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

NCT ID: NCT05030922

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

538 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2026-06-01

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.

Detailed Description

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Conditions

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Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Diet intervention

Follow up of both mother and offspring 20 years after allocation to an antiatherogenic diet during pregnancy.

Group Type EXPERIMENTAL

Antiatherogenic diet

Intervention Type OTHER

Participants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance

Control

Follow up of both mother and offspring 20 years after allocation to control group during pregnancy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Antiatherogenic diet

Participants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

Per Ole Iversen, MD

OTHER

Sponsor Role lead

Responsible Party

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Per Ole Iversen, MD

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Oslo

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Per Ole Iversen, MD

Role: CONTACT

+47 22851391

Hannibal Troensegaard, MD

Role: CONTACT

+47 46754670

Facility Contacts

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Per Ole Iversen, MD

Role: primary

+47 22851391

Hannibal Troensegaard, MD

Role: backup

+47 46754670

References

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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.

Reference Type BACKGROUND
PMID: 17547890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16202717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17217362 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37920793 (View on PubMed)

Related Links

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https://www.med.uio.no/imb/forskning/prosjekter/hjertevennlig-kost-graviditet-langtidsoppfolging/

Link to project homepage on University of Oslo domain (norwegian)

Other Identifiers

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20/00301

Identifier Type: -

Identifier Source: org_study_id

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