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Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)
NCT04404478 · View on ClinicalTrials.gov ↗
Study Summary
This research study examines the unique cultural and gender-based factors that influence how midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily life. The B-SWELL intervention uses stress reduction and goal setting to increase self efficacy in adopting healthy lifestyle behaviors. The B-SWELL intervention will be compared to an inattention control wellness group in a randomized control trial. The long-term outcome is to decrease cardiovascular disease risk in this high-risk population, midlife Black women.
Conditions Studied
Interventions
- BEHAVIORAL B-SWELL: Midlife Black Women's Stress Reduction Wellness Program
- BEHAVIORAL WE: Wellness program for Midlife Black Women
Study Locations (1)
Ohio
- University of Cincinnati, College of Nursing — Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-02-13 |
| Est. Completion | 2021-06-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04404478
The ClinicalTrials.gov registry entry for NCT04404478 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 179 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Stress appearing as the primary indexed condition, and to 2 interventions — of which B-SWELL: Midlife Black Women's Stress Reduction Wellness Program is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04404478 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04404478 about?
NCT04404478 is a clinical study titled "Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)". This research study examines the unique cultural and gender-based factors that influence how midlife Black women experience stress and incorporate healthy lifestyle behaviors into daily life. The B-SWELL intervention uses stress reduction and goal setting to increase self efficacy in adopting health...
What is the current status of trial NCT04404478?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2021-02-13. Estimated completion is 2021-06-12.
What conditions does trial NCT04404478 study?
This clinical trial studies the following conditions: Stress, Health Behavior, Depressive Symptoms, Cardiovascular Risk Factor, Self Efficacy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04404478?
The interventions under investigation include: B-SWELL: Midlife Black Women's Stress Reduction Wellness Program (BEHAVIORAL), WE: Wellness program for Midlife Black Women (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04404478?
This trial is sponsored by University of Cincinnati, which has 179 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04404478 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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