Food Insecurity Reduction & Strategy Team (FIRST)

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: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Food Insecurity
• Intervention / Treatment: Other: Nutrition program

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Santiago, MD; Phone Number: (650) 725-5071; Email: csantia2@stanford.edu

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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: Enhanced access to nutritious food (twice daily meal delivery up to 90 days post-discharge).; 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 30-days post initial discharge	Primary outcome is whether the participant had food insecurity in the past 30 days, measured at 30-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire.; 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; Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical)Never true, Sometimes true, Often true, Patient refused	30 days from discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food insecurity at 60- and 90- days post post initial discharge	The secondary outcome is whether the participant had food insecurity in the past 30 days, measured at 60-days and 90-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire: 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; Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical)Never true, Sometimes true, Often true, Patient refused	60-, and 90- days from discharge
Measures of diabetes stress	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	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	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	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): February 5, 2025
• Study Completion (Estimated): February 5, 2025

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): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: inpatient
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• 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