Effect of Weight Loss and Lactation on Cardiovascular Risk Factors (the EVA-trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Changes in body weight (kg) between visits.
研究概览
简要总结
A randomized controlled trial aiming to investigate the effects and possible interactions of diet induced weight loss and lactation on cardiometabolic profile
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women in gestational week <32, with a pre-pregnant BMI 25-35 kg/m2
- •Residence in Oslo/Bærum and surrounding area
- •Intention to breastfeed their child
- •Able to read and write in Norwegian.
排除标准
- •Medication that influences lipid or glucose metabolism
- •Chronic disease that influences lipid or glucose metabolism (e.g. diabetes (World Health Organization, WHO, 2006) or diabetes in pregnancy (WHO 2013))
- •Premature birth (before week 36)
- •Preeclampsia
- •Previous breast reducing surgery
结局指标
主要结局
Changes in body weight (kg) between visits.
时间窗: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Measured in light clothing without shoes. Together with measured height (m) will be used to calculate Body Mass Index.
Changes in markers of lipid- and glucose metabolism between visits.
时间窗: Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum)
Measured in mmol/l: total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides and glucose In percentage: HbA1c In pmol/l: insulin.
次要结局
- Changes in blood pressure, diastolic and systolic between visits(Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (15 months postpartum))
- Changes in body composition (fat free mass in kg and fat mass in kg) between visits.(Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum))
- Changes in lipid subclasses (mmol/l), lipoprotein size (nm) and apolipoproteins between visits(Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum))
- Changes in waist and hip (cm) circumference between visits(Visit 1 (2 weeks postpartum, visit 2 (6 months postpartum) and visit 3 (post weaning ~15 months postpartum))
研究者
Hilde Kristin Brekke
Professor
University of Oslo