Effects of Behavioral Stress Reduction Programs on Blood Pressure in African American Youth
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Mindfulness Meditation (MM) Program; Health Education Control Program (CTL); Lifeskills Program (LP)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will take part in a mindfulness meditation (MM) program.; Participants will take part in a health education control program (CTL); Participants will take part in a lifeskills program (LP).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention