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Recruiting NCT06090409

Encouraging a Plant Based Diet in an Underserved Urban Population

No phase Interventional Food Neophobia Food Preferences Dietary Habits

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implementing free/subsidized agricultural produce to encourage a plant-based diet..
Who it may be relevant to
Registry conditions: Food Neophobia, Food Preferences, Dietary Habits. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Food Neophobia [Time frame: 1 year]
  • Diet Inventory [Time frame: 1 year]
Secondary outcome measures (3)
  • Reduction in blood pressure [Time frame: 1 year]
  • Improvement in lipid profile [Time frame: 1 year]
  • Weight Loss [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • University of Louisville Ambulatory Internal Medicine Resident Clinic — Louisville

Identifiers

NCT: NCT06090409 · 23.0126

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