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NCT06707636

Using Life's Essential 8 in Midlife Black Women

Active, enrolled NA Last updated 13 April 2026
What this trial tests

NA trial testing Experimental: Black Women's Stress and Wellness (B-SWELL) arm in Stress in 43 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
11 October 2024
Primary endpoint
28 February 2026
31 May 2026

Quick facts

Lead sponsorOhio State University
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment43
Start date11 October 2024
Primary completion28 February 2026
Estimated completion31 May 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Ohio State University

Who can join

Adults 45 to 64, female only, with Stress or Self-Efficacy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research seeks to improve the Midlife Black Women's Stress Reduction and Wellness Intervention (B-SWELL), a program designed to lower heart disease risk in midlife Black women. The B-SWELL leverages stress reduction to facilitate the adoption and adherence to healthier lifestyle behaviors. This research study will use choice to increase engagement and minimize the effect of social determinants of health on research participation among midlife Black women. A comparative clinical trial will be conducted. Midlife Black women (ages 45-64) who reside in the Greater Cincinnati area will be recruited for participation. Women are eligible if they self-identify as Black/ African American, are between the ages of 45-64, and are willing to commit to the requirements of the study (e.g., attend 8 weekly sessions and 4 phone interviews). Participants will be randomly placed (like the flip of a coin) into either the B-SWELL or WE group. Both the B-SWELL and WE groups are 8-week programs that focus on healthy lifestyle behaviors and heart disease awareness. Women will have the choice to participate in person or virtually. Survey phone interviews will be conducted at baseline, 8-, 12-, and 16-weeks. Data collected will provide information about adherence, healthy lifestyle behaviors, and cardiovascular health. Heart health will be measured using the American Heart Association's Life's Essential 8 metric. Outcome measures include heart disease awareness, Life's Essential 8 score, stress, self-efficacy, depressive symptoms, and symptoms.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Stress

Currently open trials in the same condition.

Other Ohio State University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing