NCT02048839

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 680 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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: 1. 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 . 2. To study the association between maternal diet during pregnancy and metabolic markers in the offspring at age 3-5 years. 3. To study the association between maternal exercise habits during pregnancy and metabolic markers in the offspring at age 3-5 years. 4. 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. 5. To study the association between gut microbiota and markers of offspring health 6. To study associations between offspring cardiovascular morphology/function, offspring body size/composition, and maternal cardiovascular risk 7. To study the cost effectiveness of the intervention. METHODS: Maternal measurements 1. Height, weight, waist and hip circumference 2. Blood pressure, pulse 3. Body fat percentage 4. Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone markers, DNA sample and inflammation markers 5. Fecal and hair samples 6. Diurnal salivary cortisol assessment 7. Background questionnaire: socioeconomic and health-related background 8. Health-related quality of life (15-D). 9. 3-day food diary and exercise diary 10. ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days 11. Psychological questionnaires 12. Pulse wave velocity (PWV) will be assessed 13. Advanced glycation endproducts - a marker of cardiovascular health will be assessed 14. Dental and oral health 15. Bone health 16. VHRU of arterial structure Paternal measurements 1. Background questionnaire (incl. height, weight, age) 2. DNA-sample (buccal) 3. 3-day food diary 4. Psychological questionnaires 5. Physical activity questionnaire (12 months) Measurements of children 1. Body weight, height, blood pressure, pulse 2. Body fat percentage 3. Psychological questionnaires 4. Food and physical activities diaries 5. ActiGraph, assessment of physical activity and sleep for 7 days 6. Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium metabolism, DNA-sample and samples for inflammation markers 7. Fecal, urine and hair samples 8. A copy of child welfare center card (e.g. data on growth, immunizations, health) 9. Endothelial function and pulse wave velocity (PWV) 10. Bone health with peripheral CT 11. Heart structure and function 12. 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.

Conditions

• Type 2 Diabetes
• Obesity
• Metabolic Syndrome

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2014-01-29
• Last updated: 2019-04-16

Locations

1 site across 1 country: Finland