Trial record 13 of 214 for:    (childhood OR child) AND (female OR girl) AND obesity NOT (male OR men)

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 is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Saila Koivusalo, Helsinki University
ClinicalTrials.gov Identifier:
NCT02048839
First received: January 27, 2014
Last updated: July 28, 2014
Last verified: July 2014
  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

    1. in reducing the incidence of T2DM and cardiovascular disease and their risk factors
    2. in preventing obesity
    3. on biomarkers
    4. 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 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

Paternal measurements

  1. Background questionnaire (incl. height, weight, age)
  2. DNA-sample (buccal)
  3. 3-day food diary
  4. Psychological questionnaires

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, 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)

TIMETABLE

Follow up starts in January 2014, and will continue until 2018. Data analysis starts in 2016 and results will be reported from 2016 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 Helsinki University:

Primary Outcome Measures:
  • Type 2 Diabetes [ Time Frame: 3-5 years post partum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolic syndrome and cardiovascular morbidity [ Time Frame: 3-5 years post partum ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Obesity [ Time Frame: 3-5 years post partum ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood, saliva, hair, urine and fecal samples


Estimated Enrollment: 550
Study Start Date: January 2014
Estimated Primary Completion Date: February 2018 (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

Ages Eligible for Study:   3 Years to 50 Years
Genders Eligible for Study:   Both
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:

  • none.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02048839

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

No publications provided

Responsible Party: Saila Koivusalo, MD PhD, Helsinki University
ClinicalTrials.gov Identifier: NCT02048839     History of Changes
Other Study ID Numbers: Radiel 5Y
Study First Received: January 27, 2014
Last Updated: July 28, 2014
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Obesity
Diabetes Mellitus, Type 2
Metabolic Syndrome X
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on August 28, 2014