Plant-Based Food Program for Food Insecurity

Overseen By Azaria V Lewis, DO, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Above poverty line, No food insecurity

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Azaria V Lewis, DO

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for low-income families struggling with food insecurity and malnutrition, including children. Participants should be interested in learning about plant-based nutrition and willing to incorporate it into their diets.

Inclusion Criteria

My family earns below the poverty line and we struggle to afford enough food.

I am between the ages of 0 and 99.

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

My family is above the federal poverty line and we have enough food.

Families who are not actively receiving outpatient primary care (all arms)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend 5 nutrition classes and receive plant-based food prescriptions or meals

5 weeks

5 visits (in-person)

Follow-up

Participants are monitored for changes in food insecurity and nutrition knowledge

Up to 1 year

Quarterly surveys and tests

Treatment Details

Interventions

• Plant-Based Food Prescription Program

Trial Overview The study tests whether providing plant-based foods, with or without a prescription, along with education on plant-based nutrition can help improve the health of food-insecure families.

Participant Groups

Group I: Plant-Based Nutrition Education Only (single intervention 1) Experimental Treatment 1 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) 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.

Group II: Plant-Based Food Provision Only (single intervention 2) Experimental Treatment 1 Intervention

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.

Group III: Plant-Based Food Provision + Plant-Based Nutrition Education (dual intervention) Experimental Treatment 2 Interventions

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).

Group IV: Neither Intervention (no intervention) Active Control 1 Intervention

Participants in Arm 4 will be recipients of non-plant-based meals from Village FREEdge (up to two meals per day with a maximum of two meals per pick-up), however, will be enrolled in neither intervention (neither the plant-based food prescription or the nutrition education course) and 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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

American Academy of Pediatrics

Collaborator

Trials

46

Recruited

4,071,000+

Committee of Interns and Residents SEIU Healthcare

Collaborator

Trials

1

Recruited

100+