Encouraging a Plant Based Diet in an Underserved Urban Population

Not Applicable

Recruiting

• Conditions: Food Preferences; Food Neophobia; Dietary Habits
• Interventions: Other: Implementing free/subsidized agricultural produce to encourage a plant-based diet.

• Registration Number: NCT06090409
• Lead Sponsor: University of Louisville

Brief Summary

The investigator's goal is to promote a plant-based diet amongst the underserved urban population of Louisville with the help of educational aids and the provision of affordable resources.

Detailed Description

Primary care clinic patients who screen positive for food insecurity between 2021-2023 will be eligible for this study (\~200 patients). Patients will be recruited by one of four means: during standard clinic visits, or via phone, Electronic Medical Record message, or mail. Registry of patients will be de-identified and list of identifiers will be stored separately from the data set. Data will be stored on password protected computers only available to select research staff. Investigators will utilize a preamble in lieu of informed consent.

The primary outcome will be to measure the readiness of patients to adhere to a plant-based diet. Investigators will assess readiness using Food Neophobia inventory and will perform a brief Diet Inventory at simultaneous timepoints. Education surrounding benefits and easy ways to increase plant-based eating will be distributed to all participating patients. Enrollment in a local income-based subsidized Community Supported Agriculture share (weekly farm produce box during growing season) will be offered to all patients. Patients can opt into this service, and we will track which patients enroll. Before, during, and after the Community Sponsored Agriculture produce time period, Food Neophobia and Diet Inventory will be reassessed.

Adherence to plant-based eating between the patients who received access to subsidized food and education versus those who received education alone will be evaluated. Qualitative open-ended feedback will be obtained at all time points.

The secondary outcomes are to measure weight loss, reduction in blood pressure, and improvement in hemoglobin A1C and lipid profile wherever applicable.

Statistical significance is not attempting to be reached, but rather the associations between food neophobia and ability to change diet will be evaluated, as well as other qualitative open-ended feedback.

Study Timeline

• Study First Submitted: 2023-03-17
• Study Start: 2023-06-14
• Study First Submitted QC: 2023-10-16
• Study First Posted: 2023-10-19
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients age 18 and older screening as food insecure since 2021
• Patients willing to complete survey data

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Free/Subsidized Community Supported Agriculture (CSA) produce along with education.	Implementing free/subsidized agricultural produce to encourage a plant-based diet.	Patients who self-elect to enroll in subsidized/free Community-supported agriculture produce shares will also receive Education on the benefits of a plant-based diet.
Education Alone	Implementing free/subsidized agricultural produce to encourage a plant-based diet.	Patients will receive educational information about the benefits of plant-based eating.

Primary Outcome Measures

Name	Time	Method
Food Neophobia	1 year	Assess the readiness of participants to adhere to a plant-based diet while identifying potential barriers to the adhering to the diet.
Diet Inventory	1 year	Measure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce.

Secondary Outcome Measures

Name	Time	Method
Weight Loss	1 year	measure of weight will be recorded when done per Standard of Care.
Reduction in blood pressure	1 year	Systolic and diastolic blood pressure will be recorded when done per Standard of Care.
Improvement in lipid profile	1 year	measure of hemoglobin A1C will be recorded when done per Standard of Care.

Trial Locations

Locations (1)

University of Louisville Ambulatory Internal Medicine Resident Clinic; 🇺🇸 Louisville, Kentucky, United States