Clinical trial NCT05896644: Eat Well Produce Benefit for Diabetes and Food Insecurity
Official title: An Evaluation of Eat Well, a Produce Benefit, for Patients With Diabetes and At-risk for Food Insecurity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Food Insecurity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 2177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1C
timeFrame: 18 months pre program, during program enrollment, up to 12 months
measure: Change in number of ED Visits
timeFrame: up to 18 months pre program, during program enrollment, up to 12 months
Secondary outcomes:
measure: Outpatient visits
timeFrame: up to 18 months pre program, during program, and up to 18 months post program
measure: Hospitalizations
timeFrame: up to 18 months pre program, during program, and up to 18 months post program
measure: Change in weight
timeFrame: up to 18 months pre program, during program, and up to 18 months post program enrollment
measure: Change in body mass index (BMI)
timeFrame: up to 18 months pre program, during program, and up to 18 months post program
measure: Change in cholesterol
timeFrame: up to 18 months pre program, during program, and up to 18 months post program
measure: Medication adherence (proportion of days covered)
timeFrame: up to 18 months pre program, during program, and up to 18 months post program
measure: Change in number of diabetes and hypertension medications
timeFrame: up to 18 months pre program, during program, and up to 18 months post program
measure: Change in blood pressure
timeFrame: up to 18 months pre program, during program, and up to 18 months post program
measure: Change in HbA1C
timeFrame: 18 months post program
measure: Change in number of ED Visits
timeFrame: 18 months post program
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
References: