The Physiology of the Weight Reduced State Data Coordinating Center

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.

Grant Number: 5U24DK128125-05
NIH Institute/Center: NIH
Principal Investigator: Steven Belle