Addressing Food Insecurity: Plant-Based Food Prescription Program

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06614920
Status
Recruiting
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Conditions

  • Food Insecurity
  • Food Insecurity Among Children
  • Health Literacy
  • Low Income Population
  • Nutrition Poor
  • Nutrition, Healthy

Eligibility Criteria

Sex
ALL
Age
N/A - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Plant-Based Food Provision (with or without food prescription) — OTHER
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jan 9, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Freedom Lab 4300 NW 12th AveMiamiFlorida33127
Brayland M Brown, MBA
[email protected]
954-600-3326
Azaria V Lewis, DO, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Freedom Lab 4300 NW 12th Ave· Miami, FL

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