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- Klinische proef NCT02048839
Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors
SUBJECTS:
All participants in the RADIEL-study (2008-2011) who delivered (n=535), will be invited to this follow-up study, with their children (age 3-5 years) and the father. The investigations are carried out during two separate visits. The father receives mail questionnaires
OVERALL OBJECTIVES:
- To determine the long-term effectiveness of a lifestyle intervention in high risk women and their offspring a in reducing the incidence of T2DM and cardiovascular disease and their risk factors b in preventing obesity c on biomarkers d on genetic and epigenetics markers .
- To study the association between maternal diet during pregnancy and metabolic markers in the offspring at age 3-5 years.
- To study the association between maternal exercise habits during pregnancy and metabolic markers in the offspring at age 3-5 years.
- To study the association between maternal a) glucose-insulin metabolism b) lipid metabolism c) adipoinsulinar axis and d) inflammatory markers and birth size and later health outcomes in the mothers and their offspring.
- To study the association between gut microbiota and markers of offspring health
- To study associations between offspring cardiovascular morphology/function, offspring body size/composition, and maternal cardiovascular risk
- To study the cost effectiveness of the intervention.
METHODS:
Maternal measurements
- Height, weight, waist and hip circumference
- Blood pressure, pulse
- Body fat percentage
- Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone markers, DNA sample and inflammation markers
- Fecal and hair samples
- Diurnal salivary cortisol assessment
- Background questionnaire: socioeconomic and health-related background
- Health-related quality of life (15-D).
- 3-day food diary and exercise diary
- ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days
- Psychological questionnaires
- Pulse wave velocity (PWV) will be assessed
- Advanced glycation endproducts - a marker of cardiovascular health will be assessed
- Dental and oral health
- Bone health
- VHRU of arterial structure
Paternal measurements
- Background questionnaire (incl. height, weight, age)
- DNA-sample (buccal)
- 3-day food diary
- Psychological questionnaires
- Physical activity questionnaire (12 months)
Measurements of children
- Body weight, height, blood pressure, pulse
- Body fat percentage
- Psychological questionnaires
- Food and physical activities diaries
- ActiGraph, assessment of physical activity and sleep for 7 days
- Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium metabolism, DNA-sample and samples for inflammation markers
- Fecal, urine and hair samples
- A copy of child welfare center card (e.g. data on growth, immunizations, health)
- Endothelial function and pulse wave velocity (PWV)
- Bone health with peripheral CT
- Heart structure and function
- VHRU of arterial structure
TIMETABLE
Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2017 and results will be reported from 2018 onwards in international peer-reviewed journals.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
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Helsinki, Finland
- Helsinki University
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- all study subjects form Radiel intervention study, who delivered a baby
Exclusion Criteria:
- none.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
---|
Radiel Intervention group and their children
Participated the Radiel- intervention study (2008-2011) in the Intervention group: Lifestyle counselling during and after pregnancy (up to 1 year post partum)
|
Radiel Control Group with their children
Control group in the Radiel- intervention study.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Type 2 Diabetes
Tijdsspanne: 3-5 years post partum
|
3-5 years post partum
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Metabolic syndrome and cardiovascular morbidity
Tijdsspanne: 3-5 years post partum
|
3-5 years post partum
|
Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Obesity
Tijdsspanne: 3-5 years post partum
|
3-5 years post partum
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Radiel 5Y
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
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