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

Trial Summary

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 data supports the effectiveness of the treatment Food Bags for addressing food insecurity?

Research shows that food pantries, like the one at Massachusetts General Hospital, can effectively provide food to those in need, improving food security and potentially health outcomes. The FOOD program in NYC cancer centers has successfully distributed meals to food-insecure patients, suggesting that similar interventions can help address food insecurity. ^{1 2 3 4 5}

Is the Food Bags treatment safe for humans?

The research articles provided do not contain specific safety data about the Food Bags treatment or its safety in humans. ^{1 6 7 8 9}

How do Food Bags differ from other treatments for food insecurity?

Food Bags are unique because they provide direct, tangible assistance to individuals facing food insecurity by offering pre-packed food items, which may not always meet specific cultural or dietary needs. Unlike traditional food banks that offer limited choice, newer models are exploring more personalized approaches, but Food Bags remain a straightforward method of addressing immediate food needs. ^{1 10 11 12 13}

What is the purpose of this trial?

Many children and adults receiving medical treatments have higher costs, which can make it harder for them to afford groceries. When someone can't afford enough food, and they do not receive proper nutrition it can make treatment more difficult. By doing this study investigators hope to learn more about whether addressing food insecurity by giving patients bags of food in clinic can help improve nutrition, reduce costs, and improve transplant and cellular therapy outcomes.

Research Team

Anthony Sung, MD

Principal Investigator

The University of Kansas Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Implementation of a food insecurity screening and referral program in student-run free clinics in San Diego, California. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Food Insecurity Screening of Hospitalized Patients: A Descriptive Analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Development of a Medically Tailored Hospital-based Food Pantry System. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Massachusetts General Hospital Revere Food Pantry: Addressing hunger and health at an academic medical center community clinic. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

People with diabetes, respiratory, liver or mental disorders, higher urinary antimony, bisphenol A, or pesticides had higher food insecurity: USA NHANES, 2005-2006. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Talking to patients about food insecurity. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Dietary risk of donated food at an Australian food bank: an audit protocol. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing the effect of adverse economic events on severity of hunger among food pantry clients. [2023]

10. England pubmed.ncbi.nlm.nih.gov

The impact of novel and traditional food bank approaches on food insecurity: a longitudinal study in Ottawa, Canada. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A scoping review of the social dimensions in food insecurity and poverty assessments. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Food insecurity is an ongoing national concern. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Enablers and barriers of harnessing food waste to address food insecurity: a scoping review. [2022]