Child, PreschoolPhase 2/3PAKTNCT00623844
Prevention Through Activity in Kindergarten Trial
A Phase 2/3 study testing physical activity in people with Child, Preschool, run by University of Wuerzburg.
Trial summary
Objectives: The PAKT project shall evaluate the effects of an exercise intervention in kindergarten combined with an educational training of parents and kindergarten teachers on behavior and health status of children. Read more about this study
- Who is it for?
- Ages 43 to 67 monthsHealthy volunteers can take part
- Conditions the study is for
- Child, Preschool
- What is being tested?
- physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 718 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Nov 2008
- Phase
- Phase 2/3
- 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 43 to 67 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in participating kindergartens
Who cannot join
- Health conditions restricting physical activity
- Age < 43 months or > 67 months
About this study
Official title: Prevention Through Acitivity in Kindergarten Trial
Objectives: The PAKT project shall evaluate the effects of an exercise intervention in kindergarten combined with an educational training of parents and kindergarten teachers on behavior and health status of children.
Study design: Baseline measurements were performed on more than 700 kindergarten children aged 43-67 months in May to July 2007. The kindergartens are located in and around Wuerzburg in Germany. Kindergartens were then randomized in an intervention (21 kindergartens) and a control (20 kindergartens) group. The intervention group offers a daily exercise class lasting at least 30 min. Parents and teachers of the children in the intervention program receive educational training. In addition, the children have activity homework involving the entire family. The control kindergartens keep their routine. Follow-up measurements of physical activity (actigraph), motor skills, body mass index, skinfold thickness, and blood pressure take place in January/February 2008, June/July 2008, and September/October 2008. The number of accidents in and outside of the kindergartens and the number of children missing the kindergarten due to infections are monitored continuously.
Use of results: If the PAKT program should proof effective, the results will be published in scientific journals and made public using the press. With the help of the GEK, the program will then be implemented nationwide in kindergartens.
- Conditions
- Child, Preschool
- Being tested
- physical activity
- Keywords
- Prevention, Physical activity, Obesity, Motor skills, Kindergarten
- Medical subject headings
- Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityBehavioural
activity program at kindergarten 5 * 30 min per week plus education of parents (letters, flyers, presentations, counselling) plus activity homework for children involving also the families
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Physical activity intervention: structured daily 30-min activity classes at preschool, activity homeworks, parent and teacher education Receives: Behavioral: physical activity |
| Control | No intervention | Keep usual activities in kindergarten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Accelerometry over 7 days
Measured: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
motor skills
Composite score of several motor tasks
Measured: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
Secondary outcomes (5)
adiposity
BMI, skinfolds
Measured: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
blood pressure
Measured: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
accidents
Measured: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
infections
Measured: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
television viewing time
Measured: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startMay 2007
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child, PreschoolStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Collaborators
- Gmünder ErsatzKasse GEK, University of Cologne
- Responsible party
- Principal investigator, Helge Hebestreit, University of Wuerzburg
- Investigators
- Helge Hebestreit, MD, PhD, Principal investigator, University of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623844
- Sponsor's protocol ID
- BMBF 01EL0606
- Acronym
- PAKT
- Status last verified
- Dec 2014
- First submitted
- 14 Feb 2008
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Roth K, Mauer S, Obinger M, Ruf KC, Graf C, Kriemler S, Lenz D, Lehmacher W, Hebestreit H. Prevention through Activity in Kindergarten Trial (PAKT): a cluster randomised controlled trial to assess the effects of an activity intervention in preschool children. BMC Public Health. 2010 Jul 12;10:410. doi: 10.1186/1471-2458-10-410.
PubMed 20624316
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Through Acitivity in Kindergarten Trial
- ClinicalTrials.gov ID
- NCT00623844
- Acronym / sponsor ID
- PAKT / BMBF 01EL0606
- Conditions
- Child, Preschool
- Keywords
- Prevention, Physical activity, Obesity, Motor skills, Kindergarten
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Collaborators
- Gmünder ErsatzKasse GEK, University of Cologne
- Study start
- May 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 26 Feb 2008 (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.
Objectives: The PAKT project shall evaluate the effects of an exercise intervention in kindergarten combined with an educational training of parents and kindergarten teachers on behavior and health status of children.
Study design: Baseline measurements were performed on more than 700 kindergarten children aged 43-67 months in May to July 2007. The kindergartens are located in and around Wuerzburg in Germany. Kindergartens were then randomized in an intervention (21 kindergartens) and a control (20 kindergartens) group. The intervention group offers a daily exercise class lasting at least 30 min. Parents and teachers of the children in the intervention program receive educational training. In addition, the children have activity homework involving the entire family. The control kindergartens keep their routine. Follow-up measurements of physical activity (actigraph), motor skills, body mass index, skinfold thickness, and blood pressure take place in January/February 2008, June/July 2008, and September/October 2008. The number of accidents in and outside of the kindergartens and the number of children missing the kindergarten due to infections are monitored continuously.
Use of results: If the PAKT program should proof effective, the results will be published in scientific journals and made public using the press. With the help of the GEK, the program will then be implemented nationwide in kindergartens.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: physical activityPhysical activity intervention: structured daily 30-min activity classes at preschool, activity homeworks, parent and teacher education |
| Control | No intervention | –Keep usual activities in kindergarten |
Who may qualify
- Ages
- 43 to 67 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children in participating kindergartens
Key exclusion criteria (2 listed)
- Health conditions restricting physical activity
- Age < 43 months or > 67 months
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 activityactivity program at kindergarten 5 * 30 min per week plus education of parents (letters, flyers, presentations, counselling) plus activity homework for children involving also the families | Behavioural | Intervention |
Primary outcome
Physical activity
Time frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
Accelerometry over 7 days
motor skills
Time frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
Composite score of several motor tasks
5 secondary outcomes
adiposity
Time frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
blood pressure
Time frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
accidents
Time frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
infections
Time frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
television viewing time
Time frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention
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 31 Mar 2015.
- Derived from this study: PubMed 20624316Roth K, Mauer S, Obinger M, Ruf KC, Graf C, Kriemler S, Lenz D, Lehmacher W, Hebestreit H. Prevention through Activity in Kindergarten Trial (PAKT): a cluster randomised controlled trial to assess the effects of an activity intervention in preschool children. BMC Public Health. 2010 Jul 12;10:410. doi: 10.1186/1471-2458-10-410.
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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.
Helge Hebestreit, MD, PhD principal investigator
University of Wuerzburg
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing physical activity in people with Child, Preschool, run by University of Wuerzburg.
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 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Physical activity (time frame: baseline, after 4-5 and 8-9 months of intervention, 2-4 months after intervention). The study lists 2 primary outcomes in all. 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 NCT00623844, which also lists 1 linked publication.
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 31 Mar 2015.