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

项目摘要/摘要 优化、理解和恢复俄克拉荷马州HIV患者胰岛素敏感性的营养(Nutiish-OK) 研究采用交叉研究设计，广泛适用于许多疾病的预防和治疗 HIV疾病的慢性并存。它采用以社区为基础的参与性取向，以最大限度地包容 少数族裔和其他代表性不足的人群，这也确保了研究结果将是相关的， 这是可行的，并产生了缩小健康差距的最大潜力。泛泛地说，滋养-OK将澄清 将食物不安全与胰岛素抵抗联系起来的营养和非营养行为风险途径 艾滋病毒携带者的收入。它的主要重点将是严格评估和控制饮食摄入量，如 一个有影响力的途径，辅之以对其他生物途径的二次调查， 包括慢性炎症和微生物群。这项研究将在俄克拉何马州进行，包括艾滋病毒- 生活在城市和农村社区的积极分子。它由三个目标组成。首先，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，以确定 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 主要研究样本(n=100)采集强化措施膳食摄入量和肠道微生物群样本。数据 分析将使用从子研究中重复回忆的方法来调整饮食摄入量的测量误差。结构性 将使用方程建模来检验这项研究的总体概念性多层次框架的粮食安全和 胰岛素抵抗。其次，研究小组将调整家庭杂货店和烹饪自理 营养-OK干预措施，以解决关键的营养差距和其他健康风险行为，如 艾滋病毒携带者中胰岛素抵抗的重要途径贡献者。这一改编将被告知 根据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确定 与食物不安全的艾滋病毒携带者(n=56个定性研究对象)的关系。第三，研究小组将 实施为期12周的Nutiish-OK干预，评估其可行性、可接受性和初步效果 使用随机等待名单对照设计的影响(n=270)。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，并按以下方式在城市组进一步分层 低和极低的粮食安全状况。初步研究结果包括胰岛素抵抗，以及多发性 二次成果也与NIDDK的使命密切相关。这些次要结果包括 饮食摄入量和营养状况、慢性炎症、危害健康的行为，包括吸烟、身体健康 缺乏活动，睡眠不足，微生物群组成发生变化。

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.