Encouraging a Plant Based Diet in an Underserved Urban Population

Assessing Dietary Patterns and Implementing Cost-effective Interventions to Encourage a Plant-based Diet in an Underserved Urban Population

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Murphy; Phone Number: 5025922388; Email: erin.murphy@louisville.edu
• Study Contact Backup: Name: Anuja Abhyankar; Email: anuja.abhyankar@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville Ambulatory Internal Medicine Resident Clinic
      • Contact: Erin Murphy; Phone Number: 502-592-2388; Email: erin.murphy@louisville.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: Education Alone; Patients will receive educational information about the benefits of plant-based eating.	Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: Oatly Group AB
• Investigators: Principal Investigator: Erin Murphy, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Food Neophobia, Plant-based Diet
• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders; Avoidant Restrictive Food Intake Disorder
• Other Study ID Numbers: 23.0126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient identifiers will be visible to Principal investigator and Co-Investigatory and kept in separate password-protected database. Other study investigators will see Individual Participant Data with identifiers removed.
• IPD Sharing Time Frame: entirety of study and for 1 year after
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No