Food InsecurityNutriConnectNCT06263751
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
A study testing Product prescription program- NutriConnect Credit and Product prescription program- NutriConnect Delivery in people with Food Insecurity, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Food Insecurity
- What is being tested?
- Product prescription program- NutriConnect Credit and Product prescription program- NutriConnect Delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2024to 23 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (>= 18 years)
- Received care at either medical floors or observation unit at the Bares Jewish Hospital (BJH), and discharged to home.
- Being screened positive for food or financial insecurity.
- Have elevated cardiovascular risk, i.e., self-reported diabetes, hypertension, hyperglycemia, or calculated BMI meeting obesity.
Who cannot join
- Does not have competence to provide informed consent.
- Is under suicide watch.
- Is in police custody.
- In hospice or palliative care.
- Not have a stable home.
- Is pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NutriConnect: Enhancing Health and Food Security Through Sustainable Solutions and Partnerships
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.
Read the 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.
- Conditions
- Food Insecurity
- Being tested
- Product prescription program- NutriConnect Credit, Product prescription program- NutriConnect Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Product prescription program- NutriConnect CreditOther
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.
Product prescription program- NutriConnect DeliveryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (Control) | No intervention | Patient is screened for food or financial insecurity, if positive, social worker will refer him/her to community service programs. |
| NutriConnect Credit | Experimental | Patient is given $20 credit to their Schnucks (grocery) Reward account every other week for F\&V shopping. Receives: Other: Product prescription program- NutriConnect Credit |
| NutriConnect Delivery | Experimental | Patient receives produce (F\&V) box (with equivalent $20 value) delivered to home every other week. Receives: Other: Product prescription program- NutriConnect Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in F&V intake
pre- and post-changes in F\&V consumption (cups/day, continuous).
Measured: 6-month
Secondary outcomes (1)
Household food insecurity
pre- 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
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start25 Mar 2024
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Schnuck Markets, Inc., BJC HealthCare
- Responsible party
- Sponsor
- Investigators
- Jing Li, MD, DrPH, MS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263751
- Sponsor's protocol ID
- 202401096
- Other IDs
- 24FIM1268045
- Acronym
- NutriConnect
- Status last verified
- Jan 2026
- First submitted
- 8 Feb 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data includes self-reported socio-demographic information, data on fruit and vegetable intake, food security status, and health status. Qualitative data includes implementation process, experiences and perspectives of both the intervention delivers and recipients, and other implementation-related factors and outcomes. The dataset includes de-identified quantitative data sets, transcriptions of qualitative interviews, codebooks for all qualitative and quantitative data, descriptive documentation of variables along with their relationships to outcomes, as well as the analytic plan and program. For the purposes of sharing and disseminating, all direct identifiers and any indirect identifiers that could be used in conjunction with other publicly available information to identify individuals will be removed from the study data. All transcriptions of focus group will also be void of any personal identifiers.
Publications
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.
PubMed 40972889
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NutriConnect: Enhancing Health and Food Security Through Sustainable Solutions and Partnerships
- ClinicalTrials.gov ID
- NCT06263751
- Acronym / sponsor ID
- NutriConnect / 202401096
- Conditions
- Food Insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Schnuck Markets, Inc., BJC HealthCare
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care (Control) | No intervention | –Patient is screened for food or financial insecurity, if positive, social worker will refer him/her to community service programs. |
| NutriConnect Credit | Experimental | Other: Product prescription program- NutriConnect CreditPatient is given $20 credit to their Schnucks (grocery) Reward account every other week for F\&V shopping. |
| NutriConnect Delivery | Experimental | Other: Product prescription program- NutriConnect DeliveryPatient receives produce (F\&V) box (with equivalent $20 value) delivered to home every other week. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (>= 18 years)
- Received care at either medical floors or observation unit at the Bares Jewish Hospital (BJH), and discharged to home.
- Being screened positive for food or financial insecurity.
- Have elevated cardiovascular risk, i.e., self-reported diabetes, hypertension, hyperglycemia, or calculated BMI meeting obesity.
Key exclusion criteria (6 listed)
- Does not have competence to provide informed consent.
- Is under suicide watch.
- Is in police custody.
- In hospice or palliative care.
- Not have a stable home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Product prescription program- NutriConnect CreditPatient 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. | Other | NutriConnect Credit |
| Product prescription program- NutriConnect DeliveryPatient 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. | Other | NutriConnect Delivery |
Primary outcome
change in F&V intake
Time frame: 6-month
pre- and post-changes in F\&V consumption (cups/day, continuous).
1 secondary outcome
Household food insecurity
Time frame: 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 40972889Yoo 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.
- Individual participant dataSharing planned: Yes. The data includes self-reported socio-demographic information, data on fruit and vegetable intake, food security status, and health status. Qualitative data includes implementation process, experiences and perspectives of both the intervention delivers and recipients, and other implementation-related factors and outcomes. The dataset includes de-identified quantitative data sets, transcriptions of qualitative interviews, codebooks for all qualitative and quantitative data, descriptive documentation of variables along with their relationships to outcomes, as well as the analytic plan and program. For the purposes of sharing and disseminating, all direct identifiers and any indirect identifiers that could be used in conjunction with other publicly available information to identify individuals will be removed from the study data. All transcriptions of focus group will also be void of any personal identifiers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Li, MD, DrPH, MS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Product prescription program- NutriConnect Credit and Product prescription program- NutriConnect Delivery in people with Food Insecurity, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in F&V intake (time frame: 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.