Food Insecurity Reduction & Strategy Team (FIRST)

Stanford University

Status: Enrolling

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

Treatments: Other: Nutrition program

Study type: Interventional

Funder types: Other

Identifiers

NCT06329375

72967

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

SoC group

No Intervention group

Description:

Standard of care (SOC)

Nutrition program (Intervention)

Experimental group

Description:

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.

Treatment:

Other: Nutrition program