Diet and Well-being of Young Danish Children

Study Overview
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Brief Summary
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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
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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).

Official Title
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The SKOT I Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children

Conditions
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Overweight or Obesity, Biomarkers of Metabolic Syndrome, Programming and Tracking, Growth Acceleration

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy singletons born at term (week 37-43) between August 2006 and September 2007 with no disease that could influence food intake or growth Exclusion Criteria: born preterm (before week 37) non-Danish speaking parents.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| growth and development<br>Growth and development of a random sample of healthy Danish infants | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9, 18 and 36 months of age | 
| Body composition in early childhood | 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. | 36 months of age | 
| Metabolic syndrome score in early life | Composite outcome consisting of triglycerides, high lipoprotein (HDL) and glucose measured in plasma/serum, waist circumference and blood pressure. | 9 and 36 months of age | 
| Diet in periods of early life | The diet is recorded using self-reported 7-day record questionnaire. | 9, 18 and 36 months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breastfeeding duration in infancy and early childhood | Questionnaire used for assessment of exclusive and partially breastfeeding. | 9, 18 and 36 months of age | 
| Insulin like growth factor at 9 and 36 months of age | Insulin like growth factor-1 and insulin like growth factor binding protein-3 concentrations in plasma. | 9 and 36 months of age | 
| Physical activity, sedentary behavior and sleep in early childhood | 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. | 9, 18 and 36 months of age | 
| Bone mass in 3-year-old children | Bone mass is measured by Dual-energy X-ray Absorptiometry | 36 months of age | 
| Vitamin D status in infancy | 25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age. | 9 months of age | 
| Allergy and chronic diseases | Assessment of diseases by questionnaires | 9 and 36 months of age | 
| Appetite hormones in infancy | Leptin and adiponectin concentrations measured from blood samples | 9 months of age | 
| Change in gut microbiota | Microbiota in the faeces analysed using polymerase chain reaction (PCR) | 9, 18 and 36 months of age | 
| Achievement of milestones | 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 | 9 and 36 months of age | 
| Metabolomics in the urine | Metabolomics analysed using urine samples. | 9, 18 and 36 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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growth,, infancy,, children,, diet,, breastfeeding, complementary feeding, early life programming, tracking, physical activity