The National Institutes of Health (NIH), through its National Center for Complementary and Integrative Health (NCCIH) in partnership with the National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH), has released a limited competition funding opportunity titled “Advancing the Science of Complementary and Integrative Health Approaches to Improve Maternal Health Outcomes (R01 Clinical Trial Required)”. This opportunity is intended for investigators currently funded under the NIH’s Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative. Its purpose is to support the design and implementation of multi-site feasibility clinical trials investigating mind and body interventions that aim to promote healthy pregnancies and improve maternal health outcomes.

This funding opportunity focuses on testing the feasibility of complementary and integrative approaches with psychological and/or physical components, such as yoga, acupuncture, mindfulness, massage, tai chi, and biofeedback. The expectation is that applications will generate necessary scientific data to prepare for a larger, future clinical efficacy or effectiveness study. The opportunity prioritizes studies that test delivery fidelity, participant recruitment and retention across sites, and data collection processes. Only applicants from the existing IMPROVE Initiative research community are eligible, particularly those affiliated with the Maternal Health Centers of Excellence. These applicants are encouraged to collaborate with investigators who possess expertise in complementary and integrative health.

The funding opportunity allows for up to $350,000 in direct costs per year for a maximum of three years. A total of $1.5 million is anticipated to fund up to three awards in fiscal year 2026. Applications must propose a randomized controlled design with at least one comparator arm and provide strong preliminary data from prior single-site studies. These data should demonstrate tolerability, participant retention, intervention adherence, and the feasibility of the delivery method. Applications should also showcase the research team’s track record in conducting similar trials and include strong scientific justifications for the design and proposed methods.

Eligibility is restricted to currently funded IMPROVE investigators and their research partners under specified prior RFAs. Foreign organizations and non-domestic components of U.S. organizations are not eligible to apply. Required registrations include those with SAM, Grants.gov, eRA Commons, and others. Applications must be submitted via ASSIST, institutional S2S solutions, or Grants.gov Workspace, and must follow all specified NIH guidelines.

Applications must be submitted by May 5, 2025, following an open date of April 5, 2025. Letters of Intent are encouraged by April 5, 2025. The earliest project start date for selected proposals is expected in December 2025. Proposals must address specific research objectives, including the feasibility of intervention delivery, data collection, and recruitment across multiple sites. Evaluation criteria include the significance, innovation, feasibility, investigator expertise, and institutional resources, all assessed through NIH’s rigorous peer-review process.