Effect of Lifestyleintervention With Diet and Physical Activity in Obese Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Maternal weight gain
研究概览
简要总结
Purpose: To evaluate if lifestyle intervention (diet and exercise) can reduce maternal weight gain, the incidence of pregnancy complications and minimize the number of macrosomic infants.
详细描述
Obese pregnant women with a BMI>30 are randomized to Diet + Exercise, Exercise or control (1:1:1) in order to reduce maternal weight gain to less than 5 kg during pregnancy.
The effect on the children of mothers in this study is evaluated in the study: Is it possible to reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention during Pregnancy (NCT01235676)
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
- 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
- •Age >18 years
- •BMI > 30
- •Singleton pregnancy
- •Must speak and understand Danish
排除标准
- •Alcohol or drug abuse
- •Diabetes type I or other critical medical disease.
结局指标
主要结局
Maternal weight gain
时间窗: At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012
次要结局
- Pregnancy complications(At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012)
- Glucose tolerance in pregnancy(At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012)
- Birth weight(At delivery, avarage 27 weeks after inclusion. For the last participant this will be aproximately April 2012)
研究者
Kristina Renault
MD
Hvidovre University Hospital