Clinical trial NCT05019274: Culinary Medicine vs. Nutrition Education in Diabetes
Official title: The Impact of Culinary Medicine vs. Nutrition Education on Diabetes Outcomes: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Disease: 1. Type 2 Diabetes
Keywords: Type 2 diabetes
culinary medicine
medical nutrition therapy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pragmatic effectiveness trial randomizes patients 1:1 to a series of 6 virtual Culinary Medicine classes or 6 standard of care nutrition visits .
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* No nutrition visit in the past 12 months.
* Hemoglobin A1C ≥ 7.5% within the past six months.
* Diagnosed with established Type 2 Diabetes \> 12 months
* Receiving primary care at Hatcher Station Health Center and an assigned primary care provider within the past 18 months.
* Completion of at least 2 of the 4 Health Living with Diabetes (HLWD) virtual and/or in-person sessions.

Exclusion Criteria:

* Patients who cannot hear virtual and/or in-person instruction
* Patients who cannot read or speak English or Spanish
* Patients who are unable to understand study information
* Patients younger than 18 years of age
* Patients who are unable to communicate with voice (for participation in phone surveys, focus groups and semi-structured interviews)
* Patients without access to a smart phone or other device with internet and/or data capability to participate in virtual classes
* We will exclude patients with chronic kidney disease (CKD) stage 4 or 5 (eGFR \< 30 or on dialysis) because their renal function may require additional nutritional counseling and dietary modifications beyond the scope of the proposed culinary medicine and nutrition sessions delivered in this study.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 3, 6, and 12 months
Secondary outcomes:
measure: Change in weight
timeFrame: 3, 6, and 12 months
measure: Change in BMI
timeFrame: baseline, 6 and 12 months
measure: Change in blood pressure
timeFrame: baseline, 6, and 12 months
measure: Food security score
timeFrame: baseline, 6 months and 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center in Dallas
name: Michael E Bowen, MD
role: PRINCIPAL_INVESTIGATOR
References: