Using Life's Essential 8 in Midlife Black Women

NCT ID: NCT06707636

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-11
• Study Completion Date: 2026-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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. Sessions will last approximately 90 minutes.

Group Type: ACTIVE_COMPARATOR

Active Comparator: Wellness (WE) arm

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Holly Jones

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ohio State University

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dr. Holly J Jones, PhD

Role: CONTACT

jones.7935@osu.edu

614-247-6082

Sandra Solove, MA

Role: CONTACT

solove.3@osu.edu

614-247-8366

Facility Contacts

Holly Jones, PhD

Role: primary

jones.7935@osu.edu

614-247-6082

Other Identifiers

2024B0010

Identifier Type: -

Identifier Source: org_study_id