Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the "CARRDIP"-Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 538
- Locations
- 2
- Primary Endpoint
- Cardiovascular health score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Previous pregnancy complications
Arms & Interventions
Diet intervention
Follow up of both mother and offspring 20 years after allocation to an antiatherogenic diet during pregnancy.
Intervention: Antiatherogenic diet (Other)
Control
Follow up of both mother and offspring 20 years after allocation to control group during pregnancy.
Outcomes
Primary Outcomes
Cardiovascular health score
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
Per Ole Iversen, MD
Professor
University of Oslo