A program to reduce stress related to racism in African American women

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

This study is testing a stress reduction program for African American women aged 50 to 75 to see if it can improve their well-being and health by helping them cope with stress from racism.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 50 Years to 75 Years
• Sex: Female
• Sponsor: Loyola University (other)
• Locations: 1 site (Maywood, Illinois)
• Trial ID: NCT05902741 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a stress reduction program called Resilience, Stress, and Ethnicity (RiSE) in improving well-being, inflammation, and epigenetic factors in African American women aged 50 to 75 who are at risk for heart or metabolic diseases. Participants will be randomly assigned to either the RiSE program, which focuses on cognitive-behavioral strategies to address social stressors like racism, or a Health Education Program (HEP) that provides general health education. Both groups will meet online for two hours weekly over eight weeks, with additional booster sessions following the intervention. The study will measure biological markers through saliva samples to assess the impact of the interventions.

Who should consider this trial

Good fit: Ideal candidates for this study are post-menopausal African American women aged 50 to 75 with specific health risk factors.

Not a fit: Patients with a history of significant cardiovascular issues, major immune-related diseases, or active cancer are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve the mental and physical health of African American women by reducing stress and inflammation linked to racism.

How similar studies have performed: While the specific approach of integrating race-based stress reduction is novel, similar interventions targeting stress reduction have shown promise in other studies.

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)

Where this trial is running

Maywood, Illinois

• Loyola University Chicago — Maywood, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Karen Saban, RN, PhD — Loyola University Chicago
• Study coordinator: Karen Saban, RN, PhD

Conditions: Racism, Stress, Inflammation