The Physiology of the Weight Reduced State Clinical Trial Consortium (UG3/UH3 Clinical Trial Required) | RFA DK 19 017

Opportunity Information: Apply for RFA DK 19 017

The Physiology of the Weight Reduced State Clinical Trial Consortium (RFA-DK-19-017) is an NIH cooperative agreement funding opportunity designed to support mechanistic clinical trials that explain why some people maintain weight loss while others regain it. The central premise is that after intentional weight loss, the body often responds with physiological adaptations such as increased appetite signals and reduced energy expenditure, which together promote weight regain. This program is aimed at understanding those adaptations in detail and, importantly, understanding why they vary across individuals.

The FOA specifically calls for multidisciplinary teams to run collaborative, mechanistic clinical trials that study participants both before and after they achieve successful weight loss through a behavioral or lifestyle intervention. The required focus is on measuring the extent, durability, and underlying mechanisms of post-weight-loss physiological changes over time. Mechanisms of interest include metabolic factors (for example, changes in energy expenditure, substrate utilization, hormonal responses, and other metabolic pathways) as well as biobehavioral factors that may influence appetite, satiety, food intake behavior, and related neurobehavioral responses. A key expectation is that applicants will collect tissue and other biospecimens so investigators can probe biological pathways altered by weight loss and identify signatures that may predict difficulty maintaining the reduced weight.

This opportunity is not intended to fund traditional intervention testing. In other words, applications should not be framed around proving that a particular treatment, program, or strategy is effective for weight loss or long-term weight maintenance. Instead, the weight loss intervention serves as a standardized way to induce weight reduction so investigators can then examine the body’s compensatory responses and the biology of the weight-reduced state. The clinical trial is therefore mechanistic in purpose: it is meant to explain the physiology and sources of variability, not to establish efficacy of a weight management intervention.

The award uses the two-phase UG3/UH3 structure, which is milestone-driven and emphasizes readiness and accountability. The UG3 phase is a planning and preparation period of about one year. During this time, teams are expected to finalize and operationalize protocols, set up recruitment and retention plans, refine mechanistic measurements and biospecimen procedures, and establish data quality and project governance processes. Only projects that meet predefined milestones transition to the UH3 phase, which supports the actual execution of the clinical trial for up to four additional years. Applications must include detailed plans for both phases, including clear project management approaches and measurable performance milestones for each phase.

The consortium structure is also a defining feature. This FOA runs in parallel with a companion solicitation for a Data Coordinating Center (RFA-DK-19-018, U24; clinical trial not allowed). Applicants to the UG3/UH3 consortium mechanism should expect to coordinate with that Data Coordinating Center and to operate as part of a broader collaborative network, aligning data standards, biospecimen handling expectations, and cross-study coordination requirements typical of NIH cooperative agreements, where NIH staff have substantial involvement in stewardship and coordination.

Eligibility is broad and includes many U.S.-based organization types: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly notes additional eligible applicants such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. Non-U.S. entities and non-U.S. components of U.S. organizations are not eligible to apply, but foreign components, as defined by NIH policy, may be included when allowable and justified.

Administratively, this is a discretionary NIH opportunity using the cooperative agreement funding instrument, categorized under food and nutrition/health (CFDA 93.847). The original posting dates to late 2019 with an original closing date of June 11, 2020. The FOA does not specify an award ceiling or expected number of awards in the text provided, but the overall design signals a competitive, milestone-based program intended to build a coordinated set of mechanistic trials that collectively map the biology of the weight-reduced state and explain individual differences in long-term 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 Clinical Trial Consortium (UG3/UH3 Clinical Trial Required)" 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 19 017

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