Recruiting

Food Support Intervention

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06946355

Conditions

Food Insecurity

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

Interventions

In-hospital food support intervention

Post-discharge food support intervention

Study Details

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

Study ID

NCT06946355

Start date

May 27, 2025

Status verified date

Jun, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

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 Design

Enrollment

9119 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

In-hospital food support intervention

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

Post-discharge food support intervention

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

Primary outcome measure

  • 30-day urgent reutilization [ Time Frame: 30 days post-discharge ]
  • Hunger during hospitalization [ Time Frame: Within 36 hours before discharge ]
  • Post-discharge hunger and food insecurity [ Time Frame: 14 Days post-discharge ]

Central Contacts and Locations

Central contacts

Kathy Auger

+15138033234katherine.auger@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Jun 13, 2025

Last verified

Jun, 2025

Keywords

  • Pediatric
  • Hospitalization
  • Food Intake

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2025-06-13.