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

Food Insecurity Clinical Trial

— NutriConnect  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263751
• Other study ID #: 202401096
• Secondary ID: 24FIM1268045
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: Jing Li, MD, DrPH, MS
• Phone: (314) 273-9386
• Email: l.jing[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Food Insecurity

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	BJC HealthCare, Schnuck Markets, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported health status	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
Primary	change in F&V intake	pre- and post-changes in F&V consumption (cups/day, continuous).	6-month
Secondary	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	6-month