Recruiting

Plant-Based Food

Sponsor:

University of Miami

Code:

NCT06614920

Conditions

Health Literacy

Nutrition, Healthy

Nutrition Poor

Food Insecurity

Food Insecurity Among Children

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

Plant-Based Food Provision (with or without food prescription)

Plant-Based Nutrition Education

Study Details

Brief summary:

Reduce food insecurity by improving plant-based health food consumption, access, health and nutrition literacy and the health of the food-insecure families we serve.

Conditions

Health Literacy

Nutrition, Healthy

Nutrition Poor

Food Insecurity

Food Insecurity Among Children

Study ID

NCT06614920

Start date

Jan 9, 2025

Status verified date

Feb, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants will be all ages 0-99 (all arms)
  • Families living under the federal poverty line AND who have food insecurity (all arms except Arm 2 which can include families with income above the federal poverty line who do not have food insecurity).
  • Families cared for in either the Pediatric Mobile Clinic, Pediatric, Family Medicine, Internal Medicine or Med-Peds primary care clinics in the UHealth/Jackson Health System/Dade County Street Response.

Exclusion Criteria:

  • Families who are not under the federal poverty line AND are not food insecure (all arms except Arm 2, which will include participants of all socioeconomic statuses and regardless of food security status, with no exclusion criteria in this category).
  • Families who are not actively receiving outpatient primary care (all arms).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention)

Participants will enroll in one of four study arms based on their eligibility and interest. In Arm 1 (dual intervention- food prescription and nutrition education), we will ask participants to attend 5 nutrition classes where they will be asked to complete one survey and two brief nutrition knowledge tests (one before the class starts and one after the class is finished) each class, one survey every 3 months thereafter and one additional nutrition test 1 year after starting the program. Each class will divide participants by age (detailed in Arm 2 description).

Participants in Arm 1 only (dual intervention) will be provided with a food prescription at the end of each class. Participants will bring this food prescription to Village FREEdge, where it will function as a voucher. Each voucher will allow for participants to pick up enough food for 6 meals per person in their household (with household maximum of 5 people)(enough meals for 3 days- 2 meals per person per day).

experimental: Plant-Based Nutrition Education Only (single intervention 1)

Participants will enroll in one of four study arms based on their eligibility and interest. In Arm 1 (dual intervention- food prescription and nutrition education) and Arm 2 (single intervention 1- nutrition education only) we will ask participants to attend 5 nutrition classes where they will be asked to complete one survey and two brief nutrition knowledge tests (one before the class starts and one after the class is finished) each class, one survey every 3 months thereafter and one additional nutrition test 1 year after starting the program. Each class will divide participants by age. If participants are 14 years old or older, they will listen to a 45-minute plant-based nutrition lecture and engage in a 45-minute interactive activity, including but not limited to plant-based meal preparation. Participants younger than 14 years old will be guided through age-appropriate interactive activities for the full 1.5-2 hours in a nearby classroom.

Interventions

Plant-Based Food Provision (with or without food prescription)

Food Prescription: Participants will bring the food prescription obtained from the nutrition class to Village FREEdge, food pantry at the Freedom Lab, where it will function as a voucher. Each voucher will allow for participants to pick up enough plant-based food for 6 meals per person in their household (with household maximum of 5 people)(enough meals for 3 days- 2 meals per person per day). We expect that participants will pick up food twice per week from Village FREEdge to obtain enough meals to feed each participant's household for 6 days out of the week for up to 1 year.

Without food prescription: Participants will be given plant-based meals from Village FREEdge (up to two meals per day with a maximum of two meals per pick-up) without the use of a food prescription.

Plant-Based Nutrition Education

A once weekly classes for a 5-week nutrition course. The parents/guardians would bring their children and any additional household member(s) to the nutrition class, which will organize participants in different classrooms by age (children 4 years, 4-12 years old, 12-14 years old, 14+ years old). Each classrooms will engage in age-appropriate interactive nutrition-based activities. All children below 18 will engage in interactive activities for the full 1.5 hours. Adolescents aged 14 up will join the classroom with adults and listen to a 45 minute lecture and engage in a subsequent 45 minute interactive activity that incorporates content from the lecture. The interactive activities for the children range from creating a fruit and veggie "Tik Tok" song and performing it, drawing foods on a "balanced plate", etc. The interactive activities for participants 14 year old and older range from discussions about fiber in diet, guided plant-based meal preparation, reading nutrition label etc.

Primary outcome measure

  • Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables [ Time Frame: Up to 1 year ]
  • Number of Servings of Unprocessed and Minimally Processed Whole Grains [ Time Frame: Up to 1 year ]
  • Number of Servings of Unprocessed and Minimally Processed Legumes [ Time Frame: Up to 1 year ]
  • Number Servings of Unprocessed and Minimally Processed Nuts/Seeds [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Locations

Freedom Lab 4300 NW 12th Ave

Recruiting

Miami, Florida, United States, 33127

Contacts

Principal Investigator:

Azaria V Lewis, DO, MS

More Information

Sponsor

University of Miami

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • Plant-based food prescription program
  • Plant-based
  • Food prescription
  • Food insecurity
  • Poverty
  • Nutrition education
  • Plant-based nutrition literacy
  • Plant-based nutrition education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-02-04.