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

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This notice of funding opportunity (NOFO) invites investigators currently funded through the NIH Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative to develop applications to test the feasibility of complementary and integrative approaches with psychological and/or physical inputs (often called mind and body interventions) to promote healthy pregnancies and enhance maternal health outcomes. Currently funded IMPROVE investigators- particularly the Maternal Health Centers of Excellence- are encouraged to partner with investigators with complementary and integrative health expertise. Eligibility is limited to currently funded investigators of the IMPROVE initiative. Applications submitted under this NOFO are expected to propose a multisite feasibility clinical trial that will provide new information that is scientifically necessary for the planning and conduct of a subsequent clinical efficacy or effectiveness study, pragmatic trial, or dissemination and implementation trial on a mind and body intervention to enhance maternal health. It is expected that applications to this NOFO will describe the planned future clinical trial and in so doing demonstrate that the proposed (R01) research is scientifically necessary to design or plan the subsequent fully powered, full-scale clinical trial. Under this R01, the data collected should be used to fill gaps in scientific knowledge, including, but not limited to the following: assessing whether the intervention can be delivered with fidelity across sites; demonstrating feasibility of recruitment, accrual, and randomization of participants across sites; demonstrating participant adherence to the intervention, as well as retention of participants throughout the study across sites; refining and assessing the feasibility of protocolized multimodal interventions, and/or demonstrating feasibility of data collection across sites in preparation for a future fully powered, multisite efficac