Skip to content

Diet and Well-being of Young Danish Children

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02170428
Acronym
SKOT I
Enrollment
263
Registered
2014-06-23
Start date
2007-05-31
Completion date
2010-10-31
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

growth,, infancy,, children,, diet,, breastfeeding, complementary feeding, early life programming, tracking, physical activity

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).

Interventions

None listed

Sponsors

Technical University of Denmark
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Months to 3 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in anthropometric measurements in periods of early childhood.9, 18 and 36 months of ageComposite 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 childhood36 months of ageBody 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.
Metabolic syndrome score in early life9 and 36 months of ageComposite outcome consisting of triglycerides, high lipoprotein (HDL) and glucose measured in plasma/serum, waist circumference and blood pressure.
Diet in periods of early life9, 18 and 36 months of ageThe diet is recorded using self-reported 7-day record questionnaire.

Secondary

MeasureTime frameDescription
Vitamin D status in infancy9 months of age25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age.
Allergy and chronic diseases9 and 36 months of ageAssessment of diseases by questionnaires
Appetite hormones in infancy9 months of ageLeptin and adiponectin concentrations measured from blood samples
Breastfeeding duration in infancy and early childhood9, 18 and 36 months of ageQuestionnaire used for assessment of exclusive and partially breastfeeding.
Achievement of milestones9 and 36 months of ageAchievement 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 urine9, 18 and 36 months of ageMetabolomics analysed using urine samples.
Change in gut microbiota9, 18 and 36 months of ageMicrobiota in the faeces analysed using polymerase chain reaction (PCR)
Insulin like growth factor at 9 and 36 months of age9 and 36 months of ageInsulin like growth factor-1 and insulin like growth factor binding protein-3 concentrations in plasma.
Physical activity, sedentary behavior and sleep in early childhood9, 18 and 36 months of agePhysical 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 children36 months of ageBone mass is measured by Dual-energy X-ray Absorptiometry

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026