Twelve-year Follow-up on the Treatment of Obese Pregnant Women (TOP) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 497
- 试验地点
- 2
- 主要终点
- Body composition
研究概览
简要总结
The participant (both mother and child) in the initial TOP study will be invited to a follow-up study to evaluate the effect of life style intervention during pregnancy on both mother and their offspring 12 years after the intervention. The study will contribute to understanding the transfer of obesity between generations and how to treat as well as prevent obesity.
详细描述
The initial study (Treatment of Obese Pregnant women (TOP) study) was performed at Hvidovre Hospital, University of Copenhagen in 2009-12 and included 425 pregnant women with pre-gestational BMI ≥ 30kg/m2 in gestational week 11-14. They were randomized 1:1:1 into: 1) a low-calorie Mediterranean-style diet and pedometer assisted physical activity (PA) intervention 2) a pedometer assisted PA intervention alone or 3) no intervention (control). Primary outcome was gestational weight gain (GWG). 389 women completed the study.
The participants (both mother and child in pair) who completed the initial TOP study will be invited to a 3-hour examination now 12 years after the intervention during pregnancy to evaluate the effect of the intervention on both mother and child long term.
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
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants/mothers in the initial TOP study will be invited with their offspring born following the pregnancy during the initial study to the 12-year follow-up study
排除标准
- •There are no exclusion criteria as the potential study population has already been selected at the baseline study in 2009-2012
结局指标
主要结局
Body composition
时间窗: 2 years data collection
Fatt mass index offspring, DXA scan + BMI mothers
次要结局
- Liver stiffness(2 years data collection)
- Lung function(2 years data collection)
- Large artery stiffness(2 years data collection)
- Eye examination(2 years data collection)
- Blood pressure(2 years data collection)
- Relative fitness level(2 years data collection)
- Sex hormones(2 years data collection)
- Metabolic and inflammatory markers(2 years data collection)
- Mental health(2 years data collection)
- Glycemic variability(2 years data collection)
- Diet composition(2 years data collection)
- Level and pattern of physical activity(2 years data collection)
- Epigenetic examinations(2 years data collection)
- Puberty stage(2 years data collection)