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

Not Applicable

Completed

• Conditions: PreDiabetes; Obesity
• Interventions: Behavioral: Reduced Carbohydrate Diet; Behavioral: High Carbohydrate Diet

• Registration Number: NCT04745572
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Study Start: 2021-05-14
• Primary Completion: 2023-11-21
• Study Completion: 2023-11-21
• Status Verified: 2024-10
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Reduced Carbohydrate Diet	Reduced Carbohydrate Diet	Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with reduced carbohydrate diet plan.
High Carbohydrate Diet	High Carbohydrate Diet	Enrollment in a group-based behavioral weight loss intervention based on the Diabetes Prevention Program curriculum with high carbohydrate diet plan.

Primary Outcome Measures

Name	Time	Method
Changes in body weight	week 16 visit	Measured on digital scale at final visit.

Secondary Outcome Measures

Name	Time	Method
Change in glucose	week 16 visit	Serum glucose will be measured in a fasted state.
Change in hemoglobin A1c	week 16 visit	A1c is a measure of average glucose over the previous 3 months.
Change in insulin	week 16 visit	Serum insulin will be measured in a fasted state.
Changes in QUICKI index	week 16 visit	Predictor of insulin resistance that will be calculated from glucose and insulin measures

Trial Locations

Locations (1)

UAB Highlands Family and Community Medicine Clinic; 🇺🇸 Birmingham, Alabama, United States