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

Hypertension Clinical Trial

Official title:

Stress Reduction: Impact on Blood Pressure in African American Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241813
• Other study ID #: 330
• Secondary ID: R01HL078216
• Status: Completed
• Phase: N/A
• First received: October 17, 2005
• Last updated: December 13, 2012
• Start date: January 2005
• Est. completion date: December 2009

Study information

• Verified date: December 2012
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Hypertension

Intervention

Behavioral:
• Mindfulness Meditation (MM) Program
Participants will take part in a mindfulness meditation (MM) program.
• Health Education Control Program (CTL)
Participants will take part in a health education control program (CTL)
• Lifeskills Program (LP)
Participants will take part in a lifeskills program (LP).

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting SBP and 24-hour ambulatory SBP		Measured after 12-week intervention and at 12-week follow-up	No
Secondary	Overnight urine NE excretion		Measured after 12-week intervention and at 12-week follow-up	No
Secondary	Overnight sodium excretion		Measured after 12-week intervention and at 12-week follow-up	No
Secondary	SBP reactivity to behavioral stressors		Measured after 12-week intervention and at 12-week follow-up	No
Secondary	Self-reported hostility and anger		Measured after 12-week intervention and at 12-week follow-up	No
Secondary	Percent of endothelium-dependent arterial vasodilation to reactive hyperemia		Measured after 12-week intervention and at 12-week follow-up	No
Secondary	Left ventricular mass index and resting heart rate		Measured after 12-week intervention and at 12-week follow-up	No