Food Insecurity Reduction & Strategy Team

NCT06329375 | Recruiting

• 1 other identifier: 72967
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To describe the social-demographic and clinical factors associated with food insecurity in the hospitalized diabetic population.
2. 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. 3.To enhance community engagement and develop a systematic implementation plan for long-term roll-out of the nutrition program.

Conditions

Diabetes Mellitus, Type 2; Food Insecurity; Diabetes Mellitus, Type 1

Keywords

inpatient

Outcome Measures

Primary Outcomes (1)

• Food insecurity at 60 -days post initial 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 Outcomes (5)

• Food insecurity at 30- and 90- days post post initial discharge

  30-, and 90- days from discharge

• Measures of diabetes stress

  30-,60-, and 90- days from discharge

• Measures of hypoglycemia

  30-,60-, and 90- days from discharge

• Measures of medication adherence

  30-,60-, and 90- days from discharge

• Hospitalization

  30-,60-, and 90- days from discharge

Study Arms (2)

SoC group

NO INTERVENTION

Standard of care (SOC)

Nutrition program (Intervention)

EXPERIMENTAL

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

Interventions

Nutrition program OTHER

Nutrition program with twice daily meal delivery up to 90 days post-discharge and food and diet education at discharge.

Nutrition program (Intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Medicine

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Interventions

Food Assistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations

Study Officials

• Neera Ahuja, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Christine Santiago, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Santiago, MD

CONTACT

(650) 725-5071; csantia2@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Associate Chief Medical Officer- Inpatient Care Services, Division Chief- Hospital Medicine

Model Details: Participants will be prospectively randomized into either a nutrition program (intervention), or receiving state-of-the-art standard of care (SOC) in a 4:1 ratio. 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

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 25, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-04

Locations

US (1)