|- candidate number||8752|
|- NTR Number||NTR2646|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-dec-2010|
|- Secondary IDs||2010/251 METC VUMC|
|- Public Title||LINC-study: LInking EDCs in maternal Nutrition and Child health.|
|- Scientific Title||LINC-study: LInking EDCs in maternal Nutrition and Child health.|
|- hypothesis||It is hypothesized that increased prenatal exposure to Endocrine Disrupting Chemicals (EDCs) is related to an increased risk of obesity later in life.|
|- Healt Condition(s) or Problem(s) studied||Endocrine Disrupting Chemicals, Prenatal exposure, Childhood obesity|
|- Inclusion criteria||Women eligible for participation should be living in the area of Zwolle and shoud be less than twelve weeks pregnant at their first visit to the midwifery clinic. They should be able to fill out Dutch questionnaires. Incapacitated subjects will not be asked to participate.|
|- Exclusion criteria||Women with pre-eclampsia or twin pregnancies are excluded from further participation. Preeclampsia is defined as pregnancy-induced hypertension (1x > diastolic pressure > 90 mmHg) in association with proteinuria (>0.3 g/day). Furthermore major congenital anomalies at birth will be reason for exclusion.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||17-jan-2011|
|- planned closingdate||1-okt-2013|
|- Target number of participants||500|
|- Interventions||No intervention is planned as this is an observational study.|
|- Primary outcome||The main study endpoint is BMI at the age of twelve months in relation to levels of exposure markers of EDCs in cord blood.|
|- Secondary outcome||1. Gestational age;|
2. Birth weight;
3. Birth height;
4. Head circumference (at birth, 6 and 12 months);
5. Waist circumference (at birth, 6 and 12 months);
9. Behaviour, sleep, crying.
|- Timepoints||Birth, six months and twelve months.|
|- Trial web site||http://linc.theobelixproject.org|
|- CONTACT FOR PUBLIC QUERIES||MSc. Marijke Cock, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Margot Eck, van, Sluijs, van der - Bor, van der|
|- Sponsor/Initiator ||Vrije Universiteit Amsterdam|
(Source(s) of Monetary or Material Support)
|Vrije Universiteit Amsterdam, European Union: KBBE-2B-227391|
|- Brief summary||Rationale: |
Obesity prevalence is still increasing, which reflects the complexity of treatment. Emphasis is shifting towards prevention; however more knowledge is needed on the aetiology of obesity. A certain class of chemicals has the ability to mimic hormones, disturbing endocrine pathways. Animal studies have shown that prenatal exposure to some of these endocrine disrupting chemicals (EDCs) increases body weight in offspring. However, prospective studies in humans are lacking. It is hypothesized that increased prenatal exposure to EDCs is related to an increased risk of obesity later in life.
To relate exposure markers of EDCs with effect biomarkers, health outcome data and other parameters via multiple regression and multivariate analysis, while taking into account relevant confounders and covariates.
This project is embedded in a European multidisciplinary study in which four cohorts participate, in combination with results obtained from animal studies. The current project is designed as an observational cohort study.
The cohort (N = 500) will be based on women living in the city of Zwolle. Women eligible for participation should be less than twelve weeks pregnant at their first visit to the midwifery clinic. They should be able to fill out Dutch questionnaires.
Main study parameters/endpoints:
The main study endpoint is BMI at the age of twelve months in relation to levels of exposure markers of EDCs in cord blood.
Data will be primarily obtained from regular health care as it is provided for women and children (midwifery clinics and youth health care). Further data on maternal health topics, demographics, diet and exposure of mother and child will be collected by means of questionnaires and collection and analysis of cord blood.
Exposure variables will be categorized in tertiles and it will be tested whether BMI differs significantly between these tertiles. Stepwise regression will be used to quantify the relation between BMI and exposure. Predefined models will be tested which include important covariates.
|- Main changes (audit trail)|
|- RECORD||8-dec-2010 - 27-dec-2010|