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Food-based Support for Hospitalized Children and Their Families

Study acronym: FRESH
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Enrolling by Invitation Eligibility criteria expanded, about 15 words · Site details revised Show 2 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Site details revised
  2. Lead sponsor: Children's Hospital Medical Center, Cincinnati to Children's Hospital Medical Center, Cincinnati Secondary endpoints: details revised at 2 of 7 entries · Site details revised · Eligibility criteria expanded, about 2 words Show 3 more changesShow less
    • Secondary endpoints: details revised at 2 of 7 entries
    • Site details revised
    • Eligibility criteria expanded, about 2 words
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of May 26, 2025 to May 27, 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of May 26, 2025 to May 27, 2025
  4. Start date: May 5, 2025 to May 26, 2025v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06946355
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Food Insecurity
Enrollment 9,119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov