Encouraging a Plant Based Diet in an Underserved Urban Population

NCT ID: NCT06090409

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2024-12-31

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.

Conditions

Food Neophobia; Food Preferences; Dietary Habits

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Providing educational material on the benefits of a plant-based diet, simple recipes, food swaps and free/subsidized produce.

Education Alone

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Providing educational material on the benefits of a plant-based diet, simple recipes, food swaps and free/subsidized produce.

Interventions

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

Providing educational material on the benefits of a plant-based diet, simple recipes, food swaps and free/subsidized produce.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• N/A

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oatly Group AB

UNKNOWN

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Erin Murphy

Assistant Professor, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin Murphy

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville Ambulatory Internal Medicine Resident Clinic

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erin Murphy

Role: CONTACT

erin.murphy@louisville.edu

5025922388

Anuja Abhyankar

Role: CONTACT

anuja.abhyankar@louisville.edu

Facility Contacts

Erin Murphy

Role: primary

erin.murphy@louisville.edu

502-592-2388

Other Identifiers

23.0126

Identifier Type: -

Identifier Source: org_study_id