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Effects of Behavioral Stress Reduction Programs on Blood Pressure in African American Youth

2012年12月13日 更新者:Medical University of South Carolina

Stress Reduction: Impact on Blood Pressure in African American Youth

This study will examine the effects of two behavioral stress reduction programs, mindfulness meditation (MM) and the lifeskills program (LP), and a health education control program (CTL) on blood pressure.

研究概览

详细说明

BACKGROUND:

African Americans (AA) experience a high prevalence and early onset of essential hypertension (EH), which has been partly attributed to exposure to chronic environmental stress. AA youth exhibit higher resting blood pressure (BP) than whites. Since BP ranking tracks from late childhood onward, AA adolescents with high normal BP are at increased risk for development of EH. The need for developing effective primary prevention programs for EH is highlighted by the fact that EH is now a pediatric problem due to recent increased prevalence among youth. There have been no previous controlled studies evaluating stress reduction approaches on BP control in AA youth, particularly within the framework of an underlying psychological and physiological-based model of stress-induced EH.

This study is in response to a 'Request for Applications' entitled "Research on Mind-Body Interactions and Health," which was issued by the Office of the Director, National Institutes of Health (NIH).

DESIGN NARRATIVE:

This study will examine the effects of two behavioral stress reduction programs, MM and LP, and CTL on cardiovascular function at rest, during laboratory stress, and in the natural environment. Participants will include 320 ninth graders (50% male) with high normal systolic BP (SBP) (SBP ranging from greater than or equal to the 50th percentile to less than or equal to the 95th percentile on three occasions). Following BP screenings and baseline evaluation, participants will be assigned to a CTL, MM, LP, or MM plus LP group. Participants will be re-evaluated after a 12-week intervention and again at a 12-week follow-up. The specific aims of this study are to determine whether MM and/or LP results in the following: 1) decreases in the primary outcome variables of resting SBP and 24-hour ambulatory SBP; 2) decreases in sympathetic nervous system (SNS) tone (decreased overnight urine norepinephrine [NE] excretion) and decreases in sodium intake (decreased overnight sodium excretion); 3) decreases in SBP reactivity to behavioral stressors; 4) decreases in SNS arousal (decreased urinary NE excretion) and greater increases in renal function (increased urinary sodium excretion) to the behavioral stressors; 5) decreases in self-reported hostility and anger; 6) improvement in vascular function (increases in percent of endothelium-dependent arterial vasodilation to reactive hyperemia); and 7) improvement in ventricular structure and function (decreases in left ventricular mass index and resting heart rate). It is anticipated that the combination of MM and LP will result in greater positive impacts than either treatment alone. The study will be conducted by teachers during school health classes. If these programs are shown to be successful, they may be incorporated into the regular school curriculum.

研究类型

介入性

注册 (实际的)

283

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • South Carolina
      • Charleston、South Carolina、美国、29425
        • Medical University of South Carolina

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 17年 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • In ninth grade
  • SBP ranging from greater than or equal to 50th percentile to less than or equal to 95th percentile on three occasions

Exclusion Criteria:

  • Clinical Hypertension

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Health Education Control Program (CTL)
Participants will take part in a health education control program (CTL)
实验性的:Mindfulness Meditation
Mindfulness Meditation (MM) Program
Participants will take part in a mindfulness meditation (MM) program.
实验性的:Lifeskills
Lifeskills Program (LP)
Participants will take part in a lifeskills program (LP).
实验性的:MM plus LP
Mindfulness Meditation (MM) Program plus Lifeskills Program (LP)
Participants will take part in a mindfulness meditation (MM) program.
Participants will take part in a lifeskills program (LP).

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Resting SBP and 24-hour ambulatory SBP
大体时间:Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up

次要结果测量

结果测量
大体时间
Overnight urine NE excretion
大体时间:Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up
Overnight sodium excretion
大体时间:Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up
SBP reactivity to behavioral stressors
大体时间:Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up
Self-reported hostility and anger
大体时间:Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up
Percent of endothelium-dependent arterial vasodilation to reactive hyperemia
大体时间:Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up
Left ventricular mass index and resting heart rate
大体时间:Measured after 12-week intervention and at 12-week follow-up
Measured after 12-week intervention and at 12-week follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Frank A. Treiber, Ph.D.、Medical University of South Carolina

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2005年1月1日

初级完成 (实际的)

2009年12月1日

研究完成 (实际的)

2009年12月1日

研究注册日期

首次提交

2005年10月17日

首先提交符合 QC 标准的

2005年10月17日

首次发布 (估计)

2005年10月19日

研究记录更新

最后更新发布 (估计)

2012年12月17日

上次提交的符合 QC 标准的更新

2012年12月13日

最后验证

2012年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 330
  • R01HL078216 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Health Education Control Program (CTL)的临床试验

3
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