The Physiology of the Weight Reduced State Data Coordinating Center (U24 Clinical Trial Not Allowed) | RFA DK 19 018

Opportunity Information: Apply for RFA DK 19 018

The Physiology of the Weight Reduced State Data Coordinating Center (U24 Clinical Trial Not Allowed), RFA DK 19 018, is a National Institutes of Health cooperative agreement opportunity to fund a centralized Data Coordinating Center (DCC) that will support a multi-site clinical research effort focused on why some people are able to maintain weight loss while others regain weight. The overall scientific aim of the broader program is to clarify the physiological mechanisms that drive individual differences in the ability to stay at a reduced body weight over time. While the DCC itself is not allowed to conduct a clinical trial under this FOA, it is designed to work hand-in-hand with a companion funding announcement that supports the Clinical Centers running the clinical trial activities.

This U24 award is specifically meant to provide the data and operational backbone for a companion clinical trial consortium funded under RFA DK-19-017 (UG3/UH3 Clinical Trial Required). In that companion trial, Clinical Centers recruit and follow participants before and after a behavioral or lifestyle weight loss intervention. The clinical work is intended to measure the extent and durability of physiological adaptations to weight loss and to probe mechanisms that may include metabolic changes and biobehavioral factors. A key expectation across the consortium is the collection of tissue and other biospecimens, which can later be used to identify metabolic pathways that shift after weight loss and may make long-term maintenance harder. In practical terms, the DCC would be the central hub that helps standardize how data and specimens are defined, collected, tracked, cleaned, analyzed, and shared across sites so the trial can answer these questions reliably.

The project structure is phased, and applicants have to plan for both phases up front. The award supports an initial planning and preparation period of about one year, followed by a study phase lasting up to four additional years, but the transition into the longer study phase depends on meeting predefined planning milestones. This means the application is expected to lay out a clear project management approach, a timeline, and measurable performance milestones for each phase. The planning year is essentially when the DCC would finalize the cross-site operational infrastructure: establishing common data elements and case report forms, building or configuring data capture and management systems, setting up quality control and data validation procedures, coordinating data flow from Clinical Centers, and aligning governance processes such as committee structures, documentation standards, and communication routines. Once those planning deliverables are met, the study phase focuses on full operational support during participant follow-up, ongoing data monitoring and quality assurance, coordination of analyses, and facilitating consistent handling and tracking of biospecimen-related metadata in collaboration with the clinical sites and any designated biorepository arrangements.

Because this is a cooperative agreement, NIH is expected to have substantial scientific and programmatic involvement during the project, and the DCC is expected to function as an active partner with NIH and the Clinical Centers rather than operating in isolation. In most programs of this kind, the DCC role typically includes creating and maintaining the study database, implementing data security and privacy protections, supporting training for site staff on data systems and procedures, coordinating protocol-related documentation, preparing reports for oversight and steering bodies, supporting harmonized outcome definitions, and helping ensure that analyses are reproducible and interpretable across sites. Even though the FOA summary does not list every required core, it clearly signals that strong project management, milestone-driven execution, and robust coordination capacity are central to responsiveness.

Eligibility is broad and includes many U.S.-based organizations and governmental entities: state, county, city, and township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other eligible applicants. The announcement also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, the FOA makes clear that non-domestic (non-U.S.) entities and non-U.S. components of U.S. organizations are not eligible to apply as applicants; however, foreign components as defined by the NIH Grants Policy Statement are allowed, which typically means limited, well-justified international elements may be included under a U.S. applicant when necessary for the science.

Administratively, this is a discretionary funding opportunity using the cooperative agreement funding instrument (U24) in the Food and Nutrition and Health activity areas, under CFDA 93.847. The sponsoring agency is NIH. The original closing date listed for this opportunity was June 11, 2020, and the FOA record shows no stated award ceiling and no expected awards number in the provided source data. Overall, the opportunity is best understood as funding the central coordination infrastructure required to run a complex, multi-center investigation of the “weight-reduced state,” with an emphasis on consistent data systems, milestone-based readiness to launch the main study phase, and integrated support for the consortium’s efforts to understand the metabolic and biobehavioral biology that influences weight-loss maintenance.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "The Physiology of the Weight Reduced State Data Coordinating Center (U24 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2019-11-22.
• Applicants must submit their applications by 2020-06-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA DK 19 018

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