Using Life's Essential 8 in Midlife Black Women
Using Life's Essential 8 to Lower Heart Disease Risk in Midlife Black Women
1 other identifier
interventional
43
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2024
CompletedFirst Submitted
Initial submission to the registry
November 14, 2024
CompletedFirst Posted
Study publicly available on registry
November 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedApril 13, 2026
April 1, 2026
1.4 years
November 14, 2024
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Life's Essential 8 (LE8) score
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 cardiovascular health.
From baseline to 16 weeks
Secondary Outcomes (3)
Patient Health Questionnaire (PHQ-9)
from baseline to 16 weeks.
Pittsburgh Sleep Quality Index (PSQI)
From baseline to 16 weeks
researcher-developed symptoms check list
From baseline to 16 weeks
Other Outcomes (3)
Perceived stress (PSS-10)
from baseline to 16 weeks.
Genral Self Efficacy (GSE)
From baseline to 16 weeks
Super Woman Syndrome
baseline
Study Arms (2)
Black Women's Stress and Wellness (B-SWELL) arm
EXPERIMENTALThe B-SWELL arm consists of 8-weekly sessions. Sessions last 90 minutes and focus on stress reduction, heart disease, and healthy lifestyle changes. The American Heart Association's Life's Essential 8 metrics are leveraged and culturally tailored in the B-SWELL materials. Participants will also receive personalized health coaching.
Wellness (WE) arm
ACTIVE COMPARATORThis is an attention control group. Participants placed in his arm will receive 8-weekly sessions focused on the Life's Essential 8 metrics. Sessions will last approximately 90 minutes.
Interventions
This is an attention control group. Participants placed in his arm will receive 8-weekly sessions focused on the Life's Essential 8 metrics.
The B-SWELL arm consists of 8-weekly sessions. Sessions last 90 minutes and focus on stress reduction, heart disease, and healthy lifestyle changes. The American Heart Association's Life's Essential 8 metrics are leveraged and culturally tailored in the B-SWELL materials. Participants will also receive personalized health coaching.
Eligibility Criteria
You may qualify if:
- Identifies as Black/ African American
- Age 45-64.
- Willing to adhere to the study requirements.
You may not qualify if:
- Incarcerated or on house arrest,
- Diagnosed with terminal illness, severe mental illness, or dementia.
- Unable or unwilling to participate in 8 weekly sessions and 4 phone interviews.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University
Cincinnati, Ohio, 45221, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 14, 2024
First Posted
November 27, 2024
Study Start
October 11, 2024
Primary Completion
February 28, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Data will be will placed in the generalist database, DRYAD in accordance with NIH recommendations, at the time of publication. Data will then remain in DRYAD in perpetuity.
- Access Criteria
- Studies registered in Dryad are assigned a citable digital object identifier (DOI) number. Studies can be searched by name, DOI identifier, or topic. Datasets in DRYAD are indexed by the Thomson-Reuters Data Citation Index and include schema.org mark-up to make them discoverable in Google Dataset Search. DRYAD also integrates with any SWORD/OAI-PMH compliant repository, allowing its records to be discoverable through additional third-party aggregators.
This study will provide prospective survey data from a randomized pilot trial at four timepoints over a period of 16 weeks. The sample (N=64) consists of Black women ages 45-64. The data collected will include survey responses designed to assess viability of the optimized Midlife Black Women's Stress and Wellness intervention (B-SWELL). Surveys will include researcher developed tools (i.e., demographics, satisfaction, feedback, and symptoms check list), and seven validated tools (Cohen's Perceived Stress Scale, General Self-Efficacy scale, American Heart Association's Life's Essential 8 score, Perceived General Health scale, Patient Health Questionnaire, and Pittsburgh Sleep Quality Index). Coding, recodes, and analyses related to each tool will be performed according to instruction as they have been validated to ensure production of accurate results.