N/A
N=52
Stress-reduction Wellness Program for Midlife Black Women (B-SWELL)
Cardiovascular Risk Factor · Stress · Self Efficacy · Depressive Symptoms · Health Behavior
Bottom Line
View on ClinicalTrials.gov: NCT04404478 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: American Heart Association's Life's Simple Seven (LS7) Score — 8.76; 8.21 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- B-SWELL: Midlife Black Women's Stress Reduction Wellness Program (Behavioral); WE: Wellness program for Midlife Black Women (Behavioral)
- Age
- Adult · 40+ yrs
- Sex
- Female
- Sponsor
- University of Cincinnati
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American Heart Association's Life's Simple Seven (LS7) Score |
8.76; 8.21 | — |
| SECONDARY Unhealthy Days |
2.52; 3.09 | — |
| SECONDARY Perceived General Health |
17; 13 | — |
| SECONDARY Patient Health Questionnaire (PHQ9) |
4.80; 5.39 | — |
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.
Eligibility Criteria
Inclusion Criteria
- fluent in the English language,
- ability to hear and talk well enough to engage in everyday conversation,
- access to a telephone with messaging,
- access to WIFI,
- willingness to participate for duration of the study.
Exclusion Criteria
- recent immigration to the U.S.,
- prisoner or on house arrest,
- pregnant,
- terminal illness (i.e., late stage cancer, end-of-life condition, renal failure requiring dialysis),
- history of Alzheimer's, dementia, or severe mental illness (i.e., suicidal tendencies, schizophrenia, or severe untreated depression),
- any other major health conditions or disabilities prohibiting safe participation in the program.
Data sourced from ClinicalTrials.gov (NCT04404478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.