The Physiology of the Weight Reduced State Data Coordinating Center

由最多2个临床中心、一个数据协调中心(DCC)和NIDDK组成的联合体 “项目科学家”的任务是“了解减肥状态的生理学” 以及保持体重的个体变异性的机制。在它们的应用程序中， 临床中心将建议对患有以下疾病的成年人进行行为/生活方式减肥干预 超重和/或肥胖，并设计至少12个月的体重维持阶段 在此期间，成功减肥的参与者将被纵向跟踪。至 完成该联盟的首要科学目标，(可能)共同的临床 将设计和实施行为/生活方式干预试验， 满足有待确定的成功减肥定义将在以下时间进行前瞻性的跟踪 至少12个月来评估减肥维持情况。在这两个阶段，数据和 将收集生物标本以确定范围、持续时间和潜在的行为， 维持体重减轻的代谢、细胞和分子机制(即因素 影响能量摄入量和代谢适应/能量调节的调节 支出)。将会有共同的结果、评估和生物群落，但有可能 也要针对具体地点，特别是机械性很强的措施。辅助研究将会是 鼓励“利用收集的数据和生物样本，以及招募的队列来 扩大集团的科学产出。 我们的DCC将为研究设计、研究实施、监测和数据分析提供支持。我们包括 减肥和维护干预、体重恢复评估、组学和 谁将与临床中心的专家合作。我们将开发一种安全的 分布式数据录入系统，并维护一个安全的临床、实验室和 其他信息。为方便进行辅助研究，我们会保留生物检疫菌剂。 库存。DCC将制定安全性和有效性分析计划。我们会准备材料 对于单一机构审查委员会(SIRB)，向指导委员会所作的介绍，数据 和安全监测委员会，以及科学会议，用于出版物和其他目的 经指导委员会批准。我们将提供后勤支持和协调 联合体活动，包括会议和电话会议、辅助研究和出版物 和演示流程。我们将归档文档和所有数据、干预 材料，并在研究结束时协调所有标本的归档。贝儿医生和金医生的 在进行、分析和评估多中心临床试验结果方面具有丰富的专业知识 检查减肥和维持体重的前瞻性队列研究将有助于 圆满完成该联合体的各项目标。

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.