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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

NCT02048839 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 680

Last updated 2019-04-16

No results posted yet for this study

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

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Eligibility

Min Age
3 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Finland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02048839 on ClinicalTrials.gov