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NCT Number: NCT06585085

Physical Activity and Sedentary Behavior During Pregnancy

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).

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Key information

Conditions

Pregnant Woman Behavior Motor Activity

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location status: Recruiting

Location contact

Chloé BARASINSKI

CONTACT

[email protected]

Chloé BARASINSKI

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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

  1. 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

    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

  2. Women's participation at PA sessions

    Time frame: 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

  3. 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

    PA time measured with a tri-axial accelerometer at the hip

  4. 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

    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

  5. 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

    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

  6. Impact of physical activity on maternal antenatal morbidity

    Time frame: 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)

  7. Impact of sedentary behaviour on maternal antenatal morbidity

    Time frame: 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)

  8. Impact of physical activity on perpartum maternal morbidity

    Time frame: 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)"

  9. Impact of sedentary behaviour on perpartum maternal morbidity

    Time frame: 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)"

  10. Impact of physical activity on postpartum maternal morbidity

    Time frame: 6 months postpartum

    : presence of a depressive state assessed by the Edinburgh Depression Scale (EPDS) (with a discriminant threshold of the EPDS ≥ 11)

  11. Impact of sedentary behaviour on postpartum maternal morbidity

    Time frame: 6 months postpartum

    : presence of a depressive state assessed by the Edinburgh Depression Scale (EPDS) (with a discriminant threshold of the EPDS ≥ 11)

  12. Impact of physical activity on the experience of childbirth

    Time frame: 4 weeks postpartum

    Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE)

  13. Impact of sedentary behaviour on the experience of childbirth

    Time frame: 4 weeks postpartum

    Evaluation using the Questionnaire for Assessing the Childbirth Experience (QACE)

  14. 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

    Score obtained in the WHOQOL-Bref questionnaire

  15. 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

    Score obtained in the WHOQOL-Bref questionnaire

  16. 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

    Score obtained in the WHOQOL-Bref questionnaire

  17. 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

    Score obtained in the WHOQOL-Bref questionnaire

  18. Impact of physical activity on the quality of life of pregnant women at 2 months postpartum

    Time frame: between 6 and 10 weeks postpartum

    Score obtained from the WHOQOL-Bref questionnaire

  19. Impact of sedentary behaviour on the quality of life of pregnant women at 2 months postpartum

    Time frame: between 6 and 10 weeks postpartum

    Score obtained from the WHOQOL-Bref questionnaire

  20. Impact of physical activity on the quality of life of pregnant women at 6 months postpartum

    Time frame: between 20 and 24 weeks postpartum

    Score obtained from the WHOQOL-Bref questionnaire

  21. Impact of sedentary behaviour on the quality of life of pregnant women at 6 months postpartum

    Time frame: between 20 and 24 weeks postpartum

    Score obtained from the WHOQOL-Bref questionnaire

  22. 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

    ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form

  23. 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

    ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form

  24. 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

    ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form

  25. 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

    ICIQ-SF questionnaire score - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form

  26. Impact of physical activity on the occurrence of urinary incontinence at 6 months postpartum

    Time frame: between 20 and 24 weeks postpartum

    Score on the ICIQ-SF questionnaire - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form

  27. Impact of sedentary behaviour on the occurrence of urinary incontinence at 6 months postpartum

    Time frame: between 20 and 24 weeks postpartum

    Score on the ICIQ-SF questionnaire - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form

  28. Impact of physical activity on sexual quality of life

    Time frame: between 20 and 24 weeks postpartum

    Score on the FSFI Female Sexual Function Index questionnaire

  29. Impact of sedentary behaviour on sexual quality of life

    Time frame: between 20 and 24 weeks postpartum

    Score on the FSFI Female Sexual Function Index questionnaire

  30. Impact of physical activity on early neonatal morbidity

    Time frame: 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"

  31. Impact of sedentary behaviour on early neonatal morbidity

    Time frame: 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"

  32. Impact of physical activity on the newborn's birth weight

    Time frame: At delivery

    occurence of large for gestational age newborns (birth weight greater than the 95th percentile according to gestational age according to Audipog curves)

  33. Impact of sedentary behaviour on the newborn's birth weight

    Time frame: At delivery

    occurence of large for gestational age newborns (birth weight greater than the 95th percentile according to gestational age according to Audipog curves)

  34. 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-effectiveness incremental study (including modelling of the gains linked to the reduction in C-section)

  35. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • ASM Omnisports - Pôle Sport-Santé
  • Ministère de la Santé et de la Prévention
  • Observatoire national de l'activité physique et de la sédentarité
  • Office Municipal du Sport - Espace Sport Santé
  • Réseau de Santé en Périnatalité d'Auvergne
  • Ville de Clermont-Ferrand

Registry information

Official study title

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

Acronym: PREGMOUV

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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