An Evaluation of Eat Well, a Produce Benefit, for Patients With Diabetes and At-risk for Food Insecurity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,177
- 试验地点
- 2
- 主要终点
- Change in HbA1C
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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
- •has Medicaid as insurance payer OR
- •lives in Area Deprivation Index (ADI) zip code of 7th decile or harder
排除标准
- 未提供
研究组 & 干预措施
Eat Well
The experimental group will participate in the Eat Well Produce Prescription program, receiving an $80 monthly benefit for eligible produce for 12 months and diabetes education materials through email, including curated nutrition and diet information from the Diabetes Resource Page, consistent with standard of care at Duke University Health System.
干预措施: Eat Well (Other)
Control
The control group will receive usual care (including diabetes educational materials) without the prescription benefit.
结局指标
主要结局
Change in HbA1C
时间窗: 18 months pre program, during program enrollment, up to 12 months
A measure of average blood sugar levels over the past 3 months.
Change in number of ED Visits
时间窗: up to 18 months pre program, during program enrollment, up to 12 months
Number of ED visits throughout the study period
次要结局
- Outpatient visits(up to 18 months pre program, during program, and up to 18 months post program)
- Hospitalizations(up to 18 months pre program, during program, and up to 18 months post program)
- 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)
- Change in cholesterol(up to 18 months pre program, during program, and up to 18 months post program)
- 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 blood pressure(up to 18 months pre program, during program, and up to 18 months post program)
- Change in HbA1C(18 months post program)
- Change in number of ED Visits(18 months post program)
- Medication adherence (proportion of days covered)(up to 18 months pre program, during program, and up to 18 months post program)