Encouraging a Plant Based Diet in an Underserved Urban Population
Assessing Dietary Patterns and Implementing Cost-effective Interventions to Encourage a Plant-based Diet in an Underserved Urban Population
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2023
CompletedStudy Start
First participant enrolled
June 14, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedOctober 1, 2024
September 1, 2024
1.6 years
March 17, 2023
September 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Reduction in blood pressure
1 year
Improvement in lipid profile
1 year
Weight Loss
1 year
Study Arms (2)
Free/Subsidized Community Supported Agriculture (CSA) produce along with education.
EXPERIMENTALPatients 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 COMPARATORPatients will receive educational information about the benefits of plant-based eating.
Interventions
Providing educational material on the benefits of a plant-based diet, simple recipes, food swaps and free/subsidized produce.
Eligibility Criteria
You may qualify if:
- Patients age 18 and older screening as food insecure since 2021
- Patients willing to complete survey data
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Louisvillelead
- Oatly Group ABcollaborator
Study Sites (1)
University of Louisville Ambulatory Internal Medicine Resident Clinic
Louisville, Kentucky, 40202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Murphy
University of Louisville
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, M.D.
Study Record Dates
First Submitted
March 17, 2023
First Posted
October 19, 2023
Study Start
June 14, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- entirety of study and for 1 year after
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.