The Physiology of the Weight Reduced State Data Coordinating Center

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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.