Status:

RECRUITING

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

Lead Sponsor:

University of Alabama at Birmingham

Conditions:

Disabilities

Obesity and Overweight

Eligibility:

All Genders

18-75 years

Phase:

NA

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

January 15 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06976307

Start Date

January 15 2026

End Date

June 1 2026

Last Update

August 8 2025

Active Locations (1)

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Wellness Health and Research Facility (WHARF)

Birmingham, Alabama, United States, 35209