Impact of Pregnant Women Education in Case of Overweight or Obesity on Risk of Child Overweight and Pregnancy Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 2
- 主要终点
- 30 per cent reduction of rapid infancy weight gain at two years defined as > +0,67 change in weight SD score. The 0,67 SD represents the difference between the displayed centile lines on standard infant growth charts.
研究概览
简要总结
Metabolic environment of the foetus during pregnancy in obese women is altered and the child exposed at an increased risk of obesity. Rapid infancy and childhood weight gain is associated with subsequent obesity.
The purpose of the study is to test the efficacy of an educational intervention during pregnancy in obese or overweight women, on the reduction of rapid infancy weight gain in the two first years of life.
详细描述
In a first time, we propose to pregnant overweight women to participate a study based on the follow up of their pregnancy and of their child during the two first years of life. Women in agreement with the study sign a consent form and fill in a questionnaire about their quality of live.
We secondly randomized the women in two groups:
Group A: in this group an intervention is delivered. It provide education, at regularly scheduled sessions (20 weeks, 28 weeks, 35 weeks, and 2 month after delivering) and two dietary consulting. The sessions that stress about healthy eating and modest exercise assemble several women (no more than 10). Women in agreement with this intervention sign a consent form.
Group B: in this group, pregnant women are managed with standard care (at least one dietary consulting is proposed around 26 weeks).
Risk factors for child obesity are researched by questionnaire (parents smoking habit, mother and father level of education, family history of obesity, risk factors for gestational diabetes…). Mother weight measured at every clinic visit, is recorded as complications during pregnancy (HTA, preeclampsia, diabetes, fetal malformation …) and during delivery. Mother glycosylated haemoglobin is measured at birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
2
干预措施: Follow-up (Other)
1
Therapeutic education
干预措施: Therapeutic education (Other)
结局指标
主要结局
30 per cent reduction of rapid infancy weight gain at two years defined as > +0,67 change in weight SD score. The 0,67 SD represents the difference between the displayed centile lines on standard infant growth charts.
时间窗: 30 Months
次要结局
- -increase of breastfeeding (number of women and duration)(30 months)
- -reduction 1 and 2 years after pregnancy of mother weight and BMI (except second pregnancy)(30 months)
- -reduction of rapid infancy weight gain between 0 and 6 months(30 months)
- -reduction of the number of children with BMI over 19 at 2 years(30 months)
- -reduction of incidence of gestational diabetes, preeclampsia, HTA during pregnancy, caesarean, fetal macrosomia(30 months)
- -reduction of spontaneous feeding at 4 months(30 months)
- -reduction of abnormality of lipid and glycaemia test in women, 2 years after the pregnancy(30 months)