360 (Behavioral)
Usual care - Wait list control
Participants that will be on the wait list will be evaluated. These participants will be enrolled into the treatment program 16-20 weeks after the first treatment group.
干预措施: Usual care - Wait list control (Other)
结局指标
主要结局
Change in Cardiovascular health (CVH) based on the Life's Essential 8 score (LE8)
时间窗: Baseline, 16 weeks
LE8 CVH Score will be averaged for each participant at baseline and 16 weeks on the individual LE8 metrics (i.e., scores of 0-100 for eight items). An average score of 0 to 49 is defined as low CVH, 50 to 79 is moderate CVH, and 80 to 100 is high CVH.
次要结局
- Change in mental health based on the perceived stress scale(Baseline, 16 weeks)
- Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale(Baseline, 16 weeks)
- Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) instrumental support scale(Baseline, 16 weeks)
- Change in social health via the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scale(Baseline, 16 weeks)
研究者
Jennifer Garner
Associate Professor
University of Michigan