Addressing non-medical health-related social needs through a community-based lifestyle intervention during the COVID-19 pandemic: The Black Impact program.
Joshua J Joseph, Darrell M Gray, Amaris Williams...
https://pubmed.ncbi.nlm.nih.gov/36893165/Actively Recruiting
Led by Ohio State University · Updated on 2025-10-06
340
Participants Needed
1
Research Sites
52 weeks
Total Duration
This research investigates a community-based lifestyle intervention called Black Impact, designed to improve cardiovascular health CVH among Black men, who have the shortest life expectancy among non-indigenous groups partly due to lower CVH. The study evaluates Black Impacts effects on CVH and psychosocial stress, aiming to better understand how the program reduces cardiovascular disease risk. This investigation is a randomized, wait-list controlled trial focused on addressing health equity through innovative, multi-modal approaches. The Black Impact intervention lasts 24 weeks and includes weekly 90-minute sessions combining physical activity and health education. Participants join groups based on their location and receive guidance from a health coach, a community health worker addressing social needs and connecting participants to care, and a fitness trainer. The intervention adapts elements from established programs like the Diabetes Prevention Program and the American Heart Associations Check, Change, Control programs. Participants will engage in weekly group sessions and be monitored over 24 weeks for changes in cardiovascular health using the American Heart Associations Lifes Essential 8 metrics. Assessments include stress levels, blood pressure, blood lipids, glucose, body mass index, diet, physical activity, nicotine exposure, sleep health, social functioning, and biological markers such as hair cortisol and gut microbiome health. The study also explores the resources needed to sustain partnerships that support cardiovascular health equity. Participation lasts at least 24 weeks with ongoing evaluation.
CONDITIONS
Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention
S
Sean Matambo
L
Luiza Reopell
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Ohio State University
Lead Sponsor
American Heart Association
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Black Impact Intervention | Waitlist Control |
|---|---|---|
| What it is | A 24-week, group-based community lifestyle change program for Black men. The intervention incorporates weekly in-person group meetings, health coaching, structured exercise with a trainer, and support from a community health worker. The curriculum is adapted from the Diabetes Prevention Program and American Heart Association Check, Change, Control, with added focus on psychosocial stress reduction and addressing social needs. | No structured behavioral intervention or community group program is provided during the 24-week study period; participants may continue usual health behaviors but do not receive coaching or group sessions. The intervention is offered after study completion. |
| Role in trial | The intervention arm receiving the active, group-based, community-delivered lifestyle program, intended to improve cardiovascular and psychosocial outcomes. | Serves as the trial’s comparator arm; participants receive no structured group intervention during the main trial, modeling usual health behaviors and care. |
| Primary use or aim | To evaluate whether a culturally tailored lifestyle program can reduce psychosocial stress and improve cardiovascular risk profiles among Black men. | To provide an untreated comparison group reflecting standard health behaviors and psychosocial outcomes among Black men in the community. |
| How it is given or performed | Participants attend 90-minute in-person group sessions each week for 24 weeks. Sessions include physical activity, health education, social support, and navigation to health and social services, all led by trained staff and a community health worker. | No organized intervention is delivered during the 24-week main period; participants do not receive group meetings, coaching, or trainer-led activities; usual individual care continues outside the study. |
| Evidence status | The Black Impact intervention is under evaluation in this ongoing randomized trial. A prior pilot study showed improved cardiovascular health metrics among Black men participating in the group-based program, but definitive evidence awaits completion of this larger trial. | Waitlist control provides a benchmark for cardiovascular and psychosocial health in the absence of a structured intervention, mirroring current usual care and behaviors. No special benefit is expected during the waitlist period. |
| Important limitations | Large-scale effectiveness, long-term sustainability, and generalizability to other populations or regions remain unproven outside this trial. Active participation may be limited by personal schedules, travel, or group attendance barriers, and the culturally tailored content may not be widely adaptable. | Waitlist control does not model the effect of standard, guideline-endorsed lifestyle programming (which is rarely implemented systematically for Black men), and participants may be motivated to change health behaviors before access to the program. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants take part in the 24-week Black Impact community-based lifestyle intervention, meeting weekly in groups for coaching and physical activity led by a health coach, community health worker, and trainer.
Weekly visits for up to 24 weeks
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Joshua J Joseph, Darrell M Gray, Amaris Williams...
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https://pubmed.ncbi.nlm.nih.gov/40996070/Joshua J Joseph, Timiya S Nolan, Amaris Williams...
https://pubmed.ncbi.nlm.nih.gov/35146467/Sarah Addison, Yesol Yang, Faith Metlock...
https://pubmed.ncbi.nlm.nih.gov/36231354/Ohio State University
Lead Sponsor
American Heart Association
Collaborating Sponsor