Nutrition
Conditions
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.
Interventions
OTHERAntiatherogenic diet
Participants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance
Sponsors
Per Ole Iversen, MD
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular health score | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood samples - Lipid profile | 1 day | Ratio of non-HDL cholesterol to HDL cholesterol in blood |
| Anthropometry | 1 day | Waist-to-hip ratio (WHR) |
| Body fat percentage | 1 day | Measured by bioimpedance |
| Ultrasound examination of liver | 1 day | Ultrasound-Guided Attenuation Parameter (UGAP) of liver |
| Ultrasound examination of carotid artery | 1 day | Intima-media thickness in carotid artery |
| Blood samples - Glukose metabolism | 1 day | Hemoglobin A1c concentration in blood as a measure of long term blood sugar levels |
| Mean arterial pressure (MAP) | 1 day | Measured by |
Countries
Norway
Outcome results
None listed