Using Life's Essential 8 in Midlife Black Women

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.

Conditions

• Stress
• Self-Efficacy
• Heart Disease Risk Factors
• Depression Symptoms
• Awareness
• Perceived Stress
• Lifestyle Intervention
• Behavior Change

Interventions

BEHAVIORAL

Experimental: 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.

BEHAVIORAL

Active 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.

Sponsors & Collaborators

• Ohio State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

64 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-11

Primary Completion

2026-02-28

Completion

2026-05-31

Countries

• United States

Study Locations