Nutrition for Precision Health, powered by the All of Us Research Program: Research Coordinating Center

精准健康营养，由“我们所有人研究计划”提供支持：研究协调中心

• 批准号: 10382053
• 负责人: MARIE G GANTZ
• 金额: $ 349.92万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-01 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10382053
• 关键词: Address; Affect; Algorithms; All of Us Research Program; Artificial Intelligence; Bioinformatics; Biometry; Characteristics; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Collection; Communication; Communication Tools; Complex; Consensus; Custom; Data; Data Collection; Development; Diet; Dietary Assessment; Dietary Intervention; Dietary Practices; Domiciles; Ensure; Epidemiologist; FAIR principles; Food Patterns; Funding; Goals; Health; Individual; Information Systems; Infrastructure; Institutional Review Boards; International; Intervention; Intervention Studies; Intervention Trial; Leadership; Logistics; Machine Learning; Medical; Mission; Monitor; Multi-Institutional Clinical Trial; Nature; Nutrition Assessment; Nutritional; Nutritional Science; Nutritional status; Observational Study; Outcome; Participant; Phase; Phenotype; Physicians; Population; Precision Health; Principal Investigator; Privatization; Process; Protocols documentation; Quality Control; Recording of previous events; Reporting; Research; Research Design; Research Personnel; Resources; Safety; Site; Specimen; Speed; System; Technical Expertise; Technology Assessment; Time; Time Study; TimeLine; Training; United States National Institutes of Health; Universities; complex data; data curation; data ecosystem; data exchange; data management; data pipeline; data quality; data standards; data submission; data tools; design; dietary; electronic data capture system; empowered; evidence base; experience; feeding; flexibility; implementation facilitation; improved; individual response; innovation; meetings; metadata standards; mobile application; multidisciplinary; nutrition; operation; point-of-care diagnostics; precision nutrition; prediction algorithm; sensor; tool; wearable platform; web portal; web site

PROJECT SUMMARY/ABSTRACT The overarching goal of the proposed RTI International–Cornell Research Coordinating Center (RCC) is to provide seamless operational support and multidisciplinary experience for building consensus in the Nutrition for Precision Health Consortium (NPHC). In the 1-year planning phase, we will prioritize efficiency and objectivity in facilitating the design of diet modules (1: usual dietary assessment; 2: controlled feeding dietary intervention; and 3: domiciled dietary intervention) nested in All of Us and their research protocols. In the 4- year implementation phase, we will facilitate the implementation of Modules 1–3, enable the flow of quality data and specimens across the NPHC, and integrate curated, Artificial intelligence (AI)–ready data into the All of Us Researcher Workbench, using our established data coordination processes and systems. Innovations in our approach include tools for conducting dietary studies in hard-to-reach populations, idiographic (or subject-as-own-control) clinical trials, and wearables research tools and analytics. Specifically, the proposed RCC will excel in administrating and coordinating NPHC and its research initiatives, clinical interventions, and data and biospecimen sharing, as follows: Aim 1: Optimize the scientific rigor of Modules 1–3 Aim 2: Ensure NPHC study data are FAIR (Findable, Accessible, Interoperable, and Reusable) Aim 3: Enable seamless data collection, curation, and transfer including to the Researcher Workbench Aim 4: Minimize time to launch of Modules 1–3 Aim 5: Maximize the efficiency of consortium communications and collaborations NPHC is being launched to address major research gaps in nutrition; the nature of these gaps and the complexity of the NPHC activities cannot be underscored enough. RCC will be led by Multiple Principal Investigators with complementary expertise in coordinating center and multisite leadership and biostatistics (Dr. Gantz at RTI) and nutritional intervention and clinical expertise (Dr. Mehta at Cornell University) with the support of a strong and diverse team, organized around cores for Design and Analytics, Data Curation and Systems, and Study Implementation. Other key components include single IRB and medical safety monitoring. The RCC will also benefit from our collective institutional strengths, with an expert pool of wide- ranging research and clinical backgrounds pertinent to the NPHC (e.g., omics, bioinformatics, AI, clinical trial intervention, nutritional assessment). The proposed RCC is immediately and amply prepared to support to NPHC in its mission to develop clinically meaningful algorithms that predict individual responses to food and dietary patterns and to improve health across diverse U.S. populations.

项目概要/摘要 拟议的 RTI 国际-康奈尔研究协调中心 (RCC) 的总体目标是 提供无缝的运营支持和多学科经验，以建立营养领域的共识 对于Precision Health Consortium (NPHC)来说，在1年的规划阶段，我们将优先考虑效率和效率。 促进饮食模块设计的客观性（1：常规饮食评估；2：控制喂养饮食 干预；和 3：本地饮食干预）嵌套在“我们所有人”及其研究方案中 4-。 年实施阶段，我们将促进模块 1-3 的实施，实现质量流动 NPHC 中的数据和样本，并将精选的人工智能 (AI) 数据集成到 All of Us Researcher Workbench，使用我们既定的数据协调流程和系统。 我们方法的创新包括在难以接触的人群中进行饮食研究的工具， 具体（或受试者作为自己的对照）临床试验，以及可穿戴设备研究工具和分析。 具体来说，拟议的 RCC 将在管理和协调 NPHC 及其研究方面表现出色 倡议、临床干预以及数据和生物样本共享，如下： 目标 1：优化模块 1-3 的科学严谨性 目标 2：确保 NPHC 研究数据公平（可查找、可访问、可互操作和可重复使用） 目标 3：实现无缝数据收集、管理和传输，包括传输到研究人员工作台 目标 4：最大限度地缩短模块 1-3 的启动时间 目标5：最大化联盟沟通与协作的效率 发起 NPHC 是为了解决营养方面的重大研究空白； NPHC 活动的复杂性怎么强调都不为过。RCC 将由多重委托人领导。 在协调中心和多站点领导力和生物统计学方面具有互补专业知识的研究人员 （RTI 的 Gantz 博士）以及营养干预和临床专业知识（康奈尔大学的 Mehta 博士） 支持强大且多元化的团队，围绕设计和分析、数据管理和 系统和研究实施其他关键组成部分包括单一 IRB 和医疗安全。 RCC 还将受益于我们的集体机构优势，以及广泛的专家库。 与 NPHC 相关的一系列研究和临床背景（例如组学、生物信息学、人工智能、临床试验 干预、营养评估）。拟议的 RCC 立即做好充分准备以支持 NPHC 的使命是开发具有临床意义的算法来预测个体对食物和食物的反应 饮食模式并改善美国不同人群的健康。