Food as Medicine for HIV: A Randomized Trial of Medically Tailored Meals and Lifestyle Intervention

项目摘要/摘要 在当代的实践中，对于艾滋病毒携带者来说，2型糖尿病(T2 DM)已经成为一种重要的 合并症。2型糖尿病在艾滋病毒携带者中的患病率是普通人群的1.5倍。其中包括 患有2型糖尿病的艾滋病毒携带者体重增加的风险更大，饮食质量更低，血红蛋白A1c更高。 所有这些都使艾滋病毒携带者和2型糖尿病患者面临包括慢性肾脏在内的并发症的极大风险 疾病、心血管疾病和过早死亡。粮食不安全，“无法获得足够的食物 积极、健康的生活“，是造成这一风险的主要因素。粮食不安全的情况是中国的2到3倍 艾滋病毒携带者比一般人群更多。粮食不安全与T2 DM控制较差和 2型糖尿病并发症较多。 医学上量身定做的送餐上门计划缓解了艾滋病毒携带者的食物不安全感。医学上的 在20世纪90年代，为了治疗艾滋病患者的食物不安全，特制膳食应运而生。医学特制膳食 该计划提供由注册营养师根据个人的医疗需求量身定做的全面准备的食物。 尽管艾滋病毒护理发生了变化，但为艾滋病毒携带者量身定做的医疗膳食干预措施并没有跟上步伐。 大多数医学上量身定做的膳食计划并不提供对抗 在现代艾滋病毒护理中看到的健康威胁。这些威胁包括抗逆转录病毒的代谢效应。 药物、慢性炎症、衰老和肥胖环境。出于这些原因，测试是至关重要的 为艾滋病毒携带者量身定做的医疗用餐的新模式。 我们的研究团队开发了一种医学上量身定做的膳食干预方法，它将送餐和 旨在改善减肥和糖尿病自我管理的循证生活方式干预。这个 该项目的目标是测试这种为医学量身定做的膳食干预是否可以改善 血红蛋白A1c、体重和患者报告的结果，如食物不安全、生活质量和糖尿病 与标准的医学上量身定做的膳食干预相比较。 因此，我们提出了一项随机比较有效性试验来评估以社区为基础的医学 量身定做膳食干预(n=200)。它将在不同的艾滋病毒和2型糖尿病患者中进行， 被推荐为医学上量身定做的食物。成人血红蛋白A1c在7.0%到12.0%之间，体重指数≥为25 Kg/m2(具有亚洲血统的人为≥23 kg/m2)将被登记并随机分配到干预或 标准的医疗量身定做的食物。干预组将接受送餐和密集的生活方式 干预12个月，而对照组将在标准营养的同时进行送餐 接受12个月的教育。结果将在6个月、12个月和18个月进行评估。主要结果是 6个月时的血红蛋白A1c。次要结果包括体重、食物安全、生活质量和糖尿病。 苦恼。

PROJECT SUMMARY/ABSTRACT In contemporary practice for people with HIV, type 2 diabetes mellitus (T2DM) has become an important comorbidity. T2DM is 1.5 times more common in people with HIV than the general population. Among those with T2DM, people with HIV have greater risk for weight gain, lower diet quality, and higher hemoglobin A1c. All of this puts people with HIV and T2DM at substantial risk for complications, including chronic kidney disease, cardiovascular disease, and premature mortality. Food insecurity, “lack of access to enough food for an active, healthy life”, is a major contributor to this risk. Food insecurity is 2 to 3 times more common among people with HIV than the general population. Food insecurity is associated with both worse T2DM control and more T2DM complications. Medically tailored meal home delivery programs relieve food insecurity for people with HIV. Medically tailored meals emerged to treat food insecurity among those with AIDS in the 1990's. Medically tailored meal programs deliver fully prepared meals, tailored by a registered dietitian to an individual's medical needs. Although HIV care has changed, medically tailored meal interventions for people with HIV have not kept pace. Most medically tailored meal programs do not provide the intensive lifestyle intervention needed to counter the health threats seen in modern HIV care. These threats include the metabolic effects of anti-retroviral medications, chronic inflammation, aging, and obesogenic environments. For these reasons, it is critical to test new models of medically tailored meal for people with HIV. Our research team has developed a medically tailored meal intervention that combines meal delivery with an evidence-based lifestyle intervention designed to improve weight loss and diabetes self-management. The goal for this project is to test whether this medically tailored meal intervention can lead to improvements in hemoglobin A1c, weight, and in patient-reported outcomes such as food insecurity, quality of life, and diabetes distress, compared with a standard medically tailored meal intervention. Thus, we propose a randomized comparative effectiveness trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among diverse participants with HIV and T2DM, referred for medically tailored meals. Adults with 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 standard medically tailored meals. The intervention group will receive meal delivery and intensive lifestyle intervention for 12 months, while the comparison group will receive meal delivery along with standard nutrition education for 12 months. Outcomes will be assessed at 6, 12, and 18 months. The primary outcome is hemoglobin A1c at 6 months. Secondary outcomes include weight, food security, quality of life, and diabetes distress.