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

食物就是药物：针对 2 型糖尿病和食物不安全患者的医学定制膳食的随机临床试验

基本信息

批准号：
10682586
负责人：
Seth A Berkowitz
金额：
$ 54.67万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-08-01 至 2025-07-31
项目状态：
未结题

项目摘要

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.

项目摘要/摘要粮食不安全，“无法获得足够的食物来实现活跃，健康的生活”，影响了3000万的20％以上美国人患有糖尿病。粮食不安全在种族/族裔少数群体中更为普遍，社会经济地位。此外，粮食不安全与糖尿病控制较差并增加有关并发症，即使调整了其他危险因素。粮食不安全是导致差异的主要因素糖尿病结果。医疗量身定制的餐（MTM）送货计划是糖尿病患者的承诺干预措施和粮食不安全。 MTM计划提供由注册营养师营养师量身定制的全面准备食物个人的特定医疗需求，并提供教育以帮助优化疾病自我管理。粮食不安全通常与粮食补贴有关 - 提供可能是的其他财务资源花在食物上。虽然食品补贴和MTM都可以增加健康食品的获取，但MTM可以帮助克服其他糖尿病管理障碍，包括缺乏时间，能力，知识和技能准备适当的饭菜。这些程序的使用通常称为“食物是医学”，因为目的是准确提供帮助预防糖尿病并发症的食物。 MTM正在收到越来越多的公众注意，但到目前为止，还没有进行全面试验来测试其对糖尿病结果的影响与其他粮食不安全干预有关。我们的研究团队开发了一种医学量身定制的膳食干预措施，结合了健康的规定根据个人的特定营养需求量身定制的食物，并采用基于证据的生活方式干预措施在接受的同时，将餐点交付时期作为跳板来改善糖尿病的自我管理用餐和餐后完成。 MTM在提高飞行员的饮食质量方面非常成功随机临床试验。缺少的是爆炸性（功效）随机试验测试是否医学量身定制的饮食干预可以改善糖尿病结果，例如血红蛋白A1C，以及在患者报告的结果中，例如糖尿病困扰，生活质量和低血糖。这，我们提出了一项随机试验，以评估基于社区的医学量身定制餐干预（n = 200）。它将在参考医学量身定制的餐点的不同参与者中进行。有类型的成年人 2种糖尿病，血红蛋白A1C在7.0％至12.0％之间，BMI≥25kg/m2（亚洲患者≥23kg/m2 祖先）将被招募并随机分配给干预措施或通常的护理 +食品补贴。干预小组将获得餐点及其随之而来的生活方式干预，为期6个月，而通常的护理 +食物补贴集团将获得每月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个月时血红蛋白A1c。次要结果包括改变生理，行为和社会心理措施。