Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Research Coordinating Center

The National Institutes of Health, through the National Institute of Diabetes and Digestive and Kidney Diseases, is seeking applications for a U24 Cooperative Agreement to establish a Research Coordinating Center (RCC). The RCC will lead and harmonize a consortium of clinical centers focused on testing optimal anti-obesity medication (AOM) treatment strategies for children and adolescents. Key research priorities include determining the optimal developmental stage for AOM initiation, dosing, frequency, duration, and the role of adjunct lifestyle therapies to maximize benefits and minimize risks. The RCC is responsible for providing administrative support, statistical design and analysis expertise, and research coordination via a central laboratory, while maintaining a Federally-compliant online infrastructure for the submission and management of de-identified research data. The project has a maximum period of performance of five years, including up to one year for a planning phase, with annual budgets limited to 1,000,000 dollars in direct costs. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and government entities, though foreign entities are ineligible. Awards are based on a multi-stage selection process evaluating scientific and technical merit, significance, investigator qualifications, and innovation. Required application materials include an Organization Plan, a Data and Safety Monitoring Plan, and PHS Human Subjects and Clinical Trials Information. The RCC must also ensure the selection of a single Institutional Review Board and adhere to strict cybersecurity and patient confidentiality guidelines.