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

Not Applicable

Not yet recruiting

• Conditions: Disabilities; Obesity and Overweight; Prediabetes

• Registration Number: NCT06976307
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Study Start: 2025-06-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 18-75 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Change in glucose	Baseline & Week 16	Serum glucose will be measured in a fasted state.
Changes in body weight	Baseline, Week4, and Week 16	Measured on validated digital scale

Secondary Outcome Measures

Name	Time	Method
Changes in fat mass	Baseline & Week 16	As measured by dual-energy X-ray absorptiometry (DEXA)
Change in insulin	Baseline & Week 16	Serum insulin will be measured in a fasted state.
Changes in lipids	Baseline & Week 16	Fasting serum concentrations of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol
Changes in QUICKI index	Baseline & Week 16	Predictor of insulin resistance that will be calculated from glucose and insulin measures
Changes in overall strength	Baseline & Week 16	As measured by hand grip dynamometry
Changes in aerobic fitness	Baseline & Week 16	As measured by graded exercise test using arm crank

Trial Locations

Locations (1)

Wellness Health and Research Facility (WHARF); 🇺🇸 Birmingham, Alabama, United States