LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers): Identification of Modifiable Risk Factors for Childhood Obesity - a Follow-up of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 301
- 试验地点
- 2
- 主要终点
- Fat mass index , measured by DEXA scan.
研究概览
简要总结
The study is a follow-up of a Randomized Controlled Trial (RCT) performed in 2007-10 - the "Lifestyle in Pregnancy" LiP study.
The LiP study included 360 pregnant women with BMI ≥30 kg/m2 from Odense University Hospital and Aarhus University Hospital. The women were randomized to intervention with low-calorie diet and physical activity from gestational age 10-14 in pregnancy and until delivery - or to a standard care control group. The objective of the LiPO-Teen project is to perform a clinical follow-up study of the eligible 301 mothers who completed the trial until delivery with a liveborn child, and their 14 year-old offspring. The overall ambition is to understand whether lifestyle intervention in pregnancy prevents obesity and its complications across generations, with a specific focus on modifiable factors.
详细描述
LiPO Teen (the Lifestyle in Pregnancy and Offspring Teenagers): Identification of modifiable risk factors for childhood obesity - a follow-up of a randomized controlled trial.
The objective of the LiPO-Teen project is to perform a clinical follow-up study of the eligible 301 mothers who completed the trial until delivery with a liveborn child, and their 14 year-old offspring.
In the original trial women were randomized 1:1 to intervention or control. The participants (both mother and child in pair) who completed the initial LiP study will be invited to a 2-hour examination now 14 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
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mothers in the initial LiP study selected at the baseline study in 2007-2010
- •Teenagers of mothers in the initial LiP study
排除标准
- 未提供
结局指标
主要结局
Fat mass index , measured by DEXA scan.
时间窗: 2 years data collection
Body composition Assessed by Dual-Energy X-ray Absorptiometry (DEXA). Hologic Horizon, serie number: 301872M. Fat mass, lean mass and bone density will be calculated. Fat mass index in both mothers and offspring (Fat mass index (FMI) defined as: FM (kg) / height (m)2).
次要结局
- Electrolytes(2 years data collection)
- Leukocytes(2 years data collection)
- Blood pressure(2 years data collection)
- Metabolic markers(2 years data collection)
- Diet composition(2 years data collection)
- Physical activity (PA)(2 years data collection)
- Epigenetic examinations(2 years data collection)
- Metabolic and inflammatory markers(2 years data collection)
- Glycemic variability(2 years data collection)
- Mental health(2 years data collection)
- Puberty stage(2 years data collection)
- Leptin(2 years data collection)
- HsCRP.(2 years data collection)
- IL6(2 years data collection)
- Vitamin D(2 years data collection)
- Selenium(2 years data collection)
- Zinc.(2 years data collection)
- Ferritin(2 years data collection)
- Liver enzymes(2 years data collection)
- HbA1c(2 years data collection)
- Insulin(2 years data collection)
- C-peptide(2 years data collection)
- Adiponectin(2 years data collection)
- Kidney function (e-GFR)(2 years data collection)
研究者
Birgitte Moeller Luef
M.D, Ph.D Student
Odense University Hospital