Problem-Based LearningNCT03493659
The Effects of Standing Tutorials on Problem-Based Learning (PBL) Among Undergraduate Students
A study testing Standing during Concept Test, Standing during regular tutorial session and Standing during Concept Test and regular tutorial session in people with Problem-Based Learning, run by Maastricht University at 1 site in Netherlands.
Trial summary
Problem-based learning (PBL) is an education model utilized by Maastricht University and many other universities worldwide. PBL occurs in small, collaborative tutorials, under the facilitation of a tutor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Problem-Based Learning
- What is being tested?
- Standing during Concept Test, Standing during regular tutorial session and Standing during Concept Test and regular tutorial session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Apr 2018to 30 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Matriculated undergraduate students of Maastricht University
- Students who have given their consent to participate in this study.
- The course subject is well-established and mandatory for all students within the specific bachelor's programme. A well-established course will be chosen so that clear scoring is possible on the concept tests (explained in the Materials and Analysis sections) that will be administered to the students. The course should be mandatory for all students within the bachelor's programme so as to reduce the selection bias that may otherwise occur if we decide to select tutorial groups that only specific groups of students signed up for. An example of a well-established and mandatory course for students in the Biomedical Sciences bachelor's programme at Maastricht University would include 'Brain, behaviour and movement, 'Human genetics, reproduction and prenatal development' and so on.
- The course coordinators and tutors who are the gatekeepers of the students would have given their permission and cooperation in planning the study into the tutorials.
- The duration of the course would last at least 10 tutorial classes.
- The duration of each tutorial is 2 hours.
- The timing of the tutorial groups will have to be similar to minimize any effects arising due to tests being carried out at different times of the day.
- The course is taught in English.
Who cannot join
- For the standing tutorials, those who are suffering from musculoskeletal discomfort or pathologies that may prevent or influence movement
- Non-matriculated student of Maastricht University
- Non-matriculated student of the chosen course for the study
Trial locations and contacts
1 site in 1 country.
About this study
Problem-based learning (PBL) is an education model utilized by Maastricht University and many other universities worldwide. PBL occurs in small, collaborative tutorials, under the facilitation of a tutor. This study explores the effects of standing tutorials, compared against sitting tutorials, on PBL among undergraduate students. A quantitative approach will be taken to objectively measure students' learning, and a qualitative approach will be taken to obtain a deeper understanding of the processes of learning.
It is hypothesized that students in the standing tutorials will be able to recall more academic concepts and link the concepts better than students in the sitting tutorials (H1). Audio-recording of the tutorials will be used to measure the discussions within the tutorials. The transcriptions obtained from the recording will be studied through text analysis. It is hypothesized that students in the standing tutorials will produce more discussions, and therefore a higher word count (H2). It is also hypothesized that the students in the standing tutorials will use more word categories that are conducive to the discussion and learning process (H3).
Read more
Through the qualitative approach, the content of the transcriptions will be analysed through a thematic analysis. It is hypothesized that the students in the standing tutorials will produce more learning-oriented interactions (H4).
Two additional factors that would be measured are subsequent physical activity and academic achievement. ActivPAL accelerometers will be used to measure the students' daily activity, to find out if the students' daily activities are affected by the standing tutorials, for example, students may sit more as a result of fatigue from the standing tutorials, or conversely transfer the active behaviour from the standing tutorials to other activities outside the tutorial group.It is hypothesized that standing tutorials do not affect the students' subsequent physical activity, and therefore there will be no significant differences of daily activity between students in the sitting and standing tutorials (H5). With regards to academic achievement, it is hypothesized that the students in the standing tutorials will have higher academic achievements after the course compared to the students in the sitting tutorials (H6).
- Conditions
- Problem-Based Learning
- Being tested
- Standing during Concept Test, Standing during regular tutorial session, Standing during Concept Test and regular tutorial session
- Keywords
- Standing, Sitting, Learning, Problem-Based Learning, Undergraduate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standing during Concept TestBehavioural
The participants will stand with a standing desk at an ergonomically correct height during the administration of the Concept Test.
