NCT05624775

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Feb 2022

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

Study Start

First participant enrolled

February 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

November 14, 2022

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Change in Healthy Food Servings by the Nourishing the Community Through Culinary Medicine survey (NCCM)

    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)

    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)

    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)

    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)

    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)

    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 Outcomes (7)

  • Change in Hemoglobin A1c (HbA1c)

    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

    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

    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

    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)

    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)

  • +2 more secondary outcomes

Study Arms (1)

Virtual Culinary Medicine

EXPERIMENTAL
Behavioral: Virtual Culinary Medicine

Interventions

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

Virtual Culinary Medicine

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

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

Study Officials

  • Natalia I Heredia, PhD., MPH

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 22, 2022

Study Start

February 1, 2022

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations