Physical Activity and Sedentary Behavior During Pregnancy
NCT Number: NCT06585085
Acronym: PREGMOUV
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pregnant Woman
Interventions: BEHAVIORAL: In person PA sessions|BEHAVIORAL: Interactive videoconference PA sessions|BEHAVIORAL: In person and by videoconference (mixed format) PA sessions.
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
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 630
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2027-10
Locations: CHU de Clermont-Ferrand, Clermont-Ferrand, 63000, France

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).

Primary Outcome Measures: 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 Outcome Measures: 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, 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, 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, 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, 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, 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, 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), 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), 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)", 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)", 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), 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), 6 months postpartum|Impact of physical activity on the experience of childbirth, Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE), 4 weeks postpartum|Impact of sedentary behaviour on the experience of childbirth, Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE), 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, between 20 and 24 weeks postpartum|Impact of physical activity on sexual quality of life, Score on the FSFI Female Sexual Function Index questionnaire, between 20 and 24 weeks postpartum|Impact of sedentary behaviour on sexual quality of life, Score on the FSFI Female Sexual Function Index questionnaire, 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", 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", 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), 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), 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), 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, Data collected during the pregnancy and until 6 month of post-partum