Physical Activity and Sedentary Behavior During Pregnancy
- Conditions
- Pregnant Woman
- Interventions
- Behavioral: In person PA sessionsBehavioral: Interactive videoconference PA sessionsBehavioral: In person and by videoconference (mixed format) PA sessions.
- Registration Number
- NCT06585085
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 630
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B In person PA sessions In-person supervised PA sessions C Interactive videoconference PA sessions Interactive videoconference PA sessions D In person and by videoconference (mixed format) PA sessions. In person and by videoconference (mixed format) PA sessions
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method women's adherence in terms of reduction of Sedentary Behaviors at the end of the 2nd trimester between 24 and 30 weeks of gestation 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
Impact of physical activity on maternal antenatal morbidity At delivery occurrence of maternal pathology during pregnancy (gestational arterial hypertension \[PAS ≥ 140 mm Hg and a PAD ≥ 90 mm Hg occurring after 20 weeks of gestation\] and/or, pre-eclampsia \[hypertension with albuminuria \> 0.3g/L per 24 hours\] and/or gestational diabetes diagnosed by orally induced hyperglycaemia after 23 SA)
Impact of sedentary behaviour on the experience of childbirth 4 weeks postpartum Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE)
Women's participation at PA sessions After 39 weeks of gestation, end of planned participation in 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
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 PA time measured with a tri-axial accelerometer at the hip
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 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
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 Qualitative study by means of semi-structured telephone interviews with a minimum of 100 women, i.e. a minimum of 25 women per group, a number to be adapted according to the data saturation that will be obtained
Impact of sedentary behaviour on maternal antenatal morbidity At delivery occurrence of maternal pathology during pregnancy (gestational arterial hypertension \[PAS ≥ 140 mm Hg and a PAD ≥ 90 mm Hg occurring after 20 weeks of gestation\] and/or, pre-eclampsia \[hypertension with albuminuria \> 0.3g/L per 24 hours\] and/or gestational diabetes diagnosed by orally induced hyperglycaemia after 23 SA)
Impact of physical activity on perpartum maternal morbidity 24 hours after delivery A composite criterion: "occurrence of 3rd or 4th degree perineal lesions and/or occurrence of immediate postpartum haemorrhage (blood loss \> 500mL in the 24 hours after delivery)"
Impact of sedentary behaviour on perpartum maternal morbidity 24 hours after delivery A composite criterion: "occurrence of 3rd or 4th degree perineal lesions and/or occurrence of immediate postpartum haemorrhage (blood loss \> 500mL in the 24 hours after delivery)"
Impact of physical activity on postpartum maternal morbidity 6 months postpartum : presence of a depressive state assessed by the Edinburgh Depression Scale (EPDS) (with a discriminant threshold of the EPDS ≥ 11)
Impact of physical activity on the quality of life of pregnant women at 6 months postpartum between 20 and 24 weeks postpartum Score obtained from the WHOQOL-Bref questionnaire
Impact of sedentary behaviour on postpartum maternal morbidity 6 months postpartum : presence of a depressive state assessed by the Edinburgh Depression Scale (EPDS) (with a discriminant threshold of the EPDS ≥ 11)
Impact of physical activity on the experience of childbirth 4 weeks postpartum Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE)
Impact of physical activity on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy between 24 and 30 weeks of gestation Score obtained in the WHOQOL-Bref questionnaire
Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 2nd trimester of pregnancy between 24 and 30 weeks of gestation Score obtained in the WHOQOL-Bref questionnaire
Impact of physical activity on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy between 32 and 37 SA+6day weeks of gestation Score obtained in the WHOQOL-Bref questionnaire
Impact of sedentary behaviour on the quality of life of pregnant women at the end of the 3rd trimester of pregnancy between 32 and 37 SA+6day weeks of gestation Score obtained in the WHOQOL-Bref questionnaire
Impact of physical activity on the quality of life of pregnant women at 2 months postpartum between 6 and 10 weeks postpartum Score obtained from the WHOQOL-Bref questionnaire
Impact of sedentary behaviour on the quality of life of pregnant women at 2 months postpartum between 6 and 10 weeks postpartum Score obtained from the WHOQOL-Bref questionnaire
Impact of sedentary behaviour on the quality of life of pregnant women at 6 months postpartum between 20 and 24 weeks postpartum Score obtained from the WHOQOL-Bref questionnaire
Impact of physical activity on the occurrence of urinary incontinence in the 2nd trimester of pregnancy between 24 and 30 weeks of gestation ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Impact of sedentary behaviour on the occurrence of urinary incontinence in the 2nd trimester of pregnancy between 24 and 30 weeks of gestation ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Impact of physical activity on the occurrence of urinary incontinence in the 3rd trimester of pregnancy between 32 and 37 SA+6day weeks of gestation ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Impact of sedentary behaviour on the occurrence of urinary incontinence in the 3rd trimester of pregnancy between 32 and 37 SA+6day weeks of gestation ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Impact of physical activity on the occurrence of urinary incontinence at 6 months postpartum between 20 and 24 weeks postpartum Score on the ICIQ-SF questionnaire - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Impact of sedentary behaviour on the occurrence of urinary incontinence at 6 months postpartum between 20 and 24 weeks postpartum Score on the ICIQ-SF questionnaire - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Impact of physical activity on sexual quality of life between 20 and 24 weeks postpartum Score on the FSFI Female Sexual Function Index questionnaire
Impact of sedentary behaviour on sexual quality of life between 20 and 24 weeks postpartum Score on the FSFI Female Sexual Function Index questionnaire
Impact of physical activity on early neonatal morbidity At delivery a composite criterion: "Apgar score \<7 at 5 min and/or arterial pH \<7.10 and/or transfer and/or intra-hospital transfer to a neonatal unit"
Impact of sedentary behaviour on early neonatal morbidity At delivery a composite criterion: "Apgar score \<7 at 5 min and/or arterial pH \<7.10 and/or transfer and/or intra-hospital transfer to a neonatal unit"
Impact of physical activity on the newborn's birth weight At delivery occurence of large for gestational age newborns (birth weight greater than the 95th percentile according to gestational age according to Audipog curves)
Impact of sedentary behaviour on the newborn's birth weight At delivery occurence of large for gestational age newborns (birth weight greater than the 95th percentile according to gestational age according to Audipog curves)
Cost-effectiveness analysis from the point of view of health insurance of the proposed intervention methods Data collected during the pregnancy and until 2 month of post-partum Cost-effectiveness incremental study (including modelling of the gains linked to the reduction in C-section)
cost-utility study analysis from the point of view of health insurance of the proposed intervention methods Data collected during the pregnancy and until 6 month of post-partum Cost-utility study (based on the usefulness felt by women) from the point of view of health insurance using the EQ5D-5L (5 Level Euroqol 5 Dimensions) and a mapping analysis of the WHOQOL-Bref
Trial Locations
- Locations (1)
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France