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Recruiting

NCT Number: NCT06614920

Addressing Food Insecurity: Plant-Based Food Prescription Program

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.

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Key information

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Freedom Lab 4300 NW 12th Ave

Miami, Florida, 33127, United States

Location status: Recruiting

Location contact

Azaria V Lewis, DO, MS

PRINCIPAL_INVESTIGATOR

Brayland M Brown, MBA

CONTACT

[email protected]

954-600-3326

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables

    Time frame: 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.

  2. Number of Servings of Unprocessed and Minimally Processed Whole Grains

    Time frame: Up to 1 year

    The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed whole grains.

  3. Number of Servings of Unprocessed and Minimally Processed Legumes

    Time frame: Up to 1 year

    The participants will record in a weekly log the number of servings per day of unprocessed/minimally processed legumes.

  4. Number Servings of Unprocessed and Minimally Processed Nuts/Seeds

    Time frame: 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 outcomes

  1. Presence of Food Insecurity

    Time frame: 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."

  2. Change in Plant-Based Nutrition Knowledge of Participants

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Azaria V Lewis, DO, MS

CONTACT

[email protected]

707-741-1396

Azaria V Lewis, DO, MS

CONTACT

[email protected]

305-585-7476

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • American Academy of Pediatrics
  • Committee of Interns and Residents SEIU Healthcare

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 26, 2024
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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