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Food-based Support for Hospitalized Children and Their Families

Food-based Randomized Trial for Enhancing Support of Hospitalized Children and Their Families

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06946355
Acronym
FRESH
Enrollment
9119
Registered
2025-04-27
Start date
2025-05-27
Completion date
2029-12-31
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Insecurity

Keywords

Pediatric, Hospitalization, Food Intake

Brief summary

The goal of this clinical trial is to learn if an intervention to provide food support to families who are part of government or self-pay insurances will provide benefits. The main questions it aims to answer are: * Determine the effect of implementing an in-hospital food support intervention for low-income parents on reutilization and family-centered outcomes. * Among families with baseline food insecurity, determine the effectiveness of a post-discharge food support intervention and as-needed social work referral on reutilization and family-centered outcomes. Researchers will compare the in-hospital food support intervention and will be rolled out to sequential hospital units. In addition, the post-discharge food support intervention will be compared to standard discharge. Some participants will: * Receive in-hospital meal cards or standard care during hospitalization * Receive post-discharge food support intervention or standard discharge * Complete a 14-day post discharge follow-up survey

Interventions

OTHERIn-hospital food support intervention

The in-hospital food support intervention will provide two meals for up to two parents per day.

OTHERPost-discharge food support intervention

The post-discharge intervention will provide families with grocery gift cards and frozen meals at the time of discharge.

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
Yes

Inclusion criteria

* All families of patients less than 21 years of age with Medicaid insurance or uninsured will be eligible

Exclusion criteria

* Patients admitted for end-of-life care, patients who will be discharged to a location other than home, patients who live independently, and patients in county custody.

Design outcomes

Primary

MeasureTime frameDescription
30-day urgent reutilization30 days post-dischargeValidated measure of unplanned readmission/ED/urgent care use via electronic health record (EHR)
Hunger during hospitalizationWithin 36 hours before dischargeUSDA Six-Item Short Form of the Food Security Survey Module, adapted to measure hunger in hospital. Families with lower scores are less likely to experience food insecurity. The family's level of food insecurity increases with the score. * Raw score 0-1-High food security * Raw score 2-4-Low food security * Raw score 5-6-Very low food security
Post-discharge hunger and food insecurity14 Days post-dischargeUSDA Six-Item Short Form of the Food Security Survey Module. Families with lower scores are less likely to experience food insecurity. The family's level of food insecurity increases with the score. * Raw score 0-1-High food security * Raw score 2-4-Low food security * Raw score 5-6-Very low food security

Secondary

MeasureTime frameDescription
30-day unplanned readmission30 Days post-dischargeValidated measure of unplanned readmission
30-day Emergency department utilization30 Days post-dischargeEmergency department utilization
Understanding of discharge instructions Confidence in care at home14 Days post-dischargePediatric Transition Experience Measure (P-TEM)-Transition Preparation Domain
Return to normal routine14 Days post-dischargeFamily designed measure that assesses a family's return to normal routines
Post-Discharge coping14 Days post-dischargePost-Discharge Difficulty Coping Scale is measured at 14-day post-discharge phone call. Post-Discharge Coping Difficulty Scale uses an 11-point scaling format (0-10) with total scores ranging from 0 to 100. Higher scores represent greater coping difficulty.
Out of pocket expensesWithin 36 hours before dischargeExpenses paid by the family during the hospitalization
Ability to pay for medications14 Days post-dischargeFamily-reported measure regarding difficulty paying for medications

Countries

United States

Contacts

CONTACTKathy Auger
katherine.auger@cchmc.org+15138033234
PRINCIPAL_INVESTIGATORKathy Auger

katherine.auger@cchmc.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026