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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00241813
First received: October 17, 2005
Last updated: December 13, 2012
Last verified: December 2012
  Purpose
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.

Condition Intervention
Cardiovascular Diseases Heart Diseases Hypertension Behavioral: Mindfulness Meditation (MM) Program Behavioral: Health Education Control Program (CTL) Behavioral: Lifeskills Program (LP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Stress Reduction: Impact on Blood Pressure in African American Youth

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Resting SBP and 24-hour ambulatory SBP [ Time Frame: Measured after 12-week intervention and at 12-week follow-up ]

Secondary Outcome Measures:
  • Overnight urine NE excretion [ Time Frame: Measured after 12-week intervention and at 12-week follow-up ]
  • Overnight sodium excretion [ Time Frame: Measured after 12-week intervention and at 12-week follow-up ]
  • SBP reactivity to behavioral stressors [ Time Frame: Measured after 12-week intervention and at 12-week follow-up ]
  • Self-reported hostility and anger [ Time Frame: Measured after 12-week intervention and at 12-week follow-up ]
  • Percent of endothelium-dependent arterial vasodilation to reactive hyperemia [ Time Frame: Measured after 12-week intervention and at 12-week follow-up ]
  • Left ventricular mass index and resting heart rate [ Time Frame: Measured after 12-week intervention and at 12-week follow-up ]

Enrollment: 283
Study Start Date: January 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Health Education Control Program (CTL)
Health Education Control Program (CTL)
Behavioral: Health Education Control Program (CTL)
Participants will take part in a health education control program (CTL)
Experimental: Mindfulness Meditation
Mindfulness Meditation (MM) Program
Behavioral: Mindfulness Meditation (MM) Program
Participants will take part in a mindfulness meditation (MM) program.
Experimental: Lifeskills
Lifeskills Program (LP)
Behavioral: Lifeskills Program (LP)
Participants will take part in a lifeskills program (LP).
Experimental: MM plus LP
Mindfulness Meditation (MM) Program plus Lifeskills Program (LP)
Behavioral: Mindfulness Meditation (MM) Program
Participants will take part in a mindfulness meditation (MM) program.
Behavioral: Lifeskills Program (LP)
Participants will take part in a lifeskills program (LP).

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.

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241813

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Frank A. Treiber, Ph.D. Medical University of South Carolina
  More Information

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00241813     History of Changes
Other Study ID Numbers: 330
R01HL078216 ( U.S. NIH Grant/Contract )
Study First Received: October 17, 2005
Last Updated: December 13, 2012

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on September 21, 2017