Diet and Well-being of Young Danish Children

Overweight or Obesity Clinical Trial

— SKOT I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170428
• Other study ID #: D201
• Secondary ID: H-KF-2007-0003
• Status: Completed
• Start date: May 2007
• Est. completion date: October 2010

Study information

• Verified date: November 2019
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Faculty of Sciences, University of Copenhagen	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Technical University of Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anthropometric measurements in periods of early childhood.	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.	9, 18 and 36 months of age
Primary	Body composition in early childhood	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.	36 months of age
Primary	Metabolic syndrome score in early life	Composite outcome consisting of triglycerides, high lipoprotein (HDL) and glucose measured in plasma/serum, waist circumference and blood pressure.	9 and 36 months of age
Primary	Diet in periods of early life	The diet is recorded using self-reported 7-day record questionnaire.	9, 18 and 36 months of age
Secondary	Breastfeeding duration in infancy and early childhood	Questionnaire used for assessment of exclusive and partially breastfeeding.	9, 18 and 36 months of age
Secondary	Insulin like growth factor at 9 and 36 months of age	Insulin like growth factor-1 and insulin like growth factor binding protein-3 concentrations in plasma.	9 and 36 months of age
Secondary	Physical activity, sedentary behavior and sleep in early childhood	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.	9, 18 and 36 months of age
Secondary	Bone mass in 3-year-old children	Bone mass is measured by Dual-energy X-ray Absorptiometry	36 months of age
Secondary	Vitamin D status in infancy	25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age.	9 months of age
Secondary	Allergy and chronic diseases	Assessment of diseases by questionnaires	9 and 36 months of age
Secondary	Appetite hormones in infancy	Leptin and adiponectin concentrations measured from blood samples	9 months of age
Secondary	Change in gut microbiota	Microbiota in the faeces analysed using polymerase chain reaction (PCR)	9, 18 and 36 months of age
Secondary	Achievement of milestones	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	9 and 36 months of age
Secondary	Metabolomics in the urine	Metabolomics analysed using urine samples.	9, 18 and 36 months of age

External Links

•   Study homepage