Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
FEMALE
NCT05902741

The Impact of a Race-Based Stress Reduction Intervention

Led by Loyola University · Updated on 2025-09-09

300

Participants Needed

1

Research Sites

223 weeks

Total Duration

On this page

Sponsors

L

Loyola University

Lead Sponsor

C

Columbia University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

The Impact of a Race-Based Stress Reduction Intervention

Who Can Participate

Age: 50Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Between the ages of 50 and 75
  • Female
  • Post-menopausal (without menstrual period for at least 12 consecutive months)
  • Self-identified African American or Black
  • Able to write, read, and speak English
  • Must have at least one of the following:
    • Waist circumference greater than 88 cm
    • Systolic blood pressure over 130 mmHg and/or diastolic blood pressure over 88 mmHg or on antihypertensive medications
    • Diagnosed and/or being treated for hypercholesterolemia
    • History of Type 2 diabetes
Not Eligible

You will not qualify if you...

  • History of myocardial infarction, ischemic heart disease, angina, stent placement, coronary artery bypass, left ventricular hypertrophy, congestive heart failure, or ischemic stroke
  • Any major immune-related disease such as rheumatoid arthritis or lupus
  • Use of immune-altering medications like glucocorticoids
  • Periodontal disease, bleeding gums, or dental work within the past 72 hours
  • Current smoker or smoked within the past 3 months
  • Active cancer
  • Active infection
  • Substance abuse
  • Cognitive or psychiatric disorder affecting ability to participate in classes (Brief Screen for Cognitive Impairment score of 8 or higher)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Loyola University Chicago

Maywood, Illinois, United States, 60153

Actively Recruiting

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Research Team

K

Karen Saban, RN, PhD

CONTACT

C

Cara Joyce, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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The Impact of a Race-Based Stress Reduction Intervention | DecenTrialz