NCT05019274

Culinary Medicine vs. Nutrition Education in Diabetes

The Impact of Culinary Medicine vs. Nutrition Education on Diabetes Outcomes: A Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This pragmatic trial compares the effectiveness of virtual culinary medicine classes vs. standard of care medical nutrition visits to improve glycemic control in patients with uncontrolled type 2 diabetes . Culinary medicine teaches healthy eating principles through a combination of experiential cooking classes and focused didactic sessions. The primary study outcome is glycemic improvement (A1c). Qualitative evaluation will assess participant experience, impact, and durability of behavior changes related to nutrition. A short term cost analysis will be conducted to inform program costs and cost effectiveness.

Detailed description

A total of 130 participants with uncontrolled type 2 diabetes will be recruited from a safety-net health system that provides comprehensive care for the uninsured and underinsured residents of Dallas County, Texas. Eligible participants will be actively engaged in primary care and recruited from clinical practice. Participants will be randomized to two arms: Culinary Medicine and standard of care medical nutrition therapy (MNT). Certified culinary medicine instructors will deliver a series of 6 monthly Culinary Medicine classes virtually with participants cooking in their own homes. A series of 6 standard of care medical nutrition sessions will be delivered by the health system using a combination of individual and group sessions both in person and virtually. All participants will be enrolled in a 12 month food assistance program in partnership with community based partners to provide access to healthy foods. Classes will be delivered over 6 months, and participants will be followed for an additional 6 months to assess the durability of glycemic response and behavior changes. A cost analysis will examine the system cost to deliver the intervention and the short term cost effectiveness examining the cost per participant achieving a clinically meaningful reduction in A1c.

Conditions

• Primary Disease: 1. Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	Culinary Medicine Intervention	Participants randomized to the Culinary Medicine intervention will complete a series of 6 virtual culinary medicine cooking classes (1 class per month for 6 months). Virtual sessions will be delivered via Zoom using a combination of large group instruction and small group break-out sessions in which participants prepare a recipe in their home kitchen with the virtual assistance from trained group facilitators. After preparing the dish, participants will enjoy the dish they prepared and report-back to the large group about their dish and experience. Classes will be conducted in English and Spanish with language-concordant instructors and facilitators.
OTHER	Standard of Care Nutrition Visits	Participants randomized to standard of care nutrition visits will complete a series of 6 nutrition visits (1 session per month for 6 months) led by bilingual (English/Spanish) dieticians. Sessions will consist of a mix of individual and small group sessions per standard of care in the clinic.

Timeline

• Start date: 2021-08-09
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-08-24
• Last updated: 2024-03-06

Locations

1 site across 1 country: United States