Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01713764
Status:
COMPLETED
Last Update Posted:
2013-12-30
First Post:
2012-08-24
Brief Title:
A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
Status:
COMPLETED
Status Verified Date:
2013-12
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:
SUCCEED
Brief Summary:
The study is a small pilot designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale The present study is a randomized controlled clinical trial comparing two mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight one using on a low-carbohydrate diet LC and the other using a moderate-carbohydrate diet promoted by the American Diabetes Association ADA Intervention content will include information about nutrition carbohydrate restriction or American Diabetes Association recommended diet and emotion regulation and mindful eating strategies
Detailed Description:
Approximately 40 individuals with Type II diabetes or prediabetes will be randomized in a 11 ratio to treatment groups Groups will meet for 12 weekly sessions then approximately biweekly for 3 sessions for a total of 15 15-2 hour sessions over 45 months Participants will be evaluated at 0 1 month 3 months and 6 months Our outcome of interest is HbA1c glycated hemoglobin a measure indicative of blood glucose levels and tied to diabetes severity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None