Lower attainment of cardiovascular health (CVH), indicated by the American Heart Association's Life's Simple 7 (LS7; physical activity, diet, cholesterol, blood pressure, body mass index, smoking, glycemia) and Life's Essential 8 (LE8; LS7+sleep) metrics, is a major contributor to Black men having the shortest life-expectancy of any non-indigenous race/sex group. Unfortunately, a paucity of literature exists on interventions aimed at improving CVH among Black men. The team of clinician scientists and community partners co-developed a community-based lifestyle intervention titled Black Impact: a 24-week intervention for Black men with less-than-ideal CVH (\<4 LS7 metrics in the ideal range) with 45 minutes of weekly physical activity, 45 minutes of weekly health education, and engagement with a health coach, group fitness trainer, and community health worker. Single-arm pilot testing of the intervention (n=74) revealed high feasibility, acceptability, and retention and a 0.93 (95% confidence interval: 0.40, 1.46, p\<0.001) point increase in LS7 score at 24 weeks. Secondary outcomes included improvements in psychosocial stress (i.e., perceived stress, depressive symptoms), patient activation, and social needs. Thus, robustly powered clinical trials are needed to determine the efficacy of Black Impact and to evaluate the underlying interpersonal and molecular pathways by which Black Impact improves psychosocial stress and CVH. Thus, the investigators propose a randomized, wait-list controlled trial of Black Impact. This novel, community-based intervention to provide a scalable model to improve CVH and psychosocial stress at the population level and evaluate the biological underpinnings by which the intervention mitigates cardiovascular disease risk. The proposed study aligns with American Heart Association's commitment to addressing CVH equity through innovative, multi-modal solutions.
The inclusion criteria are: 1) Black men (self-report); 2) adult age 18 years or older; 3) Life's Essential 8 total average score < 80; 4) English speaking; and 5) lives in Metropolitan Columbus, Ohio.
healthcare provider-imposed limitations on physical activity.
Parallel
Black Impact 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.
Cardiovascular Health
The primary outcome for the randomized controlled trial is change in cardiovascular health at 24-week follow-up, which will be calculated using between-subject differences rather than within-subject differences, using a linear mixed-effects to evaluate changes from baseline in Life's Essential 8 score (range 0-100, higher scores are better). Study wave will be a covariate in the models. 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 (e.g. log, square-root, Box-Cox) used as needed to satisfy modelling assumptions (e.g. normality, constant variance) and achieve appropriate model fit.
Change in Perceived Stress
Change in psychosocial stress (perceived stress) will be examined using changes in the perceived stress scale via linear mixed models with subject level random effects to account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.
Change in Life's Essential 8 Blood Pressure
Change in Life's Essential 8 Blood Pressure (range 0-100, higher is better) will be measured via an automated sphygmomanometer and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.
Change in Life's Essential 8 Blood Lipids
Change in Life's Essential 8 Blood Lipids via Non-HDL Cholesterol (range 0-100, higher is better) will be measured via a blood sample and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.
Change in Life's Essential 8 Blood Glucose
Change in Life's Essential 8 Blood Glucose via hemoglobin A1c (range 0-100, higher is better) will be measured via a blood sample and examined using linear mixed models with subject level random effects will account for longitudinal measures on each subject, with treatment by time interactions testing differences in changes over time across study arms. Model fitting strategy will check model specification and fit by examining concordance with distributional assumptions.
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Ohio State University
Lead sponsor
American Heart Association
Collaborator
