- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland
- Helsinki University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all study subjects form Radiel intervention study, who delivered a baby
Exclusion Criteria:
- none.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Type 2 Diabetes
Time Frame: 3-5 years post partum
|
3-5 years post partum
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Metabolic syndrome and cardiovascular morbidity
Time Frame: 3-5 years post partum
|
3-5 years post partum
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Obesity
Time Frame: 3-5 years post partum
|
3-5 years post partum
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Radiel 5Y
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain