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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06329375
Other study ID # 72967
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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