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

食物作为治疗艾滋病毒的药物：医学定制膳食和生活方式干预的随机试验

• 批准号: 10311121
• 负责人: Seth A Berkowitz
• 金额: $ 63.62万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10311121
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adult; Affect; Aftercare; Aging; Anti-Retroviral Agents; Asian ancestry; Behavior; Body Weight decreased; Body mass index; Cardiovascular Diseases; Caring; Chronic; Chronic Kidney Failure; Clinical; Cognitive; Communities; Complications of Diabetes Mellitus; Data; Diabetes Mellitus; Diet; Dietitian; Dimensions; Distress; Effectiveness; Enrollment; Environment; Food; General Population; Glycosylated hemoglobin A; Goals; HIV; Health; Health behavior; Home; Human immunodeficiency virus test; Incentives; Individual; Inflammation; Intervention; Interview; Knowledge; Lead; Life; Medical; Medicine; Metabolic; Methods; Modeling; Modernization; Non-Insulin-Dependent Diabetes Mellitus; Nutritional; Obesity; Outcome; Participant; Pathway interactions; Patient Outcomes Assessments; Patients; Persons; Pharmaceutical Preparations; Positioning Attribute; Premature Mortality; Prevalence; Quality of life; Randomized; Randomized Clinical Trials; Reporting; Research; Risk; Role; Self Efficacy; Structure; Testing; Time; Treatment Efficacy; Variant; Weight; Weight Gain; active comparator; base; behavior change; cardiometabolic risk; combat; comorbidity; comparative effectiveness trial; comparison group; diabetes distress; diabetes management; diabetes risk; diabetes self-management; effective intervention; evidence base; experimental study; food insecurity; food quality; food security; group intervention; improved; innovation; intervention effect; lifestyle intervention; nutrition education; obesity management; obesogenic; primary outcome; programs; psychologic; randomized trial; recruit; response; secondary analysis; secondary outcome; skills; standard of care; therapy design; tool

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.

项目摘要/摘要 在当代艾滋病毒患者的当代实践中，2型糖尿病梅利氏菌（T2DM）已成为重要 合并症。 T2DM在艾滋病毒患者中比一般人群高的1.5倍。其中 使用T2DM，患有艾滋病毒的人会增加体重增加，饮食质量较低和血红蛋白A1c的风险更大。 所有这些使患有艾滋病毒和T2DM的人面临并发症的很大风险，包括慢性肾脏 疾病，心血管疾病和早死亡。粮食不安全，“无法获得足够的食物 积极，健康的生活”是造成这种风险的主要贡献者。粮食不安全性是2至3倍 艾滋病毒的人比普通人群。粮食不安全性与T2DM控制较差和 更多T2DM并发症。 医疗量身定制的餐饮送货课程为艾滋病毒患者救出粮食不安全。医学上 量身定制的饭菜是为了治疗1990年代有艾滋病患者的粮食不安全。医学量身定制的餐 计划提供全面准备的餐点，由注册营养师量身定制，以满足个人的医疗需求。 尽管艾滋病毒的护理发生了变化，但对艾滋病毒患者进行医学量身定制的饮食干预措施并没有保留空间。 大多数医学量身定制的饮食计划没有提供对抗的强化生活方式干预措施 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作用 药物，慢性炎症，衰老和肥胖环境。由于这些原因，测试至关重要 艾滋病毒患者的医学量身定制餐的新型号。 我们的研究团队开发了一种医学量身定制的餐干预措施，将餐点结合在一起 旨在改善体重减轻和糖尿病自我管理的循证生活方式干预措施。这 该项目的目标是测试这种量身定制的餐干预是否可以改善 血红蛋白A1C，体重和患者报告的结果，例如粮食不安全，生活质量和糖尿病 与标准的医疗饮食干预相比，苦恼。 这，我们提出了一项随机比较有效性试验，以评估基于社区的医学 量身定制的餐干预（n = 200）。它将在患有艾滋病毒和T2DM的潜水员参与者中进行 转介医学量身定制的餐点。血红蛋白A1C的成年人在7.0％至12.0％之间，BMI≥25 kg/m2（亚洲血统的人≥23kg/m2）将被招募并随机分配给干预措施或 标准的医疗餐点。干预小组将获得餐点和密集的生活方式 干预12个月，而比较组将获得餐点以及标准营养 教育12个月。结果将在6、12和18个月进行评估。主要结果是 血红蛋白A1c在6个月时。次要结果包括体重，粮食安全，生活质量和糖尿病 困扰。