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Culinary Medicine vs. Nutrition Education in Diabetes

Primary Purpose

Primary Disease: 1. Type 2 Diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culinary Medicine Intervention
Standard of Care Nutrition Visits
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Disease: 1. Type 2 Diabetes focused on measuring Type 2 diabetes, culinary medicine, medical nutrition therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Parkland Health and Hospital System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Culinary Medicine

Nutrition Education

Arm Description

Series of 6 virtual group Culinary Medicine sessions delivered monthly for 6 months

Series of 6 standard of care nutrition visits delivered by clinic dieticians. These are a mix of individual and group sessions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in weight
Change in BMI
Change in blood pressure
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.

Full Information

First Posted
July 30, 2021
Last Updated
September 5, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05019274
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Disease: 1. Type 2 Diabetes
Keywords
Type 2 diabetes, culinary medicine, medical nutrition therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Culinary Medicine
Arm Type
Experimental
Arm Description
Series of 6 virtual group Culinary Medicine sessions delivered monthly for 6 months
Arm Title
Nutrition Education
Arm Type
Active Comparator
Arm Description
Series of 6 standard of care nutrition visits delivered by clinic dieticians. These are a mix of individual and group sessions.
Intervention Type
Other
Intervention Name(s)
Culinary Medicine Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care Nutrition Visits
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Description
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.
Time Frame
3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Change in weight
Time Frame
3, 6, and 12 months
Title
Change in BMI
Time Frame
baseline, 6 and 12 months
Title
Change in blood pressure
Time Frame
baseline, 6, and 12 months
Title
Food security score
Description
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.
Time Frame
baseline, 6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Bowen, MD
Organizational Affiliation
UT Southwestern Medical Center in Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Culinary Medicine vs. Nutrition Education in Diabetes

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