Food InsecurityFRESHNCT06946355
Food-based Support for Hospitalized Children and Their Families
A study testing In-hospital food support intervention and Post-discharge food support intervention in people with Food Insecurity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Food Insecurity
- What is being tested?
- In-hospital food support intervention and Post-discharge food support intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,119 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients must be currently admitted to a hospital unit where the study is active
- All families of patients less than 21 years of age with Medicaid insurance or uninsured will be eligible
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Food-based Randomized Trial for Enhancing Support of 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.
Read more
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
- Conditions
- Food Insecurity
- Being tested
- In-hospital food support intervention, Post-discharge food support intervention
- Keywords
- Pediatric, Hospitalization, Food Intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-hospital food support interventionOther
The in-hospital food support intervention will provide two meals for up to two parents per day.
Post-discharge food support interventionOther
The post-discharge intervention will provide families with grocery gift cards and frozen meals at the time of discharge.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | No post-discharge food support offered; no in-hospital food support offered; social work consults available per standard of care |
| Both In-Hosptial and Post-Discharge | Active comparator | 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. Receives: Other: In-hospital food support intervention; Other: Post-discharge food support intervention |
| Post-Discharge No In-Hospital | Active comparator | 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. Receives: Other: Post-discharge food support intervention |
| In-Hospital No Post-Discharge | Active comparator | 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. Receives: Other: In-hospital food support intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day urgent reutilization
Validated measure of unplanned readmission/ED/urgent care use via electronic health record (EHR)
Measured: 30 days post-discharge
Hunger during hospitalization
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
Measured: Within 36 hours before discharge
Post-discharge hunger and food insecurity
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
Measured: 14 Days post-discharge
Secondary outcomes (7)
30-day unplanned readmission
Validated measure of unplanned readmission
Measured: 30 Days post-discharge
30-day Emergency department utilization
Emergency department utilization
Measured: 30 Days post-discharge
Understanding of discharge instructions Confidence in care at home
Pediatric Transition Experience Measure (P-TEM)-Transition Preparation Domain
Measured: 14 Days post-discharge
Return to normal routine
Family designed measure that assesses a family's return to normal routines
Measured: 14 Days post-discharge
Post-Discharge coping
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.
Measured: 14 Days post-discharge
Out of pocket expenses
Expenses paid by the family during the hospitalization
Measured: Within 36 hours before discharge
Ability to pay for medications
Family-reported measure regarding difficulty paying for medications
Measured: 14 Days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start27 May 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 9,119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Kathy Auger, Principal investigator, katherine.auger@cchmc.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946355
- Sponsor's protocol ID
- 2023-0331
- Other IDs
- 1R01HD114702-01A1
- Acronym
- FRESH
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food-based Randomized Trial for Enhancing Support of Hospitalized Children and Their Families
- ClinicalTrials.gov ID
- NCT06946355
- Acronym / sponsor ID
- FRESH / 2023-0331
- Conditions
- Food Insecurity
- Keywords
- Pediatric, Hospitalization, Food Intake
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 9,119 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 27 May 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –No post-discharge food support offered; no in-hospital food support offered; social work consults available per standard of care |
| Both In-Hosptial and Post-Discharge | Active comparator | Other: In-hospital food support intervention, Other: Post-discharge food support interventionThe 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. |
| Post-Discharge No In-Hospital | Active comparator | Other: Post-discharge food support interventionThe 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. |
| In-Hospital No Post-Discharge | Active comparator | Other: In-hospital food support interventionThe 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 may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients must be currently admitted to a hospital unit where the study is active
- All families of patients less than 21 years of age with Medicaid insurance or uninsured will be eligible
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-hospital food support interventionThe in-hospital food support intervention will provide two meals for up to two parents per day. | Other | Both In-Hosptial and Post-Discharge, In-Hospital No Post-Discharge |
| Post-discharge food support interventionThe post-discharge intervention will provide families with grocery gift cards and frozen meals at the time of discharge. | Other | Both In-Hosptial and Post-Discharge, Post-Discharge No In-Hospital |
Primary outcome
30-day urgent reutilization
Time frame: 30 days post-discharge
Validated measure of unplanned readmission/ED/urgent care use via electronic health record (EHR)
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
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
7 secondary outcomes
30-day unplanned readmission
Time frame: 30 Days post-discharge
30-day Emergency department utilization
Time frame: 30 Days post-discharge
Understanding of discharge instructions Confidence in care at home
Time frame: 14 Days post-discharge
Return to normal routine
Time frame: 14 Days post-discharge
Post-Discharge coping
Time frame: 14 Days post-discharge
Out of pocket expenses
Time frame: Within 36 hours before discharge
Ability to pay for medications
Time frame: 14 Days post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
Related trials for Food Insecurity
Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
Improving Healthy Food Access in Food Insecurity Populations in Normal and Emergency Situations
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruitingObservational study
Addressing Food Insecurity in Pregnancy
Food Insecurity, Pregnancy
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathy Auger principal investigator
katherine.auger@cchmc.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-hospital food support intervention and Post-discharge food support intervention in people with Food Insecurity, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day urgent reutilization (time frame: 30 days post-discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.