Standing during regular tutorial sessionBehavioural
The participants will stand with a standing desk at an ergonomically correct height during their regular tutorial sessions.
Standing during Concept Test and regular tutorial sessionBehavioural
The participants will stand with a standing desk at an ergonomically correct height during the administration of the Concept Test and during their regular tutorial sessions.
| Study group | Role | What they receive |
|---|---|---|
| Sit-Sit | No intervention | The participants will sit during the tutorials, and sit during the concept tests given to measure their learning. |
| Sit-Stand | Active comparator | The participants will sit during the tutorials. Intervention: Behavioral: Standing during Concept Test will be administered Receives: Behavioral: Standing during Concept Test |
| Stand-Stand | Active comparator | The participants will stand during the tutorials, and stand during the concept tests given to measure their learning. Intervention: Behavioral: Standing during Concept Test and regular tutorial session will be administered. Receives: Behavioral: Standing during Concept Test and regular tutorial session |
| Stand-Sit | Active comparator | The participants will stand during the tutorials. Intervention: Behavioral: Standing during regular tutorial session will be administered.
However, participants will sit during the concept tests given to measure their learning. Receives: Behavioral: Standing during regular tutorial session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Process of Learning
The discussions that are carried out during PBL will be audio-recorded and undergo text and thematic analysis
Measured: 1 hour
Outcome of Learning
Concept Tests will be administered where students list the number of concepts they can recall, and draw a concept map. Both the recalled concepts and the map will be scored independently and combined for a final score.
Measured: 10 minutes
Academic Achievement
Grades of Final Exam
Measured: 2 hours
Secondary outcomes (2)
Change of Subsequent Physical Activity
Participants' subsequent physical activity will be measured for 10 days, using the ActivPAL accelerometer, to measure whether standing tutorials (compared against sitting tutorials) have an affect on the participants' daily life's physical activity.
Measured: 7 days
Positive and Negative Affect Schedule (PANAS)
Participants' overall feelings and emotions are compared between groups in the standing tutorials and sitting tutorials.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start10 Apr 2018
- Primary completion29 Jun 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem-Based LearningStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either a sitting or a standing tutorial, where their learning will be measured.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493659
- Sponsor's protocol ID
- 00909
- Status last verified
- Mar 2018
- First submitted
- 16 Mar 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Standing Tutorials on Problem-Based Learning (PBL) Among Undergraduate Students
- ClinicalTrials.gov ID
- NCT03493659
- Acronym / sponsor ID
- 00909
- Conditions
- Problem-Based Learning
- Keywords
- Standing, Sitting, Learning, Problem-Based Learning, Undergraduate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 10 Apr 2018 (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.
Problem-based learning (PBL) is an education model utilized by Maastricht University and many other universities worldwide. PBL occurs in small, collaborative tutorials, under the facilitation of a tutor. This study explores the effects of standing tutorials, compared against sitting tutorials, on PBL among undergraduate students. A quantitative approach will be taken to objectively measure students' learning, and a qualitative approach will be taken to obtain a deeper understanding of the processes of learning.
It is hypothesized that students in the standing tutorials will be able to recall more academic concepts and link the concepts better than students in the sitting tutorials (H1). Audio-recording of the tutorials will be used to measure the discussions within the tutorials. The transcriptions obtained from the recording will be studied through text analysis. It is hypothesized that students in the standing tutorials will produce more discussions, and therefore a higher word count (H2). It is also hypothesized that the students in the standing tutorials will use more word categories that are conducive to the discussion and learning process (H3).
Through the qualitative approach, the content of the transcriptions will be analysed through a thematic analysis. It is hypothesized that the students in the standing tutorials will produce more learning-oriented interactions (H4).
Two additional factors that would be measured are subsequent physical activity and academic achievement. ActivPAL accelerometers will be used to measure the students' daily activity, to find out if the students' daily activities are affected by the standing tutorials, for example, students may sit more as a result of fatigue from the standing tutorials, or conversely transfer the active behaviour from the standing tutorials to other activities outside the tutorial group.It is hypothesized that standing tutorials do not affect the students' subsequent physical activity, and therefore there will be no significant differences of daily activity between students in the sitting and standing tutorials (H5). With regards to academic achievement, it is hypothesized that the students in the standing tutorials will have higher academic achievements after the course compared to the students in the sitting tutorials (H6).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants are assigned to either a sitting or a standing tutorial, where their learning will be measured.
| Arm | Type | Receives |
|---|---|---|
| Sit-Sit | No intervention | –The participants will sit during the tutorials, and sit during the concept tests given to measure their learning. |
| Sit-Stand | Active comparator | Behavioral: Standing during Concept TestThe participants will sit during the tutorials. Intervention: Behavioral: Standing during Concept Test will be administered |
| Stand-Stand | Active comparator | Behavioral: Standing during Concept Test and regular tutorial sessionThe participants will stand during the tutorials, and stand during the concept tests given to measure their learning. Intervention: Behavioral: Standing during Concept Test and regular tutorial session will be administered. |
| Stand-Sit | Active comparator | Behavioral: Standing during regular tutorial sessionThe participants will stand during the tutorials. Intervention: Behavioral: Standing during regular tutorial session will be administered. However, participants will sit during the concept tests given to measure their learning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Matriculated undergraduate students of Maastricht University
- Students who have given their consent to participate in this study.
- The course subject is well-established and mandatory for all students within the specific bachelor's programme. A well-established course will be chosen so that clear scoring is possible on the concept tests (explained in the Materials and Analysis sections) that will be administered to the students. The course should be mandatory for all students within the bachelor's programme so as to reduce the selection bias that may otherwise occur if we decide to select tutorial groups that only specific groups of students signed up for. An example of a well-established and mandatory course for students in the Biomedical Sciences bachelor's programme at Maastricht University would include 'Brain, behaviour and movement, 'Human genetics, reproduction and prenatal development' and so on.
- The course coordinators and tutors who are the gatekeepers of the students would have given their permission and cooperation in planning the study into the tutorials.
- The duration of the course would last at least 10 tutorial classes.
Key exclusion criteria (3 listed)
- For the standing tutorials, those who are suffering from musculoskeletal discomfort or pathologies that may prevent or influence movement
- Non-matriculated student of Maastricht University
- Non-matriculated student of the chosen course for the study
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 |
|---|---|---|
| Standing during Concept TestThe participants will stand with a standing desk at an ergonomically correct height during the administration of the Concept Test. | Behavioural | Sit-Stand |
| Standing during regular tutorial sessionThe participants will stand with a standing desk at an ergonomically correct height during their regular tutorial sessions. | Behavioural | Stand-Sit |
| Standing during Concept Test and regular tutorial sessionThe participants will stand with a standing desk at an ergonomically correct height during the administration of the Concept Test and during their regular tutorial sessions. | Behavioural | Stand-Stand |
Primary outcome
Process of Learning
Time frame: 1 hour
The discussions that are carried out during PBL will be audio-recorded and undergo text and thematic analysis
Outcome of Learning
Time frame: 10 minutes
Concept Tests will be administered where students list the number of concepts they can recall, and draw a concept map. Both the recalled concepts and the map will be scored independently and combined for a final score.
Academic Achievement
Time frame: 2 hours
Grades of Final Exam
2 secondary outcomes
Change of Subsequent Physical Activity
Time frame: 7 days
Positive and Negative Affect Schedule (PANAS)
Time frame: 5 minutes
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 15 Aug 2019.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standing during Concept Test, Standing during regular tutorial session and Standing during Concept Test and regular tutorial session in people with Problem-Based Learning, run by Maastricht University at 1 site in Netherlands.
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 8 inclusion and 3 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 15 Aug 2019. 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 Netherlands. 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?
Process of Learning (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 15 Aug 2019.