Development of an Adaptive Treatment for Weight Loss in People With Prediabetes

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

May 14, 2021

Primary Completion Date

November 21, 2023

Study Completion Date

November 21, 2023

Conditions
PreDiabetesObesity
Interventions
BEHAVIORAL

High Carbohydrate Diet

Participants randomized to this group will participate in a group-based weight behavioral management program and consume a high carbohydrate (HC) diet. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed at week 4. Responders will continue with their 1st stage assignment for the remainder of the study. Non-responders will be randomized to 2nd stage intervention of either combine HC diet with time-restricted eating (TRE) or HC diet with additional exercise counseling and support.

BEHAVIORAL

Reduced Carbohydrate Diet

Participants randomized to this group will participate in a group-based behavioral weight management program and consume a reduced carbohydrate (RC) diet. Because this is a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed at week 4. Responders will continue with their 1st stage assignment for the remainder of the study. Non-responders will be randomized to 2nd stage intervention of either combine RC diet with time-restricted eating (TRE) or RC diet with additional exercise counseling and support.

Trial Locations (1)

35205

UAB Highlands Family and Community Medicine Clinic, Birmingham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

General Mills

INDUSTRY

lead

University of Alabama at Birmingham

OTHER

NCT04745572 - Development of an Adaptive Treatment for Weight Loss in People With Prediabetes | Biotech Hunter | Biotech Hunter