Inflammation Clinical Trial
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
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
Status | Recruiting |
Enrollment | 300 |
Est. completion date | January 31, 2028 |
Est. primary completion date | January 31, 2028 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 75 Years |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Loyola University Chicago | Maywood | Illinois |
Lead Sponsor | Collaborator |
---|---|
Loyola University | Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Current perceived stress | Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome. | 8 months | |
Secondary | General coping | Ways of Coping Questionnaire. Scores range for 0 to 198 for total scale with higher scores suggesting more coping. | 8 months | |
Secondary | Coping with discrimination | Coping with Discrimination Scale. Scores range from 25 to 150 with higher scores suggesting more coping. | 8 months | |
Secondary | Internalized racism | Appropriated Racial Oppression Scale. Scores range from 24 to 168 with higher score suggesting worse outcome. | 8 months | |
Secondary | Resistance and empowerment | Resistance and Empowerment Against Racism Scale. Scores range from 26 to 130 with higher score suggesting better outcome. | 8 months | |
Secondary | DNA methylation | Targeted DNA methylation of targeted candidate genes | 8 months | |
Secondary | Stress overload | Stress Overload Scale. Scores range from 30 to 150 with higher score suggesting worse outcome. | 8 months | |
Secondary | Depressive symptoms | Beck Depression Inventory (BDI). Scores range from 0 to 63 with higher score suggesting worse outcome. | 8 months | |
Secondary | Anxiety | Generalized Anxiety Disorder-7 (GAD-7). Scores range from 0 to 21 with higher score suggesting worse outcome. | 8 months | |
Secondary | Fatigue | NIH Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a | 8 months | |
Secondary | Sleep disturbance | NIH PROMIS Short Form v1.0 | 8 months | |
Secondary | Inflammatory burden- C-reactive protein (CRP) | Salivary CRP | 8 months | |
Secondary | Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha) | Salivary TNF-alpha | 8 months | |
Secondary | Inflammatory burden - Interleukin-6 (IL-6) | Salivary IL-6 | 8 months | |
Secondary | Inflammatory burden - Interleukin-1 beta (IL-1B) | Salivary IL-1B | 8 months | |
Secondary | Inflammatory burden - Interferon gamma (IFN-?), | Salivary IFN-y | 8 months |
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