Home Food Delivery for Diabetes Management in Patients of Rural Clinics

摘要 在美国，大约有3000万(~9%)的人患有2型糖尿病(T2 DM)，这个数字是 预计将继续上升。2与此同时，1500万(11.8%)美国家庭经历了粮食不安全，3 定义为无法获得足够量的健康食品。2型糖尿病与粮食不安全密切相关 对于美国成年人：非常低的食品安全与T2 DM患病率增加100%以上相关 与来自高粮食安全家庭的成年人相比。4农村地区的居民受到的威胁尤其大 粮食不安全和2型糖尿病的交集。农村地区的粮食不安全流行率是农村地区的1.2倍 6农村地区的2型糖尿病患病率比大都市地区高17%。 研究表明，改善食物不安全的2型糖尿病患者的健康指标是有希望的。这些研究 已经测试了分发健康食品的干预措施，并显示出改善成功的初步迹象 血糖控制、糖尿病困扰、自我报告的糖尿病管理和食品安全。22-24，29我们将测试 此方法首次在农村地区采用，既可提高参与者的忠诚度，又可扩展： 我们将使用适合2型糖尿病的食品盒送货上门，其中包括循证教育材料和 改善农村饮食不安全的T2 DM患者血糖控制和饮食质量的食谱。这一干预 采用卫生公平框架：30，31解决农村粮食不安全的具体需求和障碍 家庭面临许多健康和经济差距的风险。我们的长期目标是改造农村居民的 T2 DM的管理。本研究的目标是确定干预的有效性，即 可扩展和可持续，并通过减轻农村参与者的粮食不安全来促进患者的依从性 与完成现有干预措施相关的困难。我们的具体目标是：1.比较 健康食品提供干预(HFDI)加上标准护理和单独标准护理的有效性 改善农村食物不安全的2型糖尿病患者的糖尿病相关结局。2.比较 HFDI加标准护理和单独标准护理对改善农村食品饮食质量的效果 2型糖尿病患者缺乏安全感。3.比较成本效益，以了解HFDI加上标准护理成本 与仅与标准护理相关的结果的关系。我们将进行全力以赴的、可比较的 有效的随机对照试验，包括400名食物不安全的2型糖尿病患者。这些患者将从 为农村人口服务的诊所。患者将被随机分配到HFDI加标准护理或 仅标准护理一项，每只手臂有200人。基线和随访数据(干预后、6个月后 干预和干预后12个月)将从两个研究分支的患者中收集。健康的人 食品发放干预的结果和调查结果将适用于农村弱势人口。 该提案直接涉及国家卫生研究院与粮食安全有关的资金优先事项。

ABSTRACT Approximately 30 million (~9%) of all people in the US have type 2 diabetes (T2DM),1 and this number is expected to continue to rise.2 At the same time, 15 million (11.8%) US households experience food insecurity,3 defined as lack of access to adequate amounts of healthy food. T2DM and food insecurity are strongly related for U.S. adults: Very low food security is associated with an over 100% increase in T2DM prevalence compared with adults from high food-secure households.4 Residents of rural areas are particularly threatened by the intersection of food insecurity and T2DM. Food insecurity prevalence in rural areas is 1.2 times higher than in metropolitan areas.6 T2DM prevalence in rural areas is 17% higher than in metropolitan areas.7 Recent studies have shown promise for improving health indicators for food insecure people with T2DM. These studies have tested interventions distributing healthy food and shown preliminary indications of success for improving glycemic control, diabetes distress, self-reported diabetes management, and food security.22-24,29 We will test this approach for the first time in rural areas in a way that both promotes participant adherence and is scalable: we will employ home-delivery of T2DM-appropriate food boxes with evidence based-educational materials and recipes to improve glycemic control and diet quality of rural food insecure patients with T2DM. This intervention adopts a health equity framework:30,31 it addresses specific needs and barriers of rural food insecure households at risk for many health and economic disparities. Our long-term goal is to transform rural residents' management of T2DM.This study's objective is to determine the effectiveness of an intervention that is scalable and sustainable and promotes patient adherence by mitigating rural food insecure participants' difficulties associated with completing existing interventions. Our specific aims are: 1. Compare the effectiveness of the Healthy Food Delivery Intervention (HFDI) plus standard care and standard care alone to improve diabetes-related outcomes among rural food insecure patients with T2DM. 2. Compare the effectiveness of the HFDI plus standard care and standard care alone to improve diet quality among rural food insecure patients with T2DM. 3. Compare cost-effectiveness to understand HFDI plus standard care costs in relationship to outcomes in relation to standard care alone. We will conduct a fully-powered, comparative effectiveness RCT that includes 400 food insecure patients with T2DM. These patients will be recruited from clinics serving rural populations. Patients will be randomly assigned to either the HFDI plus standard care or standard care alone, with 200 in each arm. Baseline and follow up data (post-intervention, six months post- intervention, and 12 months post-intervention) will be collected from patients in both study arms. The Healthy Food Delivery intervention (HFDI) outcomes and findings will be applicable to vulnerable rural populations. This proposal directly addresses NIH funding priorities related to food insecurity.32