Department of Human Nutrition, Faculty of Sciences, University of Copenhagen
Frederiksberg, 1958, Denmark
NCT Number: NCT02170428
The overall objective with the study was to contribute to the scientific basis for dietary and life strategies, policies and dietary guidelines to infants and young children in Denmark and with special focus on prevention of obesity and diet related chronic diseases such as type 2 diabetes, ischemic heart disease and osteoporosis.
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Notify Me9 month–3 year
All sexes
Observational
Frederiksberg, 1958, Denmark
The SKOT I study is a prospective cohort study monitoring healthy young children from 9 to 36 months of age. In 2007, 2211 families from Copenhagen were randomly selected through the National Civil Registry and invited to participate in the study by letter. The participants were invited to three examinations at 9 months ±2 weeks, 18 months ±4 weeks and 36 months ±3 months. A total of 330 children are included in the study, where 312 have completed the 9 months examination, 291 completed the 18 months examination and 263 completed the 3-year examination. All examinations took place at Department of Nutrition, Exercise and Sports, Frederiksberg Denmark. The examinations involved collecting a broad spectrum of data. Following data were collected: anthropometry (weight, height, age- and sex-specific Z-scores for body composition, triceps and subscapularis skinfolds), background interview (concerning 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 sample, blood samples (9 and 36 months), Bio impedance analysis (36 months), 7 day diet registration, general questionaire (concerning e.g. sleep, daycare, attendance and use of screen devices), psychomotor questionnaire (motoric development), 7 day physical activity monitoring and dual energy x-ray absorptiometry scan (36 months).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 9, 18 and 36 months of age
The diet is recorded using self-reported 7-day record questionnaire.
Time frame: 9, 18 and 36 months of age
Questionnaire used for assessment of exclusive and partially breastfeeding.
Time frame: 9 and 36 months of age
Insulin like growth factor-1 and insulin like growth factor binding protein-3 concentrations in plasma.
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.
Time frame: 36 months of age
Bone mass is measured by Dual-energy X-ray Absorptiometry
Time frame: 9 months of age
25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age.
Time frame: 9 and 36 months of age
Assessment of diseases by questionnaires
Time frame: 9 months of age
Leptin and adiponectin concentrations measured from blood samples
Time frame: 9, 18 and 36 months of age
Microbiota in the faeces analysed using polymerase chain reaction (PCR)
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
Time frame: 9, 18 and 36 months of age
Metabolomics analysed using urine samples.
University of Copenhagen
Other
The SKOT I Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children
Acronym: SKOT I
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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