Encouraging a Plant Based Diet in an Underserved Urban Population
Primary Purpose
Food Neophobia, Food Preferences, Dietary Habits
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implementing free/subsidized agricultural produce to encourage a plant-based diet.
Sponsored by
About this trial
This is an interventional other trial for Food Neophobia focused on measuring Food Neophobia, Plant-based Diet
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
Sites / Locations
- University of Louisville Ambulatory Internal Medicine Resident ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Free/Subsidized Community Supported Agriculture (CSA) produce along with education.
Education Alone
Arm Description
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.
Patients will receive educational information about the benefits of plant-based eating.
Outcomes
Primary Outcome Measures
Food Neophobia
Assess the readiness of participants to adhere to a plant-based diet while identifying potential barriers to the adhering to the diet.
Diet Inventory
Measure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce.
Secondary Outcome Measures
Reduction in blood pressure
Systolic and diastolic blood pressure will be recorded when done per Standard of Care.
Improvement in lipid profile
measure of hemoglobin A1C will be recorded when done per Standard of Care.
Weight Loss
measure of weight will be recorded when done per Standard of Care.
Full Information
NCT ID
NCT06090409
First Posted
March 17, 2023
Last Updated
October 16, 2023
Sponsor
University of Louisville
Collaborators
Oatly Group AB
1. Study Identification
Unique Protocol Identification Number
NCT06090409
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
Oatly Group AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Neophobia, Food Preferences, Dietary Habits
Keywords
Food Neophobia, Plant-based Diet
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Free/Subsidized Community Supported Agriculture (CSA) produce along with education.
Arm Type
Experimental
Arm Description
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.
Arm Title
Education Alone
Arm Type
Active Comparator
Arm Description
Patients will receive educational information about the benefits of plant-based eating.
Intervention Type
Other
Intervention Name(s)
Implementing free/subsidized agricultural produce to encourage a plant-based diet.
Intervention Description
Providing educational material on the benefits of a plant-based diet, simple recipes, food swaps and free/subsidized produce.
Primary Outcome Measure Information:
Title
Food Neophobia
Description
Assess the readiness of participants to adhere to a plant-based diet while identifying potential barriers to the adhering to the diet.
Time Frame
1 year
Title
Diet Inventory
Description
Measure adherence to the plant-based diet between the education only group and the education + free/subsidized agricultural produce.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Reduction in blood pressure
Description
Systolic and diastolic blood pressure will be recorded when done per Standard of Care.
Time Frame
1 year
Title
Improvement in lipid profile
Description
measure of hemoglobin A1C will be recorded when done per Standard of Care.
Time Frame
1 year
Title
Weight Loss
Description
measure of weight will be recorded when done per Standard of Care.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Murphy
Phone
5025922388
Email
erin.murphy@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anuja Abhyankar
Email
anuja.abhyankar@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Murphy
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville Ambulatory Internal Medicine Resident Clinic
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Murphy
Phone
502-592-2388
Email
erin.murphy@louisville.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
entirety of study and for 1 year after
Learn more about this trial
Encouraging a Plant Based Diet in an Underserved Urban Population
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