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Behavioural Intervention

Nutrition Program for Food Insecurity (FIRST Trial)

N/A

Recruiting

Led By Neera Ahuja, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Type 1 or Type 2 Diabetes Mellitus

Be older than 18 years old

Must not have

Plans to be discharged to a skilled nursing facility

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to address the issues caused by food disparities and their impact on health by implementing a community health intervention program. The study has the following objectives:1. Understand the factors related to food insecurity

Who is the study for?

This trial is for California residents with Type 1 or Type 2 Diabetes who are admitted to Stanford Healthcare inpatient unit, have food insecurity, and are covered by Mom's Meals. It aims to help those struggling with access to nutritious food.

What is being tested?

The study tests a nutrition program against standard care for diabetic patients facing food insecurity. Participants will be randomly assigned mostly to the intervention group receiving meal deliveries and education on diet post-hospital discharge.

What are the potential side effects?

Since this trial involves a nutrition program rather than medication, side effects may include changes in digestion or dietary habits as participants adjust to new eating patterns and types of foods provided.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Type 1 or Type 2 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I plan to go to a skilled nursing facility after discharge.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30-,60-, and 90- days from discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30-,60-, and 90- days from discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30-,60-, and 90- days from discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Food insecurity at 60 -days post initial discharge

Secondary study objectives

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

Hospitalization

Measures of diabetes stress

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Nutrition program (Intervention)Experimental Treatment1 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 II: SoC groupActive Control1 Intervention

Standard of care (SOC)

0 / 2Eligibility criteria met