NCT01235676已完成不适用
Is it Possible to Reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention During Pregnancy ?
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- amount of fat tissue
研究概览
简要总结
0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle intervention during pregnancy
详细描述
Obese pregnant women (BMI > 30) are randomized to exercise, diet or control (1:1:1) in order to reduce weight gain during pregnancy. Shortly after birth, tissue composition will be measured (DEXA)in 200 infants (65 from each group). The amount of fat tissue is subsequently analyzed between the groups and compared to results from another 65 infants of lean mothers
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 (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term neonates Informed and written consent from both parents -
排除标准
- •Sick or preterm infants No consent
研究组 & 干预措施
Exercise
Experimental
Exercise to reduce weight gain
干预措施: Exercise (Behavioral)
Diet
Experimental
Calorie restriction to reduce weight gain
干预措施: diet (Behavioral)
结局指标
主要结局
amount of fat tissue
时间窗: at birth
次要结局
- birth weight(at birth)
研究者
Ole Pryds
MD
Hvidovre University Hospital
研究点 (1)
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