Encouraging a Plant Based Diet in an Underserved Urban Population

Dietary Habits Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06090409
• Other study ID #: 23.0126
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: University of Louisville
• Contact: Erin Murphy
• Phone: 5025922388
• Email: erin.murphy[@]louisville.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients age 18 and older screening as food insecure since 2021

• Patients willing to complete survey data

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Dietary Habits
• Food Neophobia
• Food Preferences

Intervention

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.

Locations

Country	Name	City	State
United States	University of Louisville Ambulatory Internal Medicine Resident Clinic	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Oatly Group AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Diet Inventory	Measure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce.	1 year
Secondary	Reduction in blood pressure	Systolic and diastolic blood pressure will be recorded when done per Standard of Care.	1 year
Secondary	Improvement in lipid profile	measure of hemoglobin A1C will be recorded when done per Standard of Care.	1 year
Secondary	Weight Loss	measure of weight will be recorded when done per Standard of Care.	1 year