Clinical trial NCT06090409: Encouraging a Plant Based Diet in an Underserved Urban Population
Official title: Assessing Dietary Patterns and Implementing Cost-effective Interventions to Encourage a Plant-based Diet in an Underserved Urban Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Neophobia
Food Preferences
Dietary Habits
Keywords: Food Neophobia, Plant-based Diet
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Oatly Group AB
First posted: 2023-10-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Food Neophobia
timeFrame: 1 year
measure: Diet Inventory
timeFrame: 1 year
Secondary outcomes:
measure: Reduction in blood pressure
timeFrame: 1 year
measure: Improvement in lipid profile
timeFrame: 1 year
measure: Weight Loss
timeFrame: 1 year
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Ambulatory Internal Medicine Resident Clinic
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Erin Murphy
role: PRINCIPAL_INVESTIGATOR
References: