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.
Black women (self-report)
Adult ages 30-79 years
Stage 2 or greater Cardiovascular-Kidney-Metabolic Syndrome
English speaking
None
Parallel
Inspire HER Intervention
BehavioralThe 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.
Feasibility (Preliminary Effect on PREVENT Score)
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)
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)
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)
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.
Dose-Response on Preliminary Effect
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
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
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:
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.
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University of Alabama at Birmingham
Lead sponsor
American Heart Association
Collaborator
Ohio State University
Collaborator
Tuskegee University
Collaborator
