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

Frequently Asked Questions (FAQs)

What is the Physiology of the Weight Reduced State Clinical Trial Consortium (RFA-DK-19-017)?

It is an NIH cooperative agreement funding opportunity to support mechanistic clinical trials focused on the biology of the weight-reduced state. The goal is to explain why some people maintain weight loss while others regain it, with particular attention to post-weight-loss physiological adaptations and why they vary across individuals.

What problem is this consortium trying to understand?

The program centers on the idea that after intentional weight loss, the body often adapts in ways that promote regain, including stronger appetite signals and reduced energy expenditure. The consortium aims to measure these changes, understand their mechanisms, and explain person-to-person variability.

What type of studies is NIH looking to fund under this FOA?

The FOA calls for collaborative, multidisciplinary, mechanistic clinical trials that study participants before and after they achieve successful weight loss through a behavioral or lifestyle intervention. The trials are expected to focus on the extent, durability, and mechanisms of physiological changes that occur after weight loss.

Is this opportunity meant to fund standard weight loss or weight maintenance interventions?

No. The FOA is not intended to fund traditional intervention testing aimed at proving a specific treatment, program, or strategy is effective for weight loss or long-term weight maintenance. The weight loss intervention is used primarily as a standardized way to induce weight reduction so investigators can study compensatory responses and underlying biology.

What does "mechanistic clinical trial" mean in the context of this FOA?

In this program, the clinical trial is designed to explain physiology and sources of variability after weight loss. The emphasis is on understanding mechanisms, biological pathways, and measurable physiological and biobehavioral changes rather than establishing intervention efficacy.

When are participants expected to be studied?

Participants are expected to be studied both before and after they achieve successful weight loss through a behavioral or lifestyle intervention, with follow-up over time to evaluate the durability and trajectory of post-weight-loss adaptations.

What kinds of mechanisms or outcomes are of interest?

Mechanisms of interest include metabolic factors (such as changes in energy expenditure, substrate utilization, hormonal responses, and other metabolic pathways) and biobehavioral factors that may influence appetite, satiety, food intake behavior, and related neurobehavioral responses.

Does the FOA require collection of biospecimens?

Yes. 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.

What is the UG3/UH3 two-phase structure?

The award uses a milestone-driven UG3/UH3 structure. The UG3 phase is a planning and preparation period of about one year, followed by a UH3 phase that supports executing the clinical trial for up to four additional years, contingent on meeting predefined milestones.

What happens during the UG3 phase?

During UG3 (about one year), teams are expected to finalize and operationalize protocols, develop recruitment and retention plans, refine mechanistic measurements and biospecimen procedures, and establish data quality and project governance processes.

What is required to transition from UG3 to UH3?

Only projects that meet predefined milestones transition to UH3. Applications are expected to include measurable performance milestones for each phase and a clear project management approach that supports readiness and accountability.

How long can the UH3 phase last and what does it support?

The UH3 phase can support the execution of the clinical trial for up to four additional years, after successful completion of UG3 milestones.

What is the role of the consortium and collaboration requirements?

This FOA supports a consortium model. Awardees should expect to operate as part of a broader collaborative network, including cross-study coordination and alignment with consortium expectations typical of NIH cooperative agreements.

Is there a companion funding opportunity related to this program?

Yes. This FOA runs in parallel with a companion solicitation for a Data Coordinating Center: RFA-DK-19-018 (U24). The Data Coordinating Center FOA does not allow a clinical trial.

How are applicants expected to interact with the Data Coordinating Center?

Applicants to the UG3/UH3 consortium mechanism should expect to coordinate with the Data Coordinating Center, including aligning on data standards, biospecimen handling expectations, and cross-study coordination requirements.

What does it mean that this is an NIH cooperative agreement?

The cooperative agreement instrument implies substantial involvement by NIH staff in stewardship and coordination, consistent with the collaborative and networked nature of the consortium.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based organization types such as state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; non-federally recognized tribal organizations; 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.

Are minority-serving institutions and community-based organizations eligible?

Yes. The FOA explicitly notes additional eligible applicants including HBCUs, Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, and faith-based or community-based organizations, among others.

Are U.S. territories or possessions eligible to apply?

Yes. The FOA lists U.S. territories or possessions among eligible applicants.

Can non-U.S. organizations apply?

No. Non-U.S. entities and non-U.S. components of U.S. organizations are not eligible to apply based on the information provided.

Can a project include foreign components?

Yes, foreign components (as defined by NIH policy) may be included when allowable and justified, even though non-U.S. entities are not eligible to apply directly.

What is the CFDA number and general program category?

The opportunity is categorized under food and nutrition/health and is listed with CFDA 93.847.

When was this opportunity originally posted and when did it close?

The original posting dates to late 2019, and the original closing date was June 11, 2020.

Does the provided text state an award ceiling or the expected number of awards?

No. The text provided does not specify an award ceiling or the expected number of awards.

What is the overall aim of the program across the consortium?

The overall design is 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.