Encouraging a Plant Based Diet in an Underserved Urban Population

University of Louisville (UOFL)

Status: Enrolling

Conditions: Dietary Habits; Food Neophobia; Food Preferences

Treatments: Other: Implementing free/subsidized agricultural produce to encourage a plant-based diet.

Study type: Interventional

Funder types: Other

Identifiers

NCT06090409

23.0126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• N/A

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Free/Subsidized Community Supported Agriculture (CSA) produce along with education.

Experimental group

Description:

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.

Treatment:

Other: Implementing free/subsidized agricultural produce to encourage a plant-based diet.

Education Alone

Active Comparator group

Description:

Patients will receive educational information about the benefits of plant-based eating.

Treatment:

Other: Implementing free/subsidized agricultural produce to encourage a plant-based diet.