Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oatly Group AB | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free/Subsidized Community Supported Agriculture (CSA) produce along with education. | Experimental | Patients who self-elect to enroll in subsidized/free Community-supported agriculture produce shares will also receive Education on the benefits of a plant-based diet. |
|
| Education Alone | Active Comparator | Patients will receive educational information about the benefits of plant-based eating. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Diet Inventory | Measure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in blood pressure | Systolic and diastolic blood pressure will be recorded when done per Standard of Care. | 1 year |
| Improvement in lipid profile | measure of hemoglobin A1C will be recorded when done per Standard of Care. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Murphy | Contact | 5025922388 | erin.murphy@louisville.edu | |
| Anuja Abhyankar | Contact | anuja.abhyankar@louisville.edu |
| Name | Affiliation | Role |
|---|---|---|
| Erin Murphy | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Ambulatory Internal Medicine Resident Clinic | Recruiting | Louisville | Kentucky | 40202 | United States |
Patient identifiers will be visible to Principal investigator and Co-Investigatory and kept in separate password-protected database. Other study investigators will see Individual Participant Data with identifiers removed.
entirety of study and for 1 year after
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000080146 | Avoidant Restrictive Food Intake Disorder |
| D005518 | Food Preferences |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D001522 | Behavior, Animal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| Weight Loss | measure of weight will be recorded when done per Standard of Care. | 1 year |