Food Bags for Food Insecurity

(NOURISH Trial)

Recruiting at 3 trial locations

Overseen By Anthony Sung, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Intolerance to oral nutrition

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if providing bags of food to individuals undergoing transplants or cell therapy can enhance nutrition, reduce costs, and improve health outcomes. One group of participants will receive bags of shelf-stable food, recipes, and educational materials, while another group will receive information about local food banks. The trial targets individuals planning to undergo a transplant or cell therapy who have faced food insecurity over the past year. The study seeks to assess whether addressing food insecurity in this manner can impact treatment success. As an unphased trial, participants contribute to innovative research that could enhance support for future patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that providing food bags is safe for patients?

Research has shown that distributing food bags can safely and effectively assist people facing food shortages. Studies have found that these programs significantly reduce food insecurity. For instance, one study reported a drop in food insecurity from 100% to just 5.9% after a few weeks of food assistance.

Distributing food bags presents no major safety concerns. This straightforward method ensures people have enough to eat. These bags typically contain long-lasting, easy-to-store items. Similar studies have reported no negative effects, indicating that this approach is well-received and provides valuable support to those in need. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Food Bags" approach because it directly addresses food insecurity by providing tangible resources—shelf-stable food bags, recipes, and educational materials—directly to patients. Unlike the standard practice of merely providing information about local food banks, this method ensures immediate access to nutritious food, which can be crucial for those in urgent need. Additionally, the educational component empowers individuals with cooking skills and knowledge, potentially leading to long-term improvements in food security.

What evidence suggests that providing food bags can improve nutrition and treatment outcomes for patients facing food insecurity?

Research has shown that providing food aid can improve reliable access to meals. In one study, the number of people with enough food increased from 11% to 18%, while those with very little food decreased from 39% to 25%. This indicates that food aid can enhance meal access. Lack of food is linked to poor diet quality, so providing food bags, which participants in the Food Bags Group of this trial will receive, might improve dietary habits. Better nutrition could lead to improved health for those undergoing treatments like transplants or cellular therapy. Although more research is needed, early findings suggest that addressing food insecurity can make a positive difference. ^{6 7 8 9 10}

Who Is on the Research Team?

Anthony Sung, MD

Principal Investigator

The University of Kansas Cancer Center

Are You a Good Fit for This Trial?

This trial is for children and adults undergoing CAR-T cell therapy, bone marrow transplant, or hematopoietic stem cell transplant who are struggling to afford enough food. The study aims to help those facing food insecurity.

Inclusion Criteria

Screen positive for food insecurity by answering 'often true' or 'sometimes true' to specific questions

I am planning to undergo a transplant or cell therapy.

I can read and write in English or Spanish.

Exclusion Criteria

Patients who do not tolerate oral nutrition at the time of study enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bags of shelf-stable food for 2-3 days for one individual twice a week in clinic, along with educational materials

Up to 1 year

Twice a week in clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of malnutrition, cognitive function, and quality of life

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Food Bags

Trial Overview The intervention being tested is the provision of food bags to patients in clinical settings. The goal is to see if this support improves nutrition, reduces healthcare costs, and enhances treatment outcomes.

How Is the Trial Designed?

Group I: Food Bags Group Experimental Treatment 1 Intervention

Patients will be given bags of shelf-stable food for 2-3 days for one individual twice a week in clinic. Additionally, they will receive recipes, handouts, and videos to help with education and food preparation.

Group II: Information Group Active Control 1 Intervention

These participants will receive information on their local food banks according to standard of care.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Memorial Sloan-Kettering Cancer Center, USA

Collaborator

Trials

2

Recruited

370+

Published Research Related to This Trial

Over half of the food pantry clients studied (50.5%) experienced very low food security, which was linked to lower consumption of fruits, vegetables, and fiber, indicating a significant impact on diet quality.

