RECRUITING
I'm interested ...!!
The Impact of a Race-Based Stress Reduction Intervention
The goal of this clinical trial is to learn whether a stress reduction program called Resilience, Stress, and Ethnicity (RiSE) improves well-being, inflammation, and the epigenome in African American (AA) women who have risk factors for heart or metabolic disease. The main question it aims to answer is whether an intervention that integrates cognitive-behavioral strategies focused on the impact that social stress, such as racism, has on the body, racial identity development, and empowerment. Participants will placed in one of the two following groups: * The RiSE program will focus on teaching participants how to reduce their stress levels and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks. * The Health Education program will include education on how to improve general health and will meet online weekly for approximately 2 hours each week for 8 consecutive weeks. Participants will provide saliva to measure cytokines and DNA methylation (DNAm), complete questionnaires, and have blood pressure, heart rate, and weight measured at the following clinic visits: 1. Prior to starting the intervention 2. Mid-way through the intervention (Week 4) 3. End of the intervention (Week 8) 4. Six (6) months after the completion of the intervention
Conditions:
🦠 Racism 🦠 Stress 🦠 Inflammation
🗓️ Study Start (Actual) 18 October 2023
🗓️ Primary Completion (Estimated) 31 January 2028
✅ Study Completion (Estimated) 31 January 2028
👥 Enrollment (Estimated) 300
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Maywood, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Between the ages of 50 and 75
    • * Female
    • * Post-menopausal (without menstrual period for at least 12 consecutive months)
    • * Self-identified AA or Black
    • * Able to write, read, speak English
    • * Must have at least 1 of any of the following:
    • * Waist circumference \>88 cm
    • * Systolic BP\>130 mmHg and/ or diastolic BP\>88 mmHg or on antihypertensive medications
    • * Diagnosed and/or being treated for hypercholesterolemia
    • * History of Type 2 diabetes

    Exclusion Criteria:

    • * History of myocardial infarction or ischemic heart disease/angina, stent placement, coronary artery bypass, left ventricular hypertrophy, congestive heart failure, or ischemic stroke
    • * Any major immune-related disease (e.g., rheumatoid arthritis. lupus)
    • * Use of immune-altering medications, such as glucocorticoids
    • * Periodontal disease, bleeding gums, dental work in past 72 hours
    • * Current smoker or has smoked in past 3 months
    • * Active cancer
    • * Active infection
    • * Substance abuse
    • * Cognitive or psychiatric disorder that would affect ability to participate in classes (Brief Screen for Cognitive Impairment total score of 8 or higher)
Ages Eligible for Study: 50 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 2 May 2023
  • First Submitted that Met QC Criteria 5 June 2023
  • First Posted 15 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 January 2024
  • Last Update Posted 22 January 2024
  • Last Verified January 2024
I'm interested ...!!