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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1
Wellness Health and Research Facility (WHARF)
Birmingham, Alabama, United States, 35209