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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; PreDiabetes
• Intervention / Treatment: Behavioral: High Carbohydrate Diet; Behavioral: Reduced Carbohydrate Diet

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Drew Sayer, PhD; Phone Number: 205-354-8950; Email: sayerd@uab.edu
• Study Contact Backup: Name: Chelsi Reynolds, MS; Phone Number: 205-600-8023; Email: cnreynolds@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • UAB Highlands Family and Community Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Carbohydrate Diet; 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; 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.
Experimental: Reduced Carbohydrate Diet; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight	Measured on digital scale in order to determine "responder" or "non-responder" status.	week 4 visit
Changes in body weight	Measured on digital scale at final visit.	week 16 visit
Change in glucose	Serum glucose will be measured in a fasted state.	week 16 visit
Change in insulin	Serum insulin will be measured in a fasted state.	week 16 visit
Changes in lipids	Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol	week 16 visit
Changes in fat mass	As measured by bioelectrical impedance analysis (BIA) on the InBody S10 body composition analyzer.	week 16 visit
Changes in QUICKI index	Predictor of insulin resistance that will be calculated from glucose and insulin measures	week 16 visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in overall strength	As measured by hand grip dynamometry	week 16 visit
Changes in aerobic fitness	As measured by the 3-minute step test.	week 16 visit
Diet Intake and Physical Activity Monitoring	7-day food logs and weekly physical activity logs	week 4 visit
Diet Intake and Physical Activity Monitoring	7-day food logs and weekly physical activity logs	week 16 visit

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: General Mills
• Investigators: Principal Investigator: Holly Wyatt, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): November 21, 2023
• Study Completion (Actual): November 21, 2023

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: weight loss; exercise training; time restricted eating; reduced carbohydrate diet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Body Weight Changes; Hyperglycemia; Weight Loss; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: IRB-300006816

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No