Cardiovascular Risk Reduction-Diet in Pregnancy - Follow up 20 Years After the "CARRDIP"-Trial (CARRDIP20)

Per Ole Iversen, MD

Status: Enrolling

Conditions: Nutrition

Treatments: Other: Antiatherogenic diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05030922

20/00301

Details and patient eligibility

About

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.

Enrollment: 538 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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538 participants in 2 patient groups

Diet intervention

Experimental group

Description:

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

Treatment:

Other: Antiatherogenic diet

Control

No Intervention group

Description:

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