Health BehaviorPArC-AVENCT05018559
Physical Activity-related Health Competence in Apprenticeship and Vocational Education
A study testing BuG lesson and Tutoring system in people with Health Behavior, run by University of Erlangen-Nürnberg at 1 site in Germany.
Trial summary
Although the health-promoting effects of physical activity are well known and apprentices often possess an insufficient amount of physical activity, there is a lack of interventions promoting physical activity in vocational education and training. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- BuG lesson and Tutoring system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2018to 9 Sep 2019
- 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
- First-year apprentices from the automotive mechatronics and nursing care sectors
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich-Alexander-University Erlangen-Nürnberg
Erlangen, 91058
About this study
Although the health-promoting effects of physical activity are well known and apprentices often possess an insufficient amount of physical activity, there is a lack of interventions promoting physical activity in vocational education and training. Against this background, the PArC-AVE project uses a co-creation approach to develop and implement physical activity-promoting interventions tailored to the needs of the target group and the given setting in two vocational education and training institutions. The purpose of this study is to evaluate the effectiveness of the co-created interventions in vocational education and training, namely the BuG lesson in nursing care and the tutoring system in automotive mechatronics. Therefore, the investigators conducted two non-randomized controlled trials from October 2018 to September 2019.
- Conditions
- Health Behavior
- Being tested
- BuG lesson, Tutoring system
- Keywords
- physical activity promotion
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuG lessonBehavioural
Participants of the intervention group in nursing care received a co-created setting-specific intervention to promote physical activity called BuG lesson. The BuG lesson comprises a weekly 90-minute lesson for apprentices of nursing care during regular school hours, covering physical activity and health in theory and practice. Previously, the nursing teachers voluntarily underwent a qualification process as physical activity instructors, enabling them to conduct the BuG lessons independently.
Tutoring systemBehavioural
Participants of the intervention group in automotive mechatronics received a co-created setting-specific intervention to promote physical activity called tutoring system. In the tutoring system, automotive mechatronics apprentices act as physical activity promotors for their fellow apprentices. In the sense of a peer-to-peer approach, apprentices voluntarily participate in a workshop to be qualified as tutors. Subsequently, the tutoring system takes place every two weeks for about ten to fifteen minutes during regular working hours, allowing the tutors to discuss the issues of physical activity and health among their peers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group nursing care | Experimental | Participants receive a co-created physical activity intervention called BuG lesson (German: 'Bewegt und Gesund'-Stunde; English: PA and health lesson). Receives: Behavioral: BuG lesson |
| Control group nursing care | No intervention | Participants do not receive any treatment in addition to their vocational education and training curriculum. |
| Intervention group automotive mechatronics | Experimental | Participants receive a co-created physical activity intervention called tutoring system. Receives: Behavioral: Tutoring system |
| Control group automotive mechatronics | No intervention | Participants do not receive any treatment in addition to their vocational education and training curriculum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in self-reported physical activity: BSA questionnaire
The Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivität Fragebogen; BSA-F) is a German questionnaire that assesses the amount of physical activity during the last four weeks. It differentiates between leisure-time/transportation activities (physical activity score) and sport-/exercise-related activities (sports score). Participants are required to report the frequency and duration of activities executed during the last four weeks. Minutes of leisure-time physical activity per week and sport-/exercise-related activity per week are calculated to get the physical activity and the sports score. Both scores can be combined to receive the overall volume of physical activity completed during leisure-time/transportation and sport-/exercise-related activities.
Measured: Baseline and 6 to 9 months
Changes in physical activity-related health competence: BGK Questionnaire
This will be measured by the German version of the Physical Activity-Related Health Competence questionnaire. The questionnaire consists of 44 total items that measure three sub-competencies necessary for a health-promoting physical activity behavior: movement competence (20 items; min = 0, max = 17.6), control competence (10 items; min = 0, max = 10.8), physical activity-related self-regulation competence (14 items; min = 0, max = 14.8). Higher scores indicate higher competencies.
Measured: Baseline and 6 to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start15 Oct 2018
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
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 Health BehaviorStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
- Investigators
- Klaus Pfeifer, Prof. Dr., Principal investigator, Friedrich-Alexander-University Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018559
- Sponsor's protocol ID
- PArC-AVE
- Acronym
- PArC-AVE
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated for this study are available from the corresponding author upon request.
Publications
Grune E, Popp J, Carl J, Semrau J, Pfeifer K. Examining the sustainability and effectiveness of co-created physical activity interventions in vocational education and training: a multimethod evaluation. BMC Public Health. 2022 Apr 15;22(1):765. doi: 10.1186/s12889-022-13133-9.
