Food-based Support for Hospitalized Children and Their Families

NCT ID: NCT06946355

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

9119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-27

Study Completion Date

2029-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Food Insecurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

In-hospital food support intervention

Intervention Type OTHER

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

Post-discharge food support intervention

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Post-discharge food support intervention

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

In-hospital food support intervention

Intervention Type OTHER

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

Interventions

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In-hospital food support intervention

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathy Auger

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathy Auger

Role: CONTACT

+15138033234

Other Identifiers

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1R01HD114702-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023-0331

Identifier Type: -

Identifier Source: org_study_id

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