The Physiology of the Weight Reduced State Clinical Trial Consortium (UG3/UH3 Clinical Trial Required)

Following intentional weight loss, physiological processes including altered appetite and decreased energy expenditure create a tendency toward regain of lost weight. This Funding Opportunity Announcement (FOA) invites UG3/UH3 cooperative agreement applications from multi-disciplinary teams that propose to conduct collaborative mechanistic clinical trials focused on elucidation of the physiological mechanisms underlying individual variability in maintenance of reduced weight over time. This FOA will not support studies with a goal to evaluate the efficacy of interventions for weight loss or maintenance of reduced weight. Participants must be studied before and after a successful behavioral/lifestyle weight loss intervention to determine the extent, durability, and mechanisms for physiologic adaptations to weight loss, including metabolic and biobehavioral mechanisms. It is expected that tissue biospecimens will be collected that can be used to identify potential metabolic pathways that are altered after weight loss and may render it more difficult to maintain the reduced weight. This Funding Opportunity Announcement (FOA) will use the bi-phasic, milestone-driven UG3/UH3 cooperative agreement mechanism in parallel with a companion FOA, RFA DK-19-018, Physiology of the Weight Reduced State Data Coordinating Center (U24 Clinical Trial Not Allowed). Awards made under this FOA will initially support a planning/preparation phase (UG3) for approximately one year with possible transition to a study (UH3) phase of up to four additional years once planning milestones are met. Applications submitted in response to this FOA must propose activities for both phases and are expected to include plans for project management and performance milestones for each phase.