Nourishing the Community Through Culinary Medicine- Acres Homes

The purpose of this study is to 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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes; Elevated Body Mass Index
• Intervention / Treatment: Behavioral: Virtual Culinary Medicine

• Study Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalia I Heredia, PhD., MPH; Phone Number: 713-500-9600; Email: Natalia.I.Heredia@uth.tmc.edu
• Study Contact Backup: Name: Sarah Bentley; Phone Number: (512) 482-6160; Email: Sarah.S.Bentley@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Sarah Bentley; Phone Number: (512) 482-6160; Email: Sarah.S.Bentley@uth.tmc.edu
      • Contact: Natalia I Heredia, PhD,MPH; Phone Number: 713-500-9600; Email: Natalia.I.Heredia@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention clinics; Participants will be recruited from those receiving care at University of Texas (UT) Physician Clinics serving the Acres Homes neighborhood in Houston	Behavioral: Virtual Culinary Medicine; The virtual curriculum will include five 90-minute sessions (to be held weekly or bi-weekly). 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 ($30 per class = $150 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
No Intervention: Control Clinics; Participants will be recruited from UT Physicians clinics outside of the Acres Homes service area

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Hemoglobin A1c (HbA1c)	baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Body Mass Index		baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in systolic Blood Pressure		baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in diastolic Blood Pressure		baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
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)
Change in low-density lipoprotein (LDL)		baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in Triglyceride		baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in perceived health as assessed by the Nourishing the Community Through Culinary Medicine survey (NCCM	This is a 1 item questionnaire and is scored from 1(excellent) to 6(poor) for a maximum score of 6, a higher number indicating better health	baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in fruit and vegetable consumption as assessed by the Nourishing the Community Through Culinary Medicine survey (NCCM	This is a 2 item questionnaire and is scored from 0(no servings per day ) to 5(4+ servings per day), maximum score of 10 a higher number indicating more consumption of fruit and vegetables	baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in whole grain consumption as assessed by the Nourishing the Community Through Culinary Medicine survey (NCCM	This is a 1 item questionnaire and is scored from 0(no servings per day ) to 5(4+ servings per day), maximum score of 5 a higher number indicating more consumption of whole grains	baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in typical food consumption behaviors as assessed 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 (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in Perceived Barriers of Eating Fruits and Vegetables as assessed by the Nourishing the Community Through Culinary Medicine survey (NCCM	This consists of 13 items that are scored from 0( strongly agree) to 4( strongly disagree) for a maximum score of 52, a higher number indicating better outcome	baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in Eating/cooking/using nutrition labels by the Nourishing the Community Through Culinary Medicine survey (NCCM)	This consists of 10 items that are scored from 1( never) to 5( always) for a maximum score of 50, a higher number indicating better outcome	baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in Barriers to Healthy Eating by the Nourishing the Community Through Culinary Medicine survey (NCCM)	This consists of 4 items that are scored from 1( strongly agree) to 5( strongly disagree) for a maximum score of 20, a higher number indicating better outcome	baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Change in Self-efficacy in cooking food and meal planning by the Nourishing the Community Through Culinary Medicine survey (NCCM)	This consists of 5 items that are scored from 0( not at all sure) to 4( extremely sure ) for a maximum score of 20, a higher number indicating more self efficacy	baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Natalia I Heredia, PhD., MPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HSC-SPH-23-0810; 1U54CA280804-01 (U.S. NIH Grant/Contract)

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