Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers (U01 Clinical Trial Required)
About
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 clinical centers 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. This NOFO uses a cooperative agreement mechanism (U01) and runs in parallel with a companion NOFO (RFA-DK-27-136).
The Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers grant is a U01 Clinical Trial funding opportunity designed for clinical research institutions nationwide to participate in a consortium studying anti-obesity medication treatment strategies for youth with obesity. This grant supports rigorous clinical trials that test optimal approaches to AOM use while prioritizing healthy development, adequate nutrition, mental health, and quality of life outcomes. Clinical centers can conduct independent or multicenter trials while collaborating on shared protocols, standardized measures, central laboratory services, and data analyses. The program specifically prioritizes research on optimal developmental timing for AOM initiation, weight loss rates and amounts, medication class and dosing strategies, and the role of adjunct lifestyle therapies. Researchers will also investigate predictors of treatment response and non-response. This cooperative agreement mechanism is ideal for established clinical research centers with the infrastructure to conduct pediatric obesity trials, implement standardized protocols across multiple sites, and contribute to evidence-based treatment guidelines. The consortium approach ensures robust data collection, biospecimen management, and collaborative manuscript development to advance the field of pediatric obesity treatment.
Funding Facts
● Applications openDeadline
October 9, 2026
Award Amount
Up to $1M
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Grant Amount
Up to $1M
Deadline
2026-10-09
Grant Type
federal
Application Cycle
Annual (Deadline: October 9, 2026)
Best For
Clinical research centers, academic medical institutions, hospitals, and pediatric obesity research programs
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Frequently Asked Questions
Who is eligible for Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers (U01 Clinical Trial Required)?
Clinical centers conducting pediatric obesity research are eligible to apply. U.S.-based organizations and domestic components of U.S. organizations may apply. Foreign organizations and non-domestic components of U.S. organizations are not eligible. For detailed eligibility requirements, refer to Section III. Eligibility Information in the official Notice of Funding Opportunity (NOFO), or visit the funding agency's website for complete specifications.
How much funding does Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers (U01 Clinical Trial Required) provide?
Funding amounts range from up to $1,000,000 per award cycle. However, actual award amounts may vary based on the number of applications approved, project scope, and budget justification. Contact the funding agency or review the official NOFO for the most current funding information.
How do I apply for Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers (U01 Clinical Trial Required)?
Applications are submitted through the official NIH grants submission system. The application deadline is October 9, 2026. Review the complete Notice of Funding Opportunity (NOFO) for specific submission requirements, proposal components, selection criteria, and instructions. Visit the funding agency's website or grants portal to access the application system, templates, and technical assistance resources. Ensure your clinical center meets all eligibility criteria before beginning your application.
What can Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers (U01 Clinical Trial Required) funding be used for?
Funding supports clinical trial research testing anti-obesity medication treatment strategies in youth. Eligible uses include: conducting independent or multicenter clinical trials; developing shared protocols and standardized data collection procedures; participant recruitment and assessment; biospecimen collection and central laboratory services; evaluation of optimal AOM initiation timing, dosing, and duration; assessment of adjunct lifestyle therapy approaches; measurement of outcomes related to growth, development, nutrition, mental health, and quality of life; data analysis; and collaborative manuscript development. All research must prioritize healthy development and minimize risks of AOM use in pediatric populations.
Last updated: July 5, 2026