Background Higher cardiovascular health scores, using American Heart Association's (AHA) Life's Simple 7 (LS7), have been associated with lower risk of cardiovascular disease, type 2 diabetes, cancer, and mortality among all racial/ethnic groups. Nationally, Black men have the lowest levels of LS7. Thus, a study was conducted to evaluate the impact of a community-based team lifestyle change program on LS7 among Black men. Methods Black adult males ( n = 74) from a large Midwestern city participated in Black Impact, a 24-week community-based team lifestyle change program adapted from the Diabetes Prevention Program and AHA's Check, Change, Control Blood Pressure Self-Management Program, which incorporates AHA's LS7 framework. The change in a LS7 score (range 0–14) from baseline to 12 and 24 weeks was evaluated using a linear mixed-effects model adjusted for age, education, and income. Results The mean age of participants was 52 ± 10 years. The men were sociodemographically diverse, with annual income ranging from <$20,000 (7%) to ≥$75,000 (25%). Twenty-five percent were college graduates, 73% had private insurance, and 84% were employed. In fully adjusted models, LS7 score at baseline was 7.12 and increased 0.67 (95%CI: 0.14, 1.20, p = 0.013) and 0.93 (95%CI: 0.40, 1.46, p <0.001) points at 12 and 24 weeks, respectively, compared to baseline. Sensitivity analysis evaluating 5 components (excluding diet and physical activity) and 6 components (excluding diet) also showed significant increases at 12 and 24 weeks (all p <0.01). Conclusions The Black Impact lifestyle change single-arm pilot program showed that a community-based lifestyle intervention has the potential to improve LS7 in Black men. Further randomized studies are urgently needed to improve cardiovascular health and advance cardiovascular health equity in Black men.
Background Non-medical health-related social needs (social needs) are major contributors to worse health outcomes and may have an adverse impact on cardiovascular risk factors and cardiovascular disease. The present study evaluated the effect of a closed-loop community-based pathway in reducing social needs among Black men in a lifestyle change program. Methods Black men (n = 70) from a large Midwestern city participated in Black Impact, a 24-week community-based team lifestyle change single-arm pilot trial adapted from the Diabetes Prevention Program and American Heart Association’s (AHA) Check, Change, Control Blood Pressure Self-Management Program, which incorporates AHA’s Life’s Simple 7 (LS7) framework. Participants were screened using the Centers for Medicare and Medicaid Services (CMS) Accountable Health Communities Health-Related Social Needs Screening Tool. Participants with affirmative responses were referred to a community hub pathway to address social needs. The primary outcome for this analysis is change in social needs based on the CMS social needs survey at 12 and 24 weeks using mixed effect logistic regressions with random intercepts for each participant. Change in a LS7 score (range 0–14) from baseline to 12 and 24 weeks was evaluated using a linear mixed-effects model stratified by baseline social needs. Results Among 70 participants, the mean age of participants was 52 ±10.5 years. The men were sociodemographically diverse, with annual income ranging from <$20,000 (6%) to ≥$75,000 (23%). Forty-three percent had a college degree or higher level of education, 73% had private insurance, and 84% were employed. At baseline 57% of participants had at least one social need. Over 12 and 24 weeks, this was reduced to 37% (OR 0.33, 95%CI: 0.13, 0.85) and 44% (OR 0.50, 95%CI: 0.21, 1.16), respectively. There was no association of baseline social needs status with baseline LS7 score, and LS7 score improved over 12 and 24 weeks among men with and without social needs, with no evidence of a differential effect. Conclusions The Black Impact lifestyle change single-arm pilot program showed that a referral to a closed-loop community-based hub reduced social needs in Black men. We found no association of social needs with baseline or change in LS7 scores. Further evaluation of community-based strategies to advance the attainment of LS7 and address social needs among Black men in larger trials is warranted.
Introduction In recent years, there has been increasing awareness of the lack of diversity among clinical trial participants. Equitable representation is key when testing novel therapeutic and non-therapeutic interventions to ensure safety and efficacy across populations. Unfortunately, in the United States (US), racial and ethnic minority populations continue to be underrepresented in clinical trials compared to their White counterparts. Methods Two webinars in a four-part series, titled “Health Equity through Diversity,” were held to discuss solutions for advancing health equity through diversifying clinical trials and addressing medical mistrust in communities. Each webinar was 1.5 hours long, beginning with panelist discussions followed by breakout rooms where moderators led discussions related to health equity and scribes recorded each room’s conversations. The diverse groups of panelists included community members, civic representatives, clinician-scientists, and biopharmaceutical representatives. Scribe notes from discussions were collected and thematically analyzed to uncover the central themes. Results The first two webinars were attended by 242 and 205 individuals, respectively. The attendees represented 25 US states, four countries outside the US, and shared various backgrounds including community members, clinician/researchers, government organizations, biotechnology/biopharmaceutical professionals, and others. Barriers to clinical trial participation are broadly grouped into the themes of access, awareness, discrimination and racism, and workforce diversity. Participants noted that innovative, community-engaged, co-designed solutions are essential. Conclusions Despite racial and ethnic minority groups making up nearly half of the US population, underrepresentation in clinical trials remains a critical challenge. The community engaged co-developed solutions detailed in this report to address access, awareness, discrimination and racism, and workforce diversity are critical to advancing clinical trial diversity.
Introduction: Higher cardiovascular health scores, using American Heart Association’s (AHA) Life’s Simple 7 (LS7), have been associated with lower risk of cardiovascular disease, type 2 diabetes, cancer and mortality among all racial/ethnic groups. Nationally, Black men have the lowest levels of LS7. Thus, a study was conducted to evaluate the impact of a community-based lifestyle change program on LS7 among Black men. Hypothesis: A community-based lifestyle change program will increase levels of LS7 among Black men. Methods: Black adult males (n=74) from a large Midwestern city participated in Black Impact, a 24-week community-based lifestyle change program adapted from the Diabetes Prevention Program and AHA’s Check, Change, Control Blood Pressure Self-Management Program which incorporates AHA’s LS7 framework. The change in a LS7 score (range 0-14) from baseline to 12 and 24 weeks was evaluated using a linear mixed effects model adjusted for age, education and income. Results: The mean age of participants was 52 ±10 years. The men were sociodemographically diverse with annual income ranging from <$20,000 (7%) to ≥$75,000 (25%). Twenty-five percent were college graduates, 73% had private insurance and 84% were employed. In fully adjusted models, LS7 score at baseline was 7.12 and increased 0.67 (95%CI: 0.14, 1.20, p=0.013) and 0.93 (95%CI: 0.40, 1.46, p=<0.001) points at 12 and 24 weeks, respectively, compared to baseline. Sensitivity analysis evaluating 5 components (excluding diet and physical activity) and 6 components (excluding diet) also showed significant increases at 12 and 24 weeks (all p<0.01). Conclusions: The Black Impact lifestyle change single-arm pilot program showed that a community-based lifestyle intervention has the potential to improve LS7 in Black men. Further randomized studies are urgently needed to improve cardiovascular health and advance cardiovascular health equity in Black men.
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