The Impact of a Race-Based Stress Reduction Intervention

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое RiSE
  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 pr
• Поведенческое HEP
  The HEP group will consist of classes focusing on wellness promotion. Expert speakers provide the HEP classes (e.g dietician, pharmacist).

Первичные конечные точки

• Current perceived stress [Срок оценки: 8 months]

Вторичные конечные точки (12)

• General coping [Срок оценки: 8 months]
• Coping with discrimination [Срок оценки: 8 months]
• Internalized racism [Срок оценки: 8 months]
• Resistance and empowerment [Срок оценки: 8 months]
• DNA methylation [Срок оценки: 8 months]
• Stress overload [Срок оценки: 8 months]
• Depressive symptoms [Срок оценки: 8 months]
• Anxiety [Срок оценки: 8 months]
• Fatigue [Срок оценки: 8 months]
• Sleep disturbance [Срок оценки: 8 months]
• Inflammatory burden- C-reactive protein (CRP) [Срок оценки: 8 months]
• Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha) [Срок оценки: 8 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Loyola University Chicago — Maywood

Публикации

• Saban KL, Joyce C, Nyembwe A, Janusek L, Tell D, de la Pena P, Motley D, Shawahin L, Prescott L, Potts-Thompson S, Taylor JY. The Effectiveness of a Race-Based Stress Reduction Intervention on Improving Stress-Related Symptoms and Inflammation in African American Women at Risk for Cardiometabolic Disease: Protocol for Recruitment and Intervention for a Randomized Controlled Trial. JMIR Res Protoc. PMID 40250840
• Taylor JY, Jones-Patten A, Prescott L, Potts-Thompson S, Joyce C, Tayo B, Saban K. The race-based stress reduction intervention (RiSE) study on African American women in NYC and Chicago: Design and methods for complex genomic analysis. PLoS One. 2024 Apr 10;19(4):e0295293. doi: 10.1371/journal.pone.0295293. eCollection 2024. PMID 38598554

Идентификаторы

NCT: NCT05902741 · 214133

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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