Clinical trial NCT05624775: Nourishing the Community Through Culinary Medicine
Official title: Nourishing the Community Through Culinary Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Healthy Food Servings by the Nourishing the Community Through Culinary Medicine survey (NCCM)
timeFrame: Baseline, post intervention (upto 10 weeks after baseline)
measure: Change in Typical food consumption behaviors by the Nourishing the Community Through Culinary Medicine survey (NCCM)
timeFrame: Baseline, post intervention (upto 10 weeks after baseline)
measure: Change in Perceived Barriers to Healthy Eating by the Nourishing the Community Through Culinary Medicine survey (NCCM)
timeFrame: Baseline, post intervention (upto 10 weeks after baseline)
measure: Change in Shopping, cooking, and eating behaviors by the Nourishing the Community Through Culinary Medicine survey (NCCM)
timeFrame: Baseline, post intervention (upto 10 weeks after baseline)
measure: Change in Diabetes Management by the Nourishing the Community Through Culinary Medicine survey (NCCM)
timeFrame: Baseline, post intervention (upto 10 weeks after baseline)
measure: Change in cooking self-efficacy by the Nourishing the Community Through Culinary Medicine survey (NCCM)
timeFrame: Baseline, post intervention (upto 10 weeks after baseline)
Secondary outcomes:
measure: Change in Hemoglobin A1c (HbA1c)
timeFrame: 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)
measure: Change in Body Mass Index
timeFrame: 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)
measure: Change in systolic Blood Pressure
timeFrame: 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)
measure: Change in diastolic Blood Pressure
timeFrame: 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)
measure: Change in High-density lipoprotein (HDL)
timeFrame: 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)
measure: Change in low-density lipoprotein (LDL)
timeFrame: 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)
measure: Change in Triglyceride
timeFrame: 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)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Natalia I Heredia, PhD., MPH
role: PRINCIPAL_INVESTIGATOR
References: