AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
What is being tested?
Mindfulness Meditation (MM) Program and Lifeskills Program (LP)
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

Other trials in United States

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.

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 groups in NCT00241813
Study groupRoleWhat they receive
Health Education Control Program (CTL)Active comparatorHealth Education Control Program (CTL)
Receives: Behavioral: Health Education Control Program (CTL)
Mindfulness MeditationExperimentalMindfulness Meditation (MM) Program
Receives: Behavioral: Mindfulness Meditation (MM) Program
LifeskillsExperimentalLifeskills Program (LP)
Receives: Behavioral: Lifeskills Program (LP)
MM plus LPExperimentalMindfulness 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.

  1. Resting SBP and 24-hour ambulatory SBP

    Measured: Measured after 12-week intervention and at 12-week follow-up

Secondary outcomes (6)
  1. Overnight urine NE excretion

    Measured: Measured after 12-week intervention and at 12-week follow-up

  2. Overnight sodium excretion

    Measured: Measured after 12-week intervention and at 12-week follow-up

  3. SBP reactivity to behavioral stressors

    Measured: Measured after 12-week intervention and at 12-week follow-up

  4. Self-reported hostility and anger

    Measured: Measured after 12-week intervention and at 12-week follow-up

  5. Percent of endothelium-dependent arterial vasodilation to reactive hyperemia

    Measured: Measured after 12-week intervention and at 12-week follow-up

  6. 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.

  1. First posted19 Oct 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in