Physical Activity and Sedentary Behavior During Pregnancy

NCT06585085 | Recruiting

• 2 other identifiers: RBHP 2024 BARASINSKI2024-A00459-38
• Study Type: interventional
• Target: 630
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pregnant Woman

Keywords

physical activity; sedentary behaviour; care pathway

Outcome Measures

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

  between 24 and 30 weeks of gestation

Secondary Outcomes (35)

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

  between 24 and 30 weeks of gestation

• Women's participation at PA sessions

  After 39 weeks of gestation, end of planned participation in sessions

• Pregnancy and Postpartum Evolution of PA Time

  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

• Evolution in sedentary behavior during pregnancy and postpartum

  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

• Women's perception of the determinants of their level of physical activity and sedentary behaviour

  during the 31 days after at the inclusion in the study and between 35 and 39 weeks of gestation

Study Arms (4)

A - Free PA practice

NO INTERVENTION

The women in group A (control group) will receive the usual care provided for any pregnancy, i.e. personalised information on physical activity and sedentary behaviour, with the provision of information booklets. They will be free to exercise during their pregnancy

B

EXPERIMENTAL

In-person supervised PA sessions

Behavioral: In person PA sessions

C

EXPERIMENTAL

Interactive videoconference PA sessions

Behavioral: Interactive videoconference PA sessions

D

EXPERIMENTAL

In person and by videoconference (mixed format) PA sessions

Behavioral: In person and by videoconference (mixed format) PA sessions.

Interventions

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.

B

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.

C

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.

D

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study focused on pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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,

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• 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

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Chloé BARASINSKI

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 5, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)