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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Culinary Medicine
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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