Actively Recruiting

Phase Not Applicable
Age: 0 - 99Years
All Genders
Healthy Volunteers
ID06614920

Addressing Food Insecurity: Plant-Based Food Prescription Program to Improve Healthy Food Access

Led by University of Miami · Updated on 2026-02-04

100

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

A

American Academy of Pediatrics

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to reduce food insecurity by improving access to plant-based healthy foods, enhancing nutrition literacy, and improving health among food-insecure families. It focuses on families living under the federal poverty line and involves both children and adults up to 99 years old. The study evaluates different approaches to increasing consumption of unprocessed and minimally processed fruits, vegetables, whole grains, legumes, and nuts or seeds over one year. Participants join one of four study arms based on their eligibility and interest. In the dual intervention arm, participants attend five weekly nutrition classes with age-appropriate interactive activities and receive a food prescription voucher to pick up plant-based meals from a food pantry. Some arms involve nutrition education only, with classes tailored by age, while others provide food without a prescription. Food pickup is expected twice a week for up to a year, providing enough meals for household members. During the study, participants complete surveys and nutrition knowledge tests before and after each class, with additional follow-up surveys every three months and a final knowledge test one year after starting. Researchers monitor servings of healthy plant-based foods consumed and assess food insecurity status and nutrition knowledge changes. The study includes families receiving care from specific primary care clinics, and participation spans up to one year with regular assessments and support.

CONDITIONS

Brief Title

Addressing Food Insecurity: Plant-Based Food Prescription Program

Who Can Participate

Age: 0 - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants of all ages from 0 to 99 years
  • Families living under the federal poverty line and experiencing food insecurity (except for nutrition education-only group which may include families above poverty line without food insecurity)
  • Families receiving care at Pediatric Mobile Clinic, Pediatric, Family Medicine, Internal Medicine, or Med-Peds primary care clinics in the specified health system
Not Eligible

You will not qualify if you...

  • Families not living under the federal poverty line and not experiencing food insecurity (except for nutrition education-only group which has no exclusion by socioeconomic status or food insecurity)
  • Families not actively receiving outpatient primary care

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Plant-Based Nutrition Education

Duration - 5 weeks

Participants attend weekly nutrition classes for 5 weeks. Classes are divided by age groups and include interactive activities and lectures to improve plant-based nutrition knowledge for participants of all ages.

5 weekly visits (in-person)

Plant-Based Food Provision

Duration - Up to 1 year

Participants in the dual intervention arm receive plant-based food prescriptions after each nutrition class to pick up plant-based meals from Village FREEdge. They may pick up food twice per week to feed their household for up to 1 year.

Twice weekly visits for up to 1 year

Follow-up Surveys and Nutrition Tests

Duration - Up to 1 year

Participants complete surveys and nutrition knowledge tests at baseline, after each class, every 3 months, and one year after starting to monitor changes in nutrition knowledge and food insecurity.

Surveys and tests at baseline, after classes, quarterly, and at 1 year

Trial Site Locations

Total: 1 location

1

Freedom Lab 4300 NW 12th Ave

Miami, Florida, United States, 33127

Actively Recruiting

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Research Team

A

Azaria V Lewis, DO, MS

A

Azaria V Lewis, DO, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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Published Research Related To This Trial

A pilot randomized controlled trial of a fruit and vegetable prescription program at a federally qualified health center in low income uncontrolled diabetics.

Richard Bryce, Julia A WolfsonBryce, Alicia CohenBryce...

https://pubmed.ncbi.nlm.nih.gov/34150472

Interventions to Address Food Insecurity Among Adults in Canada and the US: A Systematic Review and Meta-analysis.

Carlos Irwin A Oronce, Isomi M Miake-Lye, Meron M Begashaw...

https://pubmed.ncbi.nlm.nih.gov/35977189

Healthy Food Prescription Programs and their Impact on Dietary Behavior and Cardiometabolic Risk Factors: A Systematic Review and Meta-Analysis.

Saiuj Bhat, Daisy H Coyle, Kathy Trieu...

https://pubmed.ncbi.nlm.nih.gov/33999108

The State of US Health, 1990-2016: Burden of Diseases, Injuries, and Risk Factors Among US States.

US Burden of Disease Collaborators, Ali H Mokdad, Katherine Ballestros...

https://pubmed.ncbi.nlm.nih.gov/29634829