- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05624775
Nourishing the Community Through Culinary Medicine
August 14, 2025 updated by: Natalia Heredia, The University of Texas Health Science Center, Houston
The purpose of this study is to adapt existing Nourish Program curriculum for synchronous virtual delivery,to implement adapted virtual Culinary Medicine (CM)curriculum among target population, to assess if program participation improves participant dietary behaviors, nutrition knowledge, and cooking skills and behaviors above standard of care, to assess if program participation improves patient levels of HbA1c, Body Mass Index, Blood Pressure, HDL, LDL and Triglycerides above standard of care and to determine the feasibility and reproducibility of virtual synchronous CM classes in patients with diabetes.
Study Overview
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- type 2 diabetes and glycosylated hemoglobin (HbA1c) >7.0
- receiving care at Sanitas Medical Center clinics in August 2021 - August 2023
- English speaking or Spanish speaking.
Exclusion Criteria:
- Patients without the technological support needed to participate in the program (e.g., reliable internet and device - cell phone, tablet or laptop);
- Patients with terminal or late-stage conditions (e.g., advanced stage chronic kidney disease);
- Patients with uncontrolled mental disorder that interferes with participation in active programming;
- Patients with physical impairment that interferes with participation in active programming
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Culinary Medicine
|
The virtual curriculum will include five 90-minute sessions (to be held weekly or bi-weekly).
Participants will cook and engage virtually (with video and sound on) from their home kitchens via the digital platform.
Participants will also be expected to shop for groceries ahead of the sessions to participate in the program.
A gift card will be provided for groceries ($20 per class = $100 total).Asynchronous virtual educational content (cooking skills videos, animated nutrition education videos, and additional recipes) will be provided to engage and retain participants beyond initial sessions.
Recipes will provide enough food for a family of four.
clinic patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Healthy Food Servings by the Nourishing the Community Through Culinary Medicine survey (NCCM)
Time Frame: Baseline, post intervention (upto 10 weeks after baseline)
|
This consists of 3 items that are scored from 1 [None] to 6 [4 servings or more] for a maximum score of 18, a higher number indicating a better outcome.
|
Baseline, post intervention (upto 10 weeks after baseline)
|
|
Change in Typical food consumption behaviors by the Nourishing the Community Through Culinary Medicine survey (NCCM)
Time Frame: Baseline, post intervention (upto 10 weeks after baseline)
|
This consists of 7 items that are scored from 1 [Not at all] to 5 [More than once a day] for a maximum score of 35, a higher number indicating better outcome.
|
Baseline, post intervention (upto 10 weeks after baseline)
|
|
Change in Perceived Barriers to Healthy Eating by the Nourishing the Community Through Culinary Medicine survey (NCCM)
Time Frame: Baseline, post intervention (upto 10 weeks after baseline)
|
This consists of 9 items that are scored from 1 [Strongly Disagree] to 5 [Strongly Agree] for a maximum score of 45, a higher number indicating more perceived barriers.
|
Baseline, post intervention (upto 10 weeks after baseline)
|
|
Change in Shopping, cooking, and eating behaviors by the Nourishing the Community Through Culinary Medicine survey (NCCM)
Time Frame: Baseline, post intervention (upto 10 weeks after baseline)
|
This consists of 9 items that are scored from 1 [Never] to 5 [Always], for a maximum score of 45, with a higher number indicating more ideal shopping, cooking and eating behaviors that align with program goals.
|
Baseline, post intervention (upto 10 weeks after baseline)
|
|
Change in Diabetes Management by the Nourishing the Community Through Culinary Medicine survey (NCCM)
Time Frame: Baseline, post intervention (upto 10 weeks after baseline)
|
This consists of 18 items.
The first 16 items that are scored from 1 [Does not apply to me] to 4 [Applies to me very much] and the remaining 2 items are dichotomous scored [Yes=1] to [No=0], for a maximum score of 68, with a higher number indicates a better diabetes self-management.
|
Baseline, post intervention (upto 10 weeks after baseline)
|
|
Change in cooking self-efficacy by the Nourishing the Community Through Culinary Medicine survey (NCCM)
Time Frame: Baseline, post intervention (upto 10 weeks after baseline)
|
This consists of 10 items that are scored from 1 [Not sure at all] to 5 [Extremely sure], for a maximum of 50, with a higher number indicating more self-efficacy.
Five items ask about self-efficacy before the program, and five ask about self-efficacy after the program.
|
Baseline, post intervention (upto 10 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Hemoglobin A1c (HbA1c)
Time Frame: baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
|
Change in Body Mass Index
Time Frame: baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
|
Change in systolic Blood Pressure
Time Frame: baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
|
Change in diastolic Blood Pressure
Time Frame: baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
|
Change in High-density lipoprotein (HDL)
Time Frame: baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
|
Change in low-density lipoprotein (LDL)
Time Frame: baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
|
Change in Triglyceride
Time Frame: baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion), and post 6-months completion of NCCM (within 90 days of 6-months completion of NCCM)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Natalia I Heredia, PhD., MPH, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Actual)
December 15, 2022
Study Completion (Actual)
December 15, 2022
Study Registration Dates
First Submitted
November 14, 2022
First Submitted That Met QC Criteria
November 14, 2022
First Posted (Actual)
November 22, 2022
Study Record Updates
Last Update Posted (Actual)
August 17, 2025
Last Update Submitted That Met QC Criteria
August 14, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- HSC-SPH-21-0555
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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