Generation R Next - Optimaal Opgroeien

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorErasmus Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Temporary or complete withdrawal from participation

Gestational age > 12+0 at study entry

Trial design

Treatments tested in this trial

  • Standard care
  • Lifestyle program

Treatment groups

1,750 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Erasmus Medical Center

Lead sponsor

INDIGO Rijnmond

Collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Stichting Bevordering van Volkskracht

Collaborator

Stichting Achmea Gezondheidszor

Collaborator

Bernard van Leer Foundation

Collaborator

Ministerie van Volksgezondheid, Welzijn en Sport

Collaborator