Care Pathway Organization in Order to Increase Physical Activity Levels and Limit Sedentary Behavior During Pregnancy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 630
- 试验地点
- 2
- 主要终点
- Women's adherence to PA at the end of the second trimester
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Women's adherence to PA at the end of the second trimester
时间窗: 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
次要结局
- women's adherence in terms of reduction of Sedentary Behaviors at the end of the 2nd trimester(between 24 and 30 weeks of gestation)
- Impact of physical activity on maternal antenatal morbidity(At delivery)
- Impact of sedentary behaviour on the experience of childbirth(4 weeks postpartum)
- Women's participation at PA sessions(After 39 weeks of gestation, end of planned participation in sessions)
- 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)
- 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)
- 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)
- Impact of sedentary behaviour on maternal antenatal morbidity(At delivery)
- Impact of physical activity on perpartum maternal morbidity(24 hours after delivery)
- Impact of sedentary behaviour on perpartum maternal morbidity(24 hours after delivery)
- Impact of physical activity on postpartum maternal morbidity(6 months postpartum)
- Impact of physical activity on the quality of life of pregnant women at 6 months postpartum(between 20 and 24 weeks postpartum)
- Impact of sedentary behaviour on postpartum maternal morbidity(6 months postpartum)
- Impact of physical activity on the experience of childbirth(4 weeks postpartum)
- 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)
- 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)
- 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)
- 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)
- Impact of physical activity on the quality of life of pregnant women at 2 months postpartum(between 6 and 10 weeks postpartum)
- Impact of sedentary behaviour on the quality of life of pregnant women at 2 months postpartum(between 6 and 10 weeks postpartum)
- Impact of sedentary behaviour on the quality of life of pregnant women at 6 months postpartum(between 20 and 24 weeks postpartum)
- Impact of physical activity on the occurrence of urinary incontinence in the 2nd trimester of pregnancy(between 24 and 30 weeks of gestation)
- Impact of sedentary behaviour on the occurrence of urinary incontinence in the 2nd trimester of pregnancy(between 24 and 30 weeks of gestation)
- 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)
- 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)
- Impact of physical activity on the occurrence of urinary incontinence at 6 months postpartum(between 20 and 24 weeks postpartum)
- Impact of sedentary behaviour on the occurrence of urinary incontinence at 6 months postpartum(between 20 and 24 weeks postpartum)
- Impact of physical activity on the newborn's birth weight(At delivery)
- Impact of physical activity on sexual quality of life(between 20 and 24 weeks postpartum)
- Impact of sedentary behaviour on sexual quality of life(between 20 and 24 weeks postpartum)
- Impact of physical activity on early neonatal morbidity(At delivery)
- Impact of sedentary behaviour on early neonatal morbidity(At delivery)
- Impact of sedentary behaviour on the newborn's birth weight(At delivery)
- 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-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)