SKOT I: Diet and Well-being of Young Danish Children

Sponsor

University of Copenhagen (Other)

Overall Status

Completed

CT.gov ID

NCT02170428

Collaborator

Technical University of Denmark (Other)

263

Enrollment

Location

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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).

Study Design

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 1, 2007

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
growth and development Growth and development of a random sample of healthy Danish infants

Outcome Measures

Primary Outcome Measures

Change in anthropometric measurements in periods of early childhood. [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.
Body composition in early childhood [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.
Metabolic syndrome score in early life [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.
Diet in periods of early life [9, 18 and 36 months of age]
The diet is recorded using self-reported 7-day record questionnaire.

Secondary Outcome Measures

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