Nourishing the Community Through Culinary Medicine- Acres Homes

Diabetes Clinical Trial

Official title:

Nourishing the Community Through Culinary Medicine- Acres Homes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096506
• Other study ID #: HSC-SPH-23-0810
• Secondary ID: 1U54CA280804-01
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Natalia I Heredia, PhD., MPH
• Phone: 713-500-9600
• Email: Natalia.I.Heredia[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Elevated Body Mass Index

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Body Mass Index		baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Secondary	Change in systolic Blood Pressure		baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Secondary	Change in diastolic Blood Pressure		baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Secondary	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)
Secondary	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)
Secondary	Change in Triglyceride		baseline (within 90 days of starting the NCCM program), at program completion (within 90 days of NCCM program completion)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)