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Diet and Well-being of Young Danish Children (SKOT I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02170428
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Technical University of Denmark
Information provided by (Responsible Party):
Arne Astrup, 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.

Condition or disease
Growth Acceleration Overweight or Obesity Biomarkers of Metabolic Syndrome Programming and Tracking

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).

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Study Type : Observational
Actual Enrollment : 263 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
growth and development
Growth and development of a random sample of healthy Danish infants



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Urine, faeces, white cells, plama/serum


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy young Danish Children selected through the National Civil Registry and invited to participate by letter.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Denmark
Department of Human Nutrition, Faculty of Sciences, University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Technical University of Denmark
Investigators
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Principal Investigator: Kim F Michaelsen, MD Professor Faculty of Science, University of Copenhagen
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Responsible Party: Arne Astrup, Professor, MD, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02170428    
Other Study ID Numbers: D201
H-KF-2007-0003 ( Other Identifier: The Committees on Biomedical Research Ethics for the Capital Region of Denmark )
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Keywords provided by Arne Astrup, University of Copenhagen:
growth,
infancy,
children,
diet,
breastfeeding
complementary feeding
early life programming
tracking
physical activity
Additional relevant MeSH terms:
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Metabolic Syndrome
Overweight
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases