Clinical trial NCT06329375: Food Insecurity Reduction & Strategy Team
Official title: Food Insecurity Reduction & Strategy Team
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Food Insecurity
Diabetes Mellitus, Type 1
Keywords: inpatient
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be prospectively randomized into either a nutrition program (intervention), or receiving state-of-the-art standard of care (SOC) in a 4:1 ratio. 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 purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Food insecurity at 60 -days post initial discharge
timeFrame: 60 days from discharge
Secondary outcomes:
measure: Food insecurity at 30- and 90- days post post initial discharge
timeFrame: 30-, and 90- days from discharge
measure: Measures of diabetes stress
timeFrame: 30-,60-, and 90- days from discharge
measure: Measures of hypoglycemia
timeFrame: 30-,60-, and 90- days from discharge
measure: Measures of medication adherence
timeFrame: 30-,60-, and 90- days from discharge
measure: Hospitalization
timeFrame: 30-,60-, and 90- days from discharge
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Medicine
state: California
Study officials:
affiliation: Stanford University
name: Neera Ahuja, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Christine Santiago, MD
role: PRINCIPAL_INVESTIGATOR
References: