Black Impact Intervention for Cardiovascular Health

Recruiting in Palo Alto (17 mi)

Overseen by Joshua Joseph, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ohio State University

Disqualifiers: Physical activity limitations

No Placebo Group

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}

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.

Trial 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 (Behavioural 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Ohio State University Columbus, OH

Who Is Running the Clinical Trial?

Ohio State University Lead Sponsor

American Heart Association Collaborator

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] Adverse cardiovascular health disparities persist for African American men. Although changing health behaviors is perhaps one of the most effective methods to prevent cardiovascular disease (CVD)-related deaths, previous behavior change programs targeting single or multiple CVD risk factors in target groups have had mixed success. The purpose of this pilot study was to determine whether a multi-faceted peer group intervention model based on American Heart Association's Life's Simple 7 was feasible, safe, acceptable, and efficacious in producing meaningful risk reduction for African American men.

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

Addressing cardiovascular disparities through community interventions. [2022] To identify the components and impact of intervention programs aimed at reducing cardiovascular disparities.

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

Cardiovascular risk factor screening and intervention in African American adults. [2022] The Cardiac Health and Rehabilitation program of St. Thomas Hospital in Nashville, Tennessee, has developed a project to assess the effectiveness of a community-based cardiovascular risk assessment and intervention program directed at African American adults. The specific aim of this program is to assess the feasibility of implementing a community-based cardiovascular disease risk factor reduction program directed at African American adults. Its ultimate goal is to be able to teach African American adults cost-efficient, simple methods of exercise, nutrition, and weight management; smoking cessation; and blood pressure control. The program is expected to raise the African American community's awareness of the importance of modifiable cardiovascular disease risk factors and their effect on cardiac morbidity and mortality. The program is also expected to be able to evaluate the success of cardiovascular disease risk factor intervention and patient satisfaction with the program.

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

Setting the agenda for research and education on coronary heart disease. [2022] Coronary heart disease (CHD) disproportionately affects the African American population with death and disability. The disparity in mortality continues to exist between the general population and African Americans despite decreases in death rates in both groups since the 1970s. The National Heart, Lung, and Blood Institute (NHLBI) is committed to developing and supporting research and activities that improve the health of African Americans through community partnership initiative. One such initiative is the CHD in Blacks Project, developed to increase awareness of the adverse effects of CHD, encourage healthy lifestyle behaviors, and, among health professionals, ensure that the latest treatment guidelines from the NHLBI in high blood pressure, high blood cholesterol, and obesity are used. The NHLBI has also established a network of health professionals from across the country to assist in developing medical education programs and community education outreach activities in conjunction with the National Medical Association, the Association of Black Cardiologists, and the National Black Nurses Association.

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

Promoting Heart Health Among Rural African Americans. [2022] Cardiovascular disease is a major cause of death for people living in the United States. African Americans bear a disproportionate burden of cardiovascular disease. Interventions designed to target multiple risk factors may facilitate elimination of cardiovascular disease health disparities.

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] Cardiovascular disease remains the leading cause of death for women, and racial and ethnic minority groups disproportionately suffer from cardiovascular risk factors. We developed an intensive, culturally-tailored 12-week nutrition and physical activity program, Love Your Heart, to reduce cardiovascular risk factors for African American women in the Boston area from January to April 2011. The pilot study partnered an academic institution with two community-based organizations, the Boston Black Women's Health Institute (BBWHI) and Body by Brandy Wellness Center (BBBWC). The study sample consisted of 34 women with a mean age of 48 years (SD +/- 3), with high rates of hypertension (79%), obesity (79%), and elevated waist circumference (94%). Over 12 weeks of follow-up, there were substantial reductions in hypertension and elevated waist circumference. We found that a culturally tailored weight management program reduced weight and cardiovascular risk factors for African American women in an urban community. While small, our study suggests that targeted community-based interventions focusing on personal and group wellness have the power to reduce health disparities and improve cardiovascular health for African American women.

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

Cardiovascular disease in blacks: can we stop the clock? [2022] Blacks have the highest rates of hypertension and cardiovascular disease, with earlier onset, greater severity, and more target organ damage including coronary disease, heart failure, stroke, and end-stage renal disease. A major reason is the greater prevalence of other cardiovascular disease risk factors, particularly obesity, inactivity, and diabetes mellitus, along with socioeconomic differences, adherence, and achievement of goals. This review focuses on the burden of cardiovascular disease in blacks. Therapeutic lifestyle changes and pharmacologic interventions to decrease clinical events in this high-risk group are described. Intensive blood pressure control is a primary means of "stopping the clock" in the progression of cardiovascular disease and renal disease. Thiazide diuretics remain primary first-step agents, especially for uncomplicated hypertension; calcium channel blockers are also efficacious. However, renin-angiotensin system modulators may also be beneficial, especially with a diuretic, considering the high prevalence in this group of patients of compelling indications for use of such agents.

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

Hypertension improvement through healthy lifestyle modifications. [2022] Hypertension is the major risk factor for the development of cardiovascular and renal disease. This disease has a disproportionate effect on African Americans when compared to other races. The purpose of this project was to examine the effectiveness of healthy lifestyle modifications on blood pressure control among hypertensive African American adults. Thirty-six individuals participated in the 12-week project, with a 67% retention rate. Weekly sessions included interactive educational and walking components. Initial and final BMI measurements were recorded. Participants completed health risk assessments; pre and post questionnaires; and, daily logs ofblood pressure measurement, dietary consumption, and physical activity levels. Data were collected from the logs, BMI measurements, and questionnaires. Overall, the results revealed that participants experienced an increase in healthy lifestyle modification adoption resulting in blood pressure control improvement. Implementation of healthy lifestyle modifications is crucial in providing quality patient care to hypertensive individuals.

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

A review of interventions to reduce health disparities in cardiovascular disease in African Americans. [2022] There is a wealth of first- (type or extent) and second- (causes) generation health disparities research. Literature on health disparities interventions (third-generation research) is emerging. In this study, we compiled and qualitatively evaluated interventions to eliminate health disparities in cardiovascular disease (CVD) among African Americans.

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

mHealth Intervention Promoting Cardiovascular Health Among African-Americans: Recruitment and Baseline Characteristics of a Pilot Study. [2022] Mobile health (mHealth) interventions are promising avenues to promote cardiovascular (CV) health among African-Americans (AAs) and culturally tailored technology-based interventions are emerging for this population.

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

Creating a transdisciplinary research center to reduce cardiovascular health disparities in Baltimore, Maryland: lessons learned. [2023] Cardiovascular disease (CVD) disparities continue to have a negative impact on African Americans in the United States, largely because of uncontrolled hypertension. Despite the availability of evidence-based interventions, their use has not been translated into clinical and public health practice. The Johns Hopkins Center to Eliminate Cardiovascular Health Disparities is a new transdisciplinary research program with a stated goal to lower the impact of CVD disparities on vulnerable populations in Baltimore, Maryland. By targeting multiple levels of influence on the core problem of disparities in Baltimore, the center leverages academic, community, and national partnerships and a novel structure to support 3 research studies and to train the next generation of CVD researchers. We also share the early lessons learned in the center's design.