NCT06090409

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Completed
3 months until next milestone

Study Start

First participant enrolled

June 14, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

March 17, 2023

Last Update Submit

September 27, 2024

Conditions

Keywords

Food Neophobia, Plant-based Diet

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.

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.

Other: Implementing free/subsidized agricultural produce to encourage a plant-based diet.

Education Alone

ACTIVE COMPARATOR

Patients will receive educational information about the benefits of plant-based eating.

Other: Implementing free/subsidized agricultural produce to encourage a plant-based diet.

Interventions

Providing educational material on the benefits of a plant-based diet, simple recipes, food swaps and free/subsidized produce.

Education AloneFree/Subsidized Community Supported Agriculture (CSA) produce along with education.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Louisville Ambulatory Internal Medicine Resident Clinic

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Avoidant Restrictive Food Intake DisorderFood PreferencesFeeding Behavior

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental DisordersBehaviorBehavior, Animal

Study Officials

  • Erin Murphy

    University of Louisville

    PRINCIPAL INVESTIGATOR

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

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
entirety of study and for 1 year after

Locations