Black Impact Intervention for Cardiovascular Health

Overseen By Luiza Reopell

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Physical activity limitations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

340 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on lifestyle changes like physical activity and health education.

What data supports the effectiveness of the Black Impact Intervention treatment for cardiovascular health?

Research shows that community-based programs focusing on lifestyle changes, like exercise and nutrition, have been effective in reducing cardiovascular disease risk among African Americans. These programs often include peer support and education, which are key components of the Black Impact Intervention treatment. ^{1 2 3 4 5}

Is the Black Impact Intervention safe for humans?

The Black Impact Intervention, evaluated in studies for cardiovascular health, has been found to be safe and acceptable for participants, as shown in a pilot study involving African American men. This study focused on reducing cardiovascular disease risk through peer group support and lifestyle changes. ^{1 2 6 7 8}

How is the Black Impact Intervention treatment different from other treatments for cardiovascular health?

The Black Impact Intervention is unique because it focuses on a multi-faceted peer group support model specifically tailored for African American men, using the American Heart Association's Life's Simple 7 guidelines to reduce cardiovascular disease risk. This approach emphasizes community and cultural relevance, which is different from standard medical treatments that may not address these specific social and cultural factors. ^{1 2 9 10 11}

Research Team

Joshua Joseph, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for English-speaking Black men over 18 living in Metropolitan Columbus, Ohio, with below-average cardiovascular health as per the Life's Essential 8 score. It's not suitable for those who have been advised against physical activity by a healthcare provider.

Inclusion Criteria

I am 18 years old or older.

English speaking

Lives in Metropolitan Columbus, Ohio

Exclusion Criteria

My doctor has advised me to limit my physical activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 24-week community-based lifestyle intervention with weekly physical activity, health education, and engagement with health professionals.

24 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for changes in cardiovascular health and psychosocial stress after the intervention.

24 weeks

Long-term Follow-up

Evaluation of organizational context and resources necessary to sustain partnerships for cardiovascular health equity.

156 weeks

Treatment Details

Interventions

• Black Impact Intervention

Trial Overview The 'Black Impact' intervention is being tested to see if it can improve cardiovascular health and reduce psychosocial stress. Participants will engage in weekly physical activities, health education, and work with a health coach for 24 weeks.

Participant Groups

Group I: Black Impact Intervention Experimental Treatment 1 Intervention

Black Impact Intervention

Group II: Black Impact Waitlist Control Active Control 1 Intervention

Usual Care

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

A pilot study involving 24 African American men showed that a peer group intervention based on the American Heart Association's Life's Simple 7 was feasible and safe, with no adverse events reported during the study.

The intervention led to significant reductions in cholesterol levels and weight at one site (Washington, D.C.), indicating potential efficacy in reducing cardiovascular disease risk, although results varied by location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Group Support Intervention to Reduce Cardiovascular Disease Risk for African American Men According to Life's Simple 7 in Faith-Based Communities. Lee, S., Niakosari Hadidi, N., Lindgren, BR., et al.[2022]

Intervention programs aimed at reducing cardiovascular disparities among African Americans often focus on lifestyle changes and attitudes, but their impacts are typically short-lived due to a lack of sustainability and community support.

Most studies reviewed did not have long enough timelines to measure significant clinical outcomes, highlighting the need for more comprehensive and enduring strategies to address these disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing cardiovascular disparities through community interventions. Shaya, FT., Gu, A., Saunders, E.[2022]

The Cardiac Health and Rehabilitation program aims to implement a community-based cardiovascular risk assessment and intervention specifically for African American adults, focusing on cost-effective methods for exercise, nutrition, and weight management.

The program seeks to increase awareness of cardiovascular disease risk factors in the African American community and will evaluate both the effectiveness of the interventions and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular risk factor screening and intervention in African American adults. Anderson, JT., Watson, M., Hilleman, D.[2022]

Coronary heart disease (CHD) remains a significant health issue for the African American population, with ongoing disparities in mortality rates compared to the general population, despite overall decreases in death rates since the 1970s.

The National Heart, Lung, and Blood Institute (NHLBI) is actively working to address these disparities through initiatives like the CHD in Blacks Project, which aims to raise awareness, promote healthy lifestyle changes, and ensure that healthcare professionals follow the latest treatment guidelines for conditions like high blood pressure and cholesterol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Setting the agenda for research and education on coronary heart disease. Fulwood, R.[2022]

The 'With Every Heartbeat Is Life' program effectively improved the intentions, attitudes, norms, and self-efficacy of rural African American adults towards healthier eating and increased exercise, indicating its potential to reduce cardiovascular disease risk.

