Primary Disease: 1. Type 2 DiabetesNCT05019274
Culinary Medicine vs. Nutrition Education in Diabetes
A study testing Culinary Medicine Intervention in people with Primary Disease: 1. Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Disease: 1. Type 2 Diabetes
- What is being tested?
- Culinary Medicine Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health and Hospital System
Dallas, Texas, 75206
About this study
Official title: The Impact of Culinary Medicine vs. Nutrition Education on Diabetes Outcomes: A Randomized Trial
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.
Read the 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.
- Conditions
- Primary Disease: 1. Type 2 Diabetes
- Being tested
- Culinary Medicine Intervention, Standard of Care Nutrition Visits
- Keywords
- Type 2 diabetes, culinary medicine, medical nutrition therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culinary Medicine InterventionOther
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.
Standard of Care Nutrition VisitsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Culinary Medicine | Experimental | Series of 6 virtual group Culinary Medicine sessions delivered monthly for 6 months Receives: 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. Receives: Other: Standard of Care Nutrition Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6, and 12 months
Secondary outcomes (4)
Change in weight
Measured: 3, 6, and 12 months
Change in BMI
Measured: baseline, 6 and 12 months
Change in blood pressure
Measured: 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.
Measured: baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start9 Aug 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Disease: 1. Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Edward Bowen, University of Texas Southwestern Medical Center
- Investigators
- Michael E Bowen, MD, Principal investigator, UT Southwestern Medical Center in Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019274
- Sponsor's protocol ID
- STU-2020-1244
- Status last verified
- Mar 2024
- First submitted
- 30 Jul 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Culinary Medicine vs. Nutrition Education on Diabetes Outcomes: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05019274
- Acronym / sponsor ID
- STU-2020-1244
- Conditions
- Primary Disease: 1. Type 2 Diabetes
- Keywords
- Type 2 diabetes, culinary medicine, medical nutrition therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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 .
| Arm | Type | Receives |
|---|---|---|
| Culinary Medicine | Experimental | Other: Culinary Medicine InterventionSeries of 6 virtual group Culinary Medicine sessions delivered monthly for 6 months |
| Nutrition Education | Active comparator | Other: Standard of Care Nutrition VisitsSeries of 6 standard of care nutrition visits delivered by clinic dieticians. These are a mix of individual and group sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culinary Medicine InterventionParticipants 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. | Other | Culinary Medicine |
| Standard of Care Nutrition VisitsParticipants 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. | Other | Nutrition Education |
Primary outcome
Hemoglobin A1c
Time frame: 3, 6, and 12 months
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.
4 secondary outcomes
Change in weight
Time frame: 3, 6, and 12 months
Change in BMI
Time frame: baseline, 6 and 12 months
Change in blood pressure
Time frame: baseline, 6, and 12 months
Food security score
Time frame: baseline, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E Bowen, MD principal investigator
UT Southwestern Medical Center in Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culinary Medicine Intervention in people with Primary Disease: 1. Type 2 Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.