Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06090409

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
Phase
N/A
Study type
Interventional
Enrollment
300 (estimated)
Sponsor
University of Louisville · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
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.

Timeline

Start date
2023-06-14
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2023-10-19
Last updated
2024-10-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06090409. Inclusion in this directory is not an endorsement.