Implementing Food Referrals for Equity and Sustained Health

NCT06661538 | Recruiting Phase 2

• 2 other identifiers: IRB # 810869R01DK140573
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (5)

• Feasibility of Intervention Measure (FIM)

  4-item measure that assesses feasibility of implementing the program in that setting; score range (4-20) with higher scores referring to greater feasibility

  12 months

• Acceptability of Intervention Measure (AIM)

  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

  12 months

• Implementation Fidelity

  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

  12 months

• Adoption

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

  12 months

• Reach

  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

  12 months

Secondary Outcomes (7)

• Change in Food Security levels over a 12 month period

  12 months

• Change in Weight Status over 12 months

  12 months

• Change in Blood Pressure over 12 months

  12 months

• Change in non-fasting and fasting Lipid levels over 12 months

  12 months

• Change in HbA1c over 12 months

  12 months

Study Arms (4)

Clinic 1: Type 2 Diabetes Clinic

EXPERIMENTAL

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.

Behavioral: Food Security Screening & Referral Program

Clinic 2: Obesity Clinic

EXPERIMENTAL

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.

Behavioral: Food Security Screening & Referral Program

Clinic 3: Preventive Cardiology Clinic

EXPERIMENTAL

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.

Behavioral: Food Security Screening & Referral Program

Clinic 4: Gastroenterology Clinic

EXPERIMENTAL

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.

Behavioral: Food Security Screening & Referral Program

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.

Clinic 1: Type 2 Diabetes Clinic; Clinic 2: Obesity Clinic; Clinic 3: Preventive Cardiology Clinic; Clinic 4: Gastroenterology Clinic

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

UC San Diego

La Jolla, California, 92093, United States

ACTIVE NOT RECRUITING

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

RECRUITING

Related Publications (4)

• Becan JE, Bartkowski JP, Knight DK, Wiley TRA, DiClemente R, Ducharme L, Welsh WN, Bowser D, McCollister K, Hiller M, Spaulding AC, Flynn PM, Swartzendruber A, Dickson MF, Fisher JH, Aarons GA. A model for rigorously applying the Exploration, Preparation, Implementation, Sustainment (EPIS) framework in the design and measurement of a large scale collaborative multi-site study. Health Justice. 2018 Apr 13;6(1):9. doi: 10.1186/s40352-018-0068-3.

  PMID: 29654518 BACKGROUND

• Holtrop JS, Estabrooks PA, Gaglio B, Harden SM, Kessler RS, King DK, Kwan BM, Ory MG, Rabin BA, Shelton RC, Glasgow RE. Understanding and applying the RE-AIM framework: Clarifications and resources. J Clin Transl Sci. 2021 May 14;5(1):e126. doi: 10.1017/cts.2021.789. eCollection 2021.

  PMID: 34367671 BACKGROUND

• McCreight MS, Rabin BA, Glasgow RE, Ayele RA, Leonard CA, Gilmartin HM, Frank JW, Hess PL, Burke RE, Battaglia CT. Using the Practical, Robust Implementation and Sustainability Model (PRISM) to qualitatively assess multilevel contextual factors to help plan, implement, evaluate, and disseminate health services programs. Transl Behav Med. 2019 Nov 25;9(6):1002-1011. doi: 10.1093/tbm/ibz085.

  PMID: 31170296 BACKGROUND

• Feldstein AC, Glasgow RE. A practical, robust implementation and sustainability model (PRISM) for integrating research findings into practice. Jt Comm J Qual Patient Saf. 2008 Apr;34(4):228-43. doi: 10.1016/s1553-7250(08)34030-6.

  PMID: 18468362 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Kay Rhee, MD, MS, MA

CONTACT

858-534-6827; k1rhee@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a pilot type 2 hybrid effectiveness-implementation trial of the I-FRESH program using the Roll-out Implementation and Optimization (ROIO) design.

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 28, 2024
• Study Start: August 18, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: This information will be available 1 year after the publication of the first outcomes manuscript.
• Access Criteria: Researchers will be able to request this information by providing a detailed analysis plan or reason for the request. They may be able to obtain de-identified individual level data with this request once the proposal has been vetted and approved. Interested parties should contact Dr. Rhee via email.

Locations

US (2)