Food Insecurity Reduction & Strategy Team

Diabetes Mellitus, Type 2 Clinical Trial

— FIRST  

Official title:

Food Insecurity Reduction & Strategy Team

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06329375
• Other study ID #: 72967
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: February 5, 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Christine Santiago, MD
• Phone: (650) 725-5071
• Email: csantia2[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: February 5, 2025
• Est. primary completion date: February 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Food Insecurity

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food insecurity at 30-days post initial discharge	Primary outcome is whether the participant had food insecurity in the past 30 days, measured at 30-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire.; 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; Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical); Never true, Sometimes true, Often true, Patient refused	30 days from discharge
Secondary	Food insecurity at 60- and 90- days post post initial discharge	The secondary outcome is whether the participant had food insecurity in the past 30 days, measured at 60-days and 90-days post initial discharge by the Food Insecurity Reduction and Strategy Team (FIRST) Survey Instrument questionnaire: 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; Within the past 30 days, the food you bought just didn't last and you didn't have money to get more. (Categorical); Never true, Sometimes true, Often true, Patient refused	60-, and 90- days from discharge
Secondary	Measures of diabetes stress	Feeling overwhelmed by the demands of living with Diabetes measured using ordinal scale with range 1-6.	30-,60-, and 90- days from discharge
Secondary	Measures of hypoglycemia	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+)	30-,60-, and 90- days from discharge
Secondary	Measures of medication adherence	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.	30-,60-, and 90- days from discharge
Secondary	Hospitalization	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.	30-,60-, and 90- days from discharge