Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443814
Status:
COMPLETED
Last Update Posted:
2024-06-05
First Post:
2023-11-13
Brief Title:
Trial of Meditation for Cardiometabolic Disease in Older Black Women
Sponsor:
Robert Schneider MD
Organization:
Maharishi International University
Study Overview
Official Title:
A Clinical Trial on the Prevention of Coronary Artery Disease Insulin Resistance and Hyperlipidemia in Black Women With Meditation and Health Education
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-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
Detailed 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 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 sites139 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
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 sites139 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None