Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults (KP ENRICH) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,007
- 试验地点
- 2
- 主要终点
- 6-month change in glycosylated hemoglobin level
研究概览
简要总结
The goal of this randomized controlled trial is to compare the effect of receiving 6 months of monetary support for healthy food through a food delivery platform on change in glycosylated hemoglobin (HbA1c) levels among adults with type 2 diabetes mellitus with glycemic control that is above target level.
The main study aims are to:
- To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces glycosylated hemoglobin levels within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.
- To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces medical resource utilization within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.
详细描述
Eligible Kaiser Permanente adult members will be randomized to one of two groups:
- Intervention arm, in which subjects will receive 6 months of monetary support (with up to 4 free home deliveries and no service fees) through the Instacart platform to select and receive healthy foods (e.g., vegetables and fruit).
- Control arm, in which subjects will receive 6 months of free home deliveries and no service fees for up to 4 deliveries each month through the Instacart platform.
Glycosylated hemoglobin level will be assessed at baseline and at 6 months after enrollment. Medical resource utilization will be evaluated at 3 months, 6 months, and 12 months after enrollment. Patient-reported outcomes (i.e., diabetes quality of life, nutrition security, dietary habits, social needs, and food security) will also be assessed at baseline, 6 months, and 12 months after enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Adults aged ≥18 years old at enrollment
- •Active membership in Kaiser Permanente with Medi-Cal insurance and no additional private or commercial insurance
- •Diagnosis of Type II diabetes mellitus (not including Type I diabetes mellitus or gestational diabetes mellitus)
- •At least 2 outpatient glycosylated hemoglobin measures ≥7.5% in the prior 18 months
- •Current access to the internet via computer or mobile device
- •No interpreter needed
排除标准
- •Advanced or end-stage kidney disease (estimated glomerular filtration rate ≤15 ml/min/1.73m^2 or receiving outpatient dialysis or having a prior kidney transplant)
- •Known pregnancy at time of identification
结局指标
主要结局
6-month change in glycosylated hemoglobin level
时间窗: 6 months after enrollment
Baseline glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record prior to enrollment. Participants will complete glycosylated hemoglobin testing 6 months after enrollment.
次要结局
- 12-month change in glycosylated hemoglobin level(12 months after enrollment)
- Change in self-reported level of food security(6- and 12-months after enrollment)
- Change in self-reported diabetes-related quality of life(6- and 12-months after enrollment)
- Change in self-reported readiness to change(6- and 12-months after enrollment)
- Percentage of participants with glycosylated hemoglobin <7.5%(6- and 12-months after enrollment)
- Change in self-reported level of nutrition security(6- and 12-months after enrollment)
- All-cause hospitalizations or emergency department visits(3-, 6-, and 12-months after enrollment)
- Change in self-reported dietary habits(6- and 12-months after enrollment)