Food Insecurity Reduction & Strategy Team (FIRST)

March 11, 2026 updated by: Neera Ahuja, Stanford University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of Type 1 or Type 2 Diabetes Mellitus
  • Admitted to Stanford Healthcare inpatient unit
  • Residence in California at time of enrollment
  • Positive Screening for Food Insecurity
  • On a Healthcare Plan covered by Mom's Meals.

Exclusion Criteria:

  • Plans to be discharged to a skilled nursing facility.
  • Patients who prefer a language for which a short-form consent is not available.
  • No Home Address
  • Pregnant Participants.
  • No access to refrigerator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: SoC group
Standard of care (SOC)
Experimental: Nutrition program (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.
Other: Nutrition program
Nutrition program with twice daily meal delivery up to 90 days post-discharge and food and diet education at discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food insecurity at 60 -days post initial discharge
Time Frame: 60 days from discharge

Primary outcome is whether the participant had food insecurity in the past 30 days, measured at 60-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire.

  1. Within the past 30 days, you were worried that your food would run out before you got the money to buy more. (Categorical)

    a. Never true, Sometimes true, Often true, Patient refused

  2. Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical)

    1. Never true, Sometimes true, Often true, Patient refused
60 days from discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measures of diabetes stress
Time Frame: 30-,60-, and 90- days from discharge
Feeling overwhelmed by the demands of living with Diabetes measured using ordinal scale with range 1-6.
30-,60-, and 90- days from discharge
Measures of hypoglycemia
Time Frame: 30-,60-, and 90- days from discharge
Whether ever having a low blood sugar (low glucose or hypoglycemic) reaction in the past 4 weeks and number of times having a low blood sugar (low glucose or hypoglycemic) reaction in the past 4 weeks. (ordinal scale: 0, 1-3, 4-7, 8+)
30-,60-, and 90- days from discharge
Measures of medication adherence
Time Frame: 30-,60-, and 90- days from discharge
Proportion of participants who missed their recommended diabetes medication in the past 7 days at least once and the mean number of days that the medication was missed in the past 7 days, measured using measured by participant self-report during survey response collection at 30-,60-, and 90-days post-discharge.
30-,60-, and 90- days from discharge
Hospitalization
Time Frame: 30-,60-, and 90- days from discharge
Proportion of participants having overnight hospitalizations in the past 30 days and mean number of nights with overnight hospitalizations in the past 30 days measured by participant self-report during survey response collection at 30-,60-, and 90-days post-discharge.
30-,60-, and 90- days from discharge
Food insecurity at 30- and 90- days post post initial discharge
Time Frame: 30-, and 90- days from discharge

The secondary outcome is whether the participant had food insecurity in the past 30 days, measured at 30-days and 90-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire:

  1. Within the past 30 days, you were worried that your food would run out before you got the money to buy more. (Categorical)

    a. Never true, Sometimes true, Often true, Patient refused

  2. Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical)

    1. Never true, Sometimes true, Often true, Patient refused
30-, and 90- days from discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Neera Ahuja, MD, Stanford University
  • Principal Investigator: Christine Santiago, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72967

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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