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| Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Howard University |
|---|---|
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00681200 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertension |
Behavioral: Transcendental Meditation program Behavioral: Enhanced health education program |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Mechanisms of Meditation in Hypertension in Blacks |
| Estimated Enrollment: | 152 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Enhanced health education program
|
Behavioral: Enhanced health education program
Participants will attend meetings at which they will watch educational films, listen to guest speakers, and complete instructional activities on blood pressure regulation.
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2: Experimental
Transcendental Meditation program
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Behavioral: Transcendental Meditation program
Transcendental Meditation is a natural, effortless mental technique designed to reduce stress and improve quality of life. Participants will practice the Transcendental Meditation program at home for 20 minutes twice a day sitting comfortably with eyes closed.
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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. 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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |
| Howard University College of Medicine | Recruiting |
| Washington, District of Columbia, United States, 20060 | |
| Contact: Otelio Randall, MD 202-865-7266 orandall@howard.edu | |
| Contact: Howard University Study Staff 202-865-5466 gsvictor@howard.edu | |
| Principal Investigator: Otelio Randall, MD | |
| Principal Investigator: | Otelio Randall, MD | Howard University |
More Information
| Responsible Party: | Maharishi University of Management Research Institute ( Robert H. Schneider, MD, Director and Principal Investigator ) |
| Study ID Numbers: | 602, 1 R01 HL083944-01A1 |
| Study First Received: | May 19, 2008 |
| Last Updated: | December 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00681200 |
| Health Authority: | United States: Federal Government |
|
Blood Pressure Reduction Stress Reactivity and Recovery Meditation |
Transcendental Meditation Stress Reduction Stress Management |
|
Vascular Diseases Stress Hypertension |
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Cardiovascular Diseases |
