Health PromotionNCT02136160
Population-based Intervention to Promote Health in Elementary Schools
A study testing attitude change, behavioral change and prevention program in people with Health Promotion, run by Ludwig-Maximilians - University of Munich.
Trial summary
Population based intervention at elementary school setting aimed at contributing, to a major extent, to health education and health promotion for children aged approximately 5-10 years in Germany. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- attitude change, behavioral change and prevention program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 249 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to May 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- teacher of intervention-school
Who cannot join
- absence of consent to participate
About this study
Official title: Rakuns: Setting-based Prevention Program to Promote Positive Experiences in Health Promoting Lifestyle Choices
Population based intervention at elementary school setting aimed at contributing, to a major extent, to health education and health promotion for children aged approximately 5-10 years in Germany. Health education units with theoretical and practical exercises for use by teachers, children, and parents addresses physical activity, sedentary behavior, relaxation, nutrition, personal hygiene and body awareness.
Main questions of the pilot are:
Does health promotion take on an important role in primary schools? How do teachers evaluate training materials, homepage, content and framework conditions? How do teachers assess the efficiency of teaching units?
Read the detailed description
The program is based on actual cognitions and methods of the early education science. In the pilot phase study part (3/2013-5/2013) the investigators evaluated 210 classes of five states in Germany: NRW, Thüringen, Berlin, Sachsen-Anhalt, Schleswig-Holstein.
The long-term aim of this project is to provide an innovative concept based on current concepts in social studies and science that addresses health education of pupils in elementary schools.
- Conditions
- Health Promotion
- Being tested
- attitude change, behavioral change, prevention program
- Keywords
- elementary school, children, health promotion, teachers, prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attitude change, behavioral changeBehavioural
prevention programBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of health related behaviour due to intervention
Measured: After 6 weeks of intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startMar 2013
- Primary completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies 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
- Not applicable
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Child Health Foundation, Johnson & Johnson Citizenship Trust, in cooperation with Johnson & Johnson GmbHInitiative Rückenwirbel e.V., Gmund, Platform for Diet and Physical activity e.V. (peb)
- Responsible party
- Principal investigator, Prof. Berthold Koletzko, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136160
- Sponsor's protocol ID
- Rakuns
- Status last verified
- Dec 2023
- First submitted
- 5 May 2014
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rakuns: Setting-based Prevention Program to Promote Positive Experiences in Health Promoting Lifestyle Choices
- ClinicalTrials.gov ID
- NCT02136160
- Acronym / sponsor ID
- Rakuns
- Conditions
- Health Promotion
- Keywords
- elementary school, children, health promotion, teachers, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Child Health Foundation, Johnson & Johnson Citizenship Trust, in cooperation with Johnson & Johnson GmbHInitiative Rückenwirbel e.V., Gmund, Platform for Diet and Physical activity e.V. (peb)
- Study start
- Mar 2013
- Primary completion
- May 2013 (actual)
- First posted
- 12 May 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.
Population based intervention at elementary school setting aimed at contributing, to a major extent, to health education and health promotion for children aged approximately 5-10 years in Germany. Health education units with theoretical and practical exercises for use by teachers, children, and parents addresses physical activity, sedentary behavior, relaxation, nutrition, personal hygiene and body awareness.
Main questions of the pilot are:
Does health promotion take on an important role in primary schools? How do teachers evaluate training materials, homepage, content and framework conditions? How do teachers assess the efficiency of teaching units?
Detailed description
The program is based on actual cognitions and methods of the early education science. In the pilot phase study part (3/2013-5/2013) the investigators evaluated 210 classes of five states in Germany: NRW, Thüringen, Berlin, Sachsen-Anhalt, Schleswig-Holstein.
The long-term aim of this project is to provide an innovative concept based on current concepts in social studies and science that addresses health education of pupils in elementary schools.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- teacher of intervention-school
Key exclusion criteria (1 listed)
- absence of consent to participate
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 |
|---|---|---|
| attitude change, behavioral change | Behavioural | – |
| prevention program | Behavioural | – |
Primary outcome
Change of health related behaviour due to intervention
Time frame: After 6 weeks of intervention period
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 11 Dec 2023.
- project websiteLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing attitude change, behavioral change and prevention program in people with Health Promotion, run by Ludwig-Maximilians - University of Munich.
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: finished, as of the sponsor's last update on 11 Dec 2023. 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.
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 of health related behaviour due to intervention (time frame: After 6 weeks of intervention period). 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 11 Dec 2023.