Development of an Inclusive Adaptive Treatment Strategy for Weight Loss in People With Prediabetes Using a Sequential Multiple Assignment Randomized Trial

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 15, 2026

Primary Completion Date

June 1, 2026

Study Completion Date

June 1, 2026

Conditions
DisabilitiesObesity and OverweightPrediabetes
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)

35209

RECRUITING

Wellness Health and Research Facility (WHARF), Birmingham

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER