Physical Activity-related Health Competence in Apprenticeship and Vocational Education (PArC-AVE)

August 23, 2021 updated by: Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91058
        • Friedrich-Alexander-University Erlangen-Nürnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First-year apprentices from the automotive mechatronics and nursing care sectors

Exclusion Criteria:

  • /

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group nursing care
Participants receive a co-created physical activity intervention called BuG lesson (German: 'Bewegt und Gesund'-Stunde; English: PA and health lesson).
Behavioral: BuG lesson
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.
No Intervention: Control group nursing care
Participants do not receive any treatment in addition to their vocational education and training curriculum.
Experimental: Intervention group automotive mechatronics
Participants receive a co-created physical activity intervention called tutoring system.
Behavioral: Tutoring system
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.
No Intervention: Control group automotive mechatronics
Participants do not receive any treatment in addition to their vocational education and training curriculum.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 to 9 months
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.
Baseline and 6 to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Federal Ministry of Education and Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Klaus Pfeifer, Prof. Dr., Friedrich-Alexander-University Erlangen-Nürnberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PArC-AVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The datasets generated for this study are available from the corresponding author upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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