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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Current perceived stress
研究概览
简要总结
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:
- Prior to starting the intervention
- Mid-way through the intervention (Week 4)
- End of the intervention (Week 8)
- Six (6) months after the completion of the intervention
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 50 and 75
- •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
排除标准
- •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)
结局指标
主要结局
Current perceived stress
时间窗: 8 months
Perceived Stress Scale (PSS-10). Scores range from 0 to 40 with higher score suggesting worse outcome.
次要结局
- Inflammatory burden- C-reactive protein (CRP)(8 months)
- Inflammatory burden - Interleukin-1 beta (IL-1B)(8 months)
- Inflammatory burden - Interferon gamma (IFN-γ),(8 months)
- Stress overload(8 months)
- Inflammatory burden - Interleukin-6 (IL-6)(8 months)
- Resistance and empowerment(8 months)
- Depressive symptoms(8 months)
- Sleep disturbance(8 months)
- Inflammatory burden - Tumor necrosis factor-alpha (TNF-alpha)(8 months)
- General coping(8 months)
- Coping with discrimination(8 months)
- Internalized racism(8 months)
- DNA methylation(8 months)
- Anxiety(8 months)
- Fatigue(8 months)
研究者
Karen Saban
Professor
Loyola University