Health TrialsbyHealthPanel

Physical Activity and Sedentary Behavior During Pregnancy

ConditionPregnant Woman
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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,

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • In person PA sessions

    Behavioral

    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

    Behavioral

    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.

    Behavioral

    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.

Treatment groups

654 Participants
are divided into 4 treatment groups
Group A: A - Free PA practiceNo intervention 0 interventions
Group B: BExperimental treatment 1 intervention
Group C: CExperimental treatment 1 intervention
Group D: DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Women's adherence to PA at the end of the second trimester

measurement of the PA level, measured by accelerometer, expressed in MET.minutes/week by wearing a tri-axial accelerometer on the hip

Time frame
between 24 and 30 weeks of gestation

Secondary outcomes

1

women's adherence in terms of reduction of Sedentary Behaviors at the end of the 2nd trimester

measurement of sedentary time (defined as a state of wakefulness characterized by an energy expenditure less than or equal to 1.5 METs) between getting up and going to bed using a tri-axial hip accelerometer

Time frame
between 24 and 30 weeks of gestation
2

Women's participation at PA sessions

For women in groups B, C and D, rate of sessions completed on the number of eligible sessions according to their randomization group and the socio-demographic criteria

Time frame
After 39 weeks of gestation, end of planned participation in sessions
3

Pregnancy and Postpartum Evolution of PA Time

PA time measured with a tri-axial accelerometer at the hip

Time frame
at 4 distinct times: between 24+0d and 30+0d weeks of gestation, between 32+0d and 37+6d weeks of gestation, between 6 and 10 weeks postpartum and between 20 and 24 weeks postpartum
4

Evolution in sedentary behavior during pregnancy and postpartum

sedentary time (defined as wakefulness characterized by an energy expenditure less than or equal to 1.5 METs) between getting up and going to bed will be compared according to each intervention modality. Sedentary behavior will be measured by wearing a tri-axial accelerometer on the hip

Time frame
at 4 distinct times: between 24 and 30 weeks of gestation, between 32+0day and 37+6day weeks of gestation, between 6 and 10 weeks postpartum and between 20 and 24 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Clermont-Ferrand

Lead sponsor

Réseau de Santé en Périnatalité d'Auvergne

Collaborator

ASM Omnisports - Pôle Sport-Santé

Collaborator

Office Municipal du Sport - Espace Sport Santé

Collaborator

Observatoire national de l'activité physique et de la sédentarité

Collaborator

Ville de Clermont-Ferrand

Collaborator

Ministère de la Santé et de la Prévention

Collaborator

Source ClinicalTrials.gov
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