Food is Medicine: Randomized Trial of Medically-Tailored Food Support for Diabetes Health

摘要 在美国，2910万人患有2型糖尿病（T2 DM），4900万人患有糖尿病。 粮食不安全，对低收入社区的影响尤为严重。粮食不安全与 随着2型糖尿病的发展，在2型糖尿病患者中，血糖控制不佳， 营养、心理健康和行为途径。现有的营养安全网资源不足以 解决粮食不安全对健康的影响。政策制定者越来越认识到“粮食是 医学”-即为慢性病患者和粮食不安全的人提供医学上量身定制的粮食支持可以发挥关键作用 实现最佳的健康结果。与大型非营利营养机构Project Open Hand合作 为旧金山弗朗西斯科的低收入慢性病患者提供医疗定制的膳食和杂货 湾区，我们提出了一项通过食物支持改变糖尿病健康的随机对照试验（RCT） （CHEFS-DM）。CHEFS-DM是一项为期六个月的干预措施，提供DM定制饮食，约75% 根据美国糖尿病协会指南设计， 由注册营养师提供DM营养教育。在我们的试点研究中，干预是可行的， 可接受的，并与食品安全，饮食质量，健康行为，心理健康和 改善急性护理使用和DM控制的趋势。在这个务实的RCT中，我们建议严格 评估从安全网诊所网络招募的400名低收入成年T2 DM患者的干预措施 在加州的旧金山弗朗西斯科和阿拉米达县。利用POH的真实世界程序，我们将随机 参与者1：1干预和控制武器，以下所有参与者的调查，血压 基线和6个月时的测量、人体测量、24小时召回、病历审查和空腹抽血 评估干预措施对健康结果的影响;干预措施参与者将完成额外的 为期12个月的评估，以评估可持续性。在目标1中，我们将确定CHEFS-DM对 糖尿病健康，假设干预将改善血红蛋白A1 c（主要结局）和其他 心脏代谢结局[空腹血糖、血压（BP）、血脂、急性护理利用、DM 药物强化和健康相关生活质量（HRQoL）提高]（次要结局）。在目标2中， 我们将使用我们发布的概念框架来了解营养、心理和行为路径 CHEFS-DM可能会通过这些途径影响T2 DM的健康结果。最后，在目标3中，我们将确定成本- CHEFS-DM的有效性和可持续性，并进行混合方法过程评估，以了解 干预措施的优势和局限性，为扩大规模提供信息。我们假设干预可能是成本- 有效，甚至可能节省费用，而且在干预期结束后，健康效益将持续下去。 我们的最终目标是帮助制止粮食不安全和与糖尿病有关的发病率和死亡率的循环， 符合美国健康人2020的营养，DM相关和健康差异目标。

ABSTRACT In the United States, 29.1 million persons live with type 2 diabetes mellitus (T2DM) and 49 million persons are food-insecure, both disproportionately impacting low-income communities. Food insecurity is strongly associated with the development of T2DM and, among people with T2DM, poor glycemic control, operating through nutritional, mental health, and behavioral pathways. Existing nutrition safety-net resources are inadequate to address the health effects of food insecurity. Policy makers increasingly recognize the premise that “Food is Medicine” - i.e. that medically tailored food support for chronically ill, food-insecure people can play a critical role in achieving optimal health outcomes. In collaboration with Project Open Hand, a large non-profit nutrition agency that provides medically tailored meals and groceries to low-income, chronically ill residents of the San Francisco Bay Area, we propose a randomized controlled trial (RCT) of Changing Health through Food Support for Diabetes (CHEFS-DM). CHEFS-DM is a six-month intervention providing a DM-tailored diet meeting approximately 75% of daily energy requirements and designed based on American Diabetes Association guidelines, together with DM nutritional education provided by registered dieticians. In our pilot study, the intervention was feasible, acceptable, and associated with improvements in food security, diet quality, health behaviors, mental health, and trends towards improvements in acute care use and DM control. In this pragmatic RCT, we propose to rigorously evaluate the intervention among 400 low-income adults with T2DM recruited from networks of safety net clinics in San Francisco and Alameda counties, California. Leveraging POH's real-world programs, we will randomize participants 1:1 to intervention and control arms, following all participants with surveys, blood pressure measures, anthropometry, 24-hour recalls, medical record review and fasting blood draws at baseline and six months to assess intervention impacts on health outcomes; intervention participants will complete an additional twelve-month assessment to assess sustainability. In Aim 1, we will determine the impact of CHEFS-DM on diabetes health, hypothesizing the intervention will improve hemoglobin A1c (primary outcome) and other cardiometabolic outcomes [decreased fasting glucose, blood pressure (BP), lipids, acute care utilization, DM medication intensification and increased health-related quality of life (HRQoL)] (secondary outcomes). In Aim 2, we will use our published conceptual framework to understand the nutritional, mental, and behavioral paths through which CHEFS-DM may impact T2DM health outcomes. Finally, in Aim 3, we will determine the cost- effectiveness and sustainability of CHEFS-DM, and conduct a mixed-methods process evaluation to understand intervention strengths and limitations to inform scale-up. We hypothesize that the intervention may be cost- effective and possibly even cost saving, and that health benefits will be sustained after the intervention period. Our ultimate goal is to help stop the cycle of food insecurity and diabetes-related morbidity and mortality, consistent with the nutritional, DM-related and health disparities goals of US Healthy People 2020.