Food-based Support for Hospitalized Children and Their Families

NCT06946355 | Recruiting DMC

• 2 other identifiers: 2023-03311R01HD114702-01A1
• Study Type: interventional
• Target: 9,119
• Locations: 1 country
• Sites: 1

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

Conditions

Food Insecurity

Keywords

Pediatric; Hospitalization; Food Intake

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 30-day unplanned readmission

  30 Days post-discharge

• 30-day Emergency department utilization

  30 Days post-discharge

• Understanding of discharge instructions Confidence in care at home

  14 Days post-discharge

• Return to normal routine

  14 Days post-discharge

• Post-Discharge coping

  14 Days post-discharge

Study Arms (4)

Standard Care

NO INTERVENTION

No post-discharge food support offered; no in-hospital food support offered; social work consults available per standard of care

Both In-Hosptial and Post-Discharge

ACTIVE COMPARATOR

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; Other: Post-discharge food support intervention

Post-Discharge No In-Hospital

ACTIVE COMPARATOR

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

In-Hospital No Post-Discharge

ACTIVE COMPARATOR

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

Interventions

In-hospital food support intervention OTHER

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

Both In-Hosptial and Post-Discharge; In-Hospital No Post-Discharge

Post-discharge food support intervention OTHER

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

Both In-Hosptial and Post-Discharge; Post-Discharge No In-Hospital

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Study Officials

• Kathy Auger

  katherine.auger@cchmc.org

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathy Auger

CONTACT

+15138033234; katherine.auger@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 27, 2025
• Study Start: May 27, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

US (1)