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

Stress Reduction: Impact on Blood Pressure in African American Youth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00241813
Enrollment
283
Registered
2005-10-19
Start date
2005-01-31
Completion date
2009-12-31
Last updated
2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases, Hypertension

Brief 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.

Interventions

BEHAVIORALMindfulness Meditation (MM) Program

Participants will take part in a mindfulness meditation (MM) program.

BEHAVIORALHealth Education Control Program (CTL)

Participants will take part in a health education control program (CTL)

BEHAVIORALLifeskills Program (LP)

Participants will take part in a lifeskills program (LP).

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Resting SBP and 24-hour ambulatory SBPMeasured after 12-week intervention and at 12-week follow-up

Secondary

MeasureTime frame
Overnight sodium excretionMeasured after 12-week intervention and at 12-week follow-up
SBP reactivity to behavioral stressorsMeasured after 12-week intervention and at 12-week follow-up
Overnight urine NE excretionMeasured after 12-week intervention and at 12-week follow-up
Percent of endothelium-dependent arterial vasodilation to reactive hyperemiaMeasured after 12-week intervention and at 12-week follow-up
Left ventricular mass index and resting heart rateMeasured after 12-week intervention and at 12-week follow-up
Self-reported hostility and angerMeasured after 12-week intervention and at 12-week follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026