Food Support for Food Insecurity

(FRESH Trial)

Overseen By Kathy Auger

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: End-of-life care, Non-home discharge, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

9119 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Kathy Auger

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for families of hospitalized children under 21 years old who have Medicaid or no insurance. It aims to see if providing food support during and after hospital stays can help these families.

Inclusion Criteria

My family qualifies for Medicaid or has no insurance, and I am under 21.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-Hospital Intervention

Participants receive in-hospital meal cards or standard care during hospitalization

Duration of hospitalization

Daily meals provided

Post-Discharge Intervention

Participants receive post-discharge food support intervention or standard discharge

14 days

1 follow-up survey

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• In-hospital food support intervention
• Post-discharge food support intervention

Trial Overview The study tests two interventions: one provides meal cards to low-income parents while their child is in the hospital, and the other offers food support after discharge. The effectiveness will be measured against standard care.

How Is the Trial Designed?

Group I: Standard Care Active Control 1 Intervention

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

Group II: Both In-Hosptial and Post-Discharge Active Control 2 Interventions

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 III: Post-Discharge No In-Hospital Active Control 1 Intervention

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 IV: In-Hospital No Post-Discharge Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+