A Clinical Trial on the Prevention of Coronary Artery Disease, Insulin Resistance and Hyperlipidemia in Black Women With Meditation and Health Education
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 3
- 主要终点
- Carotid intima-media thickness (CIMT)
研究概览
简要总结
This randomized controlled trial compared the efficacy of stress reduction with meditation to a health education (HE) group in 201 older African American women over a one-year study period. They were randomly allocated to either of two behavioral treatment groups-the Transcendental Meditation (TM) program or a health education (HE) program. Participants were recruited, tested, and instructed at two clinical sites: Howard University Hospital, Washington, DC and Morehouse (School of Medicine) Healthcare, Atlanta, GA. Main outcome measures were carotid intima-media thickness, insulin resistance, and behavioral factors.
详细描述
This was a randomized controlled trial that compared the effects of stress reduction using the Transcendental Meditation technique (TM) to a health education (HE) group in 201 African American women >55 years with CVD or at high CVD risk over a one-year intervention and follow-up period.
All participants were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM) program or 2) a health education (HE) program of healthy diet, exercise and substance use control. Women participants were recruited, tested, and instructed at two sites:139 were recruited and randomized in Washington, DC and 61 in Atlanta, GA. Outcome measures were carotid intima-media thickness (IMT), insulin resistance, serum lipids, blood pressure and lifestyle (diet, exercise, substance use).
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigators, data collectors and usual medical providers were blinded to participant treatment status. Participants in both intervention groups were given similar expectations of positive outcomes.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •African American women,
- •55 years or older with at least one of the five cardiovascular conditions (below):
- •coronary heart disease or
- •positive coronary angiography or
- •previous MI or
- •coronary revascularization or
- •percutaneous transluminal coronary angioplasty (PTCA).
- •OR a risk factor assessment score of at least two points based on the Framingham study/ATP III report. Risk factors included diabetes, high systolic or diastolic BP, high cholesterol, high LDL-low HDL or smoking.
排除标准
- •Recent (last 3 months):
- •myocardial infarction
- •unstable angina
- •coronary artery by-pass grafting (CABG)
- •percutaneous transluminal coronary angioplasty (PTCA)
- •stroke within the preceding three months
- •carotid artery endarterectomy
- •atrial fibrillation
- •second or third degree AV block
- •heart failure
- •clinically significant valvular heart disease
- •major psychiatric disorders,
- •current alcohol/dependency disorder
- •other drug abuse dependency disorder
- •non-cardiac life-threatening illness
- •participating in a formal stress management program
- •plans to move out of the study area or travel extensively
- •unwillingness to accept randomization into any study group.
结局指标
主要结局
Carotid intima-media thickness (CIMT)
时间窗: 0 and 12 months
B mode ultrasound measurement of carotid artery wall thickness
次要结局
- Hemoglobin A1c(Before and after 12 months of intervention and follow up)
- Insulin resistance(0 and 12 months)
- Lipids(0 and 12 months)
- Blood pressure(0, 4 and 12 months)
- Physical Activity(0, 4 and 12 months)
研究者
Robert Schneider, MD
Director, Institute for Natural Medicine and Prevention
Maharishi International University