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)

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.12345

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.12345

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.678910

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.678910

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.89111213

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.89111213

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

NA

Neera Ahuja, MD

Principal Investigator

Stanford University

CS

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
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

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Nutrition program (Intervention)Experimental Treatment1 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 groupActive Control1 Intervention
Standard of care (SOC)

Find a Clinic Near You

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

References

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]
Quality improvement in parenteral nutrition care. [2009]
Enhanced enteral and parenteral nutrition practice and outcomes in an intensive care unit with a hospital-wide performance improvement process. [2019]
Nutrition support in the critical care setting: current practice in canadian ICUs--opportunities for improvement? [2022]
Systematised, Interdisciplinary Malnutrition Program for impLementation and Evaluation delivers improved hospital nutrition care processes and patient reported experiences - An implementation study. [2021]
Methodological challenges in performing targeting: assessing dietary risk for WIC participation and education. [2023]
Food Insecurity And Health Outcomes. [2022]
Effect of Supplemental Nutrition Assistance Program-Education (SNAP-Ed) on food security and dietary outcomes. [2020]
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 Statespubmed.ncbi.nlm.nih.gov
Position of the American Dietetic Association: domestic food and nutrition security. [2019]
11.United Statespubmed.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 Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
Position of the American Dietetic Association: food insecurity and hunger in the United States. [2019]
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