Trial of Meditation for Cardiometabolic Disease in Older Black Women

Metabolic Syndrome Clinical Trial

Official title:

A Clinical Trial on the Prevention of Coronary Artery Disease, Insulin Resistance and Hyperlipidemia in Black Women With Meditation and Health Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06443814
• Other study ID #: 1P50AT000082-03
• Status: Completed
• Phase: Phase 2
• Start date: July 2001
• Est. completion date: November 2004

Study information

• Verified date: May 2024
• Source: Maharishi International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial compared the efficacy of stress reduction with meditation to a health education (HE) group in 201 older African American women over a one-year study period. They were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM( program or 2) a health education (HE) program. Women participants were recruited, tested, and instructed at two clinical sites: Washington, DC and Atlanta, GA. Outcome measures were carotid intima medial thickness, lipid profile, glucose and insulin resistance, and behavioral factors.

Description:

This was a randomized controlled trial that compared the effects of stress reduction using the Transcendental Meditation technique (TM) to a health education (HE) group in 201 African American women >55 years with high CVD risk over a one-year intervention and follow-up period.

All participants were randomly allocated to either of two behavioral treatment groups-1) the Transcendental Meditation (TM) program or 2) a health education (HE) program of healthy diet, exercise and substance use control. Women participants were recruited, tested, and instructed at two sites:139 were recruited and randomized in Washington, DC and 61 in Atlanta, GA. Outcome measures were carotid intima medial thickness (IMT), lipid profile, glucose and insulin response, blood pressure and lifestyle (diet, exercise, substance use).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: November 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• African American women,

• age 55 or older with at least one of the five cardiovascular conditions (below):

• coronary heart disease or

• positive coronary angiography or

• previous MI or

• coronary revascularization or

• percutaneous transluminal coronary angioplasty (PTCA). These conditions were medically documented for the study eligibility and subsequent randomization.

In the absence of these CAD markers: a high risk factor assessment score of at least two points based on the Framingham study/ATP III report was also accepted for eligibility. Risk factors included diabetes, high systolic or diastolic BP, high cholesterol, high LDL-low HDL or smoking.

Exclusion Criteria:

• Myocardial infarction

• unstable angina

• coronary artery by-pass grafting (CABG)

• percutaneous transluminal coronary angioplasty (PTCA)

• stroke within the preceding three months

• carotid artery endarterectomy

• atrial fibrillation

• second or third degree AV block

• heart failure

• clinically significant valvular heart disease

• major psychiatric disorders,

• current alcohol/dependency disorder

• other drug abuse dependency disorder

• non-cardiac life-threatening illness

• participating in a formal stress management program

• plans to move out of the study area or travel extensively

• unwillingness to accept randomization into any study group.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Dyslipidemias
• Metabolic Syndrome

Intervention

Behavioral:
• Health Education
This is a didactic classroom-based control which educates the patient on adapting a healthier lifestyle through proper diet, exercise, and moderating substance usage according to current AHA guidelines. This intervention does not include a stress management component.
• Transcendental Meditation
TM is a natural, effortless mental technique practiced for 20 minutes twice a day (morning and evening) which settles down the mind and body. TM can only be taught through a certified instructor and a 7-step process taking place over 4 consecutive days after which the meditator can practice correctly at home twice a day.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Robert Schneider, MD	Howard University, Morehouse School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	carotid intima medial thickness	B mode ultrasound measure of carotid artery wall thickness	0 and 12 months
Secondary	insulin resistance and glucose	using the HOMA index	0 and 12 months
Secondary	lipid profile	LDL, HDL, total cholesterol (TC), triglycerides (TG) (for LDL, TC and TG), a higher score indicates a worst outcome, for HDL a higher score indicates a better outcome	0 and 12 months
Secondary	blood pressure	measured three times with a mercury sphygmomanometer 5 minutes apart and last two reading averaged	0, 4 and 12 months
Secondary	general perceived health	SF-36 (numerical likert scale and YES/NO response categories are variable in terms of indicating a better or worse outcome)	0, 4 and 12 months
Secondary	Dietary habits	block diet questionaire (food choice with pictures) not scaled to indicate a better or worse outcome)	0, 4 and 12 months
Secondary	Physical Activity	Exercise --using the Folsom Physical Activity Questionaire--not scaled to indicate a better or worse outcome	0, 4 and 12 months
Secondary	Substance use	substance usage questionnaire for alcohol and illicit drug usage	0, 4 and 12 months