Produce Prescription Programs for Food Insecurity

(NutriConnect Trial)

Overseen By Adam Hively, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Incompetence, Suicide watch, Police custody, Hospice, Unstable home, Pregnancy

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

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

The produce prescription program is one type of food is medicine (FIM) programs, where healthcare providers "prescribe" fruits and vegetables (F\&V) to patients with low household incomes, experience food insecurity, and one or more diet-related diseases. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on F\&V intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes such as reach, sustainability, implementation, and cost.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment NutriConnect Credit, Produce Prescription Program, and Food is Medicine Program for addressing food insecurity?

Research shows that produce prescription programs can improve health outcomes by increasing fruit and vegetable consumption, enhancing nutrition knowledge, and improving food purchasing practices, especially in low-income and food-insecure communities. These programs have been shown to make healthy eating more affordable and accessible, leading to better dietary habits and improved health. ^{1 2 3 4 5}

Is the Produce Prescription Program safe for humans?

The available research on Produce Prescription Programs, which provide fresh fruits and vegetables to participants, does not report any safety concerns. These programs are generally considered safe and aim to improve dietary habits and health outcomes by increasing access to nutritious food. ^{1 2 3 6 7}

How does the NutriConnect Credit and Delivery treatment differ from other treatments for food insecurity?

The NutriConnect Credit and Delivery treatment is unique because it involves prescribing fresh fruits and vegetables to patients, making healthy food more accessible and affordable, which is not a standard approach in addressing food insecurity. This program empowers patients to improve their diet and health by providing them with subsidized produce, which is a novel way to tackle diet-related health issues compared to traditional food assistance programs. ^{2 3 7 8 9}

Research Team

Jing Li, MD, DrPH, MS

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults over 18 who have been cared for at BJH, are going home after discharge, and struggle with food or financial insecurity. They must also be at higher risk of heart disease due to conditions like diabetes or obesity. People can't join if they can't consent, are under suicide watch or police custody, in hospice care, without a stable home, or if pregnant.

Inclusion Criteria

I was treated at BJH and went home after.

Being screened positive for food or financial insecurity

I have diabetes, high blood pressure, high blood sugar, or am considered obese.

Exclusion Criteria

I am unable to understand and give consent for treatment.

Is under suicide watch

I am currently receiving care focused on my comfort.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either NutriConnect Credit or NutriConnect Delivery every other week for 6 months

24 weeks

Bi-weekly interactions (virtual or in-person)

Follow-up

Participants are monitored for changes in fruit and vegetable intake, food security, and self-reported health status

4 weeks

1 visit (in-person or virtual)

Treatment Details

Interventions

• NutriConnect Credit
• NutriConnect Delivery

Trial Overview The study compares two ways to help people eat more fruits and veggies: NutriConnect Credit gives them credits in a rewards account; NutriConnect Delivery sends them boxes of produce. It looks at which method improves diet and food security better while considering the program's reach and costs.

Participant Groups

Group I: NutriConnect Delivery Experimental Treatment 1 Intervention

Patient receives produce (F\&V) box (with equivalent $20 value) delivered to home every other week.

Group II: NutriConnect Credit Experimental Treatment 1 Intervention

Patient is given $20 credit to their Schnucks (grocery) Reward account every other week for F\&V shopping.

Group III: Usual Care (Control) Active Control 1 Intervention

Patient is screened for food or financial insecurity, if positive, social worker will refer him/her to community service programs.

NutriConnect Credit is already approved in United States for the following indications:

Approved in United States as NutriConnect Credit for:

• Food insecurity
• Diet-related diseases

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Schnuck Markets, Inc.

Collaborator

Trials

1

Recruited

240+

BJC HealthCare

Collaborator

Trials

4

Recruited

46,700+

BJC HealthCare

Collaborator

Trials

4

Recruited

46,700+

Findings from Research

The Fruit and Vegetable Prescription Program (FVPP) in Michigan aims to improve children's diet, food security, and weight status by providing $15 prescriptions for fresh produce at pediatric clinic visits, with a total of 700 caregiver-child pairs enrolled for a two-year study.

The study will compare the effects of varying levels of exposure to the FVPP among children aged 8-16, assessing changes in their dietary habits and health outcomes, which will help determine the program's effectiveness and the necessary duration of exposure for significant impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. Saxe-Custack, A., Todem, D., Anthony, JC., et al.[2022]

A pilot food prescription program called Fresh Start Food Rx provided biweekly fresh fruits and vegetables and dietary education to four uninsured patients in South Miami, showing potential to improve dietary behaviors and attitudes toward healthy eating.

