Diet and Well-being of Young Danish Children
- Conditions
- Biomarkers of Metabolic SyndromeOverweight or ObesityGrowth AccelerationProgramming and Tracking
- Registration Number
- NCT02170428
- Lead Sponsor
- University of Copenhagen
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
- healthy singletons born at term (week 37-43) between August 2006 and September 2007 with no disease that could influence food intake or growth
- born preterm (before week 37)
- non-Danish speaking parents.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in anthropometric measurements in periods of early childhood. 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 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.
Diet in periods of early life 9, 18 and 36 months of age The diet is recorded using self-reported 7-day record questionnaire.
Metabolic syndrome score in early life 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.
- Secondary Outcome Measures
Name Time Method Insulin like growth factor at 9 and 36 months of age 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 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 36 months of age Bone mass is measured by Dual-energy X-ray Absorptiometry
Vitamin D status in infancy 9 months of age 25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age.
Allergy and chronic diseases 9 and 36 months of age Assessment of diseases by questionnaires
Appetite hormones in infancy 9 months of age Leptin and adiponectin concentrations measured from blood samples
Change in gut microbiota 9, 18 and 36 months of age Microbiota in the faeces analysed using polymerase chain reaction (PCR)
Achievement of milestones 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 9, 18 and 36 months of age Metabolomics analysed using urine samples.
Breastfeeding duration in infancy and early childhood 9, 18 and 36 months of age Questionnaire used for assessment of exclusive and partially breastfeeding.
Trial Locations
- Locations (1)
Department of Human Nutrition, Faculty of Sciences, University of Copenhagen
🇩🇰Frederiksberg, Denmark