Diet and Well-being of Young Danish Children (SKOT I)
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|ClinicalTrials.gov Identifier: NCT02170428|
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : November 13, 2019
|Condition or disease|
|Growth Acceleration Overweight or Obesity Biomarkers of Metabolic Syndrome Programming and Tracking|
|Study Type :||Observational|
|Actual Enrollment :||263 participants|
|Official Title:||The SKOT I Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
growth and development
Growth and development of a random sample of healthy Danish infants
- 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.
- Body composition in early childhood [ Time Frame: 36 months of age ]Body composition is measures by Dual-energy X-ray Absorptiometry and bio impedance. Fat mass, fat mass index (kg/m2), fat free mass index (kg/m2) are calculated.
- Metabolic syndrome score in early life [ Time Frame: 9 and 36 months of age ]Composite outcome consisting of triglycerides, high lipoprotein (HDL) and glucose measured in plasma/serum, waist circumference and blood pressure.
- Diet in periods of early life [ Time Frame: 9, 18 and 36 months of age ]The diet is recorded using self-reported 7-day record questionnaire.
- 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.
- 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.
- 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.
- Bone mass in 3-year-old children [ Time Frame: 36 months of age ]Bone mass is measured by Dual-energy X-ray Absorptiometry
- Vitamin D status in infancy [ Time Frame: 9 months of age ]25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age.
- Allergy and chronic diseases [ Time Frame: 9 and 36 months of age ]Assessment of diseases by questionnaires
- Appetite hormones in infancy [ Time Frame: 9 months of age ]Leptin and adiponectin concentrations measured from blood samples
- Change in gut microbiota [ Time Frame: 9, 18 and 36 months of age ]Microbiota in the faeces analysed using polymerase chain reaction (PCR)
- 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
- Metabolomics in the urine [ Time Frame: 9, 18 and 36 months of age ]Metabolomics analysed using urine samples.
Biospecimen Retention: Samples With DNA
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): NCT02170428
|Department of Human Nutrition, Faculty of Sciences, University of Copenhagen|
|Frederiksberg, Denmark, 1958|
|Principal Investigator:||Kim F Michaelsen, MD Professor||Faculty of Science, University of Copenhagen|