Improving physical activity and reducing sedentary behavior in pregnant women
Care Pathway Organization in Order to Increase Physical Activity Levels and Limit Sedentary Behavior During Pregnancy: a Randomized Controlled Trial
This study is testing different ways to help pregnant women be more active and less sedentary to see which method works best for their health and their baby's development.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 630 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06585085 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate different interventions that encourage pregnant women to adhere to physical activity guidelines. It will compare in-person physical activity sessions, interactive videoconference sessions, and a mixed format of both to determine which is most effective. The study focuses on the benefits of physical activity during pregnancy, including improved physical health, reduced gestational complications, and enhanced fetal development. By assessing adherence to these programs, the research seeks to identify effective strategies for increasing physical activity levels and decreasing sedentary behavior among pregnant women.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older, between 14 to 21 weeks of gestation, who are monitored in the Clermont-Ferrand metropolitan area.
Not a fit: Patients with multiple pregnancies, significant health issues, or those under guardianship may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes for both mothers and their babies during and after pregnancy.
How similar studies have performed: While no French studies have assessed the impact of a physical activity program during pregnancy, similar interventions in other regions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women of more of 18 years and who are being monitored for pregnancy in the Clermont-Ferrand metropolitan area, * Planned to give birth in a maternity unit localized in Clermont-Ferrand metropolitan area (CHU Estaing or Clinique de la Chataigneraie), * Agreeing to be randomized, to follow the physical activity program offered in the Clermont-Ferrand metropolitan area, and to follow up as part of the study, * Able to give informed consent to participate in the research, * Affiliated to a social security scheme * And between 14+0d and 21+6d weeks of gestation. Non inclusion Criteria: * Women under guardianship, curators, deprived of liberty or under court protection, * With a history of recurrent miscarriage, * Presenting a multiple pregnancy, * Hemoglobinemia \<9g/dL or symptomatic anemia, * Presenting eating disorders or a BMI ≤ 18.5 or a BMI ≥ 40, * With orthopedic limitations, * Presenting cardiovascular or pulmonary disease, * Uncontrolled thyroid disease, * Presenting a high level of smoking, * With significant health problems, * Premature rupture of membranes, * Premature labor during this pregnancy or a history of at least 2 premature births, * Persistent vaginal bleeding, * Cervical incompetence, * Evidence of intrauterine growth restriction, * Uncontrolled epilepsy, * Diabetes (previous or gestational, diagnosed in the 1st trimester) or chronic hypertension, * Or having a planned home birth.
Where this trial is running
Clermont-Ferrand
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Chloé BARASINSKI — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.