PubMed 35428289
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity-related Health Competence in Apprenticeship and Vocational Education
- ClinicalTrials.gov ID
- NCT05018559
- Acronym / sponsor ID
- PArC-AVE / PArC-AVE
- Conditions
- Health Behavior
- Keywords
- physical activity promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 24 Aug 2021 (actual)
- 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.
Although the health-promoting effects of physical activity are well known and apprentices often possess an insufficient amount of physical activity, there is a lack of interventions promoting physical activity in vocational education and training. Against this background, the PArC-AVE project uses a co-creation approach to develop and implement physical activity-promoting interventions tailored to the needs of the target group and the given setting in two vocational education and training institutions. The purpose of this study is to evaluate the effectiveness of the co-created interventions in vocational education and training, namely the BuG lesson in nursing care and the tutoring system in automotive mechatronics. Therefore, the investigators conducted two non-randomized controlled trials from October 2018 to September 2019.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention group nursing care | Experimental | Behavioral: BuG lessonParticipants receive a co-created physical activity intervention called BuG lesson (German: 'Bewegt und Gesund'-Stunde; English: PA and health lesson). |
| Control group nursing care | No intervention | –Participants do not receive any treatment in addition to their vocational education and training curriculum. |
| Intervention group automotive mechatronics | Experimental | Behavioral: Tutoring systemParticipants receive a co-created physical activity intervention called tutoring system. |
| Control group automotive mechatronics | No intervention | –Participants do not receive any treatment in addition to their vocational education and training curriculum. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First-year apprentices from the automotive mechatronics and nursing care sectors
Key exclusion criteria (1 listed)
- /
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 |
|---|---|---|
| BuG lessonParticipants of the intervention group in nursing care received a co-created setting-specific intervention to promote physical activity called BuG lesson. The BuG lesson comprises a weekly 90-minute lesson for apprentices of nursing care during regular school hours, covering physical activity and health in theory and practice. Previously, the nursing teachers voluntarily underwent a qualification process as physical activity instructors, enabling them to conduct the BuG lessons independently. | Behavioural | Intervention group nursing care |
| Tutoring systemParticipants of the intervention group in automotive mechatronics received a co-created setting-specific intervention to promote physical activity called tutoring system. In the tutoring system, automotive mechatronics apprentices act as physical activity promotors for their fellow apprentices. In the sense of a peer-to-peer approach, apprentices voluntarily participate in a workshop to be qualified as tutors. Subsequently, the tutoring system takes place every two weeks for about ten to fifteen minutes during regular working hours, allowing the tutors to discuss the issues of physical activity and health among their peers. | Behavioural | Intervention group automotive mechatronics |
Primary outcome
Changes in self-reported physical activity: BSA questionnaire
Time frame: Baseline and 6 to 9 months
The Physical Activity, Exercise, and Sport Questionnaire (Bewegungs- und Sportaktivität Fragebogen; BSA-F) is a German questionnaire that assesses the amount of physical activity during the last four weeks. It differentiates between leisure-time/transportation activities (physical activity score) and sport-/exercise-related activities (sports score). Participants are required to report the frequency and duration of activities executed during the last four weeks. Minutes of leisure-time physical activity per week and sport-/exercise-related activity per week are calculated to get the physical activity and the sports score. Both scores can be combined to receive the overall volume of physical activity completed during leisure-time/transportation and sport-/exercise-related activities.
Changes in physical activity-related health competence: BGK Questionnaire
Time frame: Baseline and 6 to 9 months
This will be measured by the German version of the Physical Activity-Related Health Competence questionnaire. The questionnaire consists of 44 total items that measure three sub-competencies necessary for a health-promoting physical activity behavior: movement competence (20 items; min = 0, max = 17.6), control competence (10 items; min = 0, max = 10.8), physical activity-related self-regulation competence (14 items; min = 0, max = 14.8). Higher scores indicate higher competencies.
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 24 Aug 2021.
- Derived from this study: PubMed 35428289Grune E, Popp J, Carl J, Semrau J, Pfeifer K. Examining the sustainability and effectiveness of co-created physical activity interventions in vocational education and training: a multimethod evaluation. BMC Public Health. 2022 Apr 15;22(1):765. doi: 10.1186/s12889-022-13133-9.
- Individual participant dataSharing planned: No. The datasets generated for this study are available from the corresponding author upon request.
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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.
Klaus Pfeifer, Prof. Dr. principal investigator
Friedrich-Alexander-University Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BuG lesson and Tutoring system in people with Health Behavior, run by University of Erlangen-Nürnberg 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: finished, as of the sponsor's last update on 24 Aug 2021. 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 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?
Changes in self-reported physical activity: BSA questionnaire (time frame: Baseline and 6 to 9 months). 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 NCT05018559, 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 24 Aug 2021.