Cardiovascular DiseasesPhase 2NCT00010608
Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
A Phase 2 study testing Transcendental Meditation and Health Education in people with Cardiovascular Diseases, run by National Center for Complementary and Integrative Health (NCCIH) at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of meditation in preventing of atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Transcendental Meditation and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 1999to Jul 2006
- Phase
- Phase 2
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American, self-identified
- Coronary artery disease (CAD/CHD) defined by laboratory examination or documented clinical history of: a)myocardial infarction; b) coronary revascularization procedure--CABG, PTCA; c) coronary angiography--at least one coronary artery with >50% stenosis
- Informed consent
- Written Permission of participant's referring physician
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Morehouse School of Medicine
Atlanta, Georgia
Maharishi University of Management
Fairfield, Iowa, 52557
Howard University Medical Center
Washington D.C., District of Columbia
About this study
The purpose of this study is to evaluate the effectiveness of meditation in preventing of atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.
Read the detailed description
Older African American women suffer from disproportionately high rates of cardiovascular (CVD) morbidity and mortality compared to white Americans. Numerous controlled studies suggest that this disparity is associated with chronic psychosocial and environmental stress. Research indicates that Transcendental Meditation (TM) may result in significant improvements in CVD risk factors in this high risk population.
Participants in this study will be randomly assigned to either active stress reduction with TM or health education control, both in addition to usual medical care, for 12 months. The primary outcome will be carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography. Secondary measures will include traditional CVD risk factors (blood pressure, serum glucose and insulin levels, obesity, and sedentary lifestyle), stress-related neurohormones (catecholamine metabolite and cortisol), psychosocial stress, and quality of life. The results of this trial will yield valuable new knowledge for the prevention of CVD through a CAM intervention in high risk older African American women.
- Conditions
- Cardiovascular Diseases
- Being tested
- Transcendental Meditation, Health Education
- Keywords
- CVD
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental MeditationBehavioural
a mantra meditation technique which originated from the Vedic tradition of India. It is practiced from 20 minutes twice a day sitting comfortably in a chair with eyes closed.
Health EducationBehavioural
didactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake
| Study group | Role | What they receive |
|---|---|---|
| Transcendental Meditation program | Experimental | A mental technique for stress reduction which is natural, easy and effortless and is practiced sitting in a chair with eyes closed for 20 minutes twice a day. Receives: Behavioral: Transcendental Meditation |
| Health Education | Active comparator | A lifestyle modification program for improving diet, exercise, salt intake and substance use. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2001 (estimated)
- Study startOct 1999
- Primary completionJul 2006
- Study completionJul 2006
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Howard University, Morehouse College of Medicine
- Investigators
- Robert H. Schneider, MD, Principal investigator, Center for Health and Aging Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010608
- Sponsor's protocol ID
- P50AT000082-01P2
- Other IDs
- P50AT000082-01, P50AT000082-02
- Status last verified
- Dec 2009
- First submitted
- 2 Feb 2001
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Meditation for Cardiovascular Disease in Older Black Women
- ClinicalTrials.gov ID
- NCT00010608
- Acronym / sponsor ID
- P50AT000082-01P2
- Conditions
- Cardiovascular Diseases
- Keywords
- CVD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Collaborators
- Howard University, Morehouse College of Medicine
- Study start
- Oct 1999
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 5 Feb 2001 (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.
The purpose of this study is to evaluate the effectiveness of meditation in preventing of atherosclerotic cardiovascular disease (CVD) in postmenopausal, older African American women.
Detailed description
Older African American women suffer from disproportionately high rates of cardiovascular (CVD) morbidity and mortality compared to white Americans. Numerous controlled studies suggest that this disparity is associated with chronic psychosocial and environmental stress. Research indicates that Transcendental Meditation (TM) may result in significant improvements in CVD risk factors in this high risk population.
Participants in this study will be randomly assigned to either active stress reduction with TM or health education control, both in addition to usual medical care, for 12 months. The primary outcome will be carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography. Secondary measures will include traditional CVD risk factors (blood pressure, serum glucose and insulin levels, obesity, and sedentary lifestyle), stress-related neurohormones (catecholamine metabolite and cortisol), psychosocial stress, and quality of life. The results of this trial will yield valuable new knowledge for the prevention of CVD through a CAM intervention in high risk older African American women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcendental Meditation program | Experimental | Behavioral: Transcendental MeditationA mental technique for stress reduction which is natural, easy and effortless and is practiced sitting in a chair with eyes closed for 20 minutes twice a day. |
| Health Education | Active comparator | Behavioral: Health EducationA lifestyle modification program for improving diet, exercise, salt intake and substance use. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- African American, self-identified
- Coronary artery disease (CAD/CHD) defined by laboratory examination or documented clinical history of: a)myocardial infarction; b) coronary revascularization procedure--CABG, PTCA; c) coronary angiography--at least one coronary artery with >50% stenosis
- Informed consent
- Written Permission of participant's referring physician
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Transcendental Meditationa mantra meditation technique which originated from the Vedic tradition of India. It is practiced from 20 minutes twice a day sitting comfortably in a chair with eyes closed. | Behavioural | Transcendental Meditation program |
| Health Educationdidactic education classes for lifestyle modification through diet, exercise, substance use control, and salt intake | Behavioural | Health Education |
Primary outcome
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography
Time frame: one year
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 7 Dec 2009.
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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.
Robert H. Schneider, MD principal investigator
Center for Health and Aging Studies
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcendental Meditation and Health Education in people with Cardiovascular Diseases, run by National Center for Complementary and Integrative Health (NCCIH) at 3 sites 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 4 inclusion and 0 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 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Carotid artery atherosclerosis (IMT) measured non-invasively by quantitative B-mode ultrasonography (time frame: one year). 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 7 Dec 2009.