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NCT Number: NCT06090409

Encouraging 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville Ambulatory Internal Medicine Resident Clinic

Louisville, Kentucky, 40202, United States

Location status: Recruiting

Location contact

Erin Murphy

CONTACT

[email protected]

502-592-2388

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

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

Other

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

Primary outcomes

  1. Food Neophobia

    Time frame: 1 year

    Assess the readiness of participants to adhere to a plant-based diet while identifying potential barriers to the adhering to the diet.

  2. Diet Inventory

    Time frame: 1 year

    Measure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce.

Secondary outcomes

  1. Reduction in blood pressure

    Time frame: 1 year

    Systolic and diastolic blood pressure will be recorded when done per Standard of Care.

  2. Improvement in lipid profile

    Time frame: 1 year

    measure of hemoglobin A1C will be recorded when done per Standard of Care.

  3. Weight Loss

    Time frame: 1 year

    measure of weight will be recorded when done per Standard of Care.

Study contacts

Contact information is provided by the study sponsor or research team.

Anuja Abhyankar

CONTACT

[email protected]

Erin Murphy

CONTACT

[email protected]

5025922388

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • Oatly Group AB

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 19, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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