Evaluating Mechanisms of Blood Pressure Reduction Using Meditation in Hypertensive African Americans (HMEC)
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|ClinicalTrials.gov Identifier: NCT00681200|
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : March 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Behavioral: Enhanced health education Behavioral: Transcendental Meditation program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Mechanisms of Meditation in Hypertension in Blacks|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||May 2012|
Active Comparator: Enhanced health education program
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 is comparison group does not have a stress management component.
Behavioral: Enhanced health education
health education and social support
Experimental: Transcendental Meditation program
Transcendental Meditation program plus health education. Basic AHA recommendations for lifestyle modification to reduce risk of heart disease will be given in a didactic classroom context.
Behavioral: Transcendental Meditation program
The TM program plus didactic-based health education classes
- In-clinic and ambulatory blood pressure [ Time Frame: Measured at Month 4 ]
- Cardiovascular hemodynamics and stress hormones [ Time Frame: Measured at Month 4 ]
- telomerase gene expression [ Time Frame: 4 months ]telomerase gene expression as measured HTERT and HTR
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681200
|United States, District of Columbia|
|Howard University College of Medicine|
|Washington, District of Columbia, United States, 20060|
|Principal Investigator:||Otelio Randall, MD||Howard University|