Food referrals to help families of children access healthy produce.
Addressing Food Insecurity in the Health Care Setting to Promote Health Equity
This program will see if clinic screening plus social-worker referrals help families of children with nutrition-related conditions who receive Medicaid or SNAP access affordable healthy food.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 2 sites (La Jolla, California and 1 other locations) |
| Trial ID | NCT06661538 on ClinicalTrials.gov |
What this trial studies
This pilot is a type 2 hybrid effectiveness-implementation trial using a Roll-Out Implementation Optimization (ROIO) design across pediatric specialty clinics. The I-FRESH program will be refined with input from hospital, clinical, and community stakeholders and includes screening for food insecurity, care navigator-led conversations about needs and readiness, active referrals to food resources, and follow-up to track utilization and fit. With each clinic roll-out the team will adapt workflows and measure implementation outcomes (like uptake and fidelity) alongside effectiveness outcomes such as food security, diet quality, and relevant health markers. The trial enrolls families of children aged 5–18 with nutrition-related illnesses who receive Medicaid or SNAP and remain in the San Diego area.
Who should consider this trial
Good fit: Ideal candidates are families in the San Diego area with a child aged 5–18 seen in diabetes, cardiology, MASLD, or GI clinics who report food insecurity and receive Medicaid or SNAP benefits.
Not a fit: Families who are not food insecure, do not receive Medicaid or SNAP, plan to move out of the area during the study, or already have stable access to healthy food are less likely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could improve families' access to healthy produce, improve children's diet quality, and reduce future cardiometabolic risk.
How similar studies have performed: Prior produce-prescription and food-referral programs have shown improved fruit and vegetable intake and reduced food insecurity in some populations, but rigorous pediatric hybrid implementation trials in specialty clinics remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * child attending Type 1 or Type 2 Diabetes clinics, Cardiology clinic, MASLD clinic, general GI clinic at RCHSD * child age between 5-18 years old * parent or caregiver who indicates that they are experiencing food insecurity and receives Medicaid or SNAP benefits * family not moving out of the San Diego area within the time frame of the study Limited exclusion criteria will be applied in order to examine the impact of this program on a heterogenous group of people and increase generalizability. Of note, all genders and races/ethnicities will be allowed to participate.
Where this trial is running
La Jolla, California and 1 other locations
- UC San Diego — La Jolla, California, United States (Active_not_recruiting)
- Rady Children's Hospital San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Kay Rhee, MD, MS, MA
- Email: k1rhee@health.ucsd.edu
- Phone: 858-534-6827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.