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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06090409
Enrollment
300
Registered
2023-10-19
Start date
2023-06-14
Completion date
2024-12-31
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Habits, Food Neophobia, Food Preferences

Keywords

Food Neophobia, Plant-based Diet

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.

Interventions

OTHERImplementing 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.

Sponsors

Oatly Group AB
CollaboratorUNKNOWN
University of Louisville
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Food Neophobia1 yearAssess the readiness of participants to adhere to a plant-based diet while identifying potential barriers to the adhering to the diet.
Diet Inventory1 yearMeasure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce.

Secondary

MeasureTime frameDescription
Reduction in blood pressure1 yearSystolic and diastolic blood pressure will be recorded when done per Standard of Care.
Improvement in lipid profile1 yearmeasure of hemoglobin A1C will be recorded when done per Standard of Care.
Weight Loss1 yearmeasure of weight will be recorded when done per Standard of Care.

Countries

United States

Contacts

Primary ContactErin Murphy
erin.murphy@louisville.edu5025922388
Backup ContactAnuja Abhyankar
anuja.abhyankar@louisville.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026