Produce Prescription Programs for Food Insecurity

(NutriConnect Trial)

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how providing fruits and vegetables can assist individuals with low incomes and diet-related health issues, such as diabetes or high blood pressure. Participants will either receive NutriConnect Credit (grocery store credits) or have NutriConnect Delivery (produce boxes) delivered to their homes. Researchers aim to determine which approach more effectively improves food security and health. Ideal candidates are adults treated at a specific hospital who face food or financial challenges and have conditions like diabetes or high blood pressure. As an unphased trial, this study offers participants an opportunity to contribute to innovative solutions for enhancing health and food security.

Will I have to stop taking my current medications?

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

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

Research has shown that programs like NutriConnect Credit and NutriConnect Delivery, which help people access fruits and vegetables, are safe and well-received. Studies on similar programs, where participants receive or purchase fresh produce, have found no safety issues. These programs aim to improve diet by making fresh produce more accessible, which is generally safe and beneficial for health. Participants typically experience better access to food and increased intake of fruits and vegetables, with no reported negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Produce Prescription Programs because they provide innovative solutions for food insecurity by directly connecting individuals with nutritious food. Unlike traditional aid programs that often focus on referrals to community services, NutriConnect Delivery and NutriConnect Credit offer direct and tangible benefits. NutriConnect Delivery ensures fresh fruits and vegetables are delivered to the participant's doorstep, providing convenience and immediate access to healthy food. Meanwhile, NutriConnect Credit empowers participants with a $20 credit every other week for purchasing fruits and vegetables at Schnucks grocery stores, giving them the autonomy to make healthier food choices. These approaches aim to directly enhance nutritional intake and improve food security in a sustainable and personalized way.

What evidence suggests that this trial's treatments could be effective for food insecurity and diet-related diseases?

Research has shown that programs like NutriConnect, which provide produce prescriptions, can improve health by encouraging increased fruit and vegetable consumption. In this trial, participants may receive NutriConnect Credit, offering a $20 credit to buy produce, which has been linked to better nutrition and food security. Alternatively, participants might receive NutriConnect Delivery, which provides boxes of produce and has shown positive effects on diet and food security. Studies indicate that both methods help reduce food insecurity and improve overall health. These programs aim to make fresh produce more accessible, leading to healthier eating habits. ^{1 2 3 6 7}

Who Is on the Research Team?

Jing Li, MD, DrPH, MS

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12581065/

NutriConnect: Enhancing health and food security through ... NutriConnect seeks to provide evidence on the effectiveness and feasibility of two produce prescription strategies to inform scalable “Food is Medicine” ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06263751

Comparing the Effectiveness of Two Produce Prescription ... NutriConnect seeks to compare the effectiveness of two produce prescription approaches on fruits and vegetables intake and food security: credit to Rewards ...

3. withpower.com withpower.com/trial/phase-food-insecurity-or-financial-constraint-plus-having-elevated-cardiovascular-risk-3-2024-6fe71

Produce Prescription Programs for Food Insecurity Research shows that produce prescription programs can improve health outcomes by increasing fruit and vegetable consumption, enhancing nutrition knowledge, and ...

4. researchgate.net researchgate.net/publication/392032575_NutriConnect_Enhancing_Health_and_Food_Security_through_Sustainable_Solutions_and_Partnerships_Design_and_Protocol_of_a_Pragmatic_Comparative_Effectiveness_Trial

(PDF) NutriConnect: Enhancing Health and Food Security ... effectiveness data are limited. Objective: To compare the impact of two produce prescription strategies, NutriConnect Credit ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12258766/

NutriConnect: Enhancing Health and Food Security ... NutriConnect seeks to provide evidence on the effectiveness and feasibility of two produce prescription strategies to inform scalable “Food is Medicine” ...

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

A pilot food prescription program promotes produce intake ... The program provided 30 pounds of fresh produce and 4 nonperishable items every 2 weeks, resulting in a 94.1% decrease in food insecurity.

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 ...