Sedentary BehaviourG072223NNCT07036276
Reducing and Breaking up School-related Sedentary Behaviour Among Adolescents Using Co-creation
A study testing Co-adapted intervention and Standard intervention in people with Sedentary Behaviour, run by University Ghent.
Trial summary
Adolescents spend the majority of the day sedentary, especially at school whilst sitting in class and at home when performing school-related tasks. As high levels of sedentary time are associated with adverse health effects, effective interventions are needed. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behaviour
- What is being tested?
- Co-adapted intervention and Standard intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Secondary schools need to have at least 150 pupils in the first two grades (Grade 7 and 8).
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reducing and Breaking Up School-related Sedentary Behaviour Among Adolescents Using Co-creation
Adolescents spend the majority of the day sedentary, especially at school whilst sitting in class and at home when performing school-related tasks. As high levels of sedentary time are associated with adverse health effects, effective interventions are needed. To improve effectiveness, literature recommends a co-creative approach in which adolescents and other key stakeholders (such as teachers) are actively involved in the choice and development of intervention strategies. Therefore, this project aims to co-adapt a previously co-created intervention targeting adolescents' school-related sedentary behaviour. Further, the effect of this co-adapted intervention on adolescents' sedentary behaviour and related determinants, sleep, and mental wellbeing will be evaluated via a three-arm clustered controlled trial, including a co-adaptation intervention arm, a standard intervention arm (including schools that were not involved in co-adapting the intervention) and a control arm (continuing their curriculum as usual). By comparing these three arms, the investigators can evaluate the added value of co-creation compared to not involving adolescents or stakeholders in the development of an intervention. Lastly, the investigators will conduct a process evaluation of (1) the co-adaptation approach used to adapt the co-created intervention and (2) the implementation of both the co-adapted and standard interventions. Studies that evaluate co-created interventions are scarce. However, if such interventions prove to be more effective, this approach could be promising to change adolescents' health behaviour.
Read the detailed description
- Introduction This research project aims to co-adapt a co-created intervention targeting school-related sedentary behaviour. In this research, co-adaptation refers to the use of co-creation principles to adapt a co-created intervention to a new context (i.e., another school). The original intervention targeting school-related sedentary behaviour was co-created with Flemish secondary school pupils, teachers, and researchers in 2021-2022. In the current study, secondary school pupils and teachers from two schools, and researchers will be involved in the co-adaptation process. Next to co-adapting the intervention, this study aims to conduct an effect evaluation of the co-adapted intervention using a three-arm clustered controlled trial. Two schools will be allocated to each arm. In the first arm, the intervention will be co-adapted and implemented (co-adaptation intervention group); in the second arm, the original intervention will be implemented (standard intervention group); and the third arm is a control condition, which schools will continue their curriculum as usual. Finally, the investigators will conduct a process evaluation, which will evaluate (1) the co-adaptation process and (2) the implementation of the intervention in both the co-adaptation and standard intervention schools.
- Participants Schools will be recruited in September 2025. The researcher will contact all secondary schools that are reachable within 40 minutes from the researcher's home town (Lier, Belgium) via e-mail and, if necessary, subsequently via telephone. If more than six schools show interest to participate, schools will be selected based on similar demographic characteristics (number of pupils and sex distribution) and education-related characteristics (such as the type of educational network). The focus of the study is on pupils and teachers in the first stage of secondary education (Grades 7 and 8, typically for ages 12-14). All pupils in these grades will be invited to participate in the study. A researcher will visit these classes to explain the study and distribute information and consent letters. Active consent will be asked from the pupils and at least one of their parents or legal representatives.
- Procedure Between September