RecruitingPhase 2NCT06707636

Using Life's Essential 8 in Midlife Black Women

Using Life's Essential 8 to Lower Heart Disease Risk in Midlife Black Women


Sponsor

Ohio State University

Enrollment

64 participants

Start Date

Oct 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 64 Years

Inclusion Criteria3

  • Identifies as Black/ African American
  • Age 45-64.
  • Willing to adhere to the study requirements.

Exclusion Criteria3

  • 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.

Interventions

BEHAVIORALExperimental: Black Women's Stress and Wellness (B-SWELL) arm

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.

BEHAVIORALActive Comparator: Wellness (WE) arm

This is an attention control group. Participants placed in his arm will receive 8-weekly sessions focused on the Life's Essential 8 metrics.


Locations(1)

Ohio State University

Cincinnati, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06707636


Related Trials