Physical Activity and Sedentary Behavior During Pregnancy

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое In person PA sessions
  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.
• Поведенческое Interactive videoconference PA sessions
  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 videoconfer
• Поведенческое In person and by videoconference (mixed format) PA sessions.
  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.

Первичные конечные точки

• Women's adherence to PA at the end of the second trimester [Срок оценки: between 24 and 30 weeks of gestation]

Вторичные конечные точки (12)

• women's adherence in terms of reduction of Sedentary Behaviors at the end of the 2nd trimester [Срок оценки: between 24 and 30 weeks of gestation]
• Women's participation at PA sessions [Срок оценки: After 39 weeks of gestation, end of planned participation in sessions]
• Pregnancy and Postpartum Evolution of PA Time [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: At delivery]
• Impact of sedentary behaviour on maternal antenatal morbidity [Срок оценки: At delivery]
• Impact of physical activity on perpartum maternal morbidity [Срок оценки: 24 hours after delivery]
• Impact of sedentary behaviour on perpartum maternal morbidity [Срок оценки: 24 hours after delivery]
• Impact of physical activity on postpartum maternal morbidity [Срок оценки: 6 months postpartum]
• Impact of sedentary behaviour on postpartum maternal morbidity [Срок оценки: 6 months postpartum]
• Impact of physical activity on the experience of childbirth [Срок оценки: 4 weeks postpartum]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Франция · 1 центр

• CHU de Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT06585085 · RBHP 2024 BARASINSKI · 2024-A00459-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