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Completed

NCT Number: NCT02170428

Diet and Well-being of Young Danish Children

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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Key information

Age range

9 month–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Human Nutrition, Faculty of Sciences, University of Copenhagen

Frederiksberg, 1958, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Bone mass in 3-year-old children

    Time frame: 36 months of age

    Bone mass is measured by Dual-energy X-ray Absorptiometry

  5. 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.

  6. Allergy and chronic diseases

    Time frame: 9 and 36 months of age

    Assessment of diseases by questionnaires

  7. Appetite hormones in infancy

    Time frame: 9 months of age

    Leptin and adiponectin concentrations measured from blood samples

  8. Change in gut microbiota

    Time frame: 9, 18 and 36 months of age

    Microbiota in the faeces analysed using polymerase chain reaction (PCR)

  9. 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

  10. Metabolomics in the urine

    Time frame: 9, 18 and 36 months of age

    Metabolomics analysed using urine samples.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Technical University of Denmark

Registry information

Official study title

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

Acronym: SKOT I

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2014
Registry last updated
Nov 13, 2019

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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