NCT06096506

Brief Summary

The purpose of this study is to assess the effect of an adapted virtual Culinary Medicine (CM) curriculum on dietary behaviors, nutrition knowledge, and cooking skills and behaviors on outcomes such as HbA1c levels, Body Mass Index, Blood Pressure, HDL, LDL, and Triglycerides, as well as to determine the feasibility and reproducibility of virtual synchronous CM classes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 17, 2026

Completed
Last Updated

March 17, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

October 17, 2023

Results QC Date

December 3, 2025

Last Update Submit

February 23, 2026

Conditions

DiabetesElevated Body Mass Index

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c (HbA1c) Level

    Marginal mean is reported.

    baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)

Secondary Outcomes (15)

  • Body Mass Index

    baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)

  • Systolic Blood Pressure

    baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)

  • Diastolic Blood Pressure

    baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)

  • High-density Lipoprotein (HDL) Level

    baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)

  • Low-density Lipoprotein (LDL) Level

    baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)

  • +10 more secondary outcomes

Study Arms (2)

Clinics Receiving the Culinary Medicine Program

EXPERIMENTAL

Participants will take part in the Culinary Medicine Program and will be recruited at University of Texas (UT) Physician Clinics serving the Acres Homes neighborhood in Houston.

Behavioral: Culinary Medicine Program

Control Clinics

NO INTERVENTION

Participants will be recruited from UT Physicians clinics outside of the Acres Homes service area.

Interventions

Culinary Medicine ProgramBEHAVIORAL

The virtual curriculum will include five 90-minute sessions (to be held weekly or bi-weekly) on basic cooking skills with behaviorally-based nutrition education. 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. 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.

Clinics Receiving the Culinary Medicine Program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving care at UT Physicians clinics
  • diagnosed with type 2 diabetes and elevated body mass index (\>=25)
  • HbA1c labs and clinic-assessed weight completed within the last 3 months
  • English speaking or Spanish speaking
  • Can obtain groceries before each class (intervention group only)

You may not qualify if:

  • Patients without the technological support needed to participate (e.g., reliable internet and device - cell phone, tablet or laptop)
  • Patients with an uncontrolled impairment that interferes with ability to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Natalia I. Heredia, Assistant Professor
Organization
The University of Texas Health Science Center at Houston
natalia.i.heredia@uth.tmc.edu
(713) 500-9600

Study Officials

  • Natalia I Heredia, PhD., MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 23, 2023

Study Start

November 8, 2023

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

March 17, 2026

Results First Posted

March 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)