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?

This trial aims to determine whether providing food support to low-income families during and after a hospital stay benefits them. It examines how meal support can reduce hospital visits and improve family life. Participants will receive various types of food support, such as in-hospital food support interventions (like meal cards) or post-discharge food support interventions (like grocery gift cards). Families with Medicaid insurance or who are uninsured, and have a child under 21, may qualify, provided the child is not in end-of-life care or living independently. As an unphased trial, this study offers families the opportunity to benefit directly from food support interventions while contributing to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on food support rather than medication changes.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Research has shown that food support programs are generally safe for people. Past studies have linked hospital food programs to better access to food, making it easier for people to obtain what they need. These programs are usually well-received and do not cause negative effects.

For food support after leaving the hospital, studies indicate that providing meals or grocery gift cards assists families in need. One study found that most recipients were satisfied and noticed improvements in their food access. These programs did not cause harm.

In summary, both in-hospital and post-hospital food support programs have proven to be safe and helpful, with no reports of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it tackles food insecurity with a comprehensive approach not typically seen in standard care. Unlike usual hospital routines that might involve social work consults without additional food support, this trial tests various combinations of in-hospital and post-discharge food assistance. One unique feature is the provision of meals to parents while they are in the hospital, which is not standard practice. Additionally, offering grocery gift cards and frozen meals upon discharge aims to extend support beyond hospital walls, addressing food insecurity in a more holistic manner. The hope is that these strategies could lead to better health outcomes by ensuring families have access to nutritious food during and after hospitalization.

What evidence suggests that this trial's food support interventions could be effective for addressing food insecurity?

Research has shown that providing food support in hospitals can improve access to food and diet quality. One study found that a food support program reduced food insecurity, defined as not having enough food, by nearly 42%. In this trial, some participants will receive in-hospital food support, while others will receive post-discharge food support. Providing food support after patients leave the hospital has yielded positive results. Specifically, another study reported an 85% decrease in hospital visits just 30 days after families received food assistance. Many families also strongly agreed that receiving food support after leaving the hospital improved their situation. These findings suggest that food support programs can effectively enhance family well-being and reduce the need for healthcare services. ^{2 5 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10753472/

Healthcare-based food assistance programmes in the ... Food insecurity programmes implemented at healthcare institutions have previously found positive impacts on food security, diet quality, ...

2. trustees.aha.org trustees.aha.org/articles/1299-hospitals-and-food-insecurity

Hospitals and food insecurity | AHA Trustee Services This briefing discusses the link between food insecurity and health issues, including chronic illness and child development, and the role of hospitals.

3. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2831307

Screening for Food Insecurity: US Preventive Services ... At the end of the study period (24 weeks), the intervention was associated with reduced food insecurity (41.9% with food insecurity while ...

4. sirenetwork.ucsf.edu sirenetwork.ucsf.edu/sites/default/files/2021-02/SIREN_FI_brief_2020_final.pdf

Food Insecurity Interventions in Health Care Settings - ucsf siren Four studies examined food insecurity; six reported on health outcomes; seven reported on diet changes; and two measured utilization impacts.

5. feedingamerica.org feedingamerica.org/sites/default/files/2023-09/Food%20Bank%20Health%20Care%20Partnerships%20Evidence%20Review%20March%202021.pdf

Key Drivers to Improve Food Security and Health Outcomes Evidence from previous research on food insecurity may demonstrate an intervention's effectiveness in addressing other important outcomes (e.g., housing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7032918/

Interventions Addressing Food Insecurity in Health Care ... Based on study design and sample size, 74% were rated low or very low quality. Studies of referral-based interventions reported moderate increases in patient ...

7. cdc.gov cdc.gov/pcd/issues/2017/17_0343.htm

Clinical-Community Partnerships to Identify Patients With ... The programs reviewed use various strategies to screen patients, including older adults, for food insecurity and to connect them to food resources.

8. publications.aap.org publications.aap.org/hospitalpediatrics/article/14/7/520/197503/Food-Insecurity-and-Community-Based-Food-Resources

Food Insecurity and Community-Based Food Resources ... Nearly one-third of caregivers endorsed ≥1 food resource needs, and resource need was negatively associated with higher food security. Notably, ...