OverweightNCT00176371
Improvement of Physical Activity and Correction of Body Mass Index in School Children
A study testing physical exercise in people with Overweight, run by University of Leipzig at 1 site in Germany.
Trial summary
There is an increasing incidence of overweight children in Germany, due to a lack of physical activity. The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- physical exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2005to Dec 2006
- Phase
- Interventional
- 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 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- School class
Who cannot join
- Condition precluding exercise
Trial locations and contacts
1 site in 1 country.
About this study
There is an increasing incidence of overweight children in Germany, due to a lack of physical activity.
The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year.
Read the detailed description
The increasing incidence of overweight children in Germany is due to a lack of physical activity and intake of unhealthy food. The importance of physical activity for the prevention of cardiovascular diseases in adults was shown in several trials. Therefore we provide additional sport lessons over the period of one year in two defined schools in Leipzig with the aim to improve physical fitness in school children. Two other classes with the -in germany- usual quantity of sport classes served as control classes.
In all classes at the beginning and at the end of the school year blood samples were taken, and a clinical investigation, a coordination test for children and a spiroergometer were performed. Additionally each child had to fill out a questionnaire.
Endurance training is emphasized in the sport lessons.
- Conditions
- Overweight
- Being tested
- physical exercise
- Keywords
- Physical fitness
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of maximal oxygen uptake
Secondary outcomes (1)
Change in body mass index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2005
- Study completionDec 2006
Why it stopped: Head of the study has left the institution. Study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Gerhard Schuler, Professor, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176371
- Sponsor's protocol ID
- school project
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 29 Jun 2018
- Results posted
- No
Publications
Walther C, Mende M, Gaede L, Muller U, Machalica K, Schuler G. [Effects of daily physical exercise at school on cardiovascular risk--results of a 2-year cluster-randomized study]. Dtsch Med Wochenschr. 2011 Nov;136(46):2348-54. doi: 10.1055/s-0031-1292049. Epub 2011 Nov 8. German.
PubMed 22068444Walther C, Gaede L, Adams V, Gelbrich G, Leichtle A, Erbs S, Sonnabend M, Fikenzer K, Korner A, Kiess W, Bruegel M, Thiery J, Schuler G. Effect of increased exercise in school children on physical fitness and endothelial progenitor cells: a prospective randomized trial. Circulation. 2009 Dec 1;120(22):2251-9. doi: 10.1161/CIRCULATIONAHA.109.865808. Epub 2009 Nov 17.
PubMed 19920000
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Physical Activity and Correction of Body Mass Index in School Children
- ClinicalTrials.gov ID
- NCT00176371
- Acronym / sponsor ID
- school project
- Conditions
- Overweight
- Keywords
- Physical fitness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Head of the study has left the institution. Study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Dec 2006
- First posted
- 15 Sep 2005 (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.
There is an increasing incidence of overweight children in Germany, due to a lack of physical activity.
The aim of this study is to improve physical fitness and activity in school children. Two classes in different schools are provided with additional sport lessons over a period of one year.
Detailed description
The increasing incidence of overweight children in Germany is due to a lack of physical activity and intake of unhealthy food. The importance of physical activity for the prevention of cardiovascular diseases in adults was shown in several trials. Therefore we provide additional sport lessons over the period of one year in two defined schools in Leipzig with the aim to improve physical fitness in school children. Two other classes with the -in germany- usual quantity of sport classes served as control classes.
In all classes at the beginning and at the end of the school year blood samples were taken, and a clinical investigation, a coordination test for children and a spiroergometer were performed. Additionally each child had to fill out a questionnaire.
Endurance training is emphasized in the sport lessons.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- School class
Key exclusion criteria (1 listed)
- Condition precluding exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical exercise | Behavioural | – |
Primary outcome
Improvement of maximal oxygen uptake
1 secondary outcome
Change in body mass index
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Derived from this study: PubMed 22068444Walther C, Mende M, Gaede L, Muller U, Machalica K, Schuler G. [Effects of daily physical exercise at school on cardiovascular risk--results of a 2-year cluster-randomized study]. Dtsch Med Wochenschr. 2011 Nov;136(46):2348-54. doi: 10.1055/s-0031-1292049. Epub 2011 Nov 8. German.
- Derived from this study: PubMed 19920000Walther C, Gaede L, Adams V, Gelbrich G, Leichtle A, Erbs S, Sonnabend M, Fikenzer K, Korner A, Kiess W, Bruegel M, Thiery J, Schuler G. Effect of increased exercise in school children on physical fitness and endothelial progenitor cells: a prospective randomized trial. Circulation. 2009 Dec 1;120(22):2251-9. doi: 10.1161/CIRCULATIONAHA.109.865808. Epub 2009 Nov 17.
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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.
Gerhard Schuler, Professor principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Overweight, run by University of Leipzig at 1 site in Germany.
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 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: withdrawn, as of the sponsor's last update on 29 Jun 2018. 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 Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
Improvement of maximal oxygen uptake. 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 NCT00176371, which also lists 2 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 29 Jun 2018.