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

NCT00681200 | Completed DMC

• 3 other identifiers: 602R01HL083944-01A1NCT00681200
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Blood Pressure Reduction; Stress Reactivity and Recovery; Meditation; Transcendental Meditation; Stress Reduction; Stress Management

Outcome Measures

Primary Outcomes (1)

• In-clinic and ambulatory blood pressure

  Measured at Month 4

Secondary Outcomes (2)

• Cardiovascular hemodynamics and stress hormones

  Measured at Month 4

• telomerase gene expression

  4 months

Study Arms (2)

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.

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.

Behavioral: Transcendental Meditation program

Interventions

Enhanced health education BEHAVIORAL

health education and social support

Enhanced health education program

Transcendental Meditation program BEHAVIORAL

The TM program plus didactic-based health education classes

Transcendental Meditation program

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maharishi International University: lead
• Howard University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Howard University College of Medicine

Washington D.C., District of Columbia, 20060, United States

Location

Related Publications (2)

• Duraimani SLC (2012) Lifestyle Modifications and Healthy Biological Aging: Effects of Telomerase Activity and Telomere Length. Ann Arbor Mich: Dissertation Information Service

  RESULT

• 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.

  PMID: 26571023 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Otelio Randall, MD

  Howard University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Natural Medicine and Prevention

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: May 1, 2012
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)