Growth AccelerationSKOT INCT02170428
Diet and Well-being of Young Danish Children
An observational study of Growth Acceleration and Overweight or Obesity, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 9 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Acceleration, Overweight or Obesity, Biomarkers of Metabolic Syndrome
- How many people
- 263 participants
- Where
- 1 siteDenmark
- Study dates
- May 2007to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy young Danish Children selected through the National Civil Registry and invited to participate by letter.
Who may be able to join
- healthy singletons born at term (week 37-43) between August 2006 and September 2007 with no disease that could influence food intake or growth
Who cannot join
- born preterm (before week 37)
- non-Danish speaking parents.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, Faculty of Sciences, University of Copenhagen
Frederiksberg, 1958
About this study
Official title: The SKOT I Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children
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.
Read the 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
- Keywords
- growth,, infancy,, children,, diet,, breastfeeding, complementary feeding, early life programming, tracking, physical activity
- Medical subject headings
- Overweight, Obesity, Breast Feeding, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| growth and development | Growth and development of a random sample of healthy Danish infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9, 18 and 36 months of age
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.
Measured: 36 months of age
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.
Measured: 9 and 36 months of age
Diet in periods of early life
The diet is recorded using self-reported 7-day record questionnaire.
Measured: 9, 18 and 36 months of age
Secondary outcomes (10)
Breastfeeding duration in infancy and early childhood
Questionnaire used for assessment of exclusive and partially breastfeeding.
Measured: 9, 18 and 36 months of age
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.
Measured: 9 and 36 months of age
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.
Measured: 9, 18 and 36 months of age
Bone mass in 3-year-old children
Bone mass is measured by Dual-energy X-ray Absorptiometry
Measured: 36 months of age
Vitamin D status in infancy
25-hydroxyvitamin D concentrations are analysed in blood samples at 9 months of age.
Measured: 9 months of age
Allergy and chronic diseases
Assessment of diseases by questionnaires
Measured: 9 and 36 months of age
Appetite hormones in infancy
Leptin and adiponectin concentrations measured from blood samples
Measured: 9 months of age
Change in gut microbiota
Microbiota in the faeces analysed using polymerase chain reaction (PCR)
Measured: 9, 18 and 36 months of age
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
Measured: 9 and 36 months of age
Metabolomics in the urine
Metabolomics analysed using urine samples.
Measured: 9, 18 and 36 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startMay 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth AccelerationStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Kim F Michaelsen, MD Professor, Principal investigator, Faculty of Science, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170428
- Sponsor's protocol ID
- D201
- Other IDs
- H-KF-2007-0003
- Acronym
- SKOT I
- Status last verified
- Nov 2019
- First submitted
- 4 Jun 2014
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SKOT I Cohort - a Prospective Cohort Study of Diet and Well-being in Young Danish Children
- ClinicalTrials.gov ID
- NCT02170428
- Acronym / sponsor ID
- SKOT I / D201
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Technical University of Denmark
- Study start
- May 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| growth and development | – | –Growth and development of a random sample of healthy Danish infants |
Who may qualify
- Ages
- 9 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy young Danish Children selected through the National Civil Registry and invited to participate by letter.
Key inclusion criteria (1 listed)
- healthy singletons born at term (week 37-43) between August 2006 and September 2007 with no disease that could influence food intake or growth
Key exclusion criteria (2 listed)
- born preterm (before week 37)
- non-Danish speaking parents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in anthropometric measurements in periods of early childhood.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 9, 18 and 36 months of age
The diet is recorded using self-reported 7-day record questionnaire.
10 secondary outcomes
Breastfeeding duration in infancy and early childhood
Time frame: 9, 18 and 36 months of age
Insulin like growth factor at 9 and 36 months of age
Time frame: 9 and 36 months of age
Physical activity, sedentary behavior and sleep in early childhood
Time frame: 9, 18 and 36 months of age
Bone mass in 3-year-old children
Time frame: 36 months of age
Vitamin D status in infancy
Time frame: 9 months of age
Allergy and chronic diseases
Time frame: 9 and 36 months of age
Appetite hormones in infancy
Time frame: 9 months of age
Change in gut microbiota
Time frame: 9, 18 and 36 months of age
Achievement of milestones
Time frame: 9 and 36 months of age
Metabolomics in the urine
Time frame: 9, 18 and 36 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Study homepageLink provided by the sponsor.
Related trials for Growth Acceleration
Recruiting
Probiotic Supplementation in Extremely Preterm Infants in Scandinavia
Necrotizing Enterocolitis, Death
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim F Michaelsen, MD Professor principal investigator
Faculty of Science, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Acceleration and Overweight or Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anthropometric measurements in periods of early childhood. (time frame: 9, 18 and 36 months of age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.