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Recruiting NCT06329375

Food Insecurity Reduction & Strategy Team

No phase Interventional Diabetes Mellitus, Type 2 Food Insecurity Diabetes Mellitus, Type 1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nutrition program.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2, Food Insecurity, Diabetes Mellitus, Type 1. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Food insecurity at 60 -days post initial discharge [Time frame: 60 days from discharge]
Secondary outcome measures (5)
  • Food insecurity at 30- and 90- days post post initial discharge [Time frame: 30-, and 90- days from discharge]
  • Measures of diabetes stress [Time frame: 30-,60-, and 90- days from discharge]
  • Measures of hypoglycemia [Time frame: 30-,60-, and 90- days from discharge]
  • Measures of medication adherence [Time frame: 30-,60-, and 90- days from discharge]
  • Hospitalization [Time frame: 30-,60-, and 90- days from discharge]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Stanford Medicine — Palo Alto

Identifiers

NCT: NCT06329375 · 72967

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