This study, conducted as a cluster randomized controlled trial among congregants from 12 rural churches in northern Florida, suggests that culturally relevant health interventions can positively influence cardiovascular health behaviors in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Heart Health Among Rural African Americans. Abbott, L., Williams, C., Slate, E., et al.[2022]

The Love Your Heart program, a 12-week culturally-tailored nutrition and physical activity intervention, effectively reduced hypertension and elevated waist circumference among 34 African American women, highlighting its potential to improve cardiovascular health.

This pilot study suggests that community-based interventions can significantly address health disparities and reduce cardiovascular risk factors in minority populations, despite the small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Love your heart: a pilot community-based intervention to improve the cardiovascular health of African American women. Rodriguez, F., Christopher, L., Johnson, CE., et al.[2022]

Blacks experience higher rates of hypertension and cardiovascular disease, often with earlier onset and more severe complications, largely due to a greater prevalence of risk factors like obesity and diabetes.

Intensive blood pressure control is crucial for managing cardiovascular and renal disease in this population, with thiazide diuretics and calcium channel blockers being effective first-line treatments, and renin-angiotensin system modulators also recommended for their additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular disease in blacks: can we stop the clock? Ferdinand, KC.[2022]

A 12-week program involving healthy lifestyle modifications led to improved blood pressure control in 36 hypertensive African American adults, highlighting the effectiveness of lifestyle changes in managing hypertension.

Participants showed increased adoption of healthy habits, which is essential for quality care in hypertensive patients, demonstrating the importance of education and physical activity in blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension improvement through healthy lifestyle modifications. Rigsby, BD.[2022]

A review of 524 abstracts identified 33 articles focused on interventions to reduce cardiovascular disease (CVD) disparities among African Americans, highlighting the need for more third-generation health disparities research.

Community-based clinics utilizing lay health volunteers were particularly effective in these interventions, although the intensity of the intervention did not correlate with the outcomes achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of interventions to reduce health disparities in cardiovascular disease in African Americans. Crook, ED., Bryan, NB., Hanks, R., et al.[2022]

The study successfully recruited 50 African-American participants, primarily women, into a pilot mHealth cardiovascular health promotion program using a community-based participatory research approach, demonstrating the feasibility of engaging this population in health interventions.

Over 90% of participants reported using mobile technology, with 60% feeling 'very comfortable' using it, indicating a high level of eHealth literacy and suggesting that African-Americans are likely to be receptive to mobile health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Intervention Promoting Cardiovascular Health Among African-Americans: Recruitment and Baseline Characteristics of a Pilot Study. Brewer, LC., Jenkins, S., Lackore, K., et al.[2022]

The Johns Hopkins Center to Eliminate Cardiovascular Health Disparities aims to address the significant impact of cardiovascular disease (CVD) disparities on African Americans in Baltimore, focusing on uncontrolled hypertension.

The center employs a transdisciplinary approach, utilizing partnerships across academic, community, and national levels to support research and training, highlighting the importance of collaboration in tackling health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating a transdisciplinary research center to reduce cardiovascular health disparities in Baltimore, Maryland: lessons learned. Cooper, LA., Boulware, LE., Miller, ER., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Peer Group Support Intervention to Reduce Cardiovascular Disease Risk for African American Men According to Life's Simple 7 in Faith-Based Communities. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Addressing cardiovascular disparities through community interventions. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular risk factor screening and intervention in African American adults. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Setting the agenda for research and education on coronary heart disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Promoting Heart Health Among Rural African Americans. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Love your heart: a pilot community-based intervention to improve the cardiovascular health of African American women. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular disease in blacks: can we stop the clock? [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Hypertension improvement through healthy lifestyle modifications. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A review of interventions to reduce health disparities in cardiovascular disease in African Americans. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

mHealth Intervention Promoting Cardiovascular Health Among African-Americans: Recruitment and Baseline Characteristics of a Pilot Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Creating a transdisciplinary research center to reduce cardiovascular health disparities in Baltimore, Maryland: lessons learned. [2023]