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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · May 8, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the best ways to help people with prediabetes and disabilities lose weight. It will last for 16 weeks and will look at different weight loss strategies to see which ones work best for participants. At the beginning of the study, participants will be assigned to follow either a high or low carbohydrate diet. After four weeks, those who have lost at least 2.5% of their weight will continue with their assigned diet. If someone hasn’t lost that much weight, they will be offered additional support, like exercise counseling or a new eating schedule, to help them succeed.

To join this study, participants need to be between 18 and 75 years old, have a body mass index (BMI) that shows they are overweight or have a disability that affects their mobility. They should also be at risk for developing type 2 diabetes. However, people who are pregnant, breastfeeding, or have certain health conditions, like diabetes or eating disorders, won't be eligible. Overall, participants can expect to receive personalized support and guidance throughout the trial, aimed at improving their health and helping them lose weight safely.

Gender

ALL

Eligibility criteria

• 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)