Clinical trial NCT06707636: Using Life's Essential 8 in Midlife Black Women
Official title: Using Life's Essential 8 to Lower Heart Disease Risk in Midlife Black Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stress
Self-Efficacy
Heart Disease Risk Factors
Depression Symptoms
Awareness
Perceived Stress
Lifestyle Intervention
Behavior Change
Keywords: perceived stress
heart disease risk factors
lifestyle intervention
behavior change
strong woman syndrome
choice
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 64
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Life's Essential 8 (LE8) score
timeFrame: From baseline to 16 weeks
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: from baseline to 16 weeks.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: From baseline to 16 weeks
measure: researcher-developed symptoms check list
timeFrame: From baseline to 16 weeks
Other outcomes:
measure: Perceived stress (PSS-10)
timeFrame: from baseline to 16 weeks.
measure: Genral Self Efficacy (GSE)
timeFrame: From baseline to 16 weeks
measure: Super Woman Syndrome
timeFrame: baseline
Locations:
city: Cincinnati
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References: