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NCT Number: NCT06946355

Food-based Support for 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

Recruiting

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Key information

Conditions

Food Insecurity

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

In-hospital food support intervention

Other

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

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.

Primary outcomes

  1. 30-day urgent reutilization

    Time frame: 30 days post-discharge

    Validated measure of unplanned readmission/ED/urgent care use via electronic health record (EHR)

  2. Hunger during hospitalization

    Time frame: Within 36 hours before discharge

    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

  3. Post-discharge hunger and food insecurity

    Time frame: 14 Days post-discharge

    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

Secondary outcomes

  1. 30-day unplanned readmission

    Time frame: 30 Days post-discharge

    Validated measure of unplanned readmission

  2. 30-day Emergency department utilization

    Time frame: 30 Days post-discharge

    Emergency department utilization

  3. Understanding of discharge instructions Confidence in care at home

    Time frame: 14 Days post-discharge

    Pediatric Transition Experience Measure (P-TEM)-Transition Preparation Domain

  4. Return to normal routine

    Time frame: 14 Days post-discharge

    Family designed measure that assesses a family's return to normal routines

  5. Post-Discharge coping

    Time frame: 14 Days post-discharge

    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.

  6. Out of pocket expenses

    Time frame: Within 36 hours before discharge

    Expenses paid by the family during the hospitalization

  7. Ability to pay for medications

    Time frame: 14 Days post-discharge

    Family-reported measure regarding difficulty paying for medications

Study contacts

Contact information is provided by the study sponsor or research team.

Kathy Auger

CONTACT

[email protected]

+15138033234

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Acronym: FRESH

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 27, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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