Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Recruiting NA study of Obesity and Hypertension, sponsored by Ohio State University.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

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 differences rather than within-subject differences, using a linear mixed-effects to evaluate changes from baseline in Life's Essential 8 score (range 0-100, higher scores are better). Study wave will be a covariate in the models. The model will contain data from baseline (0 weeks), during-intervention (12 weeks), and post-intervention (24

Interventions

  • BEHAVIORAL Black Impact Intervention

Study Locations (1)

Ohio

  • The Ohio State University - Columbus

Trial Details

FieldValue
Enrollment Target 340 participants
Start Date 2023-08-24
Est. Completion 2027-03-31
Phase NA
Ohio State University

552 total trials

What NCT06055036 shows while recruiting

NCT06055036 is an interventional study that assigns participants to a tested intervention. The registered 340 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (58% lower).

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 a single indexed study location in 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, Type 2 Diabetes, Cardiovascular Diseases, 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.

Similar trials for Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06055036's enrollment target sits among peer trials

340 195th of 1053 higher than 859 of 1,053 other Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04176172 · 340 participants · Phase 3

    Optimizing Tobacco Use Treatment for PLWHA

  • NCT04545424 · 340 participants · Phase 2

    Trial of Therapeutic Hypothermia in Patients With ARDS

  • NCT04806958 · 340 participants · NA

    The PulsePoint Study

  • NCT05323409 · 340 participants · NA

    Improving Comprehensive Care of Cancer Patients

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT06055036, the US trial registry maintained by the National Library of Medicine. NCT06055036 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.