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-the Transcendental Meditation (TM) program or a health education (HE) program. Participants were recruited, tested, and instructed at two clinical sites: Howard University Hospital, Washington, DC and Morehouse (School of Medicine) Healthcare, Atlanta, GA. Main outcome measures were carotid intima-media thickness, insulin resistance, and behavioral factors.
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 CVD or at 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-media thickness (IMT), insulin resistance, serum lipids, blood pressure and lifestyle (diet, exercise, substance use).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
201
This was 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.
TM was taught in a standardized and validated format as a simple, natural mental technique practiced for 20 minutes twice a day (morning and evening) to give rest and relaxation to mind and body. TM was taught by a certified instructor and a 7-step process taking place over 4 consecutive days after which the meditator can practice at home twice a day.
Howard University Heart Center
Washington D.C., District of Columbia, United States
Morehouse School of Medicine - Morehouse Medical Associates
Atlanta, Georgia, United States
Carotid intima-media thickness (CIMT)
B mode ultrasound measurement of carotid artery wall thickness
Time frame: 0 and 12 months
Hemoglobin A1c
Hb1c as surrogate endpoint for diabetes
Time frame: Before and after 12 months of intervention and follow up
Insulin resistance
HOMA index utilizing glucose and insulin levels at timed intervals
Time frame: 0 and 12 months
Lipids
fasting levels of serum LDL, HDL, TC, TG
Time frame: 0 and 12 months
Blood pressure
measured three times with a mercury sphygmomanometer 5 minutes apart and last two reading averaged
Time frame: 0, 4 and 12 months
Physical Activity
Exercise --using the Folsom Physical Activity Questionaire
Time frame: 0, 4 and 12 months
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