Effects of Behavioral Stress Reduction Programs on Blood Pressure in African American Youth
NCT ID: NCT00241813
Last Updated: 2012-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
283 participants
INTERVENTIONAL
2005-01-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Health Education Control Program (CTL)
Health Education Control Program (CTL)
Health Education Control Program (CTL)
Participants will take part in a health education control program (CTL)
Mindfulness Meditation
Mindfulness Meditation (MM) Program
Mindfulness Meditation (MM) Program
Participants will take part in a mindfulness meditation (MM) program.
Lifeskills
Lifeskills Program (LP)
Lifeskills Program (LP)
Participants will take part in a lifeskills program (LP).
MM plus LP
Mindfulness Meditation (MM) Program plus Lifeskills Program (LP)
Mindfulness Meditation (MM) Program
Participants will take part in a mindfulness meditation (MM) program.
Lifeskills Program (LP)
Participants will take part in a lifeskills program (LP).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* SBP ranging from greater than or equal to 50th percentile to less than or equal to 95th percentile on three occasions
Exclusion Criteria
14 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Medical University of South Carolina
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frank A. Treiber, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
330
Identifier Type: -
Identifier Source: org_study_id