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Addressing Food Insecurity: Plant-Based Food Prescription Program

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06614920
Enrollment
100
Registered
2024-09-26
Start date
2025-01-09
Completion date
2028-03-01
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERPlant-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.

OTHERPlant-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.

Sponsors

University of Miami
Lead SponsorOTHER
American Academy of Pediatrics
CollaboratorOTHER
Committee of Interns and Residents SEIU Healthcare
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Servings of Unprocessed and Minimally Processed Fruits and VegetablesUp to 1 yearThe 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 GrainsUp to 1 yearThe 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 LegumesUp to 1 yearThe 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/SeedsUp to 1 yearThe participants will record in a weekly log the number of servings per day of unprocessed/minimally processed nuts/seeds.

Secondary

MeasureTime frameDescription
Presence of Food InsecurityUp to 1 yearAffirmative 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 ParticipantsUp to 1 yearThe 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).

Countries

United States

Contacts

CONTACTAzaria V Lewis, DO, MS
Axl4415@miami.edu707-741-1396
PRINCIPAL_INVESTIGATORAzaria V Lewis, DO

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026