Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06661538

Implementing Food Referrals for Equity and Sustained Health

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.g., decreasing fat intake, increasing fruits and vegetables (FV) and fiber intake) has been associated with lower fasting serum glucose, insulin, LDL cholesterol, non-HDL cholesterol, and reduced risk of CVD later in life. Increasing awareness and access to programs that promote food equity by providing affordable healthy produce is a promising way to improve health outcomes and empower patients and communities to achieve better health and well-being. The goal of this proposal is to refine and optimize implementation strategies that connect families to community-based food security nutrition support programs through health care systems or medical clinics. The investigators will develop a multi-disciplinary, cross-sector collaboration to optimize current processes and workflows that integrate food security nutrition support programs into the healthcare system. The investigators will also work to develop a closed-loop communication system between the healthcare and healthy food access systems to support greater patient autonomy and self-efficacy to obtain, prepare, and consume healthy foods.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Food Insecurity Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UC San Diego, La Jolla, California, United States

Loading trial locations.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Food Security Screening & Referral Program

Behavioral

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 outcomes

  1. 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

  2. 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

  3. 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

  4. Adoption

    Time frame: 12 months

    Percent of clinical settings approached that participate; characteristics of settings participating compared to non participating clinical settings

  5. 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

Secondary outcomes

  1. Change in Food Security levels over a 12 month period

    Time frame: 12 months

    U.S. Household Food Security Survey Module: Six-Item Short Form; Score range of 0-6, with higher scores indicating greater food insecurity

  2. Change in Weight Status over 12 months

    Time frame: 12 months

    Weight status may be measured by BMI percentile for age and sex, %BMIp95, %BMIp50, or BMI z-score

  3. Change in Blood Pressure over 12 months

    Time frame: 12 months

    Change in systolic and diastolic blood pressures

  4. Change in non-fasting and fasting Lipid levels over 12 months

    Time frame: 12 months

    Change in total cholesterol, non-HDL cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol

  5. Change in HbA1c over 12 months

    Time frame: 12 months

    change in HbA1c levels over a 12 month period

  6. Change in Liver Function Tests over 12 months

    Time frame: 12 months

    change in AST and ALT over a 12 month period

  7. Change in Quality of Life measure over 12 months

    Time frame: 12 months

    Parent reported Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL); Score range of 0 to 100, with higher scores indicating a higher quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Kay Rhee, MD, MS, MA

CONTACT

[email protected]

858-534-6827

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Rady Children's Hospital, San Diego

Registry information

Official study title

Addressing Food Insecurity in the Health Care Setting to Promote Health Equity

Acronym: I-FRESH

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 28, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.