HypertensionHMECNCT00681200
Evaluating Mechanisms of Blood Pressure Reduction Using Meditation in Hypertensive African Americans
A study testing Enhanced health education and Transcendental Meditation program in people with Hypertension, run by Maharishi International University at 1 site in United States.
Trial summary
High blood pressure is a common health problem among people in the United States. This study will compare the effectiveness of a meditation program versus a health education program at decreasing stress and lowering blood pressure levels among African-American adults with high blood pressure. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Enhanced health education and Transcendental Meditation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identifies as African American
- Resides in Washington, DC or surrounding communities
- Has stage I hypertension, defined as systolic blood pressure between 140 and 159 mm Hg and/or diastolic blood pressure between 90 and 99 mm Hg, on average, without taking antihypertensive medications in the sympatholytic class (e.g., beta blockers, alpha antagonists, central nervous system agonists)
Who cannot join
- Blood pressure levels of less than 140/90 mm Hg or greater than 160/100 mm Hg
- History of clinical cardiovascular disease (e.g., heart attack, angina, intermittent claudication, congestive heart failure, stroke)
- Long-term kidney failure
- Any other life-threatening illness (e.g., advanced cancer)
- History of major psychiatric disorder (e.g., psychosis, dementia, substance abuse disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
Howard University College of Medicine
Washington D.C., District of Columbia, 20060
About this study
Official title: Mechanisms of Meditation in Hypertension in Blacks
High blood pressure is a common health problem among people in the United States. This study will compare the effectiveness of a meditation program versus a health education program at decreasing stress and lowering blood pressure levels among African-American adults with high blood pressure.
Read the detailed description
Hypertension, also known as high blood pressure, is one of the most common health problems among adults, particularly African Americans. If left untreated, it can lead to heart failure, kidney failure, or stroke. High blood pressure can be caused by many factors, including stress, diet, diabetes, kidney disease, or obesity. Typical treatments include taking medication, losing weight, and quitting smoking. Meditation may also be an effective way to decrease stress levels and lower blood pressure. This study will examine the effects of a specific type of meditation, Transcendental Meditation (TM), on stress and blood pressure levels. In previous studies, TM has been shown to have a positive effect on reducing blood pressure levels, but more research is needed to confirm these benefits. This study will compare the effectiveness of a TM program with an enhanced health education (EHE) program for reducing stress and blood pressure levels in African Americans with high blood pressure.
This 4-month study will enroll African Americans with early stage hypertension. Recruiting will be conducted from Howard University Medical Center in Washington, DC. First, participants will take part in 3 days of baseline testing, including a medical history review, blood pressure and heart rate measurements, an echocardiogram to obtain images of the heart, and blood and urine collection. Over a 24-hour period, blood pressure and heart rate will be measured continuously and participants will wear a pedometer to keep track of the distance they walk. Participants will also complete a stress test; a treadmill exercise test; and questionnaires on mental health, physical health, and lifestyle.
After the 3-day baseline period, participants will attend an informational meeting with the study staff and other study participants. They will then be randomly assigned to either the TM group or the EHE group. Participants in the TM group will learn a simple meditation technique over a 6-day period. They will be expected to meditate for 20 minutes twice a day for 4 months. Participants will attend follow-up meetings with a meditation instructor every 2 weeks throughout the study, and they will record their progress in a daily diary. Participants in the EHE program will take part in 14 events during the study, including watching educational films, listening to guest speakers, and participating in other instructional activities that will provide health information about blood pressure regulation. In addition, all participants will attend standard health education classes every 2 weeks. These classes will provide information about reducing the risk factors related to heart disease and stroke. Once a month, participants will attend a study visit and undergo blood pressure and heart rate measurements. At the end of the 4-month study period, all participants will undergo repeat baseline testing.
