OverweightNCT01572935
Body Weight Assessment in Swiss Primary School Children: Trend Analysis Over 10 Years
An observational study of Overweight and Obesity, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Background: Recent evidence from several countries has emerged suggesting that the increase in the prevalence of childhood obesity has slowed down substantially, or even leveled off. Also in Switzerland this trend has been observed. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- How many people
- 2,979 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2012to Sep 2012
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 3 classrooms each from 60 randomly selected schools
Who may be able to join
- age 6-12 years
- child is attending one of the selected classrooms
Who cannot join
- age below 6 or above 12 years
Trial locations and contacts
1 site in 1 country.
About this study
Background: Recent evidence from several countries has emerged suggesting that the increase in the prevalence of childhood obesity has slowed down substantially, or even leveled off. Also in Switzerland this trend has been observed. In 2002, 20.3% and 19.1% of boys and girls, respectively, were overweight or obese in Switzerland. In 2007, the prevalence of overweight was significantly lower, with 11.3% and 9.9% of school-aged boys and girls, respectively, being overweight or obese. Further trend analyses are necessary to confirm that the stabilizing trend observed reflects a long-term change in the rates of childhood overweight and obesity.
Objective and Methods: The aim of the present study is to repeat the 2002 and 2007 national studies, in order to monitor the trend in the prevalence of overweight and obesity in 6-12 year old children in Switzerland during this 5 respectively 10 year time period. Height and weight will be measured and used to calculate body mass index (BMI). BMI references form the Centers for Disease Control and Prevention will be used to determine the prevalence of underweight (< 5th percentile), overweight (≥ 85th and < 95th percentile) and obesity (≥ 95th percentile). Waist and hip circumference will be measured. Moreover, skinfold thicknesses and bioelectrical impedance analysis will be performed to calculate body fat percentage.
- Conditions
- Overweight, Obesity
- Keywords
- childhood obesity prevalence
- Medical subject headings
- Overweight, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of overweight and obesity
Assessment of the prevalence of overweight and obesity in the study population using measurements of weight and height to calculate the body mass index. The 85th and 95th percentiles of the reference population published by the Centers for Disease Control and Prevention will be used as cut-off points.
Measured: up to 7 months
Secondary outcomes (1)
Waist circumference
Assessment of waist circumference using non-strechable measuring tape.
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 2,979 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael B Zimmermann, Prof, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572935
- Sponsor's protocol ID
- EK 2011-N-50
- Status last verified
- Sep 2012
- First submitted
- 8 Feb 2012
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Aeberli I, Henschen I, Molinari L, Zimmermann MB. Stabilization of the prevalence of childhood obesity in Switzerland. Swiss Med Wkly. 2010 Jul 15;140:w13046. doi: 10.4414/smw.2010.13046. eCollection 2010.
PubMed 20349364Zimmermann MB, Gubeli C, Puntener C, Molinari L. Overweight and obesity in 6-12 year old children in Switzerland. Swiss Med Wkly. 2004 Sep 4;134(35-36):523-8. doi: 10.4414/smw.2004.10640.
PubMed 15517505Aeberli I, Ammann RS, Knabenhans M, Molinari L, Zimmermann MB. Decrease in the prevalence of paediatric adiposity in Switzerland from 2002 to 2007. Public Health Nutr. 2010 Jun;13(6):806-11. doi: 10.1017/S1368980009991558. Epub 2009 Sep 22.
PubMed 19772692
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Weight Assessment in Swiss Primary School Children: Trend Analysis Over 10 Years
- ClinicalTrials.gov ID
- NCT01572935
- Acronym / sponsor ID
- EK 2011-N-50
- Conditions
- Overweight, Obesity
- Keywords
- childhood obesity prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,979 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Apr 2012 (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.
Background: Recent evidence from several countries has emerged suggesting that the increase in the prevalence of childhood obesity has slowed down substantially, or even leveled off. Also in Switzerland this trend has been observed. In 2002, 20.3% and 19.1% of boys and girls, respectively, were overweight or obese in Switzerland. In 2007, the prevalence of overweight was significantly lower, with 11.3% and 9.9% of school-aged boys and girls, respectively, being overweight or obese. Further trend analyses are necessary to confirm that the stabilizing trend observed reflects a long-term change in the rates of childhood overweight and obesity.
Objective and Methods: The aim of the present study is to repeat the 2002 and 2007 national studies, in order to monitor the trend in the prevalence of overweight and obesity in 6-12 year old children in Switzerland during this 5 respectively 10 year time period. Height and weight will be measured and used to calculate body mass index (BMI). BMI references form the Centers for Disease Control and Prevention will be used to determine the prevalence of underweight (< 5th percentile), overweight (≥ 85th and < 95th percentile) and obesity (≥ 95th percentile). Waist and hip circumference will be measured. Moreover, skinfold thicknesses and bioelectrical impedance analysis will be performed to calculate body fat percentage.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 3 classrooms each from 60 randomly selected schools
Key inclusion criteria (2 listed)
- age 6-12 years
- child is attending one of the selected classrooms
Key exclusion criteria (1 listed)
- age below 6 or above 12 years
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
Prevalence of overweight and obesity
Time frame: up to 7 months
Assessment of the prevalence of overweight and obesity in the study population using measurements of weight and height to calculate the body mass index. The 85th and 95th percentiles of the reference population published by the Centers for Disease Control and Prevention will be used as cut-off points.
1 secondary outcome
Waist circumference
Time frame: up to 7 months
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 19 Sep 2012.
- Background: PubMed 20349364Aeberli I, Henschen I, Molinari L, Zimmermann MB. Stabilization of the prevalence of childhood obesity in Switzerland. Swiss Med Wkly. 2010 Jul 15;140:w13046. doi: 10.4414/smw.2010.13046. eCollection 2010.
- Background: PubMed 15517505Zimmermann MB, Gubeli C, Puntener C, Molinari L. Overweight and obesity in 6-12 year old children in Switzerland. Swiss Med Wkly. 2004 Sep 4;134(35-36):523-8. doi: 10.4414/smw.2004.10640.
- Background: PubMed 19772692Aeberli I, Ammann RS, Knabenhans M, Molinari L, Zimmermann MB. Decrease in the prevalence of paediatric adiposity in Switzerland from 2002 to 2007. Public Health Nutr. 2010 Jun;13(6):806-11. doi: 10.1017/S1368980009991558. Epub 2009 Sep 22.
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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.
Michael B Zimmermann, Prof principal investigator
ETH Zurich
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 Overweight and Obesity, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 2 inclusion and 1 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 19 Sep 2012. 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 Switzerland. 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?
Prevalence of overweight and obesity (time frame: up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01572935, which also lists 3 linked publications.
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 19 Sep 2012.