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NCT06055036 · ClinicalTrials.gov registry record · NA
Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention
A NA study of Obesity and Hypertension, sponsored by Ohio State University.
- Recruiting
- Registry status
- NA
- Development phase
- 340
- Enrollment target
- 1
- Study location
NCT06055036 is a NA study of Obesity and Hypertension that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 340 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06055036, a NA study of Obesity and Hypertension, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 340 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Black Impact Intervention
Study Locations (1)
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2023-08-24 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06055036
The ClinicalTrials.gov registry entry for NCT06055036 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (58% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Black Impact Intervention is the first listed.
NCT06055036 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06055036 about?
NCT06055036 is a clinical study titled "Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention". 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 t...
What is the current status of trial NCT06055036?
This trial is currently recruiting. It is a NA study. The enrollment target is 340 participants. The study started on 2023-08-24. Estimated completion is 2027-03-31.
What conditions does trial NCT06055036 study?
This clinical trial studies the following conditions: Obesity, Hypertension, Cardiovascular Diseases, Type 2 Diabetes, Sleep.
What interventions are being tested in trial NCT06055036?
The interventions under investigation include: Black Impact Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06055036?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06055036 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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