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

项目总结/摘要 粮食不安全，即“缺乏获得足够食物以过积极、健康生活的机会”，影响到3000万人口中的20%以上。 美国糖尿病患者粮食不安全在少数种族/民族和收入较低的人中更为常见 社会经济地位。此外，粮食不安全与更差的糖尿病控制有关， 即使在调整其他风险因素后，也会出现并发症。粮食不安全是造成性别不平等的一个主要因素。 糖尿病结局 医学定制餐（MTM）交付计划是糖尿病患者的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，由注册营养师营养师量身定制， 个人的具体医疗需求，并提供教育，以帮助优化疾病的自我管理。 粮食不安全问题通常通过粮食补贴来解决-提供额外的财政资源， 花在食物上。虽然食品补贴和MTM都可以增加健康食品的获得，但MTM可以帮助 克服糖尿病管理的其他障碍，包括缺乏时间、能力、知识和所需技能 准备合适的饭菜。这些程序的使用通常被称为“食物是药物”，因为其目的是 提供所需的食物，以帮助预防糖尿病并发症。MTM正在接受越来越多的公众 注意，但是，到目前为止，还没有全面的试验来测试它对糖尿病结局的影响， 与其他粮食不安全干预措施相结合。 我们的研究团队开发了一种医学上量身定制的膳食干预， 根据个人的具体营养需求量身定制的食物，以及基于证据的生活方式干预， 使用送餐期间作为跳板，以改善糖尿病自我管理，同时接受 餐后及餐后送餐完成。MTM在试点中非常成功地改善了饮食质量 随机临床试验。缺少的是一个解释性的（疗效）随机试验， 医学上定制的膳食干预可以导致糖尿病结果的改善，例如血红蛋白A1 c， 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，我们提出了一个随机试验，以评估基于社区的医疗定制膳食干预 （n=200）。它将在不同的参与者中进行，这些参与者被推荐接受医学定制的膳食。成人型 2型糖尿病，血红蛋白A1 c介于7.0%和12.0%之间，BMI ≥ 25 kg/m2（亚洲患者≥ 23 kg/m2） 将入组受试者，并随机分配至干预组或常规护理+食品补贴组。干预 组将接受为期6个月的送餐及其伴随的生活方式干预，而常规护理+食物 补贴组将得到每月30美元健康食品补贴，沿着常规糖尿病护理。成果将 在6个月和12个月时进行评估。主要结局是6个月时的血红蛋白A1 c。次要结局 包括生理、行为和心理社会测量变化。

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.