The general aim of the Generation R Study is to examine environmental and genetic causes that influence growth, development and health during fetal life, childhood and adulthood.The more specific aims of the study are: (1) To describe normal and…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Psychiatric and behavioural symptoms NEC
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The datacollection is divided into several outcomes:
- asthma
- bacterial carriage and infectious disease
- bone density
- cognition
- ethnic and social-economic health inequalities
- behaviour
- growth, overweight and obesity
- neural development
- quality of life
- body composition
- stress reactivity
- risk factors for cardiovasculair disease in children
- risk factors for cardiovasculair disease in women
- musculo-skeletale developement
- circadian rhythm
- physical activity
- sleep
Secondary outcome
not applicable
Background summary
The Generation R Study is a population-based prospective cohort study from
fetal life until young adulthood. The study is designed to identify early
environmental and genetic causes of normal and abnormal growth, development and
health during fetal life, childhood and
adulthood. The study focuses on four primary areas of research: (1) growth and
physical development; (2) behavioural and cognitive development; (3) diseases
in childhood; and (4) health and healthcare for pregnant women and children.
The Study is divided in several phases. In Phase 3 all children and their
mothters are followed from 5- 16 years. The Phase 3 - Focus at 9 all children
and their mothers are examined around the age of 9/10. Our proposed project is
based on available data (behaviour problems and sleep problems at multiple time
points, familial regularity, and harsh parenting), and will add new data:
actimetry assessments of circadian activity paterns, and epigenetic profiling
across multiple circadian clock genes.
Study objective
The general aim of the Generation R Study is to examine environmental and
genetic causes that influence growth, development and health during fetal life,
childhood and adulthood.
The more specific aims of the study are:
(1) To describe normal and abnormal growth, development and health from fetal
life until young adulthood;
(2) To identify biological, environmental and social determinants of normal and
abnormal growth, development and health from fetal life
until young adulthood;
(3) To develop and evaluate strategies for prevention and early identification
of groups at risk.
Study design
During Phase 3 of the Generation R study children and their mothers will be
examined every three years. The measurements centered around the age of 5 years
have been performed from 2008-2012 and recently finished. The Phase 3 - Focus
at 9 visit is aimed at children and their mothers around 9/10 years of age.
After this the participants will be invited around 13 and 16 years of age. The
visits at the research center will take around 2.5 hours. Furthermore, the
parents of the children will receive 1 or 2 questionnaires a year focused on
behaviour, development, life style habits and circumstances of the child.
Finally, based on information from the questionnaires, medical information
about the child will be collected from general practioners, medical
specialists, pharmacies and community health centers. Additional to study
diurnal rhythm, children wear an actigaphy watch for 9 days.
During the Focus at 9 visit several measurements on the children and their
mothers are performed:
* Allergological exam ;
* Ultrasound measurements;
* Dual Energy X Absorptiometry (Dexa) measurements (total body, left hand);
* Behavioural research;
* Hearing measurements;
* Exam of the face and jaw development;
* Physical Exam;
* Pulmonary exam;
MRI exam;
* Motor function exam;
* Retinal exam;
* Dental exam;
* Visus exam;
* Dexa right hip, spinal cord;
Peripheral Quantitative Computed Tomography (pQCT) proximale
tibia;
Mechanography/jumping plate exam;
Actigraphy exam;
Study burden and risks
The burden of participation in the Generation R Study will be on average 1.25
hours a year for the child and the mother.
There are no risks related to participation in the Generation R Study.
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Listed location countries
Age
Inclusion criteria
Pariticipation in Generation R Phase 3
Consent for participation in Generation R Phase 3
Exclusion criteria
Temporary or fully withdrawn from participating in the Generation R Study
Death of the child
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL40020.078.12 |