Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04745572
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2021-02-04
Brief Title:
Development of an Adaptive Treatment for Weight Loss in People with Prediabetes
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Development of an Adaptive Treatment Strategy for Weight Loss in People with Prediabetes Using a Sequential Multiple Assignment Randomized Trial
Status:
COMPLETED
Status Verified Date:
2024-10
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 16-week study will use an experimental approach called the Sequential Multiple Assignment Randomized Trial to help determine which combination and sequence of weight loss program features are most effective in people who are at risk for type 2 diabetes Participants in the study will be initially randomized to consume either a high or reduced carbohydrate diet After 4 weeks participants will be identified as Responders greater than or equal to 25 weight loss or Non-Responders less than 25 weight loss Responders will continue with their initial randomized group for the remainder of the trial Non-responders will be re-randomized to 2nd stage interventions of either including additional exercise counseling and training or beginning a time restricted eating protocol for the remainder of the trial
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