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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to tackle food insecurity by promoting plant-based eating and boosting nutrition knowledge. Participants will receive either plant-based meals, nutrition education, or both, depending on the trial group. The trial seeks to determine if these interventions can improve access to healthy food and enhance overall nutrition. Families living below the federal poverty line who experience food insecurity and receive primary care in certain clinics may be a good fit for this trial.

As an unphased trial, participants can contribute to innovative solutions for food insecurity and gain valuable nutrition insights.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on improving food access and nutrition, so it's unlikely that medication changes are required.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that programs prescribing plant-based foods are safe and easy to follow. Studies have found that these programs increase fruit and vegetable consumption, improve access to healthy food, and boost overall health. They also aid in long-term weight loss, supporting a healthy lifestyle. Although specific safety details are not provided, the positive results suggest participants generally experience no major side effects. No evidence indicates that eating more plant-based foods is harmful, making it a likely safe choice for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores unique ways to address food insecurity with a plant-based focus. Unlike typical food assistance programs that provide any available food, this trial integrates plant-based meals and education to improve nutrition knowledge and health outcomes. One standout feature is the "food prescription," which acts like a voucher for plant-based meals, aiming to make healthy eating more accessible. Additionally, the combination of nutrition education classes with these food provisions could empower participants to make informed dietary choices, potentially leading to better long-term health benefits.

What evidence suggests that this trial's treatments could be effective for reducing food insecurity?

Research has shown that programs prescribing plant-based foods can greatly improve diets and reduce food insecurity. In this trial, participants may be enrolled in different arms, such as the Plant-Based Food Provision + Plant-Based Nutrition Education arm, which combines food prescriptions with nutrition education. One study found that people in similar programs ate more fruits and vegetables and experienced a 94.1% drop in food insecurity. Another study found similar benefits in diet and food security for those receiving produce prescriptions. These programs may also enhance overall health by lowering risks associated with poor diets, such as heart disease and diabetes. This evidence supports the idea that plant-based food programs can effectively address food insecurity and improve health. ^{2 6 7 8 9}

Who Is on the Research Team?

Azaria V Lewis, DO

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

Impact of Produce Prescriptions on Diet, Food Security ... The study found that produce prescription program participation was associated with improvements in fruit and vegetable intake, food insecurity ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06614920

NCT06614920 | Addressing Food Insecurity: Plant-Based ... 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) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6768858/

A pilot food prescription program promotes produce intake ... Participants (n = 172) in the program reported a 94.1% decrease in the prevalence of food insecurity (p < .01) at the end of the program. An average of 29.2 ...

4. centerfornutrition.org centerfornutrition.org/fim

Food Is Medicine (FIM) Key outcomes including fruit and vegetable intake, food security status are collected from surveys of PPR participants before and after participating in the ...

5. translationalsciencebenefits.wustl.edu translationalsciencebenefits.wustl.edu/case-study/addressing-food-insecurity-with-a-produce-prescription-program/

Addressing Food Insecurity with a Produce Prescription ... Produce prescription programs are effective at reducing food insecurity, and there is preliminary evidence that they may reduce cardiometabolic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10529680/

The Impact of Produce Prescriptions on Diet, Food Security ... In this large, multi-site evaluation, produce prescriptions were associated with significant improvements in F&V intake, food security, and health status for ...

7. jneb.org jneb.org/article/S1499-4046(24)00387-7/fulltext

Examining Food Security, Fruit and Vegetable Intake ... The objective of this study was to conduct a systematic review to examine the impact of PPR programs on food security, fruit and vegetable (FV) intake, and/or ...

8. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.01345

An Urban Farm–Anchored Produce Prescription Program's ... In this retrospective cohort study, VeggieRx, an urban farm–anchored produce prescription program, was associated with sustained weight loss ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S216183132200480X

Healthy Food Prescription Programs and their Impact on ... Two-thirds of the individual studies, including 1 of the randomized trials, reported a positive effect on dietary outcomes over this time frame. In conclusion, ...