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

NCT06976307 | Recruiting

• 2 other identifiers: IRB-300006816-sub-studyCEDHARS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a sub-study to NCT04745572 to include a new cohort of participants with disabilities. 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

Disabilities; Obesity and Overweight; Prediabetes

Keywords

SMART; diet; exercise; weight loss; disabilities

Outcome Measures

Primary Outcomes (2)

• Change in glucose

  Serum glucose will be measured in a fasted state.

  Baseline & Week 16

• Changes in body weight

  Measured on validated digital scale

  Baseline, Week4, and Week 16

Secondary Outcomes (6)

• Changes in fat mass

  Baseline & Week 16

• Change in insulin

  Baseline & Week 16

• Changes in lipids

  Baseline & Week 16

• Changes in QUICKI index

  Baseline & Week 16

• Changes in overall strength

  Baseline & Week 16

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: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• BMI of 27 kg/m2 or greater for ambulatory individuals and 22 kg/m2 for individuals with spinal cord injury. Adjustments will be calculated for those with amputations and/or limb indifference
• at risk for developing type 2 diabetes (prediabetes)
• One or more physical or mobility disabilities
• Stable medication type and dosage for 3 or more months for medications likely to affect body weight and/or appetite
• Willing to complete requirements for participation

You may not qualify if:

• Pregnant, planning to become pregnant or breastfeeding
• Currently taking medication(s) for weight loss
• Medical history of Type 1 or 2 Diabetes, using exogenous insulin, using prescription or OTC weight loss medications within the past 3 months, current alcohol or drug abuse or dependence, smoker with unstable habits in the past 3 months, pacemaker or other life-threatening medical implant, eating disorder(s)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Wellness Health and Research Facility (WHARF)

Birmingham, Alabama, 35209, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Prediabetic State; Motor Activity; Weight Loss

Interventions

Diet, High-Protein Low-Carbohydrate

Condition Hierarchy (Ancestors)

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

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

• Christine Ferguson, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omer Faruq, MS

CONTACT

205-518-8292; ofaruq@uab.edu

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: Assistant Professor

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)