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

NCT ID: NCT04745572

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-14
• Study Completion Date: 2023-11-21

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 2.5% weight loss) or Non-Responders (less than 2.5% 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.

Conditions

PreDiabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

High Carbohydrate Diet

Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan.

Group Type: EXPERIMENTAL

High Carbohydrate Diet

Intervention Type: BEHAVIORAL

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.

Reduced Carbohydrate Diet

Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan.

Group Type: EXPERIMENTAL

Reduced Carbohydrate Diet

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-75 years of age
• BMI of 27 kg/m2 or greater
• at risk for developing type 2 diabetes (prediabetes)

Exclusion Criteria

• Pregnant, planning to become pregnant, or breastfeeding
• uncontrolled hypo or hyperthyroidism

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Mills

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Holly Wyatt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holly Wyatt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Highlands Family and Community Medicine Clinic

Birmingham, Alabama, United States

Countries

United States

References

Ellison KM, El Zein A, Baidwan NK, Ferguson CC, Fowler LA, Bryan DR, Reynolds C, Hermanson D, Berg KJ, Mehta T, Hill JO, Wyatt HR, Sayer RD. Adaptive dietary and exercise strategies for weight loss in Adults with Prediabetes Trial (ADAPT): a sequential multiple assignment randomized trial. Am J Clin Nutr. 2025 Oct;122(4):1093-1102. doi: 10.1016/j.ajcnut.2025.07.034. Epub 2025 Aug 7.

Reference Type: DERIVED

PMID: 40763896 (View on PubMed)

Other Identifiers

General Mills

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300006816

Identifier Type: -

Identifier Source: org_study_id