Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the "CARRDIP"-Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 538
- 试验地点
- 2
- 主要终点
- Cardiovascular health score
研究概览
简要总结
The "Cardiovascular Risk Reduction-Diet in Pregnancy" (CARRDIP) - is a randomised controlled trial with dietary intervention during pregnancy. The participants were enrolled in Norway 20 years ago and consisted of 269 pregnant, healthy mothers. The participants were randomised 1:1 to either intervention-diet or control. The intervention diet was build upon an anti-atherogenic principle and was a so called "Mediterranean diet". The participants were monitored during pregnancy, and mother and child participated in a follow-up study 1 year after birth. The current "CARRDIP20" trial is a follow-up of the same participants, both mother and offspring, 20 years after the original intervention to measure and analyse the cardiovascular health and compare the intervention group to the control group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •from original CARRDIP-trial:
- •Non-smoking pregnant women
- •BMI 19 to 32 kg/m2 at inclusion
- •Age 21 to 38 years
- •Carrying a single foetus
排除标准
- •Previous pregnancy complications
研究组 & 干预措施
Diet intervention
Follow up of both mother and offspring 20 years after allocation to an antiatherogenic diet during pregnancy.
干预措施: Antiatherogenic diet (Other)
Control
Follow up of both mother and offspring 20 years after allocation to control group during pregnancy.
结局指标
主要结局
Cardiovascular health score
时间窗: 1 day
Cardiovascular risk score by use of the most appropriate available risk score algorithm available at time of analysis, at present the preferred calculator is Life's Simple 7 - The American Heart Association https://doi.org/10.1161/CIRCULATIONAHA.109.192703
次要结局
- Body fat percentage(1 day)
- Ultrasound examination of liver(1 day)
- Ultrasound examination of carotid artery(1 day)
- Blood samples - Glukose metabolism(1 day)
- Mean arterial pressure (MAP)(1 day)
- Anthropometry(1 day)
- Blood samples - Lipid profile(1 day)
研究者
Per Ole Iversen, MD
Professor
University of Oslo