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: 10188159
• 负责人: Steven H. Belle
• 金额: $ 28万
• 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/10188159
• 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2个临床中心的财团，一个数据协调中心（DCC）和NIDDK 正在建立项目科学家，以“了解体重减轻状态的生理学 以及体重维持个体变异性的机制。”在其应用中， 临床中心将为成年人提出行为/生活方式减肥干预措施 超重和/或肥胖以及重量维护阶段至少12个月的设计 在此期间，将纵向遵循实现成功减肥的参与者。到 完成该财团的总体科学目标，这是一个（预先）常见的临床 将设计和实施行为/生活方式干预的试验和参与者 符合成功减肥的确定定义将被前瞻性地遵循 至少12个月来评估减肥维持。在两个阶段，数据和 将收集生物测量“以确定持续时间，持续时间和潜在行为， 代谢，细胞和分子机制，用于保持体重减轻（即因素 影响能量摄入和代谢适应/能量调节的调节 支出）。会有共同的结果，评估和生物测量，但可以 同样是特定地点的，特别是机械的措施。辅助研究将是 鼓励“利用收集的数据和生物测量，以及招募的队列 扩展该小组的科学产出。” 我们的DCC将支持研究设计，研究实施，监视，数据分析。我们包括 体重减轻和维护干预，体重仍然评估，OMICS和 统计数据将与临床中心的专家合作。我们将开发一个安全的 分布式数据输入系统并维护临床，实验室和 其他信息。为了促进辅助研究过程，我们将维持生物测量 存货。 DCC将制定安全性和效率分析计划。我们将准备材料 对于单一机构审查委员会（SIRB），指导委员会的演讲，数据 以及安全监测委员会以及科学会议，用于出版物和其他目的 被指导委员会批准。我们将提供后勤支持和协调 财团活动，包括会议和电话会议，辅助研究和出版物 和演示过程。我们将归档文档和所有数据，干预 材料并协调研究结束时所有标本。贝尔博士和国王 在进行，分析和评估多中心临床试验结果方面的广泛专业知识 和前瞻性队列研究检查体重减轻和维护将有助于 成功完成了该财团的目标。