Cardiovascular DiseasesNCT00241813
Effects of Behavioral Stress Reduction Programs on Blood Pressure in African American Youth
A study testing Mindfulness Meditation (MM) Program and Lifeskills Program (LP) in people with Cardiovascular Diseases and Heart Diseases, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 17 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- What is being tested?
- Mindfulness Meditation (MM) Program and Lifeskills Program (LP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 283 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- In ninth grade
- SBP ranging from greater than or equal to 50th percentile to less than or equal to 95th percentile on three occasions
Who cannot join
- Clinical Hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Stress Reduction: Impact on Blood Pressure in African American Youth
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Being tested
- Mindfulness Meditation (MM) Program, Health Education Control Program (CTL), Lifeskills Program (LP)
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation (MM) ProgramBehavioural
Participants will take part in a mindfulness meditation (MM) program.
Health Education Control Program (CTL)Behavioural
Participants will take part in a health education control program (CTL)
Lifeskills Program (LP)Behavioural
Participants will take part in a lifeskills program (LP).
| Study group | Role | What they receive |
|---|---|---|
| Health Education Control Program (CTL) | Active comparator | Health Education Control Program (CTL) Receives: Behavioral: Health Education Control Program (CTL) |
| Mindfulness Meditation | Experimental | Mindfulness Meditation (MM) Program Receives: Behavioral: Mindfulness Meditation (MM) Program |
| Lifeskills | Experimental | Lifeskills Program (LP) Receives: Behavioral: Lifeskills Program (LP) |
| MM plus LP | Experimental | Mindfulness Meditation (MM) Program plus Lifeskills Program (LP) Receives: Behavioral: Mindfulness Meditation (MM) Program; Behavioral: Lifeskills Program (LP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting SBP and 24-hour ambulatory SBP
Measured: Measured after 12-week intervention and at 12-week follow-up
Secondary outcomes (6)
Overnight urine NE excretion
Measured: Measured after 12-week intervention and at 12-week follow-up
Overnight sodium excretion
Measured: Measured after 12-week intervention and at 12-week follow-up
SBP reactivity to behavioral stressors
Measured: Measured after 12-week intervention and at 12-week follow-up
Self-reported hostility and anger
Measured: Measured after 12-week intervention and at 12-week follow-up
Percent of endothelium-dependent arterial vasodilation to reactive hyperemia
Measured: Measured after 12-week intervention and at 12-week follow-up
Left ventricular mass index and resting heart rate
Measured: Measured after 12-week intervention and at 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Frank A. Treiber, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241813
- Sponsor's protocol ID
- 330
- Other IDs
- R01HL078216
- Status last verified
- Dec 2012
- First submitted
- 17 Oct 2005
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reduction: Impact on Blood Pressure in African American Youth
- ClinicalTrials.gov ID
- NCT00241813
- Acronym / sponsor ID
- 330
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Health Education Control Program (CTL) | Active comparator | Behavioral: Health Education Control Program (CTL)Health Education Control Program (CTL) |
| Mindfulness Meditation | Experimental | Behavioral: Mindfulness Meditation (MM) ProgramMindfulness Meditation (MM) Program |
| Lifeskills | Experimental | Behavioral: Lifeskills Program (LP)Lifeskills Program (LP) |
| MM plus LP | Experimental | Behavioral: Mindfulness Meditation (MM) Program, Behavioral: Lifeskills Program (LP)Mindfulness Meditation (MM) Program plus Lifeskills Program (LP) |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- In ninth grade
- SBP ranging from greater than or equal to 50th percentile to less than or equal to 95th percentile on three occasions
Key exclusion criteria (1 listed)
- Clinical Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation (MM) ProgramParticipants will take part in a mindfulness meditation (MM) program. | Behavioural | MM plus LP, Mindfulness Meditation |
| Health Education Control Program (CTL)Participants will take part in a health education control program (CTL) | Behavioural | Health Education Control Program (CTL) |
| Lifeskills Program (LP)Participants will take part in a lifeskills program (LP). | Behavioural | Lifeskills, MM plus LP |
Primary outcome
Resting SBP and 24-hour ambulatory SBP
Time frame: Measured after 12-week intervention and at 12-week follow-up
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank A. Treiber, Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation (MM) Program and Lifeskills Program (LP) in people with Cardiovascular Diseases and Heart Diseases, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting SBP and 24-hour ambulatory SBP (time frame: Measured after 12-week intervention and at 12-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.