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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02048839
First Posted: January 29, 2014
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Saila Koivusalo, Helsinki University
  Purpose

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.


Condition
Type 2 Diabetes Obesity Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Effects of Lifestyle Intervention During Pregnancy in High Risk Women and in Their Offspring - Role of Environmental, Genetic and Epigenetic Factors

Resource links provided by NLM:


Further study details as provided by Saila Koivusalo, Helsinki University:

Primary Outcome Measures:
  • Type 2 Diabetes [ Time Frame: 3-5 years post partum ]

Secondary Outcome Measures:
  • Metabolic syndrome and cardiovascular morbidity [ Time Frame: 3-5 years post partum ]

Other Outcome Measures:
  • Obesity [ Time Frame: 3-5 years post partum ]

Biospecimen Retention:   Samples With DNA
Blood, saliva, hair, urine and fecal samples

Enrollment: 680
Study Start Date: January 2014
Study Completion Date: August 2017
Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048839


Locations
Finland
Helsinki University
Helsinki, Finland
Sponsors and Collaborators
Helsinki University
  More Information

Responsible Party: Saila Koivusalo, MD PhD, Helsinki University
ClinicalTrials.gov Identifier: NCT02048839     History of Changes
Other Study ID Numbers: Radiel 5Y
First Submitted: January 27, 2014
First Posted: January 29, 2014
Last Update Posted: September 7, 2017
Last Verified: August 2015

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases