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

NCT ID: NCT06263751

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2025-10-23

Brief Summary

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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

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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.

Conditions

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Food Insecurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Usual Care (Control)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

NutriConnect Credit

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

Group Type EXPERIMENTAL

Product prescription program- NutriConnect Credit

Intervention Type OTHER

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.

NutriConnect Delivery

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

Group Type EXPERIMENTAL

Product prescription program- NutriConnect Delivery

Intervention Type OTHER

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.

Interventions

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Product 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.

Intervention Type OTHER

Product 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schnuck Markets, Inc.

UNKNOWN

Sponsor Role collaborator

BJC HealthCare

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing Li, MD, DrPH, MS

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Barnes Jewish Hospital

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Yoo SGK, Tabak RG, Mazzucca-Ragan S, Primo A, Bohannon D, Hashimoto D, Goss CW, Wu JH, Eromosele E, Hassanieh I, Hively A, Martinez A, Wang J, Huffman MD, Li J. NutriConnect: Enhancing health and food security through sustainable solutions and partnerships: Design and protocol of a pragmatic comparative effectiveness trial. Contemp Clin Trials. 2025 Nov;158:108083. doi: 10.1016/j.cct.2025.108083. Epub 2025 Sep 17.

Reference Type DERIVED
PMID: 40972889 (View on PubMed)

Other Identifiers

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24FIM1268045

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

202401096

Identifier Type: -

Identifier Source: org_study_id

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