Food Insecurity Reduction & Strategy Team
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- Stanford University
- Study ID
- NCT06329375
- Status
- Recruiting
Conditions
- Diabetes Mellitus, Type 1
- Diabetes Mellitus, Type 2
- Food Insecurity
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nutrition program — OTHERNutrition program with twice daily meal delivery up to 90 days post-discharge and food and diet education at discharge.
Study Details
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.
Key Dates
- Start date
- Oct 7, 2024
- Status verified
- Apr 2025
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 160 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- No Intervention: SoC groupStandard 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.
Primary Outcome Measure
Food insecurity at 60 -days post initial discharge [ Time Frame: 60 days from discharge ]
Central Contacts
- Christine Santiago, MD(650) 725-5071
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford Medicine | Palo Alto | California | 94304 |
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