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

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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

Tracking Information
First Submitted Date February 27, 2015
First Posted Date March 4, 2015
Last Update Posted Date March 4, 2015
Study Start Date January 2011
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 3, 2015)
  • 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)
  • 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)
  • 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)
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 3, 2015)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Metabolomics in the urine [ Time Frame: 9, 18 and 36 months of age ]
    Metabolomics analysed using urine samples. Compare findings with SKOT-I (NCT02170428)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diet and Well-being of Young Danish Children Born by Obese Mothers
Official Title The SKOT II Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children Born by Obese Mothers
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).
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).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Urine, faeces, white cells, plama/serum
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,
Condition
  • Growth
  • Overweight
  • Metabolic Syndrome
  • Obesity
Intervention Not Provided
Study Groups/Cohorts Growth and Development
Growth and Development og healthy young children born by Obese mothers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 3, 2015)
184
Original Actual Enrollment Same as current
Actual Study Completion Date February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 9 Months to 3 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02377973
Other Study ID Numbers D209
H-3-2010-122 ( Other Identifier: The Committees on Biomedical Research Ethics for the Capital Region of Denmark )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Arne Astrup, University of Copenhagen
Study Sponsor University of Copenhagen
Collaborators
  • Technical University of Denmark
  • Hvidovre University Hospital
Investigators
Principal Investigator: Kim F Michaelsen, MD Professor Faculty of Science, University of Copenhagen
PRS Account University of Copenhagen
Verification Date February 2015