Participants reported an increase in the number of days they consumed fruits per week and a rise in vegetable servings, indicating that access to healthy foods and education can positively influence eating habits and perceptions about nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. Oliveira, JB., To, L., De La Cruz, Y., et al.[2021]

Diet is the leading cause of death in the U.S., particularly affecting marginalized communities who struggle to access nutritious food, leading to significant health disparities.

The article advocates for implementing produce prescriptions through Medicare, Medicaid, and CHIP, which have shown promise in improving health outcomes by making fruits and vegetables more affordable for patients, thus encouraging healthier dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive Care: Improving Health of Medicare, Medicaid, and Children's Health Insurance Program Patients Through Access to Fresh Fruit and Vegetables. McClain, W.[2023]

The Fruit and Vegetable Prescription (FVRx) program, tested with 54 SNAP-eligible adults over 6 months, successfully retained 77.3% of participants, who utilized nearly 90% of their produce prescriptions, indicating strong engagement and feasibility.

Participants in the FVRx program significantly increased their intake of fruits and vegetables, improved their knowledge of food preparation, and changed their food purchasing habits compared to a control group, demonstrating the program's effectiveness in enhancing nutrition-related behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Fruit and Vegetable Prescription (FVRx) Program Improves Local Fruit and Vegetable Consumption, Nutrition Knowledge, and Food Purchasing Practices. Slagel, N., Newman, T., Sanville, L., et al.[2023]

Community-based fruit and vegetable prescription programs, primarily targeting low-income, non-white females, have shown significant improvements in diet quality (94% of studies), health outcomes (83%), and food security (82%), indicating their effectiveness in promoting healthier eating habits.

Despite the positive outcomes, the considerable variation in study design and measurement techniques makes it difficult to compare the effectiveness of different program methodologies, highlighting the need for more standardized and well-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. Greatorex Brooks, E., McInerney, M.[2023]

Health care providers involved in produce prescription projects reported operational challenges such as time constraints, difficulties in engaging patients, and barriers to data sharing, which were exacerbated by the COVID-19 pandemic.

Despite these challenges, providers expressed satisfaction with the projects due to positive patient outcomes, including improved food security and clinical results, highlighting the need for dedicated staff and rigorous program evaluation to ensure sustainability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Produce prescription projects: Challenges, solutions, and emerging best practices - Perspectives from health care providers. Stotz, SA., Budd Nugent, N., Ridberg, R., et al.[2022]

Participants in the study reported positive experiences with receiving fruit and vegetable prescriptions (FVRx) from their health providers, feeling that it directly supported their health and improved their physical and mental well-being.

Despite the benefits, participants expressed a desire for more choice in the types of fruits and vegetables provided, as well as more flexible pick-up times, indicating areas for improvement in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' experiences with a community fruit and vegetable box program prescribed by their health provider. Johnson, JK., Vingilis, E., Terry, AL.[2023]

The 6-month Fruit and Vegetable Prescription Program showed positive feedback from participants, indicating that such interventions can enhance knowledge and self-efficacy regarding healthy eating habits.

Despite the program's success in improving dietary behaviors, ongoing socioeconomic barriers to accessing fresh produce highlight the need for continued efforts to address social determinants of health for sustainable change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative research study on addressing barriers to healthy diet among low-income individuals at an urban, safety-net hospital. Cahill, E., Schmidt, SR., Henry, TL., et al.[2022]

In a pilot study involving 172 participants from food-insecure areas, a collaborative food prescription program led to a remarkable 94.1% decrease in food insecurity, highlighting its effectiveness in improving access to nutritious food.

Participants received an average of 29.2 pounds of fresh produce and reported high satisfaction with the program, indicating strong community support and the potential for positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot food prescription program promotes produce intake and decreases food insecurity. Aiyer, JN., Raber, M., Bello, RS., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of a pediatric fruit and vegetable prescription program on child dietary patterns, food security, and weight status: a study protocol. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Preventive Care: Improving Health of Medicare, Medicaid, and Children's Health Insurance Program Patients Through Access to Fresh Fruit and Vegetables. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A Pilot Fruit and Vegetable Prescription (FVRx) Program Improves Local Fruit and Vegetable Consumption, Nutrition Knowledge, and Food Purchasing Practices. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Produce prescription projects: Challenges, solutions, and emerging best practices - Perspectives from health care providers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Patients' experiences with a community fruit and vegetable box program prescribed by their health provider. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Qualitative research study on addressing barriers to healthy diet among low-income individuals at an urban, safety-net hospital. [2022]

9. England pubmed.ncbi.nlm.nih.gov

A pilot food prescription program promotes produce intake and decreases food insecurity. [2020]