Nutrition Program for Food Insecurity

(FIRST Trial)

Overseen By Christine Santiago, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, No home address, others

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

Compensation: Varies

Number of Visits: 30

Duration: 12 weeks

160 Participants Needed

Trial Summary

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 data supports the idea that Nutrition Program for Food Insecurity is an effective treatment?

The available research shows that food provision interventions, like food prescriptions and food pharmacies, are gaining attention for improving nutritional health outcomes in food-insecure adults. These programs aim to bridge clinic and community settings, suggesting they can be effective in addressing food insecurity. However, the research does not provide specific data comparing the Nutrition Program for Food Insecurity to other treatments for the same condition. ^{1 2 3 4 5}

What data supports the effectiveness of the Nutrition Program for Food Insecurity treatment?

Research shows that food provision interventions, like food prescriptions and food pharmacies, can improve nutritional health outcomes for at-risk patients, especially when combined with nutrition education. This suggests that similar programs could help improve health outcomes for those facing food insecurity. ^{1 2 3 4 5}

What safety data exists for nutrition programs addressing food insecurity?

The research does not directly address safety data for nutrition programs like the Nutrition Program for Food Insecurity. However, it highlights the effectiveness of programs like SNAP-Ed in improving food security and dietary outcomes, which indirectly suggests a positive impact on health. The studies emphasize the need for rigorous study designs to strengthen evidence on dietary outcomes. The American Dietetic Association supports food and nutrition assistance programs to improve health and reduce food insecurity, indicating a general consensus on their safety and importance. ^{6 7 8 9 10}

Is the Nutrition Program for Food Insecurity safe for humans?

The Nutrition Program for Food Insecurity, including programs like SNAP-Ed, is generally considered safe for humans. These programs aim to improve food security and dietary outcomes, which can lead to better health, especially for low-income populations. ^{6 7 8 9 10}

Is the Nutrition program a promising treatment for food insecurity?

Yes, the Nutrition program is promising because it helps improve food security by providing education on nutrition and budgeting to low-income families. This can lead to better dietary habits and overall health, especially for children. ^{8 9 11 12 13}

How does the Nutrition Program for Food Insecurity treatment differ from other treatments for food insecurity?

The Nutrition Program for Food Insecurity is unique because it combines nutrition education with food assistance, aiming to improve both food security and dietary habits among low-income individuals. Unlike other treatments that may only provide food, this program also teaches budgeting and healthy lifestyle choices to help participants achieve long-term food security. ^{8 9 11 12 13}

What is the purpose of this trial?

This study seeks to address the multifaceted challenges posed by food disparities and their negative consequences on health outcomes, via a comprehensive community health intervention program. Study objectives include: 1. To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population. 2. To design, implement and evaluate a nutrition program targeting the hospitalized diabetic population. The investigators will prospectively randomize the target population into either a nutrition program (Intervention), or state-of-art standard of care (SOC) in a 4:1 ratio. Participants in the intervention group will be provided the following two resources in addition to SOC: 1) Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge) 2) Education at discharge and continuing outreach to enhance knowledge for better diet and food options. 3. To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program.

Research Team

Neera Ahuja, MD

Principal Investigator

Stanford University

Christine Santiago, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Nutrition program (Intervention) Experimental Treatment 1 Intervention

Patients in the intervention group will be provided the following two resources in addition to SOC: 1. Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge). 2. Education at discharge and continuing outreach to enhance knowledge for better diet and food options.

Group II: SoC group Active Control 1 Intervention

Standard of care (SOC)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

Parenteral nutrition should be tailored to individual patients to enhance their health status and quality of life, emphasizing the importance of a structured approach to treatment.

Future computerized programs for parenteral nutrition must be designed to prevent fragmented care by providing comprehensive clinical and therapeutic data to caregivers, ensuring coordinated decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality improvement in parenteral nutrition care. Font-Noguera, I., Cercós-Lletí, AC., Llopis-Salvia, P.[2009]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced enteral and parenteral nutrition practice and outcomes in an intensive care unit with a hospital-wide performance improvement process. Schwartz, DB.[2019]

A national survey of 66 dietitians in Canadian ICUs revealed that 39.7% of critically ill patients received no nutrition support, highlighting a significant gap in care.

Among patients who did receive nutrition support, they only received an average of 58% of their prescribed calorie and protein needs, particularly during the first 12 days in the ICU, indicating a need for quality improvement in nutrition practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition support in the critical care setting: current practice in canadian ICUs--opportunities for improvement? Heyland, DK., Schroter-Noppe, D., Drover, JW., et al.[2022]

The implementation of the SIMPLE malnutrition care program in five hospitals significantly improved nutrition care processes for at-risk patients, including increased provision of enhanced food and fluids, nutrition information, and mealtime assistance.

