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Comparing the Effectiveness of Two Produce Prescription Approaches On Fruit and Vegetable Intake and Food Security, While Exploring Implementation Outcomes Such as Reach, Implementation, Sustainability, and Cost

NutriConnect: Enhancing Health and Food Security Through Sustainable Solutions and Partnerships

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06263751
Acronym
NutriConnect
Enrollment
126
Registered
2024-02-16
Start date
2024-03-25
Completion date
2025-10-23
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Insecurity

Brief summary

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.

Detailed description

The Produce Prescription Program, as one type of Food is Medicine (FIM) initiatives, involves healthcare providers prescribing fruits and vegetables to patients often have low incomes, food insecurity, and diet-related illnesses. Previous systematic reviews have shown that these programs are associated with increased consumption of fruits and vegetables, improved diet quality, reduced food insecurity, and better management of diet-related diseases. However, the diversity in study designs, small sample sizes, and varied intervention intensities have limited the conclusive understanding of the full effects of these programs. Despite their potential benefits, critical gaps persist, notably in identifying the most effective strategies for socioeconomically disadvantaged patients. Additionally, challenges surrounding scalability, implementation, and sustainability hinder the widespread adoption of these programs. To address these gaps, the NutriConnect team employs a Designing for Dissemination and Sustainability (D4DS) approach informed by the PRISM/RE-AIM framework. This involves early engagement of key partners crucial for scalability and sustainability. The study team initiated a collaborative consortium comprising Washington University in St. Louis, BJC Healthcare, and Schnucks (regional grocery chain). NutriConnect integrates multilevel, multicomponent intervention components, including in-hospital social needs screening, produce prescription, grocery rewards, and a health and wellness program, all aimed at promoting better nutrition and health in the community. NutriConnect seeks to compare the effectiveness of two produce prescription approaches on fruits and vegetables intake and food security: credit to Rewards account (NutriConnect Credit) vs. produce box delivery (NutriConnect Delivery), while exploring implementation outcomes, with the following aims. Aim 1. Evaluate and compare the effectiveness of NutriConnect Credit with NutriConnect Delivery on changes in fruit and vegetable intake, food security, and self-reported health status. Aim 2. Explore the scalability, sustainability, and determinants of the NutriConnect program guided by PRISM/RE-AIM, aiming to identify factors crucial for future scale-up. Aim 3. Determine the implementation costs of NutriConnect using time-driven activity-based costing approach.

Interventions

OTHERProduct prescription program- NutriConnect Credit

Patient is given $20 credit to their Schnucks (grocery) Rewards account every other week for F\&V shopping. The Rewards credit can be used either through the Schnucks App or in store.

OTHERProduct prescription program- NutriConnect Delivery

Patient receives produce (F\&V) box (equivalent $20 value) delivered to home every other week. The items in the box will be pre-selected by Schnucks and the NutriConnect dieticians.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
Schnuck Markets, Inc.
CollaboratorUNKNOWN
BJC HealthCare
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the open study design, the NutriConnect team will not be able to have either patient or research coordinator/Schnucks intervention delivers blinded on group assignment. However, the assignment will be hidden from research faculty, the study biostatistician, and study analyst.

Intervention model description

240 patients will be randomized to three arms: "usual care," NutriConnect Credit, and NutriConnect Delivery with equivalent monetary value to credit. The interventions will last 6 months.

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

1. Adults (\>= 18 years) 2. Received care at either medical floors or observation unit at the Bares Jewish Hospital (BJH), and discharged to home. 3. Being screened positive for food or financial insecurity. 4. Have elevated cardiovascular risk, i.e., self-reported diabetes, hypertension, hyperglycemia, or calculated BMI meeting obesity.

Exclusion criteria

1. Does not have competence to provide informed consent. 2. Is under suicide watch. 3. Is in police custody. 4. In hospice or palliative care. 5. Not have a stable home. 6. Is pregnant.

Design outcomes

Primary

MeasureTime frameDescription
change in F&V intake6-monthpre- and post-changes in F\&V consumption (cups/day, continuous).

Secondary

MeasureTime frameDescription
Household food insecurity6-monthpre- and post-changes in household food insecurity (binary). 6-item USDA Food Security Survey, minimum value = 0, maximum value = 6, lower the score means higher the food security

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJing Li, MD, DrPH, MS

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026