Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma (NOURISH OK) - Administrative Supplement

项目总结/摘要 营养，以优化，了解和恢复胰岛素敏感性艾滋病毒俄克拉荷马州（NOURISH-OK） 这项研究采用了一种跨领域的研究设计，广泛适用于许多疾病的预防和治疗。 艾滋病的慢性合并症。它采用以社区为基础的参与性取向，以最大限度地实现包容性 少数群体和其他代表性不足的人口，这也确保了研究结果的相关性， 可操作的，并产生减少健康差距的最大潜力。广义上，NOURISH-OK将阐明 营养和非营养行为风险途径将食物不安全与胰岛素抵抗联系起来， 艾滋病毒感染者的收入。其主要重点将是严格评估和操纵饮食摄入量， 一个有影响力的途径，通过对其他生物学途径的二次研究加以补充， 包括慢性炎症和微生物组。该研究将在俄克拉荷马州进行，包括HIV- 积极的个人生活在城市和农村社区。它包括三个目标。第一，研究团队 将测试和完善粮食不安全和胰岛素抵抗的概念性综合框架， 重要的结构、社会、行为和生物途径作为候选干预点。这一目标将 使用横断面调查（n=500）和来自的为期一个月的观察子研究来完成 主要研究样本（n=100），以收集饮食摄入量和肠道微生物组样本的强化测量。数据 分析将使用来自子研究的重复回忆来调整饮食摄入的测量误差。结构 方程模型将被用来测试研究的整体概念多层次框架的粮食不安全， 胰岛素抵抗其次，研究小组将随后适应一个家庭交付的杂货和烹饪自理 NOURISH-OK干预，以解决关键的营养差异和其他健康风险行为， 艾滋病毒感染者中胰岛素抵抗的重要途径。本次改编将被告知 通过第一个目标的调查结果，并通过一系列访谈和焦点小组进一步完善和最终确定 与粮食不安全的艾滋病毒感染者（n=56定性研究对象）。第三，研究团队将 实施为期12周的NOURISH-OK干预措施，并评估其可行性、可接受性和初步可行性。 使用随机等待列表对照设计（n=270）的影响。这项研究将使用一个简单的随机等待名单 对照试验设计，按地理（城市/农村）分层，并在城市组中进一步分层， 粮食安全状况低和极低。主要研究结果包括胰岛素抵抗，沿着多种 与NIDDK的使命密切相关的次要结局。这些次要结局包括 饮食摄入和营养状况，慢性炎症，健康风险行为，包括烟草使用，身体 不活动，睡眠不足，以及微生物组组成的变化。

Project Summary / Abstract The Nutrition to Optimize, Understand, and Restore Insulin Sensitivity in HIV for Oklahoma (NOURISH-OK) Study uses a cross-cutting research design that is widely-applicable to the prevention and treatment of many chronic co-morbidities in HIV disease. It uses a community-based participatory orientation to maximize inclusion of minorities and other underrepresented populations, which also ensures study findings will be relevant, actionable, and yield the greatest potential for reducing health disparities. Broadly, NOURISH-OK will elucidate nutritional and non-nutritional behavioral risk pathways linking food insecurity to insulin resistance among low- income people living with HIV. Its primary focus will be rigorous evaluation and manipulation of dietary intake as an influential pathway, which is complemented by secondary investigation of additional biological pathways, including chronic inflammation and microbiome. The study will be conducted in Oklahoma, and include HIV- positive individuals living in urban and rural communities. It is comprised of three aims. First, the research team will test and refine a conceptual integrated framework of food insecurity and insulin resistance to identify significant structural, social, behavioral, and biological pathways as candidate intervention points. This aim will be accomplished using a cross-sectional survey (n=500) and a one-month observational sub-study from the main study sample (n=100) to collect intensive measures of dietary intake and gut microbiome samples. Data analysis will adjust for measurement error in dietary intake using replicate recalls from the sub-study. Structural equation modeling will be used to test the study’s overall conceptual multi-level framework of food insecurity and insulin resistance. Second, the research team will then adapt a home-delivered grocery and cooking self-care NOURISH-OK intervention to address key nutrition disparities and other health risk behaviors identified as significant path contributors to insulin resistance among people living with HIV. This adaptation will be informed by findings from the first aim, and further refined and finalized through a series of interviews and focus groups with people living with HIV who are food insecure (n=56 qualitative study subjects). Third, the research team will implement the 12-week NOURISH-OK intervention and assess it for feasibility, acceptability, and preliminary impact using a randomized wait-list control design (n=270). This study will use a simple randomized wait-list control trial design with stratification by geography (urban/rural) and further stratification in the urban group by low and very low food security status. Primary study outcomes include insulin resistance, along with multiple secondary outcomes that are also strongly relevant to the mission of NIDDK. These secondary outcomes include dietary intake and nutritional status, chronic inflammation, health risk behaviors, including tobacco use, physical inactivity, and inadequate sleep, and microbiome composition changes.