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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
630
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.
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.
CHU de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGWomen'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
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
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
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
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
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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.
Women's perception of the determinants of their level of physical activity and sedentary behaviour
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
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
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)
Time frame: At delivery
Impact of sedentary behaviour on maternal antenatal morbidity
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)
Time frame: At delivery
Impact of physical activity on perpartum maternal morbidity
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)"
Time frame: 24 hours after delivery
Impact of sedentary behaviour on perpartum maternal morbidity
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)"
Time frame: 24 hours after delivery
Impact of physical activity on postpartum maternal morbidity
: presence of a depressive state assessed by the Edinburgh Depression Scale (EPDS) (with a discriminant threshold of the EPDS ≥ 11)
Time frame: 6 months postpartum
Impact of sedentary behaviour on postpartum maternal morbidity
: presence of a depressive state assessed by the Edinburgh Depression Scale (EPDS) (with a discriminant threshold of the EPDS ≥ 11)
Time frame: 6 months postpartum
Impact of physical activity on the experience of childbirth
Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE)
Time frame: 4 weeks postpartum
Impact of sedentary behaviour on the experience of childbirth
Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE)
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
Score obtained in the WHOQOL-Bref questionnaire
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
Score obtained in the WHOQOL-Bref questionnaire
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
Score obtained in the WHOQOL-Bref questionnaire
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
Score obtained in the WHOQOL-Bref questionnaire
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
Score obtained from the WHOQOL-Bref questionnaire
Time frame: between 6 and 10 weeks postpartum
Impact of sedentary behaviour on the quality of life of pregnant women at 2 months postpartum
Score obtained from the WHOQOL-Bref questionnaire
Time frame: between 6 and 10 weeks postpartum
Impact of physical activity on the quality of life of pregnant women at 6 months postpartum
Score obtained from the WHOQOL-Bref questionnaire
Time frame: between 20 and 24 weeks postpartum
Impact of sedentary behaviour on the quality of life of pregnant women at 6 months postpartum
Score obtained from the WHOQOL-Bref questionnaire
Time frame: between 20 and 24 weeks postpartum
Impact of physical activity on the occurrence of urinary incontinence in the 2nd trimester of pregnancy
ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
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
ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
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
ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
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
ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
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
Score on the ICIQ-SF questionnaire - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Time frame: between 20 and 24 weeks postpartum
Impact of sedentary behaviour on the occurrence of urinary incontinence at 6 months postpartum
Score on the ICIQ-SF questionnaire - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Time frame: between 20 and 24 weeks postpartum
Impact of physical activity on sexual quality of life
Score on the FSFI Female Sexual Function Index questionnaire
Time frame: between 20 and 24 weeks postpartum
Impact of sedentary behaviour on sexual quality of life
Score on the FSFI Female Sexual Function Index questionnaire
Time frame: between 20 and 24 weeks postpartum
Impact of physical activity on early neonatal morbidity
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"
Time frame: At delivery
Impact of sedentary behaviour on early neonatal morbidity
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"
Time frame: At delivery
Impact of physical activity on the newborn's birth weight
occurence of large for gestational age newborns (birth weight greater than the 95th percentile according to gestational age according to Audipog curves)
Time frame: At delivery
Impact of sedentary behaviour on the newborn's birth weight
occurence of large for gestational age newborns (birth weight greater than the 95th percentile according to gestational age according to Audipog curves)
Time frame: At delivery
Cost-effectiveness analysis from the point of view of health insurance of the proposed intervention methods
Cost-effectiveness incremental study (including modelling of the gains linked to the reduction in C-section)
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
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
Time frame: Data collected during the pregnancy and until 6 month of post-partum