Stress Reduction and Hypertension Prevention in African Americans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 304
- 主要终点
- Blood pressure
研究概览
简要总结
There are major health disparities in Blacks associated with high blood pressure (BP) and psychosocial stress. We evaluated the effects of lifestyle modification with meditation in Black adults with high normal and normal blood pressure.
Participants (n=304) were randomized to either the Transcendental Meditation technique or Health Education control in addition to usual care for up to 36 months for BP and secondary outcomes.
详细描述
Background: Blacks suffer from disparities in hypertension, cardiovascular disease (CVD) and currently, coronavirus-19. These conditions are associated with social determinants of health and psychosocial stress. While previous trials demonstrated stress reduction lowering blood pressure in grade I range in Blacks, there is a paucity of clinical trial data in Blacks with high normal and normal BP.
Objective
This randomized controlled trial was conducted to evaluate the effect of stress reduction with the Transcendental Meditation (TM) technique in Black adults with high normal BP and normal BP using International Society of Hypertension (ISH) definitions.
Methods: A total of 304 Black adults with high normal (130-139/85-89 mm Hg) and normal BP (120-129/80-84 mm Hg) were randomized to either TM or health education (HE) arms. BP was recorded at 3, 6, 9, 12, 24, 30, and 36 months after baseline. Linear mixed model analysis was conducted to compare the BP change between TM and HE participants in the high-normal BP and normal-BP groups. Survival analysis for hypertensive events was conducted.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
This is a single-blind randomized controlled trial with all data collection personnel and investigators blinded to subjects' treatment status. The study coordinator does not collect data but receives subjects assigned treatment and then to informs them of their treatment group
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-identified Black women and men
- •no current antihypertensive medications
- •high normal BP (130-139 mm Hg and/or DBP 85-89 mm Hg) OR
- •normal BP (SBP 120-129 mm Hg and/DBP 80-84 mm Hg)
排除标准
- •use of antihypertensive medications within the previous 2 months
- •history of CVD, ie, myocardial infarction, angina, peripheral artery disease, heart failure, stroke, or renal failure, diabetes, major psychiatric or substance use disorder other life-threatening illness
- •lack of signed a consent form
结局指标
主要结局
Blood pressure
时间窗: baseline 0 to 36 months after baseline
Both systolic and diastolic BP are measured using standard clinical trial technique recommended by the American Heart Association (AHA)
次要结局
- Heart rate(baseline 0 to 36 months after baseline)
- Anger(baseline 0 to 36 months after baseline)
- Hypertensive events(baseline 0 to 36 months after baseline)
研究者
Robert Schneider, MD
Director and Dean
Maharishi International University