Despite a mean BMI of 29.5 kg/m² and women being four times more likely to be obese than men, food insecurity did not show a direct association with obesity in this group, suggesting other factors may influence weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food insecurity, poor diet quality, and obesity among food pantry participants in Hartford, CT. Robaina, KA., Martin, KS.[2022]

A new method was developed to assess the dietary risk of donated food at an Australian food bank, focusing on nutrition quality and food safety, using a detailed audit of 86,050 kg of food over five days.

The audit revealed that 1,500 images were needed to evaluate the food donations, highlighting the importance of transparency and accountability from food donors, especially given the lack of regulations for food donations in the charitable food system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary risk of donated food at an Australian food bank: an audit protocol. Mossenson, S., Giglia, R., Pulker, CE., et al.[2023]

In a study conducted at Student-run Free Clinics in San Diego, 92.5% of patients were screened for food insecurity, revealing that 74% were food insecure, including 30.7% with very low food security.

The implementation of a food insecurity screening and referral program successfully connected patients to resources, with 201 participants receiving monthly food boxes and others accessing food pantries and SNAP, highlighting the importance of addressing food insecurity in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a food insecurity screening and referral program in student-run free clinics in San Diego, California. Smith, S., Malinak, D., Chang, J., et al.[2020]

Over half (56%) of high-needs cancer patients in New York City face food insecurity, often having to choose between medical treatment and food.

The FOOD intervention has successfully set up 11 medically tailored food pantries in NYC cancer centers, providing over 307,000 meals since 2011 to help alleviate this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Medically Tailored Hospital-based Food Pantry System. Gany, FM., Pan, S., Ramirez, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11504351/

The impact of food aid interventions on food insecurity, diet ... At the end of 18 months, food-secure participants increased from 11 % to 18 %, and severely food insecure decreased from 39 % to 25 %. However, accessing food ...

2. feedingamerica.org feedingamerica.org/sites/default/files/2020-12/Food%20Security%20Evidence%20Review%20August%202020.pdf

FOOD SECURITY EVIDENCE REVIEW They represent the quality and quantity of existing evidence that an intervention is effective at improving a specified outcome(s), such as food security, or ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212267225001546

Evaluation of Food Insecurity Programs on Campus A scoping review across colleges and universities in the United States indicated that an estimated 41% of students experienced food insecurity during 2020. This ...

4. withpower.com withpower.com/trial/food-bags-for-food-insecurity-7848c

Food Bags for Food Insecurity (NOURISH Trial) Over half of the food pantry clients studied (50.5%) experienced very low food security, which was linked to lower consumption of fruits, vegetables, and fiber, ...

5. annfammed.org annfammed.org/content/17/5/436/tab-figures-data

Interventions Addressing Food Insecurity in Health Care ... This review revealed limitations in growing literature on health care-based food insecurity interventions. Low quality and lack of studies examining health or ...

6. feedingamerica.org feedingamerica.org/sites/default/files/2024-09/HCP%20Evidence%20Review%20-%20Key%20Drivers%20to%20Improve%20Food%20Security%20and%20Health%20Outcomes_FINAL.pdf

Key Drivers to Improve Food Security and Health Outcomes Food banks and health care partners should also examine community data to identify groups who may be at higher risk of food insecurity and poor health outcomes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9849926/

Food insecurity and the role of food assistance programs in ... Individuals experiencing food insecurity reported greater disruption in diet during the pandemic and reduced consumption of healthy/unhealthy foods.

8. ers.usda.gov ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/key-statistics-graphics

Food Security in the U.S. - Key Statistics & Graphics Food Security Status of U.S. Households with Children in 2023 · 82.1 percent (29.7 million) of households with children were food secure in 2023.

9. jpmph.org jpmph.org/journal/view.php?doi=10.3961/jpmph.23.505

Food is Medicine Initiative for Mitigating Food Insecurity in ... The results showed that food insecurity with a baseline value of 100% at week 0 decreased to 10.2% by week 3 of intervention and was at 5.9% by ...

10. 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.