The Physiology of the Weight Reduced State Data Coordinating Center

减肥的生理学状态数据协调中心

• 批准号: 10395562
• 负责人: Steven H. Belle
• 金额: $ 75.9万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-21 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10395562
• 关键词: Address; Adult; Affect; Ancillary Study; Archives; Behavior Therapy; Behavioral; Biometry; Body Weight decreased; Clinical Trials; Clinical Trials Data Monitoring Committees; Communication; Data; Data Analyses; Data Coordinating Center; Data Management Resources; Documentation; Energy Intake; Energy Metabolism; Epidemiology; Equipment and supply inventories; Genetic Materials; Goals; Human Resources; Institutional Review Boards; Intervention; Knowledge; Laboratories; Life Style; Logistics; Maintenance; Measures; Metabolic; Molecular; Monitor; Multi-Institutional Clinical Trial; National Institute of Diabetes and Digestive and Kidney Diseases; Obesity; Observational Study; Outcome Assessment; Output; Overweight; Participant; Phase; Physiology; Preparation; Procedures; Process; Prospective cohort study; Public Health Schools; Publications; Regulation; Reporting; Research; Research Design; Resources; Safety; Scientist; Secure; Serum; Site; Specimen; Statistical Data Interpretation; System; Tissue Sample; Training; Universities; Weight; archive data; archived data; central database; clinical center; clinical database; cohort; data centers; data management; data sharing; design; distributed data; efficacy evaluation; epidemiologic data; experience; individual variation; lifestyle intervention; meetings; operation; prospective; recruit; statistics; symposium; weight loss intervention; weight maintenance

The consortium of up to 2 Clinical Centers, a Data Coordination Center (DCC) and NIDDK Project Scientist is being established to, "understand the physiology of the weight reduced state and the mechanisms of individual variability in weight maintenance.” In their applications, the Clinical Centers will have proposed a behavioral/lifestyle weight loss intervention for adults with overweight and/or obesity and a design for a weight maintenance phase of at least 12 months during which participants who achieve successful weight loss will be followed longitudinally. To accomplish the consortium`s overarching scientific objective, a (presumably) common clinical trial of a behavioral/lifestyle intervention will be designed and implemented and participants who meet a to-be-determined definition of successful weight loss will be followed prospectively for at least 12 months to evaluate weight loss maintenance. During both phases, data and biospecimens will be collected “to determine the extent, duration, and potential behavioral, metabolic, cellular and molecular mechanisms for” maintaining a reduced weight (i.e., factors affecting regulation of both energy intake and metabolic adaptation/regulation of energy expenditure). There will be common outcomes, assessments, and biospecimens but there could also be site-specific, particularly highly mechanistic, measures. Ancillary studies will be encouraged to “leverage collected data and biospecimens, as well as the recruited cohort to expand the scientific output of the group.” Our DCC will support study design, study implementation, monitoring, data analysis. We include experts in weight loss and maintenance intervention, weight regain assessment, omics, and statistics who will collaborate with experts at the clinical centers. We will develop a secure distributed data entry system and maintain a secure central database of clinical, laboratory, and other information. To facilitate the ancillary study process, we will maintain the biospecimen inventory. The DCC will develop safety and efficacy analysis plans. We will prepare materials for the single Institutional Review Board (sIRB), presentations for the Steering Committee, Data and Safety Monitoring Board, and scientific conferences, for publications and for other purposes as approved by the Steering Committee. We will provide logistical support and coordinate consortium activities, including meetings and conference calls, ancillary study and publications and presentations processes. We will archive documentation and all data, intervention materials, and coordinate archiving all specimens at the end of the study. Dr. Belle's and King's extensive expertise in conducting, analyzing, and evaluating results of multi-center clinical trials and prospective cohort studies examining weight loss and maintenance will contribute to the successful completion of the goals of this consortium.

最多由2个临床中心、一个数据协调中心（DCC）和NIDDK组成的联盟 项目科学家正在建立，“了解减肥状态的生理学 以及体重维持中个体差异的机制。”在其应用程序中， 临床中心将为患有以下疾病的成年人提出行为/生活方式减肥干预 超重和/或肥胖，以及至少12个月的体重维持期设计 在此期间，将对成功减肥的参与者进行纵向跟踪。到 完成联盟的首要科学目标，（大概）共同的临床 将设计并实施行为/生活方式干预试验， 将前瞻性地随访符合待定的成功减肥定义的患者， 至少12个月，以评估减肥维持。在这两个阶段，数据和 将收集生物标本“以确定程度，持续时间，和潜在的行为， 用于”维持减轻的体重“的代谢、细胞和分子机制（即，因素 影响能量摄入和代谢适应/能量调节 支出）。将有共同的结果，评估和生物标本，但可能有 还应采取针对具体地点的措施，特别是高度机械化的措施。辅助研究将 鼓励“利用收集的数据和生物标本，以及招募的队列， 扩大该集团的科学产出。” 我们的DCC将支持研究设计、研究实施、监查和数据分析。我们包括 减肥和维持干预、体重恢复评估、组学和 他们将与临床中心的专家合作。我们将建立一个安全的 分布式数据输入系统，并维护安全的临床、实验室和 其他信息.为了便于辅助研究过程，我们将保存生物标本 库存DCC将制定安全性和有效性分析计划。我们会准备材料 单一机构审查委员会（sIRB）、指导委员会演示文稿、数据 和安全监测委员会以及科学会议，供出版物和其他用途 经指导委员会批准。我们将提供后勤支持和协调 联合会活动，包括会议和电话会议、辅助研究和出版物 和介绍过程。我们将存档文件和所有数据， 材料，并在研究结束时协调存档所有标本。贝儿医生和金医生 在开展、分析和评估多中心临床试验结果方面拥有丰富的专业知识 和前瞻性队列研究检查体重减轻和维持将有助于 成功实现了这个联盟的目标。