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

项目总结/摘要 在HIV感染者的当代实践中，2型糖尿病（T2 DM）已成为重要的 科摩罗。T2 DM在HIV感染者中的发病率是普通人群的1.5倍。人中 对于T2 DM，HIV感染者有更大的体重增加风险，饮食质量较低，血红蛋白A1 c较高。 所有这些都使HIV和T2 DM患者面临并发症的巨大风险，包括慢性肾脏病。 疾病、心血管疾病和过早死亡。粮食不安全，“无法获得足够的粮食， 积极、健康的生活”是造成这种风险的主要因素。粮食不安全的情况在以下人群中普遍2至3倍： 艾滋病病毒感染者比一般人多。食物不安全与T2 DM控制较差以及 更多T2 DM并发症 医疗定制餐送货上门方案减轻了艾滋病毒感染者的粮食不安全状况。医学上 20世纪90年代，为治疗艾滋病患者的粮食不安全问题，出现了量身定制的膳食。医疗定制餐 该计划提供完全准备好的膳食，由注册营养师根据个人的医疗需求量身定制。 虽然艾滋病毒护理已经发生变化，但针对艾滋病毒感染者的医学定制膳食干预措施没有跟上步伐。 大多数医学定制的膳食计划不提供对抗肥胖所需的强化生活方式干预。 现代艾滋病护理中的健康威胁。这些威胁包括抗逆转录病毒药物的代谢效应 药物、慢性炎症、衰老和致肥胖环境。出于这些原因，测试 为艾滋病病毒携带者量身定制的医疗膳食的新模式。 我们的研究团队开发了一种医学上量身定制的膳食干预，将膳食交付与 这是一种基于证据的生活方式干预，旨在改善减肥和糖尿病自我管理。的 该项目的目标是测试这种医学定制的膳食干预是否可以改善 血红蛋白A1 c、体重和患者报告的结局，如食物不安全、生活质量和糖尿病 痛苦，与标准的医学定制的膳食干预相比。 因此，我们提出了一个随机比较有效性试验，以评估一个以社区为基础的医学 定制膳食干预（n=200）。它将在不同的艾滋病毒和T2 DM参与者中进行， 推荐给我量身定制的膳食血红蛋白A1 c介于7.0%和12.0%之间且BMI ≥ 25的成人 kg/m2（亚洲血统受试者≥ 23 kg/m2），并随机分配至干预组或 标准的医疗定制餐干预组将接受送餐和强化生活方式 干预12个月，而对照组将接受沿着和标准营养 教育12个月。将在6、12和18个月时评估结局。主要结局是 6个月时的血红蛋白A1 c。次要结果包括体重、食物安全、生活质量和糖尿病 痛苦

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.