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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet intervention | Experimental | Follow up of both mother and offspring 20 years after allocation to an antiatherogenic diet during pregnancy. |
|
| Control | No Intervention | Follow up of both mother and offspring 20 years after allocation to control group during pregnancy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiatherogenic diet | Other | Participants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance |
|
| 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 |
| 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 |
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Inclusion Criteria from original CARRDIP-trial:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oslo | Oslo | Oslo | 0254 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17547890 | Background | Khoury J, Haugen G, Tonstad S, Froslie KF, Henriksen T. Effect of a cholesterol-lowering diet during pregnancy on maternal and fetal Doppler velocimetry: the CARRDIP study. Am J Obstet Gynecol. 2007 Jun;196(6):549.e1-7. doi: 10.1016/j.ajog.2007.01.017. | |
| 16202717 | Background | Khoury J, Henriksen T, Christophersen B, Tonstad S. Effect of a cholesterol-lowering diet on maternal, cord, and neonatal lipids, and pregnancy outcome: a randomized clinical trial. Am J Obstet Gynecol. 2005 Oct;193(4):1292-301. doi: 10.1016/j.ajog.2005.05.016. |
| Label | URL |
|---|---|
| Link to project homepage on University of Oslo domain (norwegian) | View source |
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There is no current plan to share individual patient data due to limitations in ethical approval and data protection considerations of the project.
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| 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 |
| 17217362 | Background | Khoury J, Henriksen T, Seljeflot I, Morkrid L, Froslie KF, Tonstad S. Effects of an antiatherogenic diet during pregnancy on markers of maternal and fetal endothelial activation and inflammation: the CARRDIP study. BJOG. 2007 Mar;114(3):279-88. doi: 10.1111/j.1471-0528.2006.01187.x. |
| 37920793 | Derived | Troensegaard H, Khoury J, Westerberg AC, Tonstad S, Roeters van Lennep J, Veierod MB, Iversen PO, Holven KB, Retterstol K. Protocol for a 20-year follow-up after a randomized controlled trial of a Mediterranean diet in pregnancy: maternal and offspring risk factors for cardiovascular disease. Front Pediatr. 2023 Oct 18;11:1256815. doi: 10.3389/fped.2023.1256815. eCollection 2023. |