Food support for hospitalized children and their families
Food-based Randomized Trial for Enhancing Support of Hospitalized Children and Their Families
This trial will test whether providing free in-hospital meals and extra food support after discharge helps low-income (Medicaid or uninsured) families of hospitalized children.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 9119 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT06946355 on ClinicalTrials.gov |
What this trial studies
The trial offers an in-hospital food support intervention that will be rolled out sequentially across hospital units and compares that to standard care, while a post-discharge food support program is compared to usual discharge practices for families with baseline food insecurity. During hospitalization some families will receive meal cards and others will receive standard care, and after discharge eligible families will receive additional food support or standard discharge resources. The team will collect a 14-day post-discharge follow-up and measure reutilization (such as readmissions or ED visits) and family-centered outcomes related to food security and wellbeing. The design combines a stepped rollout for the in-hospital intervention with a comparative post-discharge intervention among food-insecure families.
Who should consider this trial
Good fit: Families of patients under 21 years old who have Medicaid or are uninsured, who are hospitalized and will be discharged home, and who are not admitted for end-of-life care, not in county custody, and not living independently, are eligible.
Not a fit: Patients with private insurance, those discharged to locations other than home, patients admitted for end-of-life care, those in county custody, or families who are already food secure are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the interventions could reduce hospital reutilization and improve food security and family wellbeing after a child’s hospitalization.
How similar studies have performed: Prior programs and pilot studies providing food support to hospitalized families have shown promise for improving food security and some health-utilization measures, but large rigorous trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Kathy Auger — katherine.auger@cchmc.org
- Study coordinator: Kathy Auger
- Email: katherine.auger@cchmc.org
- Phone: +15138033234
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.