Clinical trial NCT06585085: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnant Woman
Keywords: physical activity
sedentary behaviour
care pathway
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Réseau de Santé en Périnatalité d'Auvergne
name: ASM Omnisports - Pôle Sport-Santé
name: Office Municipal du Sport - Espace Sport Santé
name: Observatoire national de l'activité physique et de la sédentarité
name: Ville de Clermont-Ferrand
name: Ministère de la Santé et de la Prévention
First posted: 2024-09-05
Enrollment: 630
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

Primary outcomes:
measure: Women's adherence to PA at the end of the second trimester
timeFrame: between 24 and 30 weeks of gestation
Secondary outcomes:
measure: women's adherence in terms of reduction of Sedentary Behaviors at the end of the 2nd trimester
timeFrame: between 24 and 30 weeks of gestation
measure: Women's participation at PA sessions
timeFrame: After 39 weeks of gestation, end of planned participation in sessions
measure: Pregnancy and Postpartum Evolution of PA Time
timeFrame: 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
measure: Evolution in sedentary behavior during pregnancy and postpartum
timeFrame: 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
measure: Women's perception of the determinants of their level of physical activity and sedentary behaviour
timeFrame: during the 31 days after at the inclusion in the study and between 35 and 39 weeks of gestation
measure: Impact of physical activity on maternal antenatal morbidity
timeFrame: At delivery
measure: Impact of sedentary behaviour on maternal antenatal morbidity
timeFrame: At delivery
measure: Impact of physical activity on perpartum maternal morbidity
timeFrame: 24 hours after delivery
measure: Impact of sedentary behaviour on perpartum maternal morbidity
timeFrame: 24 hours after delivery
measure: Impact of physical activity on postpartum maternal morbidity
timeFrame: 6 months postpartum
measure: Impact of sedentary behaviour on postpartum maternal morbidity
timeFrame: 6 months postpartum
measure: Impact of physical activity on the experience of childbirth
timeFrame: 4 weeks postpartum
measure: Impact of sedentary behaviour on the experience of childbirth
timeFrame: 4 weeks postpartum
measure: Impact of physical activity on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy
timeFrame: between 24 and 30 weeks of gestation
measure: Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy
timeFrame: between 24 and 30 weeks of gestation
measure: Impact of physical activity on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy
timeFrame: between 32 and 37 SA+6day weeks of gestation
measure: Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy
timeFrame: between 32 and 37 SA+6day weeks of gestation
measure: Impact of physical activity on the quality of life of pregnant women at 2 months postpartum
timeFrame: between 6 and 10 weeks postpartum
measure: Impact of sedentary behaviour on the quality of life of pregnant women at 2 months postpartum
timeFrame: between 6 and 10 weeks postpartum
measure: Impact of physical activity on the quality of life of pregnant women at 6 months postpartum
timeFrame: between 20 and 24 weeks postpartum
measure: Impact of sedentary behaviour on the quality of life of pregnant women at 6 months postpartum
timeFrame: between 20 and 24 weeks postpartum
measure: Impact of physical activity on the occurrence of urinary incontinence in the 2nd trimester of pregnancy
timeFrame: between 24 and 30 weeks of gestation
measure: Impact of sedentary behaviour on the occurrence of urinary incontinence in the 2nd trimester of pregnancy
timeFrame: between 24 and 30 weeks of gestation
measure: Impact of physical activity on the occurrence of urinary incontinence in the 3rd trimester of pregnancy
timeFrame: between 32 and 37 SA+6day weeks of gestation
measure: Impact of sedentary behaviour on the occurrence of urinary incontinence in the 3rd trimester of pregnancy
timeFrame: between 32 and 37 SA+6day weeks of gestation
measure: Impact of physical activity on the occurrence of urinary incontinence at 6 months postpartum
timeFrame: between 20 and 24 weeks postpartum
measure: Impact of sedentary behaviour on the occurrence of urinary incontinence at 6 months postpartum
timeFrame: between 20 and 24 weeks postpartum
measure: Impact of physical activity on sexual quality of life
timeFrame: between 20 and 24 weeks postpartum
measure: Impact of sedentary behaviour on sexual quality of life
timeFrame: between 20 and 24 weeks postpartum
measure: Impact of physical activity on early neonatal morbidity
timeFrame: At delivery
measure: Impact of sedentary behaviour on early neonatal morbidity
timeFrame: At delivery
measure: Impact of physical activity on the newborn's birth weight
timeFrame: At delivery
measure: Impact of sedentary behaviour on the newborn's birth weight
timeFrame: At delivery
measure: Cost-effectiveness analysis from the point of view of health insurance of the proposed intervention methods
timeFrame: Data collected during the pregnancy and until 2 month of post-partum
measure: cost-utility study analysis from the point of view of health insurance of the proposed intervention methods
timeFrame: Data collected during the pregnancy and until 6 month of post-partum
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Chloé BARASINSKI
role: PRINCIPAL_INVESTIGATOR
References: