Culinary Medicine vs. Nutrition Education in Diabetes

NCT05019274 | Completed

• 1 other identifier: STU-2020-1244
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Disease: 1. Type 2 Diabetes

Keywords

Type 2 diabetes; culinary medicine; medical nutrition therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  baseline, 6 months and 12 months

Study Arms (2)

Culinary Medicine

EXPERIMENTAL

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

Other: Culinary Medicine Intervention

Nutrition Education

ACTIVE COMPARATOR

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

Interventions

Culinary Medicine Intervention OTHER

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.

Culinary Medicine

Standard of Care Nutrition Visits OTHER

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.

Nutrition Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health and Hospital System

Dallas, Texas, 75206, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael E Bowen, MD

  UT Southwestern Medical Center in Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Internal Medicine

Model Details: This pragmatic effectiveness trial randomizes patients 1:1 to a series of 6 virtual Culinary Medicine classes or 6 standard of care nutrition visits .

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 24, 2021
• Study Start: August 9, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)