Food Insecurity Reduction & Strategy Team

NCT ID: NCT06329375

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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inpatient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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SoC group

Standard of care (SOC)

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Nutrition program

Intervention Type OTHER

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

Interventions

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Nutrition program

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Neera Ahuja

Professor of Medicine, Associate Chief Medical Officer- Inpatient Care Services, Division Chief- Hospital Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neera Ahuja, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Christine Santiago, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford Medicine

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christine Santiago, MD

Role: CONTACT

Phone: (650) 725-5071

Email: [email protected]

Facility Contacts

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Neera Ahuja, MD

Role: primary

Other Identifiers

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72967

Identifier Type: -

Identifier Source: org_study_id