Food-based Support for Hospitalized Children and Their Families (FRESH)

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

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

Study Overview

• Status: Recruiting
• Conditions: Food Insecurity
• Intervention / Treatment: Other: In-hospital food support intervention; Other: Post-discharge food support intervention

• Study Type: Interventional
• Enrollment (Estimated): 9119
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathy Auger; Phone Number: +15138033234; Email: katherine.auger@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; No post-discharge food support offered; no in-hospital food support offered; social work consults available per standard of care
Active Comparator: Both In-Hosptial and Post-Discharge; The study team will provide two meals to up to two parents per day (for a maximum of four meals per day) in the hospital. The study team will provide families with a grocery gift card and frozen meals at the time of discharge.	Other: In-hospital food support intervention; The in-hospital food support intervention will provide two meals for up to two parents per day.; Other: Post-discharge food support intervention; The post-discharge intervention will provide families with grocery gift cards and frozen meals at the time of discharge.
Active Comparator: Post-Discharge No In-Hospital; The study team will provide families with a grocery gift card and frozen meals at the time of discharge. No in-hospital food support offered; social work consults available per standard of care.	Other: Post-discharge food support intervention; The post-discharge intervention will provide families with grocery gift cards and frozen meals at the time of discharge.
Active Comparator: In-Hospital No Post-Discharge; The study team will provide two meals to up to two parents per day (for a maximum of four meals per day) in the hospital. No post-discharge food support offered; social work consults available per standard of care.	Other: In-hospital food support intervention; The in-hospital food support intervention will provide two meals for up to two parents per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day urgent reutilization	Validated measure of unplanned readmission/ED/urgent care use via electronic health record (EHR)	30 days post-discharge
Hunger during hospitalization	USDA 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	Within 36 hours before discharge
Post-discharge hunger and food insecurity	USDA 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	14 Days post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day unplanned readmission	Validated measure of unplanned readmission	30 Days post-discharge
30-day Emergency department utilization	Emergency department utilization	30 Days post-discharge
Understanding of discharge instructions Confidence in care at home	Pediatric Transition Experience Measure (P-TEM)-Transition Preparation Domain	14 Days post-discharge
Return to normal routine	Family designed measure that assesses a family's return to normal routines	14 Days post-discharge
Post-Discharge coping	Post-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.	14 Days post-discharge
Out of pocket expenses	Expenses paid by the family during the hospitalization	Within 36 hours before discharge
Ability to pay for medications	Family-reported measure regarding difficulty paying for medications	14 Days post-discharge

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Kathy Auger, katherine.auger@cchmc.org

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Pediatric; Food Intake; Hospitalization
• Other Study ID Numbers: 2023-0331; 1R01HD114702-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No