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Implementing Food Referrals for Equity and Sustained Health
NCT06661538 · University of California, San Diego
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Addressing Food Insecurity in the Health Care Setting to Promote Health Equity
About this study
The investigators will conduct a pilot type 2 hybrid effectiveness-implementation trial of the I-FRESH (Implementing Food Referrals for Equity and Sustained Health) program using a Roll-Out Implementation Optimization (ROIO) design among families with children with nutrition-related illnesses who receive Medicaid or Supplemental Nutrition Assistance Program (SNAP) benefits. The I-FRESH program, the food security nutrition support program, will be refined prior to the first clinic roll-out based on input from several hospital, clinical, and community stakeholders. The program will involve 4 main components: screening and identification of families experiencing food insecurity (FI); social worker/care navigator-led discussions with families to determine need and readiness to receive support; referrals and assistance to engage with these programs; and follow-up assessments to determine fit, track utilization, and determine need for additional referrals. With each roll-out into a new clinic, modified implementation procedures and work-flows will be evaluated using implementation and effectiveness outcomes.
Eligibility 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.
Study design
Enrollment target: 600 participants
Allocation: non_randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-08-18
Estimated completion: 2028-03-31
Last updated: 2025-11-19
Interventions
Behavioral: Food Security Screening & Referral Program
Primary outcomes
- • Feasibility of Intervention Measure (FIM) (12 months)
- • Acceptability of Intervention Measure (AIM) (12 months)
- • Implementation Fidelity (12 months)
Sponsor
University of California, San Diego · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Rady Children's Hospital, San Diego
Contacts & investigators
ContactKay Rhee, MD, MS, MA · contact · k1rhee@health.ucsd.edu · 858-534-6827
All locations (2)
UC San DiegoActive Not Recruiting
La Jolla, California, United States
Rady Children's Hospital San DiegoRecruiting
San Diego, California, United States