Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Research Coordinating Center (U24 Clinical Trial Not Allowed)

Closed Posted

Opportunity number
RFA-DK-27-136
Agency
Applications due
Award size
Not on record

Opportunity facts

Funding instrument
Cooperative Agreement
Category
  • Health
Eligible applicants
  • Independent School Districts
  • For Profit Organizations
  • State Governments
  • County Governments
  • Tribal Governments (Federally Recognized)
  • Tribal Organizations (Not Federally Recognized)
  • 501(c)(3) Nonprofits
  • Small Businesses
  • Other
  • Higher Education Inst. (Private)
  • Special District Governments
  • Public or Indian Housing Auth.
  • City/Township Governments
  • Higher Education Inst. (Public)
  • Non-501(c)(3) Nonprofits
Points of contact

Opportunity details come from Grants.gov. Updated .

About this opportunity

Written by GovTribe AI ·

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is soliciting applications for a Research Coordinating Center (RCC) serving a consortium of clinical centers testing anti-obesity medication treatment strategies in children and adolescents, with applications due October 9, 2026. This cooperative agreement (U24) funds one award of $1,000,000 in direct costs over five years, inclusive of up to one year for planning, and clinical trials are not permitted.

Eligible applicants include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, small businesses, and various government entities including state, county, city, tribal, and special district governments. Foreign organizations and non-domestic components of U.S. organizations are ineligible; foreign components are not allowed.

The RCC will lead consortium governance, providing management and administrative support; statistical design and analysis expertise; research coordination with a central laboratory; harmonization of data collection methods and common data elements; database development; data management and analysis; and facilitation of research collaborations. Priority research areas include determining optimal developmental stage for anti-obesity medication initiation, evaluating weight loss rates and amounts, testing medication class and dosing strategies, and assessing adjunct lifestyle therapy intensity to support healthy growth and development, adequate nutrition, healthy eating and physical activity, mental health and well-being, and quality of life while avoiding lifelong medication dependence.

The RCC must demonstrate experience coordinating complex multi-site studies and submit detailed organizational plans, data and safety monitoring plans, consortium assurances, resource-sharing plans, and evidence of IRB experience for multi-site research. The award operates under NIDDK programmatic involvement including Steering Committee participation, protocol reviews, site visits, and co-authorship opportunities. The RCC will coordinate two in-person Steering Committee meetings annually in the DC area and manage all consortium governance structures, regulatory approvals, and data submissions to the NIDDK Central Repository. Only one application per institution is permitted. The CFDA number is 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).

Synopsis

This Notice of Funding Opportunity (NOFO) invites applications for a Research Coordinating Center (RCC) to participate in a consortium of clinical centers that will 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 manuscriptsThe RCC will lead, manage, and harmonize efforts for the Consortium including 1) providing management and administrative support; 2) providing leadership and expertise on statistical design and analysis, 3) providing research coordination with a central laboratory, 4) harmonizing data collection methods and use of common data elements, 5) developing the database; 6) conducting data management and data analyses for Consortium studies; and 7) fostering research collaborations. This NOFO uses a cooperative agreement mechanism (U24) and runs in parallel with a companion NOFO (RFA-DK-27-121).

Eligibility

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/Foreign 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.

Files

File Type Posted
PKG00293191.pdf PDF
RFA-DK-27-136-Full-Announcement.html HTML file

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