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Diet and Well-being of Young Danish Children Born by Obese Mothers (SKOT II)

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.
 
ClinicalTrials.gov Identifier: NCT02377973
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : March 4, 2015
Sponsor:
Collaborators:
Technical University of Denmark
Hvidovre University Hospital
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

Brief Summary:
The overall aim is to provide a detailed description of growth, development and risk factors for later disease, especially obesity and metabolic disease in infants born by obese mothers and to compare them with a group of infants born by mothers without any restriction in prepregnancy BMI (SKOT I).

Condition or disease
Growth Overweight Metabolic Syndrome Obesity

Detailed Description:
The SKOT II is a prospective cohort study that includes children of obese mothers with a body mass index over 30 kg/m2. These mothers were invited to SKOT II while participating in a randomised study at Hvidovre Hospital, Copenhagen. The families were invited to three examinations, when the children were 9, 18 and 36 months of age. A total of 184 children were included in 2010. The examinations and the collecting of data are designed in the same way as SKOT I, a study of healthy children born by non-obese mother. The examinations takes place at Department of Nutrition, Exercise and Sports, Frederiksberg, Denmark. Following data were collected during the examinations: Anthropometry (weight, height, age- and sex specific Z scores for body composition, triceps- and subscapularis skinfolds), background interview (e.g. infant feeding, household income, the parent's educational level, allergy and chronic diseases), blood pressure (systolic, diastolic and mean arterial pressure), faeces- and urine samples, blood samples (at 9 and 36 months of age), bio impedance (at 36 months of age), 4 day diet registration, general questionnaire (e.g. sleep, daycare, attendance and use of screen devices), psychomotor questionnaire (motoric development) and 7 day physical activity monitoring (at 36 months of age).

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Study Type : Observational
Actual Enrollment : 184 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The SKOT II Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children Born by Obese Mothers
Study Start Date : January 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Group/Cohort
Growth and Development
Growth and Development og healthy young children born by Obese mothers



Primary Outcome Measures :
  1. Change in anthropometric measurements in periods of early childhood [ Time Frame: 9, 18 and 36 months of age ]
    Composite outcome consisting of body weight, height, body mass index (BMI) and BMI z-scores, waist-, upper arm- and head circumference, skinfold thickness measured at subscapularis and triceps. Compare the changes with those observed in SKOT-I (NCT02170428)

  2. Body composition in early childhood [ Time Frame: 36 months of age ]
    Body composition is measures by bio impedance. Fat mass, fat mass index (kg/m2), fat free mass index (kg/m2) are calculated. Compare the measurements with those observed in SKOT-I (NCT02170428)

  3. Markers of Metabolic syndrome in early life [ Time Frame: 9 and 36 months of age ]
    Markers consisting of triglycerides, high lipoprotein (HDL) and glucose measured in plasma/serum, waist circumference and blood pressure. Compare the measurements with those observed in SKOT-I (NCT02170428)

  4. Diet in periods of early life [ Time Frame: 9, 18 and 36 months of age ]
    The diet is recorded using self-reported record questionnaire (7 days at 9 and 18 month, 4 days at 36 month). Compare diet with the SKOT-I cohort (NCT02170428)


Secondary Outcome Measures :
  1. Breastfeeding duration in infancy and early childhood [ Time Frame: 9, 18 and 36 months of age ]
    Questionnaire used for assessment of exclusive and partially breastfeeding. Compare the duration with SKOT-I cohort (NCT02170428)

  2. Insulin like growth factor at 9 and 36 months of age [ Time Frame: 9 and 36 months of age ]
    Insulin like growth factor-1 and insulin like growth factor binding protein-3 concentrations in plasma. Compare the measurements with those observed in SKOT-I (NCT02170428)

  3. Physical activity, sedentary behavior and sleep in early childhood [ Time Frame: 9, 18 and 36 months of age ]
    Physical activity and sedentary behavior measured by ActiGrafph GT3X accelerometer, recording for 24 hours in 7 days at 36 months of age. Information on outdoor activity, sedentary behavior and night sleep are collected through questionnaires at 9, 18 and 36. months of age. Compare the measurements with those observed in SKOT-I (NCT02170428)

  4. Vitamin D status in infancy [ Time Frame: 9 and 36 months of age ]
    25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age. Compare the measurements with those observed in SKOT-I (NCT02170428)

  5. Allergy and chronic diseases [ Time Frame: 9 and 36 months of age ]
    Assessment of diseases by questionnaires. Compare frequencies with those observed in SKOT-I (NCT02170428)

  6. Appetite hormones in infancy [ Time Frame: 9 and 36 months of age ]
    Leptin and adiponectin concentrations measured from blood samples. Compare the measurements with those observed in SKOT-I (NCT02170428)

  7. Change in gut microbiota [ Time Frame: : 9, 18 and 36 months of age ]
    Microbiota in the faeces analysed using polymerase chain reaction (PCR). Compare findings with SKOT-I (NCT02170428)

  8. Achievement of milestones [ Time Frame: 9 and 36 months of age ]
    Achievement of age-specific milestones by questionnaires; WHO questionnaires at 9 and 36 months of age and Ages & Stages Questionnaires (ASQ) at 36 months of age. Compare findings with SKOT-I (NCT02170428)

  9. Metabolomics in the urine [ Time Frame: 9, 18 and 36 months of age ]
    Metabolomics analysed using urine samples. Compare findings with SKOT-I (NCT02170428)


Biospecimen Retention:   Samples With DNA
Urine, faeces, white cells, plama/serum


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy young Danish infants born by obese morthers, who during pregnancy were part of a intervention study at Hvidovre Hospital. In the intervention at Hvidovre Hospital study the mothers were asked to join SKOT II,
Criteria

Inclusion Criteria:

  • Healthy singletons born at term (week 37-43) with no disease that could influence food intake or growth. Born by obese mother (BMI ≥ 30 kg/m2) Mothers participated in a intervention study at Hvidovre Hospital

Exclusion Criteria:

  • Born preterm (before week 37) Non-Danish speaking parents. Chronic disease that is expected to influence growth or food intake.

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): NCT02377973


Locations
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Denmark
Department of Human Nutrition, Faculty of Sciences, University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Technical University of Denmark
Hvidovre University Hospital
Investigators
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Principal Investigator: Kim F Michaelsen, MD Professor Faculty of Science, University of Copenhagen
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Responsible Party: Arne Astrup, Professor MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02377973    
Other Study ID Numbers: D209
H-3-2010-122 ( Other Identifier: The Committees on Biomedical Research Ethics for the Capital Region of Denmark )
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: February 2015
Keywords provided by Arne Astrup, University of Copenhagen:
growth,
infancy,
children,
diet,
breastfeeding
complementary feeding
early life programming
tracking
physical activity
Additional relevant MeSH terms:
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Metabolic Syndrome
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases