Inspire HER: Inspiring the Heart and Emotions for Radical Health
ID: NCT06966258
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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.
Read Full Scientific Objectives & Methods
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.
The Black Impact intervention is an academic-community-government partnership adapted from the Diabetes Prevention Program and American Heart Association Check, Change, Control programs based on stakeholder feedback and to afford incorporation of additional evidence-based strategies for influencing target outcomes. The intervention is a 24-week community-based lifestyle intervention to improve cardiovascular health among Black men. Each participant will be assigned to a group with \>5 participants based on participant proximity to a central community meeting location. Each team will be guided weekly by a health coach who delivers content and coaching around the lifestyle intervention modeled on the diabetes prevention program and check, change, control blood pressure program, a community health worker who helps to address social needs and connects participants to primary care services, and a trainer who leads physical activity. Teams meet for 90 minutes per week.
Treatment Arms Description
Those in the Inspire Her intervention arm will receive the 24-week intervention.
Those in the wait-list control arm will receive usual care.
- 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.
- \- Healthcare provider-imposed physical activity limitations.
Primary Outcome Measures
- Feasibility (Preliminary Effect on PREVENT Score) — Time Frame: 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) — Time Frame: 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) — Time Frame: 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) — Time Frame: 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) — Time Frame: 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.
View Secondary Outcome Measures (4)
- Dose-Response on Preliminary Effect — Time Frame: 24 weeks
Dose-response will be assessed by studying the relationship between intervention engagement (i.e. attendance) and the primary study outcome (change in PREVENT score). These data will be obtained using study records and PREVENT score evaluation as identified in the primary outcome.
- Change in Conserved Transcriptional Response to Adversity — Time Frame: 24 weeks
Evaluation of change in conserved transcriptional response to adversity (CTRA) will be measured via collection of blood and measuring leukocyte gene expression to determine the CTRA at baseline, 12 and 24 weeks. For the CTRA score, background subtraction and normalization of raw data, and operationalize inflammatory and antiviral gene activity will be performed. CTRA change will be calculated using between-subject differences using a linear mixed-effects to evaluate changes from baseline. The model will contain data from baseline (0 weeks), during-intervention (12 weeks), and post-intervention (24-weeks). These models will assess differences between waitlist control and intervention participants using an interaction between time and treatment indicator. Residual plots will examine model assumptions and model fit, with transformation of the outcomes used as needed to satisfy modelling assumptions and achieve appropriate model fit.
- Change in 12,13-diHOME Expression and Associations with Biomarkers — Time Frame: 24 weeks
Evaluation of change in 12,13-diHOME expression will be measured via collection of blood and measuring leukocyte gene expression to determine the expression at baseline, 12 and 24 weeks. For the expression score, background subtraction and normalization of raw data, and operationalize inflammatory and antiviral gene activity will be performed. The expression change will be calculated using between-subject differences using a linear mixed-effects to evaluate changes from baseline. The model will contain data from baseline (0 weeks), during-intervention (12 weeks), and post-intervention (24-weeks). These models will assess differences between waitlist control and intervention participants using an interaction between time and treatment indicator. Residual plots will examine model assumptions and model fit, with transformation of the outcomes used as needed to satisfy modelling assumptions and achieve appropriate model fit.
- Mechanistic transcriptomic stress and inflammatory response to Inspire HER in Black women as compared to Black men in Black Impact: — Time Frame: 24 weeks
Heterogeneity of treatment differences between women enrolled in the Inspire HER study and men enrolled in the Black Impact 2.0 study (NCT: NCT06055036) will be examined visually using lattice graphical displays. ComBat will evaluate and address potential batch effects in CTRA (as described in the secondary outcome above) data between the two studies. Linear mixed models will estimate potential heterogeneity in response by sex via inclusion of sex\*treatment interaction terms.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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- Joseph JJ, Nolan TS, Williams A, McKoy A, Zhao S, Aboagye-Mensah E, Kluwe B, Odei JB, Brock G, Lavender D, Gregory J, Gray DM 2nd. Improving cardiovascular health in black men through a 24-week community-based team lifestyle change intervention: The black impact pilot study. Am J Prev Cardiol. 2022 Jan 13;9:100315. doi: 10.1016/j.ajpc.2022.100315. eCollection 2022 Mar.PubMed ↗
View Official Medical/Scientific Title
Inspire HER: Inspiring the Heart and Emotions for Radical Health