Physical Activity and Sedentary Lifestyle During Pregnancy: Feasibility and Impact Study on Sedentary Behavior
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Establishing Adherence of PA sessions during pregnancy
研究概览
简要总结
Background:
Physical activity (PA) has beneficial effects on health, physical condition, and the maintenance of autonomy and independence at all ages of life. It also has numerous benefits during pregnancy: maintenance or improvement of physical condition, prevention of excessive weight gain, aid in postpartum weight loss, prevention of gestational hypertension, reduction in number of macrosomic infants at birth, reduction in lower back and pelvic pain, and prevention and improvement of postpartum depressive symptoms. A recent systematic review of the literature concluded that interventions to increase PA levels among pregnant women have a positive effect on this level. The studies included in the review also showed that these interventions have a positive effect on these women's well-being and their mental and physical health. Nonetheless, no study has examined this subject in France. Moreover, to our knowledge, no study in the international literature has looked at online interactive video sessions of PA during pregnancy.
Overall, few studies allow an assessment of the effect of sedentary behavior and inadequate PA during pregnancy on maternal, neonatal, or infant outcomes. This is equally true for the health of adults whose mothers were physically active during pregnancy. Moreover, we do not know the actual level of PA of women in France. Finally, we do not know what types of intervention described in the literature would enable the best adherence by French women to their initiation or maintenance of an adequate PA level.
Study hypothesis:
Our hypothesis is that setting up a free program of physical and sports activity session for pregnant women will enable them to meet the guidelines for PA practice during this period and to reduce their sedentary behavior.
Objectives:
1.1. Principal objective To study the feasibility of setting up physical activity (PA) sessions for pregnant women during their prenatal care, by assessing its acceptability, the perceived difficulty of the sessions, and their satisfaction with these sessions.
1.2. Secondary objectives
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To evaluate the effect of these sessions:
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on the PA level and sedentary behavior of pregnant women,
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on their quality of life (QoL).
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The feasibility and impact of the sessions will be studied according to their PA level at inclusion: active or inactive.
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To identify the facilitators of and obstacles to the acceptability of these sessions, other than those studied in the objectives above.
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To measure the willingness to pay of pregnant women so that we can quantify how much they would be willing to pay for such a program, were it were not free. Willingness to pay (measured in €) makes it possible to measure indirectly the acceptability of the program to the participants and the monetary value they attribute to it.
详细描述
Type of study:
Prospective interventional cohort feasibility study of PA sessions for pregnant women.
Number of centers: 1
One center: the Clermont-Ferrand university hospital center
Study description:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult pregnant women receiving prenatal care at the Estaing UHC maternity ward,
- •Seen for prenatal care before the 21st week of gestation and booked to give birth at the Estaing UHC
- •Agreeing to follow the full PA program proposed,
- •Able to provide informed consent to participate in research,
- •And covered by the national health insurance fund (or an affiliate).
排除标准
- •Multiple pregnancy,
- •With a relative or absolute contraindication to performing PA physical activity (see Tables 1 and 2, extracted from the French national authority for health guidelines for physical activity during pregnancy),
- •Under guardianship or conservatorship,
- •Or refusing to participate in the study.
结局指标
主要结局
Establishing Adherence of PA sessions during pregnancy
时间窗: through study completion, an average of 1 year
Women's adherence to the sessions proposed (% who attend all sessions until delivery).
Establishing perceived difficulty of PA sessions during pregnancy
时间窗: through study completion, an average of 1 year
The perceived difficulty of the sessions will be evaluated by the women themselves with a self-administered questionnaire.
Establishing women's satisfaction of PA sessions during pregnancy
时间窗: day 133
Satisfaction with the PA sessions for pregnant women during their prenatal care will be based on a self-administered questionnaire. Women's overall satisfaction with the sessions will be assessed on a numeric scale ranging from 0 to 10.
次要结局
- Willingness to pay(at the end of all the sessions (9 months))
- Changes in these pregnant women's quality of life(Before the first PA session, at 6 months of gestation, and at the end of all the sessions (9 months))
- Pregnant women's PA level and sedentary behavior(before the first PA session, at the end of the sixth month of gestation, and at the end of all the sessions (9 months))
- The facilitators of and obstacles to the sessions' acceptability will be assessed in semi-directive interviews conducted by a midwife.(at the end of all the sessions (9 months))