NCT02377973|Completed
Diet and Well-being of Young Danish Children Born by Obese Mothers
SKOT II
The SKOT II Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children Born by Obese Mothers
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SKOT II
The SKOT II Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children Born by Obese Mothers
Sponsor study identifier
Secondary identifiers
OTHER · The Committees on Biomedical Research Ethics for the Capital Region of Denmark
observational
184
1 country
1
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Actual (reported)Study Completion
February 2015
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
February 2015
Actual (reported)February 2015
Actual (reported)February 27, 2015
Actual (reported)March 4, 2015
Actual (reported)Change in anthropometric measurements in periods of early childhood
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)
9, 18 and 36 months of age
Body composition in early childhood
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)
36 months of age
Markers of Metabolic syndrome in early life
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)
Growth and Development og healthy young children born by Obese mothers
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,
Department of Human Nutrition, Faculty of Sciences, University of Copenhagen
Frederiksberg, 1958, Denmark
Urine, faeces, white cells, plama/serum
Kim F Michaelsen, MD Professor
Faculty of Science, University of Copenhagen
184 participants (actual enrollment reported by the registry).
First Submitted
February 27, 2015
First Posted
March 4, 2015
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Milk Components and Metabolic Syndrome
9 and 36 months of age
Diet in periods of early life
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)
9, 18 and 36 months of age
Breastfeeding duration in infancy and early childhood
9, 18 and 36 months of age
Insulin like growth factor at 9 and 36 months of age
9 and 36 months of age
Physical activity, sedentary behavior and sleep in early childhood
9, 18 and 36 months of age
Vitamin D status in infancy
9 and 36 months of age
Allergy and chronic diseases
9 and 36 months of age
Contact the study team to confirm eligibility.
Primary Completion
February 2015
Actual (reported)Study Completion
February 2015
Actual (reported)Last Updated
March 4, 2015
Record last verified: 2015-02
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Source: ClinicalTrials.gov.
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