Culinary Medicine vs. Nutrition Education in Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Primary Disease: 1. Type 2 Diabetes

Intervention / Treatment
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* Other: Culinary Medicine Intervention
* Other: Standard of Care Nutrition Visits


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 .
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culinary Medicine<br>Series of 6 virtual group Culinary Medicine sessions delivered monthly for 6 months | Other: Culinary Medicine Intervention<br>* 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.<br>|
| Active Comparator: Nutrition Education<br>Series of 6 standard of care nutrition visits delivered by clinic dieticians. These are a mix of individual and group sessions. | Other: Standard of Care Nutrition Visits<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | A1c will be measured at baseline, 3, 6 and 12 months. Change in A1c will be assessed at 6 months (end of active intervention) and also at 12 months (i.e. 6 months after completion of active intervention) to assess the durability of the intervention on glycemic control. Pre-specified subgroup analyses will also examine A1c outcomes by: 1) prior participation in diabetes education and nutrition education. Stratified analyses by number of sessions attended will also be conducted. | 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight |  | 3, 6, and 12 months | 
| Change in BMI |  | baseline, 6 and 12 months | 
| Change in blood pressure |  | baseline, 6, and 12 months | 
| Food security score | U.S. Household Food Security Survey Module: Six-Item Short Form. The score ranges from 0 to 6 with 0 indicating high food security and 6 indicating very low food security. | baseline, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, culinary medicine, medical nutrition therapy