Food is Medicine: A Randomized Clinical Trial of Medically Tailored Meals For Individuals with Type 2 Diabetes Mellitus and Food Insecurity

项目摘要/摘要 粮食不安全，即“无法获得足够的食物以维持积极、健康的生活”，影响了3000万人口中的20%以上 患有糖尿病的美国人。粮食不安全在少数族裔和低收入群体中更为普遍。 社会经济地位。此外，粮食不安全与糖尿病控制的恶化和增加有关。 并发症，即使在调整了其他风险因素后也是如此。粮食不安全是造成贫富差距的主要原因。 糖尿病后果。 医疗定制膳食(MTM)递送计划对糖尿病患者来说是一种有前途的干预措施 和粮食不安全。MTM计划提供完全准备好的食物，由注册营养师量身定做，以 根据个人的具体医疗需求，提供教育，帮助优化疾病自我管理。 粮食不安全通常通过粮食补贴来解决--提供额外的财政资源，可以 花在食物上。虽然食品补贴和MTM都可以增加健康食品的获取，但MTM可以提供帮助 克服糖尿病管理的其他障碍，包括缺乏所需的时间、能力、知识和技能 准备合适的饭菜。这些程序的使用通常被称为‘食物就是药’，因为其目的是 提供帮助预防糖尿病并发症所需的食物。MTM正在接受越来越多的公众 注意，但到目前为止，还没有全面的试验来测试其对糖尿病预后的影响 以及其他粮食不安全干预措施。 我们的研究团队已经开发出一种医学上量身定做的膳食干预措施，它结合了提供健康的 食物，为个人的特定营养需求量身定做，并以循证的生活方式干预 以送餐时间为跳板，改善糖尿病自我管理，同时接受 用餐和餐后送餐均已完成。MTM在改善饮食质量方面取得了非常成功的试点 随机临床试验。缺少的是一项解释性(有效性)随机试验，以测试这一点 医学上量身定做的膳食干预可以改善糖尿病的结局，如血红蛋白A1c， 以及患者报告的结果，如糖尿病痛苦、生活质量和低血糖。 因此，我们提出了一项随机试验来评估基于社区的医学定制膳食干预。 200例。它将在不同的参与者中进行，这些参与者被转介到医学上量身定做的食物中。成人型 2糖尿病，血红蛋白A1c在7.0%和12.0%之间，体重指数≥为25公斤/平方米(亚洲人为≥23公斤/平方米 将被登记并随机分配到干预或日常护理+食品补贴。干预措施 小组将接受为期6个月的送餐及其随行生活方式干预，同时常规护理+食物 补贴小组将获得每月30美元的健康食品补贴，以及通常的糖尿病护理。结果将是 在6个月和12个月时进行评估。主要结果是6个月时的血红蛋白A1c。次要结果 包括生理、行为和心理社会措施的改变。

PROJECT SUMMARY/ABSTRACT Food insecurity, “lack of access to enough food for an active, healthy life”, affects over 20% of the 30 million Americans with diabetes. Food insecurity is more common in racial/ethnic minorities and those with lower socioeconomic status. Moreover, food insecurity is associated with worse diabetes control and increased complications, even after adjusting for other risk factors. Food insecurity is a major contributor to disparities in diabetes outcomes. Medically tailored meal (MTM) delivery programs are a promising intervention for individuals with diabetes and food insecurity. MTM programs deliver fully prepared food, tailored by a registered dietitian nutritionist to the specific medical needs of the individual, and provide education to help optimize disease self-management. Food insecurity is typically addressed with food subsidies—offering additional financial resources that can be spent on food. While both food subsidies and MTM can increase healthy food access, MTM can help overcome other barriers to diabetes management including lack of time, ability, knowledge, and skills needed to prepare appropriate meals. The use of these programs is often called ‘food is medicine’, as the purpose is to provide exactly the foods needed to help prevent diabetes complications. MTM are receiving increasing public attention, but there are, as of yet, no full-scale trials to test its effects on diabetes outcomes when compared with other food insecurity interventions. Our research team has developed a medically tailored meal intervention that combines provision of healthy food, tailored to the specific nutrition needs of the individual, with an evidence-based lifestyle intervention that uses the period of meal delivery as springboard to improve diabetes self-management, both while receiving meals and after meal delivery is completed. MTM was highly successful in improving diet quality in a pilot randomized clinical trial. What is missing is an explanatory (efficacy) randomized trial testing whether this medically tailored meal intervention can lead to improvements in diabetes outcomes such as Hemoglobin A1c, and in patient-reported outcomes such as diabetes distress, quality of life, and hypoglycemia. Thus, we propose a randomized trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants referred for medically tailored meals. Adults with type 2 diabetes, Hemoglobin A1c between 7.0% and 12.0%, and BMI ≥ 25 kg/m2 (≥ 23 kg/m2 for those with Asian ancestry) will be enrolled and randomly assigned to intervention or usual care + food subsidy. The intervention group will receive meal delivery and its attendant lifestyle intervention for 6 months, while the usual care + food subsidy group will receive a $30/month healthy food subsidy, along with usual diabetes care. Outcomes will be assessed at 6 and 12 months. The primary outcome is Hemoglobin A1c at 6 months. Secondary outcomes include change in physiologic, behavioral, and psychosocial measures.