Effects of Behavioral Stress Reduction Programs on Blood Pressure in African American Youth
Stress Reduction: Impact on Blood Pressure in African American Youth
2 other identifiers
interventional
283
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cardiovascular-diseases
Started Jan 2005
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 17, 2005
CompletedFirst Posted
Study publicly available on registry
October 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 17, 2012
December 1, 2012
4.9 years
October 17, 2005
December 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Resting SBP and 24-hour ambulatory SBP
Measured after 12-week intervention and at 12-week follow-up
Secondary Outcomes (6)
Overnight urine NE excretion
Measured after 12-week intervention and at 12-week follow-up
Overnight sodium excretion
Measured after 12-week intervention and at 12-week follow-up
SBP reactivity to behavioral stressors
Measured after 12-week intervention and at 12-week follow-up
Self-reported hostility and anger
Measured after 12-week intervention and at 12-week follow-up
Percent of endothelium-dependent arterial vasodilation to reactive hyperemia
Measured after 12-week intervention and at 12-week follow-up
- +1 more secondary outcomes
Study Arms (4)
Health Education Control Program (CTL)
ACTIVE COMPARATORHealth Education Control Program (CTL)
Mindfulness Meditation
EXPERIMENTALMindfulness Meditation (MM) Program
Lifeskills
EXPERIMENTALLifeskills Program (LP)
MM plus LP
EXPERIMENTALMindfulness Meditation (MM) Program plus Lifeskills Program (LP)
Interventions
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).
Eligibility Criteria
You may qualify if:
- In ninth grade
- SBP ranging from greater than or equal to 50th percentile to less than or equal to 95th percentile on three occasions
You may not qualify if:
- Clinical Hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank A. Treiber, Ph.D.
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2005
First Posted
October 19, 2005
Study Start
January 1, 2005
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 17, 2012
Record last verified: 2012-12