Diet and Well-being of Young Danish Children

NCT ID: NCT02170428

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 263 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-10-31

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).

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

growth and development

Growth and development of a random sample of healthy Danish infants

No interventions assigned to this group

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.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technical University of Denmark

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Arne Astrup

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kim F Michaelsen, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Science, University of Copenhagen

Locations

Department of Human Nutrition, Faculty of Sciences, University of Copenhagen

Frederiksberg, , Denmark

Countries

Denmark

Other Identifiers

H-KF-2007-0003

Identifier Type: OTHER

Identifier Source: secondary_id

D201

Identifier Type: -

Identifier Source: org_study_id