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Clinical Trials/NCT06614920
NCT06614920RecruitingNot Applicable

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

University of Miami1 site in 1 country100 target enrollmentStarted: January 9, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
Number of Servings of Unprocessed and Minimally Processed Fruits and Vegetables

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
— to 99 Years (Child, Adult, Older Adult)
Sex
All
Accepts 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 exclusion criteria in this category).
  • Families who are not actively receiving outpatient primary care (all arms).

Arms & Interventions

Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention)

Experimental

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).

Intervention: Plant-Based Food Provision (with or without food prescription) (Other)

Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention)

Experimental

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).

Intervention: Plant-Based Nutrition Education (Other)

Plant-Based Nutrition Education Only (single intervention 1)

Experimental

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.

Intervention: Plant-Based Nutrition Education (Other)

Outcomes

Primary Outcomes

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.

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.

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.

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

  • Presence of Food Insecurity(Up to 1 year)
  • Change in Plant-Based Nutrition Knowledge of Participants(Up to 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Azaria Lewis

Internal Medicine-Pediatric Resident Physician

University of Miami

Study Sites (1)

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