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
Official title: NutriConnect: Enhancing Health and Food Security Through Sustainable Solutions and Partnerships
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Insecurity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Schnuck Markets, Inc.
name: BJC HealthCare
First posted: 2024-02-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in F&V intake
timeFrame: 6-month
Secondary outcomes:
measure: Household food insecurity
timeFrame: 6-month
Other outcomes:
measure: Self-reported health status
timeFrame: 6-month
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jing Li, MD, DrPH, MS
role: PRINCIPAL_INVESTIGATOR
References: