The Impact of a Race-Based Stress Reduction Intervention on Well-Being, Inflammation, and DNA Methylation in African American Women at Risk for Cardiometabolic Disease

Loyola University1 site in 1 country300 target enrollmentOctober 18, 2023

ConditionsRacism Stress Inflammation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Racism
Sponsor: Loyola University
Enrollment: 300
Locations: 1
Primary Endpoint: Current perceived stress
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

Prior to starting the intervention
Mid-way through the intervention (Week 4)
End of the intervention (Week 8)
Six (6) months after the completion of the intervention

Detailed Description

Participants of both programs - RiSE and Health Education Program (HEP) - will meet weekly for 8 consecutive weeks for approximately 2 hours every week. Two booster sessions will occur one month and two months after completion of the interventions. Classes will meet synchronously over Zoom. RiSE classes will be facilitated by two trained clinical psychologists. Expert speakers will be hired to provide the HEP classes (e.g dietician, pharmacist). The investigators will vary the time of day for each 8- week program in order to meet the scheduling needs of participants. Cohorts of 9-12 participants each and sessions for the treatment and control group will be provided concurrently. Topics for the health education program (HEP) (attention-control) were selected so they would not confound the overall objectives of the RiSE program.

Registry

clinicaltrials.gov

Start Date

October 18, 2023

End Date

January 31, 2028

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Loyola University

Responsible Party

Principal Investigator

Karen Saban

Professor

Loyola University

Eligibility Criteria

Inclusion Criteria

•Between the ages of 50 and 75
•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)