Clinical trial NCT06055036: Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention
Official title: Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiometabolic Syndrome
Physical Inactivity
Hypertension
Type 2 Diabetes
PreDiabetes
Obesity
Cardiovascular Diseases
Smoking
Sleep
Hyperlipidemias
Diet, Healthy
Blood Pressure
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-09-26
Enrollment: 340
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, wait-list controlled trial with 2 arms
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria are: 1) Black men (self-report); 2) adult age 18 years or older; 3) Life's Essential 8 total average score \< 80; 4) English speaking; and 5) lives in Metropolitan Columbus, Ohio.

Exclusion Criteria:

* healthcare provider-imposed limitations on physical activity.

Primary outcomes:
measure: Cardiovascular Health
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in Perceived Stress
timeFrame: 24 weeks
measure: Change in Life's Essential 8 Blood Pressure
timeFrame: 24 weeks
measure: Change in Life's Essential 8 Blood Lipids
timeFrame: 24 weeks
measure: Change in Life's Essential 8 Blood Glucose
timeFrame: 24 weeks
measure: Change in Life's Essential 8 Body Mass Index
timeFrame: 24 weeks
measure: Change in Life's Essential 8 Diet (subjective)
timeFrame: 24 weeks
measure: Change in Life's Essential 8 Diet (objective)
timeFrame: 24 weeks
measure: Change in Life's Essential 8 Physical Activity (subjective)
timeFrame: 24 weeks
measure: Change in Life's Essential 8 Physical Activity (objective)
timeFrame: 24 weeks
measure: Change in Life's Essential 8 Nicotine Exposure
timeFrame: 24 weeks
measure: Change in Life's Essential 8 Sleep Health
timeFrame: 24 weeks
measure: Change in Central Aortic Pressure
timeFrame: 24 weeks
measure: Change in carotid-femoral pulse wave velocity
timeFrame: 24 weeks
measure: Change in patient activation
timeFrame: 24 weeks
measure: Change in Social Needs
timeFrame: 24 weeks
measure: Change in Social Functioning
timeFrame: 24 weeks
measure: Change in Social Relationships
timeFrame: 24 weeks
measure: Change in Hair Cortisol
timeFrame: 24 weeks
measure: Change in Conserved Transcriptional Response to Adversity
timeFrame: 24 weeks
measure: Change in Gut Microbiome Health
timeFrame: 24 weeks
measure: Identify the organizational context and resources necessary to align, coordinate, and sustain academic-community-government partnerships focused on advancing cardiovascular health equity.
timeFrame: 156 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joshua Joseph, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joseph JJ, Gray DM 2nd, Williams A, Zhao S, McKoy A, Odei JB, Brock G, Lavender D, Walker DM, Nawaz S, Baker C, Hoseus J, Price T, Gregory J, Nolan TS. Addressing non-medical health-related social needs through a community-based lifestyle intervention during the COVID-19 pandemic: The Black Impact program. PLoS One. 2023 Mar 9;18(3):e0282103. doi: 10.1371/journal.pone.0282103. eCollection 2023.
citation: Addison S, Yang Y, Metlock F, King M, McKoy A, Williams A, Gregory J, Gray DM 2nd, Joseph JJ, Nolan TS. The Role of Social Support in Cardiovascular Clinical Trial Participation among Black Men: Black Impact. Int J Environ Res Public Health. 2022 Sep 23;19(19):12041. doi: 10.3390/ijerph191912041.
citation: Joseph JJ, Nolan TS, Williams A, McKoy A, Zhao S, Aboagye-Mensah E, Kluwe B, Odei JB, Brock G, Lavender D, Gregory J, Gray DM 2nd. Improving cardiovascular health in black men through a 24-week community-based team lifestyle change intervention: The black impact pilot study. Am J Prev Cardiol. 2022 Jan 13;9:100315. doi: 10.1016/j.ajpc.2022.100315. eCollection 2022 Mar.