About this trial
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
Qualifiers
Between the ages of 50 and 75
Female
Post-menopausal (without menstrual period for at least 12 consecutive months)
Self-identified AA or Black
Disqualifiers
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
Trial design
Treatments tested in this trial
- RiSE
- HEP
Treatment groups
Sponsors and collaborators
Loyola University
Lead sponsor
Columbia University
Collaborator