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

NCT ID: NCT02048839

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 680 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-08-31

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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

Radiel Control Group with their children

Control group in the Radiel- intervention study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Saila Koivusalo

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Helsinki University

Helsinki, , Finland

Countries

Finland

Other Identifiers

Radiel 5Y

Identifier Type: -

Identifier Source: org_study_id