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.
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
Temporary or complete withdrawal from participation
Gestational age > 12+0 at study entry
Parallel
Standard care
Other interventionIndividual lifestyle consultation
Lifestyle program
Other interventionLifestyle 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.
Preterm birth
Birth of the child before 37 weeks of pregnancy
Low birthweight/small-for-gestational-age
Birthweight below 10th percentile corrected for gestational age
High birthweight/large-for-gestational-age
Birthweight above 90th percentile corrected for gestational age
Low Apgar-score
Apgar-score assessed 5 minutes after birth, below 7 is considered as low with higher chance on worse outcome (scale: 0-10)
Adherence to lifestyle advice (mother)
Lifestyle changes assessed via questionnaires during the study period
Sleep/wake rhythm (mother)
Sleep/wake rhythm assessed via questionnaires during the study period with the Munich Chronotype Questionnaire (MCTQ). 12 items
Sleep/wake rhythm (mother)
Sleep/wake rhythm assessed via questionnaires during the study period with the General Sleep Disturbances Questionnaire. 22 items, responses are given on an eight-point scale ranging from 0 (no days) to 7 (every day). The total score for the scale ranges between 0 and 154, with higher scores indicating a higher frequency of sleep disturbances.
Social support (mother)
Social support assessed via questionnaires during the study period with the Adaptive Functioning Scales Spouse/Partner. 6 items with 6-point Likert scale.
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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
