Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Food Insecurity
Conditions
Keywords
inpatient
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.
Interventions
OTHERNutrition program
Nutrition program with twice daily meal delivery up to 90 days post-discharge and food and diet education at discharge.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTChristine Santiago, MD
PRINCIPAL_INVESTIGATORNeera Ahuja, MD
Stanford University
PRINCIPAL_INVESTIGATORChristine Santiago, MD
Stanford University
Outcome results
None listed