NCT05030922

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
538

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2021Jun 2027

First Submitted

Initial submission to the registry

August 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

August 20, 2021

Last Update Submit

April 27, 2026

Conditions

Nutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Blood samples - Lipid profile

    1 day

  • Blood samples - Lipid profile

    1 day

  • Anthropometry

    1 day

  • Body fat percentage

    1 day

  • Ultrasound examination of liver

    1 day

  • +3 more secondary outcomes

Study Arms (2)

Diet intervention

EXPERIMENTAL

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

Other: Antiatherogenic diet

Control

NO INTERVENTION

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

Interventions

Antiatherogenic dietOTHER

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

Diet intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking pregnant women
  • Age 21 to 38 years
  • Carrying a single foetus

You may not qualify if:

  • Previous pregnancy complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, Oslo, 0254, Norway

Location

Related Publications (4)

  • 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.

    PMID: 17547890BACKGROUND

  • 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.

    PMID: 16202717BACKGROUND

  • 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.

    PMID: 17217362BACKGROUND

  • 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.

    PMID: 37920793DERIVED

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 20, 2021

First Posted

September 1, 2021

Study Start

December 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

There is no current plan to share individual patient data due to limitations in ethical approval and data protection considerations of the project.

Locations

NO(1)