- Conditions
- Hypertension
- Being tested
- Enhanced health education, Transcendental Meditation program
- Keywords
- Blood Pressure Reduction, Stress Reactivity and Recovery, Meditation, Transcendental Meditation, Stress Reduction, Stress Management
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced health educationBehavioural
health education and social support
Transcendental Meditation programBehavioural
The TM program plus didactic-based health education classes
| Study group | Role | What they receive |
|---|---|---|
| Enhanced health education program | Active comparator | This active treatment group consists of classes in health education and a social support group to enhance participant motivation and positive reinforcement to make healthier lifestyle choices (e.g. wholesome diet, increased exercise, reduced salt intake, and decreased use of alcohol and smoking). Note that this comparison group does not have a stress management component. Receives: Behavioral: Enhanced health education |
| Transcendental Meditation program | Experimental | Transcendental Meditation program plus health education. Basic American Heart Association (AHA) recommendations for lifestyle modification to reduce risk of heart disease will be given in a didactic classroom context. Receives: Behavioral: Transcendental Meditation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-clinic and ambulatory blood pressure
Measured: Measured at Month 4
Secondary outcomes (2)
Cardiovascular hemodynamics and stress hormones
Measured: Measured at Month 4
telomerase gene expression
telomerase gene expression as measured HTERT and HTR
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi International University
- Sponsor type
- University, hospital or other
- Collaborators
- Howard University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Robert Schneider, MD, Maharishi International University
- Investigators
- Otelio Randall, MD, Principal investigator, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681200
- Sponsor's protocol ID
- 602
- Other IDs
- R01HL083944-01A1, NCT00681200
- Acronym
- HMEC
- Status last verified
- Apr 2022
- First submitted
- 19 May 2008
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: outside investigators may contact the study PIs for sharing of the database
Publications
Duraimani SLC (2012) Lifestyle Modifications and Healthy Biological Aging: Effects of Telomerase Activity and Telomere Length. Ann Arbor Mich: Dissertation Information Service
Duraimani S, Schneider RH, Randall OS, Nidich SI, Xu S, Ketete M, Rainforth MA, Gaylord-King C, Salerno JW, Fagan J. Effects of Lifestyle Modification on Telomerase Gene Expression in Hypertensive Patients: A Pilot Trial of Stress Reduction and Health Education Programs in African Americans. PLoS One. 2015 Nov 16;10(11):e0142689. doi: 10.1371/journal.pone.0142689. eCollection 2015.
PubMed 26571023
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Meditation in Hypertension in Blacks
- ClinicalTrials.gov ID
- NCT00681200
- Acronym / sponsor ID
- HMEC / 602
- Conditions
- Hypertension
- Keywords
- Blood Pressure Reduction, Stress Reactivity and Recovery, Meditation, Transcendental Meditation, Stress Reduction, Stress Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Maharishi International UniversityUniversity, hospital or other
- Collaborators
- Howard University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 21 May 2008 (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.
High blood pressure is a common health problem among people in the United States. This study will compare the effectiveness of a meditation program versus a health education program at decreasing stress and lowering blood pressure levels among African-American adults with high blood pressure.
Detailed description
Hypertension, also known as high blood pressure, is one of the most common health problems among adults, particularly African Americans. If left untreated, it can lead to heart failure, kidney failure, or stroke. High blood pressure can be caused by many factors, including stress, diet, diabetes, kidney disease, or obesity. Typical treatments include taking medication, losing weight, and quitting smoking. Meditation may also be an effective way to decrease stress levels and lower blood pressure. This study will examine the effects of a specific type of meditation, Transcendental Meditation (TM), on stress and blood pressure levels. In previous studies, TM has been shown to have a positive effect on reducing blood pressure levels, but more research is needed to confirm these benefits. This study will compare the effectiveness of a TM program with an enhanced health education (EHE) program for reducing stress and blood pressure levels in African Americans with high blood pressure.
This 4-month study will enroll African Americans with early stage hypertension. Recruiting will be conducted from Howard University Medical Center in Washington, DC. First, participants will take part in 3 days of baseline testing, including a medical history review, blood pressure and heart rate measurements, an echocardiogram to obtain images of the heart, and blood and urine collection. Over a 24-hour period, blood pressure and heart rate will be measured continuously and participants will wear a pedometer to keep track of the distance they walk. Participants will also complete a stress test; a treadmill exercise test; and questionnaires on mental health, physical health, and lifestyle.
