Clinical trial NCT02170428: Diet and Well-being of Young Danish Children
Official title: The SKOT I Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Acceleration
Overweight or Obesity
Biomarkers of Metabolic Syndrome
Programming and Tracking
Keywords: growth,
infancy,
children,
diet,
breastfeeding
complementary feeding
early life programming
tracking
physical activity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Technical University of Denmark
First posted: 2014-06-23
Enrollment: 263
Sex: ALL
Minimum age (years): 9
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young Danish Children selected through the National Civil Registry and invited to participate by letter.

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).

Eligibility 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.

Primary outcomes:
measure: Change in anthropometric measurements in periods of early childhood.
timeFrame: 9, 18 and 36 months of age
measure: Body composition in early childhood
timeFrame: 36 months of age
measure: Metabolic syndrome score in early life
timeFrame: 9 and 36 months of age
measure: Diet in periods of early life
timeFrame: 9, 18 and 36 months of age
Secondary outcomes:
measure: Breastfeeding duration in infancy and early childhood
timeFrame: 9, 18 and 36 months of age
measure: Insulin like growth factor at 9 and 36 months of age
timeFrame: 9 and 36 months of age
measure: Physical activity, sedentary behavior and sleep in early childhood
timeFrame: 9, 18 and 36 months of age
measure: Bone mass in 3-year-old children
timeFrame: 36 months of age
measure: Vitamin D status in infancy
timeFrame: 9 months of age
measure: Allergy and chronic diseases
timeFrame: 9 and 36 months of age
measure: Appetite hormones in infancy
timeFrame: 9 months of age
measure: Change in gut microbiota
timeFrame: 9, 18 and 36 months of age
measure: Achievement of milestones
timeFrame: 9 and 36 months of age
measure: Metabolomics in the urine
timeFrame: 9, 18 and 36 months of age
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition, Faculty of Sciences, University of Copenhagen
Study officials:
affiliation: Faculty of Science, University of Copenhagen
name: Kim F Michaelsen, MD Professor
role: PRINCIPAL_INVESTIGATOR
References: