NCT05902741 The Impact of a Race-Based Stress Reduction Intervention

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 300 participants in total. It began in 2023-10-18 with a primary completion date of 2028-01-31.

Brief Summary

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

Eligibility Criteria

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)

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