Inspire HER: Inspiring the Heart and Emotions for Radical Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Feasibility (Preliminary Effect on PREVENT Score)
研究概览
简要总结
Poor heart health puts Black women at risk for a shorter life with more illness than people of any other non-indigenous racial group. We will refine and conduct a randomized, wait-list controlled trial of Inspire HER (a heart health lifestyle intervention for Black women that provides health education, physical activity, and social resources). We will also compare Inspire HER and Black Impact (a heart health intervention for Black men) data to study how women and men respond differently to stress. This trial aligns with American Heart Association's pledge to address heart health equity through new interventions that consider the person and the circumstances with which they live.
详细描述
Poor heart health puts Black women at risk for a shorter life with more illness than people of any other non-indigenous racial group. Yet, few studies have focused on improving heart health in Black women. Our team built and studied a 24-week program called Black Impact for Black men with less than ideal heart health. Black Impact provides 45 minutes of exercise and 45 minutes of healthy diet education and connects Black men with a health coach, fitness trainer, and community health worker. In the first study of Black Impact, Black men (n=74) had improved heart health equal to a 19% lower risk of death from heart disease. These men also reported less stress, improvement in being able to control their health, and fewer unmet social needs. Now, a study of Black Impact in 340 Black men is ongoing to understand how Black Impact works with respect to stress and heart health. Black women have reported a need for a similar heart health program. Based on feedback from Black women (n=56), we adapted Black Impact for Black women (Inspire HER). Thus, we propose to refine the Inspire HER program for Black women. Then, we will do a clinical trial of Inspire HER compared to routine living (usual care) in Black women with elevated heart health risk. We will find out if the Inspire HER program reduces heart health risk more than usual care. We will also assess how the Inspire HER program "gets under the skin" to affect the body's response to stress. Lastly, we will compare the response to stress between women of Inspire HER and men of Black Impact. Importantly, we expect this study will show promising improvements in heart health and risk. This Inspire HER trial will lay the foundation for larger future studies. Inspire HER, comparing data from Black Impact, may also help us understand how women and men in heart health programs respond differently to stress. This trial aligns with American Heart Association's pledge to address heart health equity through new interventions that consider the person and the circumstances with which they live.
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
- Single (Outcomes Assessor)
盲法说明
The statistical analyst is blinded to the intervention group.
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Black women (self-report)
- •Adult ages 30-79 years
- •Stage 2 or greater Cardiovascular-Kidney-Metabolic Syndrome
- •English speaking
- •Lives in Metropolitan Birmingham, AL area.
排除标准
- •- Healthcare provider-imposed physical activity limitations.
结局指标
主要结局
Feasibility (Preliminary Effect on PREVENT Score)
时间窗: 24 weeks
The primary outcome for the randomized controlled trial is change in cardiovascular risk as defined by PREVENT Score (a 10-year risk estimator of cardiovascular events for individuals 30-79 years of age; measure utilizes sex, age, cholesterol blood pressure, body mass index, glomerular filtration rate, diabetes, smoking status, anti-hypertensive medication, lipid-lowering medication, urine creatinine, hemoglobin A1C, and social deprivation index). PREVENT score ranges from low (\<5%) to high (\>20%) risk with low risk being better. Linear mixed effects models with random intercepts will evaluate the change from baseline to 24 weeks in primary (PREVENT score). These models will assess differences between waitlist control and intervention participants using an interaction between time and treatment indicator. We will also evaluate qualitative exit (focus group) survey data to understand perceived effect.
Feasibility (Demand or Use of Intervention)
时间窗: 24 weeks
Demand will be assessed by percent recruited of number contacted, participant self-rating of participation, percent using information at home. These data will be obtained from study records and exit survey (focus group) responses.
Feasibility (Acceptability or Participant Reaction to Intervention)
时间窗: 24 weeks
Acceptability will be assessed by participant satisfaction with the intervention and participant attendance, perceptions of usefulness, and plans/real change of behavior to apply health promotion strategies. These data will be obtained by study records and exit (focus group) surveys.
Feasibility (Implementation or Intervention FIdelity)
时间窗: 24 weeks
Implementation will be assessed using the Inspire HER curriculum and participant opinions of how the intervention was administered. These data will be obtained via study records and exit (focus group) surveys.
Feasibility (Practicality or Efficiency of Resource Allocation)
时间窗: 24 weeks
Practicality will be assessed using intervention cost per participant and identifying any revenue/savings. These data will be obtained by evaluating grant budgetary documentation.
次要结局
- Dose-Response on Preliminary Effect(24 weeks)
- Change in Conserved Transcriptional Response to Adversity(24 weeks)
- Change in 12,13-diHOME Expression and Associations with Biomarkers(24 weeks)
- Mechanistic transcriptomic stress and inflammatory response to Inspire HER in Black women as compared to Black men in Black Impact:(24 weeks)
研究者
Timiya Nolan
Associate Professor
University of Alabama at Birmingham