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

NCT04745572 | Completed

• 2 other identifiers: IRB-300006816General Mills
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

weight loss; reduced carbohydrate diet; exercise training; time restricted eating

Outcome Measures

Primary Outcomes (1)

• Changes in body weight

  Measured on digital scale at final visit.

  week 16 visit

Secondary Outcomes (4)

• Change in glucose

  week 16 visit

• Change in hemoglobin A1c

  week 16 visit

• Change in insulin

  week 16 visit

• Changes in QUICKI index

  week 16 visit

Other Outcomes (8)

• Changes in fat mass

  week 16 visit

• Changes in lipids

  week 16 visit

• Change in Blood Pressure

  week 16 visit

Study Arms (2)

High Carbohydrate Diet

EXPERIMENTAL

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

Behavioral: High Carbohydrate Diet

Reduced Carbohydrate Diet

EXPERIMENTAL

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

Behavioral: Reduced Carbohydrate Diet

Interventions

High Carbohydrate Diet 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.

High Carbohydrate Diet

Reduced Carbohydrate Diet 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.

Reduced Carbohydrate Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• General Mills: collaborator

Study Sites (1)

UAB Highlands Family and Community Medicine Clinic

Birmingham, Alabama, 35205, United States

Location

Related Publications (1)

• 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.

  PMID: 40763896 DERIVED

MeSH Terms

Conditions

Prediabetic State; Obesity; Weight Loss; Intermittent Fasting

Interventions

Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet, High-Protein; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Holly Wyatt, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: May 14, 2021
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: April 27, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)