On October 31, 2025, an exciting new clinical trial was announced that aims to address a critical health challenge—how to encourage physical activity among pregnant women. Led by the University of Central Florida and supported by prestigious sponsors including the National Institutes of Health (NIH) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the study introduces the ‘Sit Less, Move More (SLMM)’ intervention. This behavioral approach has the potential to improve maternal health outcomes during pregnancy. Clinical and regulatory professionals, along with stakeholders in maternal health, should monitor developments as the trial unfolds.
What changed?
The clinical trial introduces a behavioral intervention during pregnancy, addressing sedentary behavior and insufficient physical activity. Pregnancy often leads to reduced mobility, but the impacts of inactivity can be detrimental to both maternal and fetal health. Research on this topic remains limited, which makes this study critical in developing evidence-based strategies to support healthier pregnancies.
Study details
The intervention, known as ‘Sit Less, Move More’ (SLMM), aims to promote healthier routines among pregnant women. While currently listed on ClinicalTrials.gov as ‘Not yet recruiting,’ future enrollment will evaluate how effective the approach is in reducing the negative impact of sedentary behavior during pregnancy.
Key characteristics of the study include:
- Target conditions: Pregnancy, sedentary behavior, insufficient physical activity.
- Intervention type: Behavioral modifications to increase physical movement and decrease sedentary patterns.
- Sponsors: University of Central Florida, NIH, NICHD.
The study’s findings could potentially provide crucial insights for regulatory frameworks, healthcare protocols, and clinical practice guidelines, given the rising focus on maternal health.
Benefits and challenges
How can SLMM help pregnant women?
Physical activity during pregnancy is linked to improved outcomes, including better weight management, reduced risk of gestational diabetes, and enhanced psychological well-being. A structured behavioral change program may empower women and ensure adherence to recommended physical activity guidelines.
What challenges need addressing?
Several barriers might impact the success of SLMM. These include variations in individual motivation, differing health conditions during pregnancy, and accessibility of resources to support physical activity. Understanding these challenges will be key for successful implementation.
The regulatory landscape for maternal health interventions will play a critical role in ensuring safety and efficacy before this approach can be broadly adopted. Clinical and regulatory teams should remain vigilant for updates on trial design, patient safety monitoring, and intended outcomes.
FAQ
1. Who is conducting the study?
The study is led by the University of Central Florida, with support from NIH and NICHD.
2. What is the focus of the intervention?
It focuses on reducing sedentary behavior and fostering more physical activity during pregnancy.
3. How can healthcare providers use the findings?
Providers may incorporate evidence from this study into care plans tailored to pregnant women.
4. When will recruitment start?
The trial is currently marked as ‘Not yet recruiting’ on ClinicalTrials.gov.
Conclusion
This study aims to provide a groundbreaking intervention for pregnant women, addressing a gap in maternal healthcare. Healthcare and regulatory professionals can anticipate pivotal information that may impact guidelines and patient care strategies. Staying updated on progress will be critical for those in clinical and regulatory affairs.
Disclaimer
The information presented here is intended for healthcare professionals and regulatory teams. It is not legal or medical advice.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07223112?term=medical+device