Single Source for the Continuation of the Physiology of the Weight Reduced State (POWERS) Study (U01- Clinical Trials Required)

The National Institutes of Health, through the NIDDK, is seeking a single source application from the Data Coordinating Center for the POWERS consortium to continue the Physiology of the Weight Reduced State clinical trial. The primary objective of this effort is to investigate the physiological processes that cause individual variability in weight regain following lifestyle intervention weight loss. The scope of work includes completing participant recruitment, implementing weight loss interventions, executing all study visits, and managing the collection, storage, shipment, and analysis of biospecimens and data. Final deliverables involve the transfer of all data and biospecimens to the NIDDK Central Repository. Funding is planned at up to 3.85 million dollars for fiscal year 2027 and up to 3.25 million dollars annually for fiscal years 2028 and 2029. Applications will undergo a peer-review process focusing on the importance of the research, rigor and feasibility, and the expertise of the investigators and environment. Required submission materials include a full study protocol, a biospecimen analysis plan, a statistical analysis plan, and a milestone plan. Awardees must maintain active SAM and eRA Commons registrations and adhere to strict cybersecurity incident reporting requirements, notifying HHS agencies within 48 hours of any discovery. Future funding is contingent upon the successful achievement of performance milestones negotiated at the time of the award.