NCT05019274Completed
Culinary Medicine vs. Nutrition Education in Diabetes
The Impact of Culinary Medicine vs. Nutrition Education on Diabetes Outcomes: A Randomized Trial
Source: ClinicalTrials.gov · Last updated 6 Mar 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 30 Jul 2021
- Start date
- 9 Aug 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05019274
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 9 Aug 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Age
- Patients younger than 18 years of age
Other
- 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 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Parkland Health and Hospital System Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.