RecruitingNot ApplicableNCT05870878

Generation R Next - Optimaal Opgroeien


Sponsor

Erasmus Medical Center

Enrollment

1,750 participants

Start Date

Jan 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this randomized controlled trial is to improve birth outcomes and long-term outcomes in mother and child by optimizing lifestyle,nutrition and stress experience in the preconception period and early pregnancy in women and men The main research question that will be addressed is: Does an intervention focused on optimizing preconception and early pregnancy lifestyle, nutrition and stress improve the birth outcomes and long-term outcomes in mother and child? Participants will receive an individual lifestyle consultation at the start of the study. Depending on their study arm, participants will receive an additional lifestyle program focused on health during preconception and early pregnancy, coping with stress and adherence to a healthy(er) lifestyle. The given advices are based on national guidelines. Researchers will compare the intervention group and control group to see if (adherence to) this lifestyle program improve birth outcomes and long-term outcomes in mother and child.


Eligibility

Sex: FEMALE

Inclusion Criteria5

  • Women and their parents:
  • Planning a pregnancy or early pregnancy up to \< 12 weeks
  • With the presence of at least one of the predetermined risk factors
  • Residential address in the municipality of Rotterdam and expected residential address in the municipality of Rotterdam at the birth of their child
  • Consent for participation

Exclusion Criteria3

  • Women and their partners:
  • Temporary or complete withdrawal from participation
  • Gestational age \> 12+0 at study entry

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Interventions

OTHERStandard care

Individual lifestyle consultation

OTHERLifestyle program

Lifestyle program focusing on lifestyle advice, coping with stress and adherence to a healthy(er) lifestyle. This program consists of 3 group sessions and an online platform.


Locations(1)

Erasmus MC

Rotterdam, Netherlands

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NCT05870878


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