Evaluating Mechanisms of Blood Pressure Reduction Using Meditation in Hypertensive African Americans (HMEC)

This study has been completed.
Sponsor:
Collaborators:
Howard University
Information provided by (Responsible Party):
Robert Schneider, MD, Maharishi University of Management
ClinicalTrials.gov Identifier:
NCT00681200
First received: May 19, 2008
Last updated: March 11, 2013
Last verified: March 2013
  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: Enhanced health education
Behavioral: Transcendental Meditation program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Mechanisms of Meditation in Hypertension in Blacks

Resource links provided by NLM:


Further study details as provided by Maharishi University of Management:

Primary Outcome Measures:
  • In-clinic and ambulatory blood pressure [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular hemodynamics and stress hormones [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • telomerase gene expression [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    telomerase gene expression as measured HTERT and HTR


Enrollment: 152
Study Start Date: April 2008
Study Completion Date: May 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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. 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
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681200

Locations
United States, District of Columbia
Howard University College of Medicine
Washington, District of Columbia, United States, 20060
Sponsors and Collaborators
Maharishi University of Management
Howard University
Investigators
Principal Investigator: Otelio Randall, MD Howard University
  More Information

No publications provided

Responsible Party: Robert Schneider, MD, Director, Center for Natural Medicine and Prevention, Maharishi University of Management
ClinicalTrials.gov Identifier: NCT00681200     History of Changes
Other Study ID Numbers: 602, R01HL083944-01A1, 1 R01 HL083944-01A1
Study First Received: May 19, 2008
Last Updated: March 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Maharishi University of Management:
Blood Pressure Reduction
Stress Reactivity and Recovery
Meditation
Transcendental Meditation
Stress Reduction
Stress Management

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014