Black Impact for Heart Health
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a church-based program called Black Impact can enhance heart health in Black men at risk for conditions like heart disease and diabetes. It will assess whether the program improves health measures such as blood pressure and cholesterol. Participants will be divided into two groups: one begins the program immediately, while the other waits 24 weeks. The trial suits Black men living in Birmingham, AL, who have received medical clearance for physical activities. As an unphased trial, this study provides a unique opportunity to contribute to community health initiatives and potentially improve heart health.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that the Black Impact program is safe for improving cardiovascular health?
Research has shown that the Black Impact program aims to improve heart health in Black men by combining exercise and health education. Since the program emphasizes behavior over medication, it is generally considered safe. Participants engage in activities like exercise and receive support from health coaches, which are typically manageable. No evidence suggests harmful effects from this type of program.
Regular check-ins will monitor participants, allowing them to discuss experiences and concerns during the study. This process ensures the program remains safe and effective.12345Why are researchers excited about this trial?
Researchers are excited about Black Impact for heart health because it potentially offers a fresh approach to managing heart conditions. Unlike standard treatments that often rely on medications such as beta-blockers or ACE inhibitors, Black Impact might involve a novel mechanism, ingredient, or delivery method that presents a new way to improve heart health. By exploring these unique aspects, researchers hope to discover more effective or faster-acting options for patients, expanding the range of tools available to tackle heart issues.
What evidence suggests that the Black Impact program is effective for improving cardiovascular health in Black men?
A previous study showed that the Black Impact program improved heart health by boosting participants' Life's Simple 7 score. This score evaluates health factors like blood pressure and cholesterol, which are crucial for reducing heart disease risk. Participants also reported feeling less stressed, which benefits heart health. Black adults often face a higher risk of heart problems compared to White adults, highlighting the program's importance. In the current trial, some participants will start the Black Impact program immediately, while others will join a waitlist control group, receiving the intervention after 24 weeks of basic monitoring. Overall, early findings suggest that the Black Impact program could enhance heart health and reduce stress in Black men at risk for heart disease.16789
Are You a Good Fit for This Trial?
This trial is for Black men aged 35-70 at The Worship Center Christian Church, who are at risk for heart disease, diabetes, obesity, and related conditions. Participants should be willing to attend weekly sessions for 24 weeks and use provided health tracking tools. Specific eligibility criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants attend a 90-minute weekly session for 24 weeks, including physical activity and health education, and receive one-on-one support from a community health worker.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including biometric health screenings and surveys at baseline, 12 weeks, and 24 weeks.
Extension
Interviews with TWC leaders and interventionists to assess implementation, resource needs, and sustainability.
What Are the Treatments Tested in This Trial?
Interventions
- Black Impact
Trial Overview
The 'Black Impact' program is being tested to see if it improves cardiovascular health in Black men. It includes physical activity, education sessions, one-on-one support from a community health worker, biometric screenings and surveys. There's an immediate-start group and a delayed-start control group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
FELLAship intervention participants will receive the 24-week intervention according to the curriculum, to be delivered by a health coach, personal trainer, and community health worker.
Individuals in the waitlist control arm will not receive the intervention during the evaluation period. They will have access to the intervention post-evaluation period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
The Worship Center Christian Church
Collaborator
Citations
Design of Black Impact: A Randomized Controlled Trial ...
The single‐arm pilot showed improvements in Life's Simple 7 score (relative to a 19% reduction in cardiovascular death), psychosocial stress (ie ...
Disparities in Cardiovascular Mortality Between Black and ...
Black adults experience a disproportionately higher burden of cardiovascular (CV) risk factors and disease in comparison to White adults in the US.
3.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06055036?term=AREA%5BBasicSearch%5D(impact%2024)&rank=7Black 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 ...
Racial and Ethnic Disparities in Perceived Health Status ...
Black adults had significantly higher odds, compared with White adults, of reporting poorer perceived health (adjusted OR [AOR] = 1.72; 95% CI, ...
Race, Racism, and Cardiovascular Health: Applying a ...
We analyze the link between race, racism, and CVD, including major pathways and structural barriers to cardiovascular health, using 5 distinct social ...
6.
nhlbi.nih.gov
nhlbi.nih.gov/healthy-hearts-network-partner-spotlight/association-black-cardiologists-addressing-heart-healthAddressing Heart Health Disparities in African American ...
The African American community leads all ethnic groups in death rates due to heart disease, stroke, hypertension, and other factors in heart health.
Heart Disease and Black/African Americans
In 2024, Black or African American adults were diagnosed with hypertension (high blood pressure) 26% more frequently than the total population.1 ...
8.
newsroom.heart.org
newsroom.heart.org/news/cardiovascular-health-risks-continue-to-grow-within-black-communities-action-neededCardiovascular health risks continue to grow within Black ...
Black communities in the United States still face disproportionately higher risk of heart disease, stroke and hypertension.
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.
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