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NCT06707636
Using Life's Essential 8 in Midlife Black Women
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.
28 February 2026
Quick facts
| Lead sponsor | Ohio State University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 43 |
| Start date | 11 October 2024 |
| Primary completion | 28 February 2026 |
| Estimated completion | 31 May 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Experimental: Black Women's Stress and Wellness (B-SWELL) arm
- Active Comparator: Wellness (WE) arm
Conditions studied
- Stress — all drugs for Stress →
- Self-Efficacy — all drugs for Self-Efficacy →
- Heart Disease Risk Factors — all drugs for Heart Disease Risk Factors →
- Depression Symptoms — all drugs for Depression Symptoms →
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.
Verify or expand the search:
- PubMed search for NCT06707636
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06707636 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ohio State University
- Last refreshed: 13 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06707636.
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