Loyola University Medical Center

Gottlieb Memorial Hospital

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NCT05902741

The Impact of a Race-Based Stress Reduction Intervention

Official Title:

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

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

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)

Disease(s) and\or Condition(s)

Racism

Stress

Inflammation

Primary Purpose
  • PREVENTION
Intervention/Treatment
    • Type: BEHAVIORAL
    • Name: RiSE
    • Description: RiSE provides participants with a platform to share the emotional impact of race-based stress and to offer supportive listening to their peers. Participants explicitly discuss the experiences they have as African American women, taking into account the ways which the interaction between their racial and gender identities shapes their experiences. Facilitators review difficulties associated with addressing racism and unique experiences of Black women at interpersonal and structural levels, and provide evidence of strategies to promote effective communication and internal emotional regulation regarding experiences of racism. Facilitators provide psychoeducation on intersectionality, structural racism, overt racism, microaggressions, and internalized racism. Following this education, facilitators help participants utilize cognitive-behavioral strategies to understand consequent thoughts, feelings, and actions associated with such experiences.
    • Arm Group Labels: Resilience, Stress, and Ethnicity (RiSE) program
    • Type: BEHAVIORAL
    • Name: HEP
    • Description: The HEP group will consist of classes focusing on wellness promotion. Expert speakers provide the HEP classes (e.g dietician, pharmacist).
    • Arm Group Labels: Health Education Program (HEP)
Sponsor
  • Loyola University