Addressing Food Insecurity: Plant-Based Food Prescription Program

Not Applicable

Recruiting

• Conditions: Health Literacy; Nutrition, Healthy; Nutrition Poor; Food Insecurity; Food Insecurity Among Children; Low Income Population
• Interventions: Other: Plant-Based Food Provision (with or without food prescription); Other: Plant-Based Nutrition Education

• Registration Number: NCT06614920
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-24
• Study First Submitted QC: 2024-09-24
• Study First Posted: 2024-09-26
• Study Start: 2025-01-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention)	Plant-Based Food Provision (with or without food prescription)	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).
Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention)	Plant-Based Nutrition Education	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).
Plant-Based Nutrition Education Only (single intervention 1)	Plant-Based Nutrition Education	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 hours in a nearby classroom.
Plant-Based Food Provision Only (single intervention 2)	Plant-Based Food Provision (with or without food prescription)	In Arm 3 (single intervention 2- plant-based food provision only), 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) only and will have no classes. Although these participant will not be provided a food prescription as part of the food prescription program the plant-based meals that Village FREEdge will have available to the community members as part of their community service will be the exact same plant-based meals provided through the food prescription program.These subjects will be asked to complete one survey and a nutrition knowledge test at the beginning of the study, one survey every 3 months thereafter and one additional nutrition test 1 year into the study.

Primary Outcome Measures

Name	Time	Method
Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables	Up to 1 year	The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed fruits and vegetables.
Number of Servings of Unprocessed and Minimally Processed Whole Grains	Up to 1 year	The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed whole grains.
Number of Servings of Unprocessed and Minimally Processed Legumes	Up to 1 year	The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed legumes.
Number Servings of Unprocessed and Minimally Processed Nuts/Seeds	Up to 1 year	The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed nuts/seeds.

Secondary Outcome Measures

Name	Time	Method
Presence of Food Insecurity	Up to 1 year	Affirmative response to either of the two, validated screening questions for food insecurity. Investigators measured food insecurity using the validated two-question "Hunger Vital Sign" screening tool, with yes/no responses. These two questions are: "we worried whether our food would run out before we got money to buy more" and "the food we bought just didn't last and we didn't have money to get more."
Change in Plant-Based Nutrition Knowledge of Participants	Up to 1 year	The nutrition knowledge of participants will be measured by a change in nutrition literacy pre-post test (less than 30 multiple choice questions) scores. (The pre-test will be given prior to the plant-based nutrition education course and the post-test after completion of the course).

Trial Locations

Locations (1)

Freedom Lab 4300 NW 12th Ave; 🇺🇸 Miami, Florida, United States