Physical Activity and Sedentary Behavior During Pregnancy

NCT06585085 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Clermont-Ferrand

Phase

Not applicable

Started

2024-09-10

Last updated

2026-09-16

Condition(s) studied

Pregnant Woman

Investigational drug(s) / intervention(s)

In person PA sessionsInteractive videoconference PA sessionsIn person and by videoconference (mixed format) PA sessions.

In person PA sessions: Group B women will have access to a weekly program of 3 face-to-face PA sessions. The face-to-face sessions will be offered at one or more locations in the Clermont-Ferrand area, depending on the number of groups taking part. They will also be offered at one or more times depending on the number of groups. Locations and times will be specified on the online booking software. Women can only register for 3 sessions per week.

Interactive videoconference PA sessions: Women in Group C will have access to a weekly program of 3 PA sessions via interactive videoconferencing. These sessions will have the same format as the face-to-face sessions with visualization of the APA professional, visualization of the participants (who can also choose to be masked). The PA professional will also see the participants, so he or she can correct positions and give individualized advice at any time. Schedules will be specified on the online booking software with the videoconference link. Women can only register for 3 sessions per week.

In person and by videoconference (mixed format) PA sessions.: Women in Group D will have access to a weekly program of 3 mixed-format PA sessions, with 2 interactive distance learning sessions and 1 in-person session. The in-person sessions will be offered at one or more locations in the Clermont-Ferrand area, depending on the number of groups taking part. Locations and times will be specified on the online booking software. Women can only register for 1 face-to-face session per week. The other 2 sessions will be offered via interactive videoconferencing. These sessions will have the same format as the in-person sessions, with visualization of the APA professional, visualization of the participants. The APA professional will also see the participants, so he or she can correct positions and give individualized advice at any time. Schedules will be specified on the online booking software with the videoconference link. Women can only register for 2 videoconference's sessions per week.

Study summary

Our main objective is to evaluate the intervention that best enables women's adherence to physical activity (PA).

Our hypothesis is that identifying types of interventions suitable for pregnant women (in-person PA sessions, videoconferences or mixed format) could help improve their PA level and simultaneously reduce their sedentary behavior (SB).

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Women's adherence to PA at the end of the second trimester — between 24 and 30 weeks of gestation
measurement of the PA level, measured by accelerometer, expressed in MET.minutes/week by wearing a tri-axial accelerometer on the hip

Trial sites (1)

Facility	City	Region	Status
CHU de Clermont-Ferrand	Clermont-Ferrand	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06585085 on ClinicalTrials.gov ↗ ← All trials in France