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.

项目总结/摘要 RTI国际-康奈尔研究协调中心（RCC）的总体目标是 提供无缝的业务支持和多学科经验，以建立营养方面的共识 Precision Health Consortium（NPHC）在1年规划阶段，我们将优先考虑效率， 客观地促进饮食模块的设计（1：常规饮食评估; 2：控制喂养饮食 干预;和3：重复的饮食干预）嵌套在所有的我们和他们的研究协议。在4- 在一年的实施阶段，我们将促进模块1-3的实施，使质量流 数据和标本，并将精心策划的人工智能（AI）就绪数据集成到 我们所有的研究人员都在使用我们建立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（或受试者自身对照）临床试验，以及可穿戴设备研究工具和分析。 具体而言，拟议的RCC将擅长管理和协调NPHC及其研究 倡议、临床干预措施以及数据和生物标本共享，具体如下： 目标1：优化模块1-3的科学严谨性 目标2：确保NPHC研究数据是公平的（可查找、可解释、可互操作和可重用） 目标3：实现无缝的数据收集、管理和传输，包括向研究人员的传输 目标4：尽量缩短模块1-3的启动时间 目标5：最大限度地提高联合体通信和协作的效率 正在启动国家初级保健方案，以解决营养方面的主要研究差距;这些差距的性质和 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 在协调中心和多中心领导和生物统计学方面具有互补专业知识的研究者 (Dr.营养干预和临床专业知识（康奈尔大学的Mehta博士）， 支持一个强大而多样化的团队，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 监测.区域合作理事会还将受益于我们的集体体制优势，拥有一个广泛的专家库， 与NPHC相关的范围研究和临床背景（例如，组学，生物信息学，人工智能，临床试验 营养评估）。拟议的区域协调委员会立即做好充分准备， NPHC的使命是开发具有临床意义的算法，预测个体对食物的反应， 饮食模式，并改善美国不同人群的健康状况。