2.2. Study Design
diabetes
DIABETES
We designed a pragmatic randomized controlled trial (RCT) to compare the effectiveness of hands-on, experiential cooking classes (culinary medicine intervention) and standard of care, clinic-based medical nutrition therapy for patients with uncontrolled diabetes. This study was approved by the UT Southwestern Medical Center Institutional Review Board (STU 200-1244). Patients were enrolled in the trial for 6 months of active intervention, and an additional 6 months of post-intervention follow-up to evaluate for sustained behavioral and biometric changes. All participants received kitchen utensils and equipment and information about local food assistance. In its original design, we proposed in-person enrollment and cooking classes at a local food pantry and teaching kitchen in a community center within 2 miles of the clinic. However, the COVID-19 pandemic necessitated a shift to virtual visits where culinary medicine classes were delivered via Zoom Cloud Meetings, v5.13.11 [