Clinical trial 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Racism
Stress
Inflammation
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2023-06-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Self-identified African American women will be randomized to either the race-based stress reduction intervention group (Resilience, Stress, and Ethnicity \[RiSE\]) or the HEP.
Primary purpose: PREVENTION

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:

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

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.

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)

Primary outcomes:
measure: Current perceived stress
timeFrame: 8 months
Secondary outcomes:
measure: General coping
timeFrame: 8 months
measure: Coping with discrimination
timeFrame: 8 months
measure: Internalized racism
timeFrame: 8 months
measure: Resistance and empowerment
timeFrame: 8 months
measure: DNA methylation
timeFrame: 8 months
measure: Stress overload
timeFrame: 8 months
measure: Depressive symptoms
timeFrame: 8 months
measure: Anxiety
timeFrame: 8 months
measure: Fatigue
timeFrame: 8 months
measure: Sleep disturbance
timeFrame: 8 months
measure: Inflammatory burden- C-reactive protein (CRP)
timeFrame: 8 months
measure: Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha)
timeFrame: 8 months
measure: Inflammatory burden - Interleukin-6 (IL-6)
timeFrame: 8 months
measure: Inflammatory burden - Interleukin-1 beta (IL-1B)
timeFrame: 8 months
measure: Inflammatory burden - Interferon gamma (IFN-γ),
timeFrame: 8 months
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
Study officials:
affiliation: Loyola University Chicago
name: Karen Saban, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: