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Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers

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The National Institutes of Health, through the National Institute of Diabetes and Digestive and Kidney Diseases, is issuing a Notice of Funding Opportunity (RFA-DK-27-121) for a U01 cooperative agreement. This initiative seeks clinical centers to form a consortium dedicated to testing anti-obesity medication (AOM) treatment strategies for children and adolescents. The primary objective is to maximize the benefits and minimize the risks of AOM use while promoting healthy growth, nutritional status, and mental well-being. Priority research areas include determining the optimal developmental stage for AOM initiation, evaluating medication class, dose, frequency, and duration, and testing the intensity of adjunct lifestyle therapies. The consortium will collaborate on study protocols, common data measures, and the use of a central laboratory for biospecimen collection and data analysis. The maximum project period is five years, which may include a one-year planning phase, with annual direct cost budgets limited to 1,000,000 dollars. Eligible applicants include higher education institutions, nonprofits, and for-profit organizations, provided they maintain active SAM.gov registration and a Unique Entity Identifier. Applications are due by October 9, 2026, and will be evaluated via the NIH peer review system based on the importance of the research, rigor and feasibility of the approach, and the expertise of the investigators and their environment. Key requirements include a Consortium Assurance letter, a Data Management and Sharing Plan, and adherence to cybersecurity guidelines and human subject protections under 45 CFR Part 46.

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Clinical centers join consortium to optimize anti-obesity medication use and lifestyle treatments for youth.

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUSA

Full Description

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This Notice of Funding Opportunity (NOFO) invites applications from clinical centers to participate in a consortium to test anti-obesity medication (AOM) treatment strategies for youth with obesity that maximize benefits and minimize risks of AOM use. Such intervention strategies should support the promotion of healthy growth and development; adequate nutritional status/intake, healthy eating and physical activity behaviors; mental health and well-being (e.g., body image, self-esteem, mood, etc.), and quality of life and be feasible to implement in clinical care settings. Priority areas include testing strategies to determine optimal developmental stage for AOM initiation, rate and amount of weight loss, AOM class, dose, frequency, and duration, and content and intensity of adjunct lifestyle therapies that may be imperative to ensure normal psychological and physical development and to potentially avoid lifelong dependence on AOMs.  Investigators should also evaluate potential predictors of response/ nonresponse to various treatment strategies under evaluation. The consortium may conduct independent or multicenter trials but will collaborate on the development of protocols, use of common measures and data elements, use of a central laboratory and standardized procedures to collect data and biospecimens, and data analyses and manuscripts.   

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