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Patient-centered Goal Setting in the National Diabetes Prevention Program

Denver Health and Hospital Authority · 2023
ClinicalTrials.gov · Datasets · License: Public Domain · 2023
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naprediabetes
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% increase in participants who reach normoglycemia compared to the control arm. The study will be conducted in a health system with the 6th largest network of FQHCs in the US (Denver Health) and in partnership with a premier research institution (University of Colorado).
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