Recruiting
Phase 2

Food Security

Sponsor:

UCLA

Code:

NCT06661538

Conditions

Food Insecurity

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

Interventions

Food Security Screening & Referral Program

Study Details

Brief summary:

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.

Conditions

Food Insecurity

Study ID

NCT06661538

Start date

Aug 18, 2025

Status verified date

Nov, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Jun 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Accepted

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

600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Clinic 1: Type 2 Diabetes Clinic

Families with children who attend the Type 2 Diabetes Clinic and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group.

experimental: Clinic 2: Obesity Clinic

Families with children who attend the Obesity Clinic in Endocrinology and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group.

experimental: Clinic 3: Preventive Cardiology Clinic

Families with children who attend the Preventive Cardiology Clinic for hypertension and/or high cholesterol and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group.

experimental: Clinic 4: Gastroenterology Clinic

Families with children who attend the Gastroenterology Clinic for malnutrition or MASLD and indicate that they are experiencing food insecurity on the 2-item screener will be eligible for participation in this group.

Interventions

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 measure

  • Feasibility of Intervention Measure (FIM) [ Time Frame: 12 months ]
  • Acceptability of Intervention Measure (AIM) [ Time Frame: 12 months ]
  • Implementation Fidelity [ Time Frame: 12 months ]
  • Adoption [ Time Frame: 12 months ]
  • Reach [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Rady Children's Hospital San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Kyung Rhee, MD, MS, MA

8589665841k1rhee@health.ucsd.edu

Principal Investigator:

Kyung Rhee, MD, MS, MA

More Information

Sponsor

University of California, San Diego

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

  • Food Insecurity
  • Social Care
  • Screening
  • Type 2 Diabetes Mellitus
  • Cardiovascular Disease
  • Child Health
  • Nutrition
  • Fruit and Vegetables
  • Care Navigation
  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • NAFLD
  • Nutrition Support Programs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-11-19.