Development of an Adaptive Treatment for Weight Loss in People With Prediabetes

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

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.

Inclusion Criteria:

• 18-75 years of age
• BMI of 27 kg/m2 or greater
• at risk for developing type 2 diabetes (prediabetes)

Exclusion Criteria:

• Pregnant, planning to become pregnant, or breastfeeding
• uncontrolled hypo or hyperthyroidism