Black Impact Intervention for Cardiovascular Health

Overseen By Sean Matambo

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve heart health among Black men by testing a lifestyle program called Black Impact Intervention. The program includes weekly physical activity, health education, and support from health professionals. Researchers aim to determine if this program can reduce stress and enhance overall heart health. Black men living in Metropolitan Columbus, Ohio, with less-than-ideal heart health habits are ideal candidates for this trial. Participants will either join the program or remain on a waitlist receiving usual care. As an unphased trial, this study offers participants a unique opportunity to contribute to important research that could lead to better heart health strategies for their community.

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 prior data suggests that the Black Impact Intervention is safe?

Research has shown that the Black Impact Intervention received positive feedback in early testing. In a small study with 74 participants, the program was well-liked, and most participants remained engaged. Specifically, participants demonstrated improvements in heart health, indicating that the program is generally easy to follow.

The Black Impact Intervention emphasizes lifestyle changes, such as weekly exercise and health education, rather than medication. This approach typically results in fewer side effects compared to drug treatments. No major negative effects were reported in the studies available. Overall, the program appears safe and effective for improving heart health in Black men. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Black Impact Intervention because it focuses on a culturally tailored approach to improving cardiovascular health specifically for Black communities. Unlike standard treatments that often rely on medication or general lifestyle advice, this intervention incorporates culturally relevant education and community support to encourage heart-healthy behaviors. This personalized approach aims to increase engagement and effectiveness by addressing social and cultural factors that traditional treatments might overlook.

What evidence suggests that the Black Impact Intervention could be effective for improving cardiovascular health?

In this trial, participants will join either the Black Impact Intervention or a waitlist control group receiving usual care. A previous study showed that the Black Impact program improved the heart health of Black men. Participants experienced an average increase of 0.93 points in their Life's Simple 7 (LS7) score over 24 weeks. This score measures key areas like physical activity, diet, and blood pressure. The study results were reliable, with a confidence range of 0.40 to 1.46 and a p-value of less than 0.001, indicating significant improvements. Additionally, participants reported positive changes in stress levels, mood, and overall involvement in health activities. These early findings suggest that the Black Impact program could enhance heart health and reduce disease risk among Black men. ^{1 2 4 6 7}

Who Is on the Research Team?

Joshua Joseph, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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

English speaking

Lives in Metropolitan Columbus, Ohio

My overall health score is below 80.

Exclusion Criteria

My doctor has advised me to limit my physical activities.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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 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]

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]

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]

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]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.039380

Design of Black Impact: A Randomized Controlled Trial ... Noting that Black men continue to experience 32% higher rates of cardiovascular disease–related deaths, as compared with non‐Hispanic White men, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06055036?term=AREA%5BBasicSearch%5D(impact%2024)&rank=7

Black Impact: The Mechanisms Underlying Psychosocial ... 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 ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840894

Prevention of CVD Events and Deaths Among Black Adults ... This modeling study estimates the number of cardiovascular disease (CVD) events and deaths that could be prevented among non-Hispanic Black ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9287100/

Community-Based, Cluster-Randomized Pilot Trial of a ... The refined FAITH! App appears to be an efficacious mobile health tool to promote ideal CVH among African Americans.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9566142/

The Role of Social Support in Cardiovascular Clinical Trial ... This intervention may provide a framework by which to facilitate clinical trial participation among Black men. Keywords: Black Impact, cardiovascular disease, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666667722000022

Improving cardiovascular health in black men through a 24 ... In conclusion, Black Impact, a 24-week community-based lifestyle intervention increased CVH scores among Black men. Given the significant CVH inequities, ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/434696

Black Impact: The Mechanisms Underlying Psychosocial ... 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.