Home Food Delivery for Diabetes Management in Patients of Rural Clinics

摘要 美国约有3000万人（约9%）患有2型糖尿病（T2 DM），1这一数字是 与此同时，1500万（11.8%）美国家庭面临粮食不安全， 被定义为无法获得足够数量的健康食物。2型糖尿病与粮食不安全密切相关 对于美国成年人：食品安全极低与T2 DM患病率增加100%以上相关 4农村地区的居民尤其受到威胁 粮食不安全和2型糖尿病的交叉点。农村地区粮食不安全的发生率是其他地区的1.2倍 6农村地区的T2 DM患病率比大城市地区高17%。7最近 研究表明，有希望改善粮食不安全的T2 DM患者的健康指标。这些研究 已经测试了分发健康食品的干预措施，并显示出改善健康食品质量的初步迹象。 血糖控制、糖尿病痛苦、自我报告的糖尿病管理和食品安全。22 - 24，29我们将测试 这一方法首次在农村地区采用，既促进了参与者的参与，又具有可扩展性： 我们将采用家庭配送的T2 DM适当的食品盒与循证教育材料， 改善农村食物不安全的T2 DM患者的血糖控制和饮食质量。这种干预 通过健康公平框架：30、31它解决了农村粮食不安全的具体需要和障碍 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变农村居民的生活方式， 本研究的目的是确定干预措施的有效性， 可扩展和可持续，并通过减轻农村粮食不安全问题促进患者依从性 与完成现有干预措施有关的困难。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T2 DM患者的糖尿病相关结局。2.比较 HFDI加标准护理和仅标准护理对改善农村食物中的饮食质量的有效性 不安全的T2 DM患者。3.比较成本效益，以了解HFDI加上标准护理成本， 与单纯标准治疗结果的关系。我们将进行一次全面的比较 有效性RCT包括400例食物不安全的T2 DM患者。这些患者将从 为农村人口服务的诊所。患者将被随机分配至HFDI+标准治疗组或 基线和随访数据（干预后，干预后6个月， 干预和干预后12个月）将从两个研究组的患者中收集。健康 粮食交付干预措施的成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不安全有关的供资优先事项。

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