RECRUITING

Using Life's Essential 8 in Midlife Black Women

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-11
Study Completion:2026-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06707636

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 64 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Identifies as Black/ African American
  2. * Age 45-64.
  3. * Willing to adhere to the study requirements.
  1. * Incarcerated or on house arrest,
  2. * Diagnosed with terminal illness, severe mental illness, or dementia.
  3. * Unable or unwilling to participate in 8 weekly sessions and 4 phone interviews.

Contacts and Locations

Study Contact

Dr. Holly J Jones, PhD
CONTACT
614-247-6082
jones.7935@osu.edu
Sandra Solove, MA
CONTACT
614-247-8366
solove.3@osu.edu

Study Locations (Sites)

Ohio State University
Cincinnati, Ohio, 45221
United States

Collaborators and Investigators

Sponsor: Ohio State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-11
Study Completion Date2026-02-15

Study Record Updates

Study Start Date2024-10-11
Study Completion Date2026-02-15

Terms related to this study

Keywords Provided by Researchers

  • perceived stress
  • heart disease risk factors
  • lifestyle intervention
  • behavior change
  • strong woman syndrome
  • choice

Additional Relevant MeSH Terms

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