Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04971889
Status:
UNKNOWN
Last Update Posted:
2022-08-24
First Post:
2021-07-13
Brief Title:
Diabetes Medical Nutrition Therapy in Southeastern African American Women
Sponsor:
Meharry Medical College
Organization:
Meharry Medical College
Study Overview
Official Title:
Diabetes Medical Nutrition Therapy in Southeastern African American Women
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
A two-arm randomized controlled trial design will be used Participants will include 291 African American women with type 2 diabetes that are at risk for development andor progression of diabetes complications Both arms diabetes medical nutrition therapy MNT and diabetes MNT plus motivational interviewing MI will include 1 a 3-month active intervention period of six biweekly every other week group-based trained nutritionist-facilitated sessions 2 a 3-month maintenance intervention period which will include one group-based maintenance support session and 3 a 6-month inactive period no contact The differences between arms is the integration of culturally-adapted MI exercises during the diabetes MNT plus MI active and maintenance intervention periods
Detailed Description:
None
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