Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors

Conditions
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Type 2 Diabetes, Obesity, Metabolic Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all study subjects form Radiel intervention study, who delivered a baby Exclusion Criteria: none.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radiel Intervention group and their children<br>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<br>Control group in the Radiel- intervention study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type 2 Diabetes |  | 3-5 years post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic syndrome and cardiovascular morbidity |  | 3-5 years post partum |