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
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