The Effects of Lifestyle Intervention During Pregnancy in Obese Women on Offspring Adiposity and Metabolic Risk Factors- Comparison With Offspring of Normal Weight Women Not Participating in a Lifestyle Intervention Programme.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Child body mass 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.In addition, we have included an extra control group of children born to normal weight women, who were not part of a lifestyle intervention program during pregnancy. We have the hypothesis that the children of the normal weight women have a better metabolic profile than the children born to the obese women.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All children born to obese women who participated in the LiP study (a randomized controlled trial of lifestyle intervention during pregnancy) and children born at term to healthy women with a normal pregestational BMI.
排除标准
- •The children born to normal weight women only: preterm birth, congenital anomalies, maternal gestational diabetes, maternal diabetes mellitus, severe medical conditions in either child or mother.
结局指标
主要结局
Child body mass standard deviation score
时间窗: On average 2.9 years of age
次要结局
- anthropometric outcomes(On average 2.9 years of age)
研究者
Mette Tanvig
Medical Doctor
Odense University Hospital
