Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06707636 · ClinicalTrials.gov registry record · Phase 2
Using Life's Essential 8 in Midlife Black Women
A Phase 2 study of Stress and Self Efficacy, sponsored by Ohio State University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT06707636: Recruiting Phase 2 study of Stress and Self Efficacy, sponsored by Ohio State University.
NCT06707636 is a Phase 2 study of Stress and Self Efficacy that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 64 participants, below the 786-participant average among 152 other Stress trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06707636, a Phase 2 study of Stress and Self Efficacy, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Life's Essential 8 (LE8) is a recognized metric for cardiovascular health as defined by the American Heart Association. The LE8 score consists of 8 sub-measures. There are 4 lifestyle behaviors (Diet, Physical Activity, Nicotine Exposure and Sleep Health) and 4 health factors (BMI, Blood Lipids, Blood Glucose, and Blood Pressure). The total LE8 score is calculated as the average of the 8 individual component scores. Total scores range from 0 to 100 points. Higher scores correspond to better card
Conditions Studied
Interventions
- BEHAVIORAL Experimental: Black Women's Stress and Wellness (B-SWELL) arm
- BEHAVIORAL Active Comparator: Wellness (WE) arm
Study Locations (1)
Ohio
- Ohio State University - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2024-10-11 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
What NCT06707636 shows while recruiting
NCT06707636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 786-participant average among 152 other Stress trials with a reported enrollment target (92% lower).
The record links to 8 conditions, with Stress appearing as the primary indexed condition, and to 2 interventions - of which Experimental: Black Women's Stress and Wellness (B-SWELL) arm is the first listed.
NCT06707636 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06707636 about?
NCT06707636 is a clinical study titled "Using Life's Essential 8 in Midlife Black Women". 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...
What is the current status of trial NCT06707636?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2024-10-11. Estimated completion is 2026-02-28.
What conditions does trial NCT06707636 study?
This clinical trial studies the following conditions: Stress, Self Efficacy, Perceived Stress, Behavior Change, Awareness.
What interventions are being tested in trial NCT06707636?
The interventions under investigation include: Experimental: Black Women's Stress and Wellness (B-SWELL) arm (BEHAVIORAL), Active Comparator: Wellness (WE) arm (BEHAVIORAL).
Who is sponsoring clinical trial NCT06707636?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06707636 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress
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 NCT06707636's enrollment target sits among peer trials
64 87th of 152 higher than 64 of 152 other Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress 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
-
Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia
RECRUITING · Phase 2
-
Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
RECRUITING · Phase 2
-
Personal Relevance of Psychotherapy for Asian Americans
COMPLETED · Phase 2
-
Personalized Trials for Stress Management Against Standard of Care
COMPLETED · Phase 2
-
Efficacy of Healing Touch in Stressed Neonates
COMPLETED · Phase 2
-
Surviving Daily Life
RECRUITING
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
- NCT01853631 · 64 participants · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
- NCT03739502 · 64 participants · Phase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
- NCT03739814 · 64 participants · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- NCT03866408 · 64 participants · Early Phase 1
Insulin Regulation of Lipolysis and Lipolysis Proteins
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