Implementing Food Referrals for Equity and Sustained Health

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06661538
Phase
PHASE2
Status
Recruiting
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Conditions

  • Food Insecurity

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 18, 2025
Status verified
Nov 2025
Primary completion
Jun 15, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

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.

Primary Outcome Measure

Feasibility of Intervention Measure (FIM) [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UC San DiegoLa JollaCalifornia92093-
Rady Children's Hospital San DiegoSan DiegoCalifornia92123
Kyung Rhee, MD, MS, MA
[email protected]
8589665841
Kyung Rhee, MD, MS, MA (PRINCIPAL_INVESTIGATOR)

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