Food Insecurity
Conditions
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
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.
Interventions
BEHAVIORALFood 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Rady Children's Hospital, San Diego
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a pilot type 2 hybrid effectiveness-implementation trial of the I-FRESH program using the Roll-out Implementation and Optimization (ROIO) design.
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure (FIM) | 12 months | 4-item measure that assesses feasibility of implementing the program in that setting; score range (4-20) with higher scores referring to greater feasibility |
| Acceptability of Intervention Measure (AIM) | 12 months | 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 |
| Implementation Fidelity | 12 months | 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 |
| Adoption | 12 months | Percent of clinical settings approached that participate; characteristics of settings participating compared to non participating clinical settings |
| Reach | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Function Tests over 12 months | 12 months | change in AST and ALT over a 12 month period |
| Change in Food Security levels over a 12 month period | 12 months | U.S. Household Food Security Survey Module: Six-Item Short Form; Score range of 0-6, with higher scores indicating greater food insecurity |
| Change in Quality of Life measure over 12 months | 12 months | Parent reported Quality of Life as measured by the Pediatric Quality of Life Inventory (PedsQL); Score range of 0 to 100, with higher scores indicating a higher quality of life |
| Change in Weight Status over 12 months | 12 months | Weight status may be measured by BMI percentile for age and sex, %BMIp95, %BMIp50, or BMI z-score |
| Change in Blood Pressure over 12 months | 12 months | Change in systolic and diastolic blood pressures |
| Change in non-fasting and fasting Lipid levels over 12 months | 12 months | Change in total cholesterol, non-HDL cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol |
| Change in HbA1c over 12 months | 12 months | change in HbA1c levels over a 12 month period |
Countries
United States
Contacts
Primary ContactKay Rhee, MD, MS, MA
Outcome results
None listed