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

NCT02048839 | Completed

• 1 other identifier: Radiel 5Y
• Study Type: observational
• Target: 680
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To study the association between maternal diet during pregnancy and metabolic markers in the offspring at age 3-5 years.
3. 3.To study the association between maternal exercise habits during pregnancy and metabolic markers in the offspring at age 3-5 years.
4. 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. 5.To study the association between gut microbiota and markers of offspring health
6. 6.To study associations between offspring cardiovascular morphology/function, offspring body size/composition, and maternal cardiovascular risk
7. 7.To study the cost effectiveness of the intervention.
8. 8.Height, weight, waist and hip circumference
9. 9.Blood pressure, pulse
10. 10.Body fat percentage
11. 11.Blood tests e.g. markers of glucose metabolism and lipids, vitamin D, Calcium and bone markers, DNA sample and inflammation markers
12. 12.Fecal and hair samples
13. 13.Diurnal salivary cortisol assessment
14. 14.Background questionnaire: socioeconomic and health-related background
15. 15.Health-related quality of life (15-D).
16. 16.3-day food diary and exercise diary
17. 17.ArmBand (acceleration sensor), assessment of physical activity and sleep for 7 days
18. 18.Psychological questionnaires
19. 19.Pulse wave velocity (PWV) will be assessed
20. 20.Advanced glycation endproducts - a marker of cardiovascular health will be assessed
21. 21.Dental and oral health
22. 22.Bone health
23. 23.VHRU of arterial structure
24. 24.Background questionnaire (incl. height, weight, age)
25. 25.DNA-sample (buccal)
26. 26.3-day food diary
27. 27.Psychological questionnaires
28. 28.Physical activity questionnaire (12 months)
29. 29.Body weight, height, blood pressure, pulse
30. 30.Body fat percentage
31. 31.Psychological questionnaires
32. 32.Food and physical activities diaries
33. 33.ActiGraph, assessment of physical activity and sleep for 7 days
34. 34.Blood samples e.g. glucose- and insulin metabolism, lipids, vitamin D and calcium metabolism, DNA-sample and samples for inflammation markers
35. 35.Fecal, urine and hair samples
36. 36.A copy of child welfare center card (e.g. data on growth, immunizations, health)
37. 37.Endothelial function and pulse wave velocity (PWV)
38. 38.Bone health with peripheral CT
39. 39.Heart structure and function
40. 40.VHRU of arterial structure

Conditions

Type 2 Diabetes; Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Type 2 Diabetes

  3-5 years post partum

Secondary Outcomes (1)

• Metabolic syndrome and cardiovascular morbidity

  3-5 years post partum

Other Outcomes (1)

• Obesity

  3-5 years post partum

Study Arms (2)

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.

Eligibility Criteria

• Age: 3 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who participated the Radiel intervention study, and were originally randomly assigned to either active lifestyle intervention group or control group. They were all high risk women with BMI \>30 or prior gestational GDM. To this follow up-study we invite also the children born during the intervention.

You may qualify if:

• all study subjects form Radiel intervention study, who delivered a baby

You may not qualify if:

• none.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University

Helsinki, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva, hair, urine and fecal samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 29, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

FI (1)