Implementing Food Referrals for Equity and Sustained Health

Official title

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

Overview

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.

Detailed description

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.

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 ut

Primary outcome measures

• 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]

Secondary outcome measures (7)

• Change in Food Security levels over a 12 month period [Time frame: 12 months]
• Change in Weight Status over 12 months [Time frame: 12 months]
• Change in Blood Pressure over 12 months [Time frame: 12 months]
• Change in non-fasting and fasting Lipid levels over 12 months [Time frame: 12 months]
• Change in HbA1c over 12 months [Time frame: 12 months]
• Change in Liver Function Tests over 12 months [Time frame: 12 months]
• Change in Quality of Life measure over 12 months [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Other

Study locations

United States · 2 centers

• UC San Diego — La Jolla
• Rady Children's Hospital San Diego — San Diego

Publications

• 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 PMID 29654518
• 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
• 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
• 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
• Rhee KE, Hiller-Venegas S, Viglione C, Polich MA, Huang JS, Kim JJ, Bajwa MS, Zive M, Eichen DM, Strong DR, Stadnick NA, Brookman-Frazee L. Roll-Out Implementation Optimization (ROIO) trial to develop and test the implementation of a food security screening and referral process: a study protocol. Implement Sci Commun. 2026 Jun 19. doi: 10.1186/s43058-026-01025-7. Online ahead of print. PMID 42321957

Identifiers

NCT: NCT06661538 · IRB # 810869 · R01DK140573

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