NCT06263751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2025

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

February 8, 2024

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in F&V intake

    pre- and post-changes in F\&V consumption (cups/day, continuous).

    6-month

Secondary Outcomes (1)

  • Household food insecurity

    6-month

Other Outcomes (1)

  • Self-reported health status

    6-month

Study Arms (3)

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.

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.

Other: Product prescription program- NutriConnect Delivery

Interventions

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 Credit

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.

NutriConnect Delivery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Jing Li, MD, DrPH, MS

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 16, 2024

Study Start

March 25, 2024

Primary Completion

October 23, 2025

Study Completion

October 23, 2025

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will become available after 06/30/2025, and for 2 years.
Access Criteria
research protocol review and approval

Locations