- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06263751
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)
NutriConnect: Enhancing Health and Food Security Through Sustainable Solutions and Partnerships
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
St Louis, Missouri, United States, 63110
- Barnes Jewish Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care (Control)
Patient is screened for food or financial insecurity, if positive, social worker will refer him/her to community service programs.
|
|
|
Experimental: NutriConnect Credit
Patient is given $20 credit to their Schnucks (grocery) Reward account every other week for F&V shopping.
|
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.
|
|
Experimental: NutriConnect Delivery
Patient receives produce (F&V) box (with equivalent $20 value) delivered to home every other week.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in F&V intake
Time Frame: 6-month
|
pre- and post-changes in F&V consumption (cups/day, continuous).
|
6-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Household food insecurity
Time Frame: 6-month
|
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
|
6-month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-reported health status
Time Frame: 6-month
|
pre- and post-changes in self-reported health status (5-point Likert scale, ordinal).
5-point Likert Scale: minimum value = 1, maximum value= 5, higher score means better outcome (or strongly agree).
|
6-month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jing Li, MD, DrPH, MS, Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202401096
- 24FIM1268045 (Other Grant/Funding Number: American Heart Association)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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