After the 3-day baseline period, participants will attend an informational meeting with the study staff and other study participants. They will then be randomly assigned to either the TM group or the EHE group. Participants in the TM group will learn a simple meditation technique over a 6-day period. They will be expected to meditate for 20 minutes twice a day for 4 months. Participants will attend follow-up meetings with a meditation instructor every 2 weeks throughout the study, and they will record their progress in a daily diary. Participants in the EHE program will take part in 14 events during the study, including watching educational films, listening to guest speakers, and participating in other instructional activities that will provide health information about blood pressure regulation. In addition, all participants will attend standard health education classes every 2 weeks. These classes will provide information about reducing the risk factors related to heart disease and stroke. Once a month, participants will attend a study visit and undergo blood pressure and heart rate measurements. At the end of the 4-month study period, all participants will undergo repeat baseline testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced health education program | Active comparator | Behavioral: Enhanced health educationThis active treatment group consists of classes in health education and a social support group to enhance participant motivation and positive reinforcement to make healthier lifestyle choices (e.g. wholesome diet, increased exercise, reduced salt intake, and decreased use of alcohol and smoking). Note that this comparison group does not have a stress management component. |
| Transcendental Meditation program | Experimental | Behavioral: Transcendental Meditation programTranscendental Meditation program plus health education. Basic American Heart Association (AHA) recommendations for lifestyle modification to reduce risk of heart disease will be given in a didactic classroom context. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identifies as African American
- Resides in Washington, DC or surrounding communities
- Has stage I hypertension, defined as systolic blood pressure between 140 and 159 mm Hg and/or diastolic blood pressure between 90 and 99 mm Hg, on average, without taking antihypertensive medications in the sympatholytic class (e.g., beta blockers, alpha antagonists, central nervous system agonists)
Key exclusion criteria (5 listed)
- Blood pressure levels of less than 140/90 mm Hg or greater than 160/100 mm Hg
- History of clinical cardiovascular disease (e.g., heart attack, angina, intermittent claudication, congestive heart failure, stroke)
- Long-term kidney failure
- Any other life-threatening illness (e.g., advanced cancer)
- History of major psychiatric disorder (e.g., psychosis, dementia, substance abuse disorder)
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 |
|---|---|---|
| Enhanced health educationhealth education and social support | Behavioural | Enhanced health education program |
| Transcendental Meditation programThe TM program plus didactic-based health education classes | Behavioural | Transcendental Meditation program |
Primary outcome
In-clinic and ambulatory blood pressure
Time frame: Measured at Month 4
2 secondary outcomes
Cardiovascular hemodynamics and stress hormones
Time frame: Measured at Month 4
telomerase gene expression
Time frame: 4 months
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 14 Apr 2022.
- Results publicationDuraimani SLC (2012) Lifestyle Modifications and Healthy Biological Aging: Effects of Telomerase Activity and Telomere Length. Ann Arbor Mich: Dissertation Information Service
- Results publication: PubMed 26571023Duraimani S, Schneider RH, Randall OS, Nidich SI, Xu S, Ketete M, Rainforth MA, Gaylord-King C, Salerno JW, Fagan J. Effects of Lifestyle Modification on Telomerase Gene Expression in Hypertensive Patients: A Pilot Trial of Stress Reduction and Health Education Programs in African Americans. PLoS One. 2015 Nov 16;10(11):e0142689. doi: 10.1371/journal.pone.0142689. eCollection 2015.
- Individual participant dataSharing planned: Yes. outside investigators may contact the study PIs for sharing of the database
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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.
Otelio Randall, MD principal investigator
Howard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced health education and Transcendental Meditation program in people with Hypertension, run by Maharishi International University 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 3 inclusion and 5 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 14 Apr 2022. 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?
In-clinic and ambulatory blood pressure (time frame: Measured at Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00681200, which also lists 2 linked publications.
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 14 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.