Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the CARRDIP-Trial

Study Overview
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Brief Summary
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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.

Official Title
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Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the CARRDIP-Trial

Conditions
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Nutrition

Intervention / Treatment
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* Other: Antiatherogenic diet


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet intervention<br>Follow up of both mother and offspring 20 years after allocation to an antiatherogenic diet during pregnancy. | Other: Antiatherogenic diet<br>* Participants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance<br>|
| No Intervention: Control<br>Follow up of both mother and offspring 20 years after allocation to control group during pregnancy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular health score | 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 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples - Lipid profile | Ratio of non-HDL cholesterol to HDL cholesterol in blood | 1 day | 
| Blood samples - Lipid profile | Lipoprotein a concentration in blood | 1 day | 
| Anthropometry | Waist-to-hip ratio (WHR) | 1 day | 
| Body fat percentage | Measured by bioimpedance | 1 day | 
| Ultrasound examination of liver | Ultrasound-Guided Attenuation Parameter (UGAP) of liver | 1 day | 
| Ultrasound examination of carotid artery | Intima-media thickness in carotid artery | 1 day | 
| Blood samples - Glukose metabolism | Hemoglobin A1c concentration in blood as a measure of long term blood sugar levels | 1 day | 
| Mean arterial pressure (MAP) | Measured by | 1 day |