Limited Competition: Advancing the Science of Complementary and Integrative Health Approaches to Improve Maternal Health Outcomes (R01 Clinical Trial Required) | RFA AT 25 002

FAQs: NIH RFA-AT-25-002 (R01 Clinical Trial Required)

What is this funding opportunity?

This is an NIH funding opportunity titled "Limited Competition: Advancing the Science of Complementary and Integrative Health Approaches to Improve Maternal Health Outcomes (R01 Clinical Trial Required)" with NOFO number RFA-AT-25-002. It uses the R01 grant mechanism and requires a clinical trial.

Is this an open competition or a limited competition?

It is a limited competition. Only investigators currently funded through the NIH IMPROVE Initiative (Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone) are eligible to apply.

Who is eligible to apply?

Eligibility is intentionally narrow: only investigators with current NIH IMPROVE Initiative funding may apply. While the broader applicant category includes public and state-controlled institutions of higher education, the practical requirement is that the applicant must already be funded under IMPROVE.

Are foreign organizations eligible to apply?

No. Foreign organizations are not eligible to apply under this opportunity.

Are non-U.S. components of U.S. organizations eligible?

No. Non-U.S. components of U.S. organizations are also not eligible.

Are any international collaborations allowed at all?

Yes, foreign components are allowed as defined by NIH policy. This means certain internationally based collaborators or activities may be permitted if they meet NIH criteria and are well-justified within an otherwise eligible U.S.-led and U.S.-based application.

What is the main purpose of this R01?

The main purpose is to support multisite feasibility clinical trials that test complementary and integrative health approaches with psychological and/or physical components (often described as mind and body interventions) with the broader goal of promoting healthier pregnancies and improving maternal health outcomes.

Does the study need to be multisite?

Yes. The NOFO emphasizes multisite feasibility clinical trials and highlights the importance of generalizability and real-world delivery issues in maternal health research.

What kinds of interventions is NIH looking for?

The focus is on complementary and integrative health approaches that include psychological and/or physical components, commonly referred to as mind and body interventions. The NOFO also points to protocolized multimodal interventions, including interventions that combine more than one mind and body component delivered in a standardized sequence or dosage.

Is this intended to be a full-scale efficacy trial?

No. A central theme is that the proposed R01 should not be a full-scale efficacy trial yet. Instead, it should generate the practical and scientifically necessary groundwork to design a later, fully powered clinical trial (efficacy or effectiveness), a pragmatic trial, or a dissemination and implementation study.

What is the required focus of the proposed clinical trial?

The required focus is feasibility. Applications are expected to justify why the feasibility trial is essential for the next step and to show what key uncertainties or operational risks the feasibility study will resolve.

How does NIH define "success" for this feasibility R01?

Success is framed as producing actionable information that directly informs the design and conduct of a subsequent full-scale trial. The NOFO emphasizes that the feasibility study should de-risk a later definitive trial by demonstrating that the intervention and trial procedures can work across sites and within the intended maternal health contexts, rather than simply producing preliminary signals of benefit.

What future studies should applicants be planning for?

Applicants are expected to describe the future larger clinical trial they intend to run and indicate how the feasibility trial will support that next phase. The NOFO explicitly references future fully powered efficacy or effectiveness trials, pragmatic trials, and dissemination and implementation studies as possible next steps.

What feasibility gaps is this opportunity trying to address?

The NOFO highlights practical gaps such as whether the intervention can be delivered consistently and with fidelity across multiple sites, teams, and participant groups; whether the protocol can be implemented in a standardized way without site-to-site drift; and whether core trial procedures are workable in real maternal health contexts.

What operational trial milestones are specifically emphasized?

Operational milestones called out include recruitment and accrual across sites, the practicality of randomization procedures, participants' adherence to the intervention as designed, and retention (including the ability to follow participants successfully throughout the study period).

Why is retention highlighted as a key priority?

The NOFO notes that retention and follow-up are often challenging in pregnancy and postpartum research due to factors such as time constraints, medical complications, changing eligibility, and social barriers to continued participation.

What does the NOFO say about intervention fidelity across sites?

It explicitly raises the question of whether the intervention can be delivered consistently and with fidelity across multiple locations, teams, and participant groups. It also points to feasibility work that may include confirming that intervention training, quality assurance, and monitoring procedures are strong enough to support replication across sites.

What does the NOFO say about multimodal or protocolized interventions?

It points to the need to refine and test protocolized multimodal interventions, described as interventions that combine more than one mind and body component (for example, structured stress management plus movement-based practices) delivered in a standardized sequence or dosage.

What does the NOFO emphasize about data collection in multisite studies?

The NOFO stresses feasibility of data collection across sites, reflecting common multisite challenges such as inconsistent measurement, uneven clinical workflows, variable electronic health record systems, and differences in staff capacity. It suggests that aligned applications should address harmonized outcome definitions, common data elements where appropriate, cross-site staff training, and realistic plans for collecting, managing, and monitoring trial data.

Is collaboration encouraged, and between whom?

Yes. The NOFO strongly encourages collaboration between current IMPROVE awardees (especially Maternal Health Centers of Excellence) and researchers who bring established expertise in complementary and integrative health. Project teams are expected to combine maternal health and pregnancy-outcomes expertise with hands-on experience designing and delivering mind and body interventions in a rigorous and reproducible way.

What NIH initiative is this opportunity tied to?

This NOFO is targeted to the NIH IMPROVE Initiative (Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone) and is designed for investigators embedded in the IMPROVE research ecosystem.

What is the due date for the original application?

The original application due date listed is May 5, 2025.

What is the award ceiling?

The listed award ceiling is $350,000.

When was the NOFO created?

The NOFO was created on January 8, 2025.

Which CFDA numbers are associated with this opportunity?

The opportunity is listed under CFDA numbers 93.213, 93.242, 93.313, and 93.865.

Does this R01 explicitly require a clinical trial?

Yes. The NOFO explicitly requires a clinical trial (R01 Clinical Trial Required).

Why does NIH emphasize multisite execution for this work?

The NOFO signals that generalizability and real-world delivery issues are major concerns in maternal health research, and therefore mind and body interventions should be tested using strong clinical trial methods executed across multiple sites.

What should the feasibility trial deliver at the end?

It should deliver actionable, practical information that supports planning a later definitive study, such as evidence that recruitment, randomization, adherence, retention, intervention delivery fidelity, and harmonized data collection procedures can work consistently across participating sites and within the intended maternal health contexts.