Using Life's Essential 8 in Midlife Black Women

Phase 2

Recruiting

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

• Registration Number: NCT06707636
• Lead Sponsor: Ohio State University

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.

Detailed Description

Conduct a RCT pilot of the modified B-SWELL consisting of 64 women randomized to B-SWELL (n=32) or control (n=32). The RCT will take place in two phases. Each phase will consist of virtual and in-person groups (n=8 for groups) for the B-SWELL and attention control. Participants will receive the B-SWELL materials (binder, flash drive) prior to start. Each weekly 90-minute session is devoted to a specific LE8 behavior. Sessions will begin with meditative practice followed by interactive presentations, review of case studies, and discussion. Coaching will occur via phone during the first weeks of the intervention with booster sessions at weeks 10 and 14. The attention control (virtual or in person) will mirror the B-SWELL in format and duration however, participants will only receive publicly available AHA materials and information. The Attention control will not receive stress information, goal setting, or coaching. Facilitators and coaches will be purposefully recruited and representative of midlife Black women.

This study will take place in Cincinnati. Women will be eligible if they identify as Black/African American; are between the ages of 45 and 64 during the trial; have a reliable phone for messaging and data collection calls; and willing to commit to the study duration and data collection phone calls (at 8, 12 and 16 weeks). Women will be excluded if they have recently immigrated or resettled in the U.S. or have major health conditions prohibiting safe participation. Having CVD will not be an exclusion as those with CVD can still show improvement in LE8. Recruitment activities will include fliers, email, snowballing, and social media. Community in-person sites will be selected based upon safety, accessibility, and resources. The C-RAB members will inform recruitment through their knowledge of the communities. For example, they may recommend that fliers be placed in particular high-traffic areas or sent to specific community organizations. C-RAB members are not personnel and, thus, will be instructed to refer any questions regarding this research to the PI and/or research staff. All C-RAB activities will be monitored by the PI.

Study Timeline

• Study Start: 2024-10-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-23
• Study First Posted: 2024-11-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-12
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Life's Essential 8 (LE8) score	From baseline to 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	from baseline to 16 weeks.	Diagnostic instrument for depression symptoms. The PHQ-9 scores each of the 9 DSM-IV criteria. Question 9 screens for the presence of suicide ideation. Total scores greater than 15 are associated with moderately severe and severe depression.
Pittsburgh Sleep Quality Index (PSQI)	From baseline to 16 weeks	19-item self-report assessment of sleep quality for the previous 1-month period. Yields 7 sleep components. Each component score ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties
researcher-developed symptoms check list	From baseline to 16 weeks	Participants self-report symptoms experienced over previous 2 weeks in the checklist. Responses are yes/no.

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Cincinnati, Ohio, United States