Food Insecurity Reduction & Strategy Team

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Food Insecurity; Diabetes Mellitus, Type 1
• Interventions: Other: Nutrition program

• Registration Number: NCT06329375
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-03-22
• Study First Posted: 2024-03-25
• Study Start: 2024-10-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition program (Intervention)	Nutrition program	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 Measures

Name	Time	Method
Food insecurity at 60 -days post initial discharge	60 days from discharge	Primary outcome is whether the participant had food insecurity in the past 30 days, measured at 60-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire.; 1. Within the past 30 days, you were worried that your food would run out before you got the money to buy more. (Categorical); a. Never true, Sometimes true, Often true, Patient refused; 2. Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical); 1. Never true, Sometimes true, Often true, Patient refused

Secondary Outcome Measures

Name	Time	Method
Food insecurity at 30- and 90- days post post initial discharge	30-, and 90- days from discharge	The secondary outcome is whether the participant had food insecurity in the past 30 days, measured at 30-days and 90-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire: 1. Within the past 30 days, you were worried that your food would run out before you got the money to buy more. (Categorical); a. Never true, Sometimes true, Often true, Patient refused; 2. Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical); 1. Never true, Sometimes true, Often true, Patient refused
Measures of diabetes stress	30-,60-, and 90- days from discharge	Feeling overwhelmed by the demands of living with Diabetes measured using ordinal scale with range 1-6.
Measures of hypoglycemia	30-,60-, and 90- days from discharge	Whether ever having a low blood sugar (low glucose or hypoglycemic) reaction in the past 4 weeks and number of times having a low blood sugar (low glucose or hypoglycemic) reaction in the past 4 weeks. (ordinal scale: 0, 1-3, 4-7, 8+)
Measures of medication adherence	30-,60-, and 90- days from discharge	Proportion of participants who missed their recommended diabetes medication in the past 7 days at least once and the mean number of days that the medication was missed in the past 7 days, measured using measured by participant self-report during survey response collection at 30-,60-, and 90-days post-discharge.
Hospitalization	30-,60-, and 90- days from discharge	Proportion of participants having overnight hospitalizations in the past 30 days and mean number of nights with overnight hospitalizations in the past 30 days measured by participant self-report during survey response collection at 30-,60-, and 90-days post-discharge.

Trial Locations

Locations (1)

Stanford Medicine; 🇺🇸 Palo Alto, California, United States