Clinical trial NCT06661538: Implementing Food Referrals for Equity and Sustained Health
Official title: Addressing Food Insecurity in the Health Care Setting to Promote Health Equity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Rady Children's Hospital, San Diego
First posted: 2024-10-28
Enrollment: 600
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low-income children who receive care at one of the subspecialty clinics at Rady Children's Hospital San Diego

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.

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.

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.

Primary outcomes:
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 12 months
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 12 months
measure: Implementation Fidelity
timeFrame: 12 months
measure: Adoption
timeFrame: 12 months
measure: Reach
timeFrame: 12 months
Secondary outcomes:
measure: Change in Food Security levels over a 12 month period
timeFrame: 12 months
measure: Change in Weight Status over 12 months
timeFrame: 12 months
measure: Change in Blood Pressure over 12 months
timeFrame: 12 months
measure: Change in non-fasting and fasting Lipid levels over 12 months
timeFrame: 12 months
measure: Change in HbA1c over 12 months
timeFrame: 12 months
measure: Change in Liver Function Tests over 12 months
timeFrame: 12 months
measure: Change in Quality of Life measure over 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.