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First received: September 26, 2022

Clinical Trial: Patient-centered Goal Setting in the National Diabetes Prevention Program

Study Status: Completed

Recruit Status: RECRUITING

Condition: PreDiabetes

Study Type: INTERVENTIONAL


Official Title: Patient-centered Goal Setting in the National Diabetes Prevention Program: a Clinical Trial

Brief Summary: This is a cluster-randomized controlled trial of NDPP-Flex versus the standard NDPP to evaluate effects on glycemia, heterogeneity of treatment effects, and mechanisms of change.We will recruit 200 diverse adults with prediabetes (A1C 5.7-6.4%) and normal weight or overweight/obesity.Participants will enroll in classes (N=20) that are randomized to deliver NDPP-Flex or the standard NDPP.The trial is designed to have >95% power to detect anticipated treatment effects of ~0.2% A1C improvement and ~10%…

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