NCT06661538 · University of California, San Diego
Implementing Food Referrals for Equity and Sustained Health
(I-FRESH)
What this study is about
Food insecurity (FI) disproportionately affects those who have been historically marginalized and significantly contributes to poor health outcomes. In children, FI is associated with lower psychosocial functioning and academic achievement.
View original scientific description
Food insecurity (FI) disproportionately affects those who have been historically marginalized and significantly contributes to poor health outcomes. In children, FI is associated with lower psychosocial functioning and academic achievement. It also contributes to the development of adverse health outcomes such as obesity, type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD), and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Improving the diet quality of children (e.
Interventions
BEHAVIORAL
Food Security Screening & Referral Program
The I-FRESH (Implementing Food Referrals for Equity and Sustained Health) program is the food security nutrition support program that involves some combination and form of: 1) screening and identification of families experiencing food insecurity; 2) discussions with families to determine readiness to engage with nutrition support programs and other community resources; 3) referrals and support to engage with a program; and 4) conducting follow-up assessments to determine fit of program, track utilization, and assess need for additional referrals. The exact implementation and workflow for this program will be optimized for each clinic.
Primary outcome measures
Feasibility of Intervention Measure (FIM)
Time frame: 12 months
4-item measure that assesses feasibility of implementing the program in that setting; score range (4-20) with higher scores referring to greater feasibility
Acceptability of Intervention Measure (AIM)
Time frame: 12 months
4-item measure assessing the acceptability of the program by program staff and participants; score range (4-20) with higher scores referring to greater acceptability
Implementation Fidelity
Time frame: 12 months
Percent of families with food insecurity that were called, percent of families that were referred to a program or provided with resources, percent of families that received follow-up phone calls, percent of families that needed additional resources/referrals
Adoption
Time frame: 12 months
Percent of clinical settings approached that participate; characteristics of settings participating compared to non participating clinical settings
Reach
Time frame: 12 months
Percent of families attending clinic that completed the food insecurity screener, number of families experiencing food insecurity in that clinic, percent of families that wanted and did not want referrals to a nutrition support program
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- La Jolla, California
- San Diego, California
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Rady Children's Hospital, San Diego
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations