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

Opportunity Information: Apply for RFA AT 25 002

The NIH funding opportunity "Limited Competition: Advancing the Science of Complementary and Integrative Health Approaches to Improve Maternal Health Outcomes (R01 Clinical Trial Required)" (RFA-AT-25-002) is a targeted, limited-competition call for research teams that are already funded under the NIH IMPROVE Initiative (Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone). The main goal is to support multisite feasibility clinical trials that test complementary and integrative health approaches with psychological and/or physical components, commonly described as mind and body interventions, with the broader aim of promoting healthier pregnancies and improving maternal health outcomes. A central theme of the NOFO is that the proposed R01 should not be a full-scale efficacy trial yet; instead, it should generate the practical, scientifically necessary groundwork needed to design a later, fully powered clinical trial (efficacy or effectiveness), a pragmatic trial, or a dissemination and implementation study.

This NOFO is designed for investigators embedded in the IMPROVE research ecosystem, and it strongly encourages collaboration between current IMPROVE awardees (especially Maternal Health Centers of Excellence) and researchers who bring established expertise in complementary and integrative health. In practice, that means the project teams are expected to combine deep knowledge of maternal health, pregnancy-related outcomes, and the populations served by IMPROVE, with hands-on experience designing and delivering mind and body interventions in a rigorous, reproducible way. The NIH is clearly signaling that these interventions must be tested using strong clinical trial methods and executed across multiple sites, since generalizability and real-world delivery issues are major concerns in maternal health research.

The required focus is feasibility, and applications are expected to explain why the proposed feasibility trial is essential for the next step. Applicants are expected to describe the future larger clinical trial they intend to run and show exactly what uncertainties or operational risks the feasibility study will resolve. The NOFO emphasizes that the R01 should produce actionable information that directly informs the design and conduct of a subsequent full-scale trial, rather than simply producing preliminary signals of benefit. In other words, the success metric is whether the study meaningfully de-risks a later definitive trial by proving the intervention and trial procedures can actually work across sites and within the intended maternal health contexts.

Examples of the specific gaps this feasibility R01 is meant to address include whether the intervention can be delivered consistently and with fidelity across multiple locations, teams, and participant groups, and whether the research protocol can be implemented in a standardized way without drifting site-to-site. The NOFO also highlights operational trial milestones such as recruitment and accrual across sites, the practicality of randomization procedures, and whether participants can and will adhere to the intervention as designed. Retention is another key priority, with an expectation that applicants will test whether participants can be followed successfully throughout the study period, which is often challenging in pregnancy and postpartum research due to time constraints, medical complications, changing eligibility, and social barriers to ongoing participation.

Beyond recruitment and fidelity, the NOFO points to the need to refine and test protocolized multimodal interventions, which often describes 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. Feasibility testing may include confirming that intervention training, quality assurance, and monitoring procedures are strong enough to support replication across sites. The NOFO also stresses feasibility of data collection across sites, reflecting the reality that multisite maternal health studies can struggle with inconsistent measurement, uneven clinical workflows, variable electronic health record systems, and differences in staff capacity. A well-aligned application would therefore pay close attention to harmonized outcome definitions, common data elements where appropriate, cross-site staff training, and realistic plans for collecting, managing, and monitoring trial data.

Eligibility is intentionally narrow. Only investigators currently funded through the NIH IMPROVE Initiative are eligible to apply, making this a true limited competition rather than an open solicitation. While the broader applicant category includes public and state-controlled institutions of higher education, the practical gating requirement is existing IMPROVE funding status. Foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, foreign components are allowed as defined by NIH policy, meaning certain types of internationally based collaborators or activities may be permitted if they meet NIH criteria and are well-justified within an otherwise U.S.-led and U.S.-based eligible application.

From an administrative standpoint, this is an NIH grant using the R01 mechanism, and it explicitly requires a clinical trial. The opportunity is listed under health-related CFDA numbers 93.213, 93.242, 93.313, and 93.865. The original application due date is May 5, 2025, and the listed award ceiling is $350,000. The NOFO was created on January 8, 2025. Taken together, these details signal a relatively focused investment intended to produce high-value feasibility evidence that can quickly feed into a subsequent, more expensive and definitive multisite trial aimed at improving maternal health outcomes through well-specified mind and body interventions.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Limited Competition: Advancing the Science of Complementary and Integrative Health Approaches to Improve Maternal Health Outcomes (R01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213, 93.242, 93.313, 93.865.
• This funding opportunity was created on 2025-01-08.
• Applicants must submit their applications by 2025-05-05. (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 $350,000.00 in funding.
• Eligible applicants include: Public and State controlled institutions of higher education.

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