Patient-reported experiences regarding nutrition care also improved after the SIMPLE program was implemented, demonstrating that effective nutrition support can be achieved without increasing the number of dietetic services provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematised, Interdisciplinary Malnutrition Program for impLementation and Evaluation delivers improved hospital nutrition care processes and patient reported experiences - An implementation study. Bell, JJ., Young, AM., Hill, JM., et al.[2021]

Evaluations of dietary risk indicators in the WIC program show that individual dietary assessments, like 24-hour recalls or food frequency questionnaires, often have significant errors, leading to a high chance of misclassification.

Despite individual inaccuracies, these dietary assessments can still yield valid information at the group level, suggesting a need for improved statistical methods and indicator development for better management of nutrition education programs like WIC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodological challenges in performing targeting: assessing dietary risk for WIC participation and education. Caulfield, LE.[2023]

Food insecurity affects nearly fifty million people in the U.S. and is linked to significant negative health outcomes, with food-insecure children being at least twice as likely to report poor health and 1.4 times more likely to have asthma compared to their food-secure peers.

The Supplemental Nutrition Assistance Program (SNAP) plays a crucial role in alleviating food insecurity, which in turn helps reduce adverse health effects, particularly among vulnerable populations like children and seniors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Insecurity And Health Outcomes. Gundersen, C., Ziliak, JP.[2022]

SNAP-Ed has been shown to be effective in improving food security among low-income populations, with evidence from four reports supporting its impact.

However, the evidence for SNAP-Ed's effectiveness in improving nutrition and dietary outcomes is less consistent, highlighting the need for more rigorous studies to better evaluate its impact in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Supplemental Nutrition Assistance Program-Education (SNAP-Ed) on food security and dietary outcomes. Rivera, RL., Maulding, MK., Eicher-Miller, HA.[2020]

The Indiana SNAP-Ed program significantly improved food security scores among low-income households with children, with notable reductions in food insecurity observed one year after the intervention.

While adults in the intervention group showed improved food security, the program did not result in a significant change in food security scores for children compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SNAP-Ed (Supplemental Nutrition Assistance Program-Education) Increases Long-Term Food Security among Indiana Households with Children in a Randomized Controlled Study. Rivera, RL., Maulding, MK., Abbott, AR., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the American Dietetic Association: domestic food and nutrition security. Olson, CM., Holben, DH.[2019]

Food insecurity affects 19.3% of US adults, leading to poorer health and reduced access to healthcare compared to those who are food secure, highlighting a significant public health concern.

Among food-insecure individuals, those receiving both SNAP and food bank assistance reported the worst health outcomes, including higher rates of functional limitations, suggesting that the type and amount of food assistance can impact health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Who Is Food Insecure? Implications for Targeted Recruitment and Outreach, National Health and Nutrition Examination Survey, 2005-2010. Pruitt, SL., Leonard, T., Xuan, L., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Over 38 million people in the United States experienced food insecurity in 2004, leading to negative health outcomes such as poor dietary intake, increased chronic disease risk, and substandard academic achievement.

The American Dietetic Association emphasizes the need for immediate and long-term interventions, including better funding for food assistance programs and nutrition education, to effectively combat food insecurity and promote overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position of the American Dietetic Association: food insecurity and hunger in the United States. Holben, DH.[2019]

References

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

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Quality improvement in parenteral nutrition care. [2009]

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

Enhanced enteral and parenteral nutrition practice and outcomes in an intensive care unit with a hospital-wide performance improvement process. [2019]

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

Nutrition support in the critical care setting: current practice in canadian ICUs--opportunities for improvement? [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Systematised, Interdisciplinary Malnutrition Program for impLementation and Evaluation delivers improved hospital nutrition care processes and patient reported experiences - An implementation study. [2021]

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

Methodological challenges in performing targeting: assessing dietary risk for WIC participation and education. [2023]

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

Food Insecurity And Health Outcomes. [2022]

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

Effect of Supplemental Nutrition Assistance Program-Education (SNAP-Ed) on food security and dietary outcomes. [2020]

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

SNAP-Ed (Supplemental Nutrition Assistance Program-Education) Increases Long-Term Food Security among Indiana Households with Children in a Randomized Controlled Study. [2023]

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

Position of the American Dietetic Association: domestic food and nutrition security. [2019]

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

Who Is Food Insecure? Implications for Targeted Recruitment and Outreach, National Health and Nutrition Examination Survey, 2005-2010. [2020]

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

Strengthening US Food Policies and Programs to Promote Equity in Nutrition Security: A Policy Statement From the American Heart Association. [2022]

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

Position of the American Dietetic Association: food insecurity and hunger in the United States. [2019]