Recruiting

Observational Study

Sponsor:

Stanford University

Code:

NCT06329375

Conditions

Diabetes Mellitus, Type 2

Food Insecurity

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nutrition program

Study Details

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. 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.

Conditions

Diabetes Mellitus, Type 2

Food Insecurity

Diabetes Mellitus, Type 1

Study ID

NCT06329375

Start date

Oct 7, 2024

Status verified date

Apr, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: SoC group

Standard of care (SOC)

experimental: 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.

Interventions

Nutrition program

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

Primary outcome measure

  • Food insecurity at 60 -days post initial discharge [ Time Frame: 60 days from discharge ]

Central Contacts and Locations

Central contacts

Locations

Stanford Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

More Information

Sponsor

Stanford University

Last update posted

Aug 11, 2026

Last verified

Apr, 2026

Keywords

  • inpatient

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-08-11.