Diabetes Mellitus, Food Insecurity
Conditions
Brief summary
The goal of this clinical trial is to assess the impact of participation in Eat Well for diabetes patients who are at risk of food insecurity. The main questions it aims to answer are: * whether there is a difference in Haemoglobin (Hb) A1c measurements and emergency department (ED) utilization between the Eat Well and control groups up to 18 months post-program completion. * whether there are differences in cardiometabolic health-related outcomes for Eat Well participants. Participants in the program will receive gift/debit cards for fruits and vegetables and educational nutrition materials. Researchers will compare Eat Well participants with those only receiving educational materials to see if there are differences in cardiometabolic health outcomes.
Detailed description
This pragmatic trial aims to assess the impact of Eat Well participation for diabetes patients at risk of food insecurity. Eligible patients will receive gift/debit cards for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)-approved fruits and vegetables and be assigned to either receive the card for up to 12 months or not. Random assignment will occur using a 2 to 1 treatment to control allocation ratio. Both treatment and control groups will receive curated diabetes educational materials. The study will assess the impact of the intervention on clinical factors such as glycemic control, weight, BMI, lipids, medication adherence, medication number, blood pressure, and utilization up to 18 months pre, during, and post program enrollment using data from clinical visits. The primary analysis of interest will be differences in HbA1c measurements and ED visits between the Eat Well and control groups at 12 months of program participation, with further evaluation of differences at 12 months post-program completion.
Interventions
OTHEREat Well
A program offered by Reinvestment Partners giving clients gift/debit cards that allow the purchase of WIC approved fruits and vegetables.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be active in the Duke Diabetes Registry in the past 12 months AND * have had at least one outpatient A1c measurement AND * are at risk for food insecurity as defined by one of the following: 1. answered often true or sometimes true on one or both of the food insecurity questions as part of the electronic health record social history section (Maestro Care/ Epic of Verona WI) OR 2. answered hard or very hard to the financial stress question as part of the electronic health record social history section (Maestro Care/ Epic of Verona WI) OR 3. has Medicaid as insurance payer OR 4. lives in Area Deprivation Index (ADI) zip code of 7th decile or harder
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of ED Visits | up to 18 months pre program, during program enrollment, up to 12 months | Number of ED visits throughout the study period |
| Change in HbA1C | 18 months pre program, during program enrollment, up to 12 months | A measure of average blood sugar levels over the past 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations | up to 18 months pre program, during program, and up to 18 months post program | Number of patient hospitalizations during the study period |
| Change in weight | up to 18 months pre program, during program, and up to 18 months post program enrollment | — |
| Change in body mass index (BMI) | up to 18 months pre program, during program, and up to 18 months post program | A measure of body fat based on height and weight. |
| Change in cholesterol | up to 18 months pre program, during program, and up to 18 months post program | Measure of lipids |
| Change in number of diabetes and hypertension medications | up to 18 months pre program, during program, and up to 18 months post program | Change in diabetes and hypertension medication numbers |
| Change in blood pressure | up to 18 months pre program, during program, and up to 18 months post program | Systolic and Diastolic blood pressure |
| Change in HbA1C | 18 months post program | A measure of average blood sugar levels over the past 3 months. |
| Change in number of ED Visits | 18 months post program | Number of ED visits throughout the study period |
| Medication adherence (proportion of days covered) | up to 18 months pre program, during program, and up to 18 months post program | Medication adherence will be measured by linking EHR data with Surescripts e-prescription network data. Surescripts facilitates medication refill information exchange between healthcare organizations and pharmacies. Adherence will be calculated using the proportion of days covered (PDC) approach |
| Outpatient visits | up to 18 months pre program, during program, and up to 18 months post program | Number of outpatient visits during the study period |
Countries
United States
Outcome results
None listed