Food and Resources Expanded to Support Health and Type 2 Diabetes (FRESH-T2D)

2020年，超过3850万(10.5%)的美国家庭无法可靠地获得足够数量的 由于资金或其他资源有限，负担得起的、有营养的食物。粮食不安全、营养不良和经济困难 不利因素是导致2型糖尿病差异的关键社会健康决定因素 (T2 DM)，这是一种严重的饮食敏感型慢性疾病，影响着20%以上缺乏食物安全的成年人。应对 战略倾向于廉价的、超加工的食品，这些食品大大降低了饮食质量，并与 随着T2 DM发病率和严重程度的增加，包括血糖控制较差和体重超标。vt.给出 许多社会因素和制度助长并延续了粮食不安全和贫穷的糖尿病 结果，显然需要多层次(个人、家庭、社区)以粮食为重点 有效和可持续地解决2型糖尿病患者或高危人群饮食质量问题的干预措施。致我们的 知识，没有研究严格地测试干预计划是否明确地设计来改善两者 低收入2型糖尿病患者的食品和营养安全由联邦政府人员提供可行 合格的健康中心(FQHC)，可接受在医疗院寻求治疗的患者，或有能力 在T2 DM终点产生临床上相关的变化。这些是我们将在我们的建议中探讨的问题 随机等待名单对照试点研究--扩大食品和资源以支持健康和类型 2糖尿病(Fresh-T2 DM)-在此期间，我们以前开展了饮食和糖尿病自我管理教育 (DSME)干预(FRESH)将向50名患有T2 DM和食物不安全的成人FQHC患者提供 每月两次，为期6个月。新鲜干预包括每两个月提供一次食物；一系列食谱 其中包括新鲜食品；糖尿病自我管理教育(DSME)资源；以及四个30分钟的访问 FQHC注册营养师和认证糖尿病教育师将帮助参与者利用 满足个性化治疗目标的新鲜资源。我们将在之前的工作和现有的基础上再接再厉 与El Rio社区卫生中心的同事合作，该中心是一家获得联邦资格的卫生中心，为 &gt；110,000名保险不足、未参保的患者和南亚利桑那州社区食品银行，该地区 食品银行为5个县的18万亚利桑那州人提供服务：(具体目标1)评估可行性、可接受性、 以及参与者接受我们的新干预，在他们的医疗中心向50名患有食物不安全的T2 DM成年人提供 Home，El Rio社区卫生中心，和(特定目标2)探索血糖控制、饮食的变化 受试者在3岁和3岁时的生活质量、食物安全、糖尿病自我护理行为和健康相关生活质量 六个月。我们针对NIDDK PAS-20-160提交的试点研究的完成将产生以下数据 告知未来最终随机对照临床试验的基本原理和设计，包括招募， 保留率、遵从性和成本数据。我们的长期目标是生产一种经过测试的、有效的协调模型 CARE能够在其他FQHC和食品银行网络中复制和扩展。

In 2020, more than 38.5 million (10.5%) U.S. households were without reliable access to sufficient quantities of affordable, nutritious food due to limited money or other resources. Food insecurity, poor nutrition, and economic disadvantage are critical social determinants of health that contribute to disparities in type 2 diabetes mellitus (T2DM), a serious diet-sensitive chronic disease affecting more than 20% of food insecure adults. Coping strategies favor inexpensive, ultra-processed foods that substantially diminish diet quality and are associated with increased incidence and severity of T2DM, including poorer glycemic control and excess body weight. Given that numerous social factors and systems contribute to and perpetuate food insecurity and poor diabetes outcomes, there is a demonstrable need for multilevel (individual, household, community) food-focused interventions to effectively and sustainably address the diet quality of persons with, or at risk of, T2DM. To our knowledge, no studies have rigorously tested whether intervention programs explicitly designed to improve both food and nutrition security of low-income persons with T2DM are feasibly delivered by personnel at a Federally Qualified Health Center (FQHC), acceptable to patients seeking care in their medical home, or are capable of producing clinically relevant changes in T2DM endpoints. These are questions we will explore in our proposed randomized wait-list controlled pilot study— Food and Resources Expanded to Support Health and Type 2 Diabetes (FRESH-T2DM)— in which our previously developed food and diabetes self-management education (DSME) intervention (FRESH) will be delivered to 50 adult FQHC patients with T2DM and food insecurity twice monthly, for 6 months. The FRESH intervention consists of bimonthly food provision; a series of recipes that feature FRESH foods; diabetes self-management education (DSME) resources; and four, 30-minute visits with an FQHC Registered Dietitian Nutritionist and Certified Diabetes Educator who will help participants utilize FRESH resources to meet personalized treatment goals. We will build upon our prior work and existing collaborations with colleagues at El Rio Community Health Center, a Federally Qualified Health Center serving >110,000 underinsured, uninsured patients and the Community Food Bank of Southern Arizona, a regional food bank serving 180,000 Arizonans across 5 counties to: (Specific Aim 1) Assess the feasibility, acceptability, and participant uptake of our FRESH intervention, delivered to 50 food insecure adults with T2DM at their medical home, El Rio Community Health Center, and (Specific Aim 2) Explore changes in blood glucose control, diet quality, food security, diabetes self-care behaviors, and health-related quality of life among participants at 3 and 6 months. Completion of our pilot study —submitted in response to NIDDK PAS-20-160 —will produce data to inform the rationale and design of a future definitive randomized controlled clinical trial, including recruitment, retention, adherence, and cost data. Our long-term goal is to produce a tested, efficacious model of coordinated care capable of replication and scaling across other FQHCs and food bank networks.