160 Participants Needed

Nutrition Program for Food Insecurity

(FIRST Trial)

CS
Overseen ByChristine Santiago, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the lives of people with diabetes who face food insecurity, which is difficulty accessing enough nutritious food. It will test a new nutrition program that delivers healthy meals to participants twice a day for up to 90 days after hospital discharge, along with education and support for better food choices. Researchers will compare participants to those receiving usual hospital care to determine if the nutrition program improves health outcomes. The trial seeks individuals with Type 1 or Type 2 diabetes who are currently hospitalized, live in California, and have difficulty accessing enough nutritious food. As an unphased trial, this study offers a unique opportunity to contribute to research that could lead to innovative solutions for managing diabetes and food insecurity.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on nutrition and food access, so it's likely you can continue your medications, but please confirm with the trial coordinators.

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 to focus on nutrition and food access rather than medication changes.

What prior data suggests that this nutrition program is safe for the hospitalized diabetic population?

Research has shown that nutrition programs like SNAP (Supplemental Nutrition Assistance Program) are safe and well-received. SNAP has helped millions access healthier food, improving their diets. These programs present no major safety concerns. Participants typically receive benefits such as food delivery and nutrition education, which do not cause harmful effects.

Overall, nutrition programs aim to make healthy food more accessible and improve understanding of dietary choices. This approach is considered safe for everyone, including those in hospitals managing conditions like diabetes. The goal is to encourage healthier eating habits without adding risks.12345

Why are researchers excited about this trial?

Researchers are excited about the nutrition program for food insecurity because it offers enhanced support beyond typical care, which often focuses solely on providing basic dietary advice. Unlike standard options, this program includes twice-daily meal deliveries for up to 90 days post-discharge and ongoing educational outreach. This approach not only ensures consistent access to nutritious food but also empowers patients with knowledge to make healthier dietary choices, potentially leading to better long-term health outcomes.

What evidence suggests that this nutrition program is effective for addressing food insecurity in hospitalized diabetic patients?

Research has shown that programs like SNAP (Supplemental Nutrition Assistance Program) successfully reduce food insecurity for low-income families. SNAP has helped millions access more nutritious food, leading to better health. Studies have found that programs like SNAP improve food security and support healthier food choices. This trial's nutrition program aims to achieve similar outcomes by providing meal delivery and education to participants in the intervention group. By ensuring access to nutritious food and offering guidance on healthy eating, such programs can potentially improve the health of people with diabetes and food insecurity.24678

Who Is on the Research Team?

NA

Neera Ahuja, MD

Principal Investigator

Stanford University

CS

Christine Santiago, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for California residents with Type 1 or Type 2 Diabetes who are admitted to Stanford Healthcare inpatient unit, have food insecurity, and are covered by Mom's Meals. It aims to help those struggling with access to nutritious food.

Inclusion Criteria

Positive Screening for Food Insecurity
On a Healthcare Plan covered by Mom's Meals.
Admitted to Stanford Healthcare inpatient unit
See 2 more

Exclusion Criteria

I plan to go to a skilled nursing facility after discharge.
No Home Address
I prefer a language that does not have a short-form consent available.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a nutrition program or standard of care, with enhanced access to nutritious food and education for up to 90 days post-discharge

12 weeks
Twice daily meal delivery, ongoing education and outreach

Follow-up

Participants are monitored for food insecurity, medication adherence, diabetes stress, hypoglycemia, and hospitalization outcomes

12 weeks
Survey responses at 30, 60, and 90 days post-discharge

Long-term community engagement

Development of a systematic implementation plan for long-term roll-out of the nutrition program

What Are the Treatments Tested in This Trial?

Interventions

  • Nutrition program
Trial Overview The study tests a nutrition program against standard care for diabetic patients facing food insecurity. Participants will be randomly assigned mostly to the intervention group receiving meal deliveries and education on diet post-hospital discharge.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Nutrition program (Intervention)Experimental Treatment1 Intervention
Group II: SoC groupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Published Research Related to This Trial

Nutritionally inadequate diets are a major cause of chronic cardiometabolic diseases, and food insecurity is a key factor contributing to this issue, particularly affecting socioeconomic and racial/ethnic groups.
The paper advocates for a shift in US food assistance policies from merely addressing food security to focusing on 'nutrition security,' which emphasizes equitable access to nutritious foods that promote health and prevent disease, along with recommendations for improving existing programs.
Strengthening US Food Policies and Programs to Promote Equity in Nutrition Security: A Policy Statement From the American Heart Association.Thorndike, AN., Gardner, CD., Kendrick, KB., et al.[2022]
A performance improvement process in a 28-bed ICU led to better patient outcomes by increasing the use of enteral nutrition over parenteral nutrition and starting nutrition support sooner.
The implementation of educational programs and a systematic approach resulted in meeting patients' protein and energy needs, ultimately enhancing nutrition support practices and achieving cost savings for the community hospital.
Enhanced enteral and parenteral nutrition practice and outcomes in an intensive care unit with a hospital-wide performance improvement process.Schwartz, DB.[2019]
In 2000, over 10% of US households faced food insecurity, impacting the health and nutrition of both adults and children, leading to chronic diseases and poor academic performance.
The American Dietetic Association emphasizes the need for systematic action, including better funding for food assistance programs and nutrition education, to effectively combat food insecurity and promote health in the US.
Position of the American Dietetic Association: domestic food and nutrition security.Olson, CM., Holben, DH.[2019]

Citations

Supplemental Nutrition Assistance Program as a health ...SNAP has demonstrated its benefit as an economic support for children and families to reduce food insecurity and allow for greater spending on other vital ...
Supplemental Nutrition Assistance Program (SNAP)USDA, ERS studies have found that SNAP improves household food security in several ways. Household food security deteriorates leading up to the ...
The Supplemental Nutrition Assistance Program (SNAP)In an average month in 2024, SNAP helped an average of more than 41 million low-income people in the United States afford a nutritionally ...
SNAP: Summary of ScienceA 2019 narrative review of 14 studies found that SNAP-Ed interventions statistically improved food security in the three studies that reported ...
Data & Research | Food and Nutrition ServiceThe Food Insecurity Nutrition Incentive grant program provided $100 million to fund and evaluate projects that were intended to increase fruit and vegetable ...
Food Assistance ProgramsUSDA provides critical nutrition assistance through Food and Nutrition Service (FNS) programs that include child nutrition programs, the Supplemental Nutrition ...
The Supplemental Nutrition Assistance Program, Food ...Our key outcome variables were (1) diet (the Healthy Eating Index 2010 [HEI-2010] and intake of added sugar, solid fat, empty calories, and total calories) and ...
What Is SNAP? And Why Does It Matter? | Johns HopkinsDespite being the largest federal nutrition program—in 2024 SNAP spending totaled $99.8 billion —the benefits per person are relatively low, ...
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