---
title: Physical Activity and Sedentary Behavior During Pregnancy
nct_id: NCT06585085
overall_status: RECRUITING
phase: NA
sponsor: University Hospital, Clermont-Ferrand
study_type: INTERVENTIONAL
primary_condition: Pregnant Woman
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06585085.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06585085"
ct_last_update_post_date: 2024-09-24
last_seen_at: "2026-05-12T06:46:13.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Physical Activity and Sedentary Behavior During Pregnancy

**Official Title:** Care Pathway Organization in Order to Increase Physical Activity Levels and Limit Sedentary Behavior During Pregnancy: a Randomized Controlled Trial

**NCT ID:** [NCT06585085](https://clinicaltrials.gov/study/NCT06585085)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 630
- **Lead Sponsor:** University Hospital, Clermont-Ferrand
- **Collaborators:** Réseau de Santé en Périnatalité d'Auvergne, ASM Omnisports - Pôle Sport-Santé, Office Municipal du Sport - Espace Sport Santé, Observatoire national de l'activité physique et de la sédentarité, Ville de Clermont-Ferrand, Ministère de la Santé et de la Prévention
- **Conditions:** Pregnant Woman
- **Start Date:** 2024-09-10
- **Completion Date:** 2027-10
- **CT.gov Last Update:** 2024-09-24

## 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).

## Detailed Description

PA has beneficial effects on physical, psychological, and social health, and its regular practice helps to prevent numerous chronic diseases. During pregnancy, PA also has many benefits for women's physical condition, weight gain, gestational hypertension, lower back and pelvic pain, and postpartum depressive symptoms and may also reduce fetal macrosomia and positively affect neurogenesis, language development, memory, and other learning-associated cognitive functions. (CNSF 2021). PA is thus recommended to all pregnant women for 150 to 180 minutes a week, adapted to their health status, physical condition, and course of pregnancy. It is also recommended that women limit their Sedentary Behaviour (SB) (to ≤7 waking h/day) during pregnancy.

No French study has assessed the impact of a PA program during pregnancy, and no published study has proposed videoconference PA sessions during pregnancy. Pregnant women's adherence to PA is a limiting factor found in many interventional studies. Possible changes in maternal behavior in practicing PA and reducing SB during pregnancy could also favorably affect the health of mother and child and thus subsequent PA. Given PA's many benefits and SB's harmful effects during pregnancy, assessing programs that enable pregnant women to both increase PA levels and reduce SB seems pertinent and valuable.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **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
- **C** (EXPERIMENTAL) — Interactive videoconference PA sessions
- **D** (EXPERIMENTAL) — 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.
- **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.

## Primary Outcomes

- **Women's adherence to PA at the end of the second trimester** _(time frame: 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

## Secondary Outcomes

- **women's adherence in terms of reduction of Sedentary Behaviors at the end of the 2nd trimester** _(time frame: between 24 and 30 weeks of gestation)_
- **Women's participation at PA sessions** _(time frame: After 39 weeks of gestation, end of planned participation in sessions)_
- **Pregnancy and Postpartum Evolution of PA Time** _(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)_
- **Evolution in sedentary behavior during pregnancy and postpartum** _(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)_
- **Women's perception of the determinants of their level of physical activity and sedentary behaviour** _(time frame: during the 31 days after at the inclusion in the study and between 35 and 39 weeks of gestation)_
- **Impact of physical activity on maternal antenatal morbidity** _(time frame: At delivery)_
- **Impact of sedentary behaviour on maternal antenatal morbidity** _(time frame: At delivery)_
- **Impact of physical activity on perpartum maternal morbidity** _(time frame: 24 hours after delivery)_
- **Impact of sedentary behaviour on perpartum maternal morbidity** _(time frame: 24 hours after delivery)_
- **Impact of physical activity on postpartum maternal morbidity** _(time frame: 6 months postpartum)_
- **Impact of sedentary behaviour on postpartum maternal morbidity** _(time frame: 6 months postpartum)_
- **Impact of physical activity on the experience of childbirth** _(time frame: 4 weeks postpartum)_
- **Impact of sedentary behaviour on the experience of childbirth** _(time frame: 4 weeks postpartum)_
- **Impact of physical activity on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy** _(time frame: between 24 and 30 weeks of gestation)_
- **Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy** _(time frame: between 24 and 30 weeks of gestation)_
- **Impact of physical activity on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy** _(time frame: between 32 and 37 SA+6day weeks of gestation)_
- **Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy** _(time frame: between 32 and 37 SA+6day weeks of gestation)_
- **Impact of physical activity on the quality of life of pregnant women at 2 months postpartum** _(time frame: between 6 and 10 weeks postpartum)_
- **Impact of sedentary behaviour on the quality of life of pregnant women at 2 months postpartum** _(time frame: between 6 and 10 weeks postpartum)_
- **Impact of physical activity on the quality of life of pregnant women at 6 months postpartum** _(time frame: between 20 and 24 weeks postpartum)_
- **Impact of sedentary behaviour on the quality of life of pregnant women at 6 months postpartum** _(time frame: between 20 and 24 weeks postpartum)_
- **Impact of physical activity on the occurrence of urinary incontinence in the 2nd trimester of pregnancy** _(time frame: between 24 and 30 weeks of gestation)_
- **Impact of sedentary behaviour on the occurrence of urinary incontinence in the 2nd trimester of pregnancy** _(time frame: between 24 and 30 weeks of gestation)_
- **Impact of physical activity on the occurrence of urinary incontinence in the 3rd trimester of pregnancy** _(time frame: between 32 and 37 SA+6day weeks of gestation)_
- **Impact of sedentary behaviour on the occurrence of urinary incontinence in the 3rd trimester of pregnancy** _(time frame: between 32 and 37 SA+6day weeks of gestation)_
- **Impact of physical activity on the occurrence of urinary incontinence at 6 months postpartum** _(time frame: between 20 and 24 weeks postpartum)_
- **Impact of sedentary behaviour on the occurrence of urinary incontinence at 6 months postpartum** _(time frame: between 20 and 24 weeks postpartum)_
- **Impact of physical activity on sexual quality of life** _(time frame: between 20 and 24 weeks postpartum)_
- **Impact of sedentary behaviour on sexual quality of life** _(time frame: between 20 and 24 weeks postpartum)_
- **Impact of physical activity on early neonatal morbidity** _(time frame: At delivery)_
- **Impact of sedentary behaviour on early neonatal morbidity** _(time frame: At delivery)_
- **Impact of physical activity on the newborn's birth weight** _(time frame: At delivery)_
- **Impact of sedentary behaviour on the newborn's birth weight** _(time frame: At delivery)_
- **Cost-effectiveness analysis from the point of view of health insurance of the proposed intervention methods** _(time frame: Data collected during the pregnancy and until 2 month of post-partum)_
- **cost-utility study analysis from the point of view of health insurance of the proposed intervention methods** _(time frame: Data collected during the pregnancy and until 6 month of post-partum)_

## Locations (1)

- CHU de Clermont-Ferrand, Clermont-Ferrand, France — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.chu de clermont-ferrand|clermont-ferrand||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06585085.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06585085*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*