Opportunity Information: Apply for RFA AG 21 028
Limited Competition for the Continuation of the Look AHEAD (Action for Health in Diabetes) Study (U01 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity from the Department of Health and Human Services (HHS) that supports a continuation phase of an existing, well-known diabetes and weight-loss outcomes study. The announcement is a limited competition, meaning it is not broadly open to new research teams in the general community. Instead, it specifically invites cooperative agreement applications from investigators who are already part of the Look AHEAD (Action for Health in Diabetes) Consortium. The central purpose is to fund an additional 5 years of follow-up for participants who are currently enrolled, allowing researchers to examine longer-term outcomes that may only become clear over extended periods of time.
The grant uses the U01 cooperative agreement mechanism, which generally indicates an active partnership between NIH program staff and the award recipients. In practice, that typically means NIH has substantial scientific or programmatic involvement in coordinating and overseeing major elements of the work, which is especially common for large, multi-site consortium studies that require consistent protocols, shared data standards, and coordinated participant follow-up. The announcement also specifies "Clinical Trial Not Allowed," signaling that the funded activities are intended for follow-up, observational assessments, and evaluation of long-term outcomes rather than initiating a new clinical trial intervention under this award.
The project being supported is described as the Action for Health in Diabetes Extension (Look AHEAD-E) study. Its overarching goal is to examine the long-term effects of an intensive lifestyle intervention originally designed to produce weight loss. Rather than focusing only on short-term changes in body weight or near-term clinical markers, this continuation emphasizes broader outcomes across time, including health status, functional outcomes, and healthcare utilization. This kind of extended follow-up is important because lifestyle interventions can have delayed or evolving effects, and the durability of benefits (or emergence of new patterns in risks and outcomes) often cannot be adequately assessed without long-term tracking of the same participants.
From an administrative standpoint, the opportunity is listed as discretionary funding in the health activity category, with CFDA number 93.866. The Funding Opportunity Number is RFA AG 21 028, and the FOA was created on July 22, 2020, with an original closing date of October 30, 2020. The announcement indicates an award ceiling of $1,000,000 and anticipates a single award (ExpectedAwards: 1), which aligns with a continuation-style effort where one coordinating structure or lead consortium arrangement is funded to support consistent follow-up across the cohort.
Eligibility, as presented in the source data, includes independent school districts and public housing authorities/Indian housing authorities, along with a broader category noted as "Others (see text field entitled Additional Information on Eligibility for clarification)." However, the most important practical eligibility limitation is the limited-competition requirement: only investigators currently participating in the Look AHEAD Consortium are being invited to apply. In other words, even if an organization fits a general eligibility type, participation in the existing consortium is the key gatekeeper for this particular funding announcement.
Overall, this FOA is best understood as a targeted, continuation-oriented investment by NIH to preserve and extend the scientific value of an established cohort. By funding another five years of follow-up, the agency is aiming to strengthen evidence on how an intensive lifestyle intervention aimed at weight loss relates to long-term health outcomes, day-to-day function, and patterns of healthcare use, all of which are central to understanding real-world, long-horizon impacts for people living with diabetes.Apply for RFA AG 21 028
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of the Look AHEAD (Action for Health in Diabetes) Study (U01 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): 93.866.
- This funding opportunity was created on Jul 22, 2020.
- Applicants must submit their applications by Oct 30, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Independent school districts, Public housing authorities/Indian housing authorities, Others (see text field entitled Additional Information on Eligibility for clarification).
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FAQs: Limited Competition for the Continuation of the Look AHEAD (Action for Health in Diabetes) Study (U01 Clinical Trial Not Allowed)
What is this funding opportunity?
This is a National Institutes of Health (NIH) funding opportunity from the Department of Health and Human Services (HHS) to support a continuation phase of the Look AHEAD (Action for Health in Diabetes) study. It is designed to fund additional follow-up for participants already enrolled in the established cohort.
What is the official program name described in the opportunity?
The continuation effort is described as the Action for Health in Diabetes Extension (Look AHEAD-E) study.
What is the main purpose of the continuation award?
The central purpose is to fund an additional 5 years of follow-up for currently enrolled participants. This extended period is intended to help researchers evaluate longer-term outcomes that may only become apparent over time.
Is this a broad, open competition?
No. This is a limited competition. It is not broadly open to new research teams from the general community.
Who is invited to apply under this limited competition?
The announcement specifically invites cooperative agreement applications from investigators who are already part of the Look AHEAD (Action for Health in Diabetes) Consortium.
If an organization is generally eligible, can it apply without being part of the consortium?
Based on the information provided, the most important practical eligibility limitation is the limited-competition requirement. Participation in the existing Look AHEAD Consortium is the key gatekeeper for this funding announcement, even if an organization fits a general eligibility category.
What funding mechanism is being used?
The opportunity uses the U01 cooperative agreement mechanism.
What does a U01 cooperative agreement imply about NIH involvement?
A U01 typically indicates an active partnership between NIH program staff and the award recipients, with substantial scientific or programmatic involvement. This is common for large, multi-site consortium studies that require coordinated protocols, shared data standards, and consistent participant follow-up.
Are clinical trials allowed under this opportunity?
No. The announcement specifies "U01 Clinical Trial Not Allowed," indicating the funded activities are intended for follow-up, observational assessments, and evaluation of long-term outcomes rather than starting a new clinical trial intervention under this award.
What type of research activities are supported?
The supported activities focus on extending follow-up of existing participants and assessing long-term outcomes. The continuation emphasizes tracking outcomes across time rather than launching a new intervention.
What outcomes does the continuation phase emphasize?
The continuation emphasizes broader long-term outcomes, including health status, functional outcomes, and healthcare utilization, in the context of the intensive lifestyle intervention originally designed to produce weight loss.
Why is long-term follow-up important for this study?
Extended follow-up helps assess whether effects of a lifestyle intervention persist, fade, or evolve over time. Some benefits or risks may emerge only after many years, so continuing to track the same participants strengthens evidence about long-horizon impacts for people living with diabetes.
How long is the continuation period being funded?
The opportunity is intended to support an additional 5 years of follow-up.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA AG 21 028.
When was the FOA created?
The FOA was created on July 22, 2020.
What was the original closing date listed for this opportunity?
The original closing date was October 30, 2020.
What is the award ceiling for this opportunity?
The announcement indicates an award ceiling of $1,000,000.
How many awards are expected?
The opportunity anticipates a single award (ExpectedAwards: 1), consistent with a continuation-style effort that supports coordinated follow-up across the cohort.
What is the CFDA number associated with this opportunity?
The CFDA number is 93.866.
How is the opportunity categorized administratively?
It is listed as discretionary funding in the health activity category.
What general eligibility categories are listed in the source information?
The eligibility list includes independent school districts and public housing authorities/Indian housing authorities, as well as a broader category noted as "Others (see text field entitled Additional Information on Eligibility for clarification)."
What is the overall goal of the Look AHEAD-E continuation?
The overarching goal is to examine the long-term effects of the intensive lifestyle intervention originally designed to produce weight loss, with an emphasis on outcomes that matter over extended periods such as health status, function, and healthcare utilization.
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