The Effect of Lifestyle Intervention in Pregnancy - Follow-up on the Offspring in Early Childhood.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Body Mass Index standard deviation score
研究概览
简要总结
Children born to obese women are at risk of increased adiposity and later adverse metabolic outcomes. We have conducted a follow-up study on an existing clinical trial, called the LiP study (Lifestyle in Pregnancy), registration number NCT00530439,in which 360 obese pregnant women were randomized to either lifestyle intervention or routine obstetric care. This present study follows the children until 3 years of age. We have the hypothesis, that the intervention during pregnancy results in a lower degree of adiposity and metabolic risk factors in the offspring. Clinical examination is taking place at age 2.5-3 years including anthropometric measurements, Dual energy x-ray (DXA) scans and blood samples measuring metabolic markers.
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
- 30 Months 至 40 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children born to women who were part of the preceding LiP study and who completed the LiP study until birth. Inclusion criteria for the LiP study:
- •singleton pregnant
- •BMI >/= 30 and </= 45 E xclusion Criteria for preceding LiP study:
- •Chronic diseases
- •Not Danish speaking
- •Abuse of alcohol or drugs
- •Preterm delivery in earlier pregnancies
排除标准
- 未提供
结局指标
主要结局
Body Mass Index standard deviation score
时间窗: On average 2.9 years of age
次要结局
- Fat mass percent(On average 2.9 years of age)
研究者
Mette Tanvig
Medical Doctor
Odense University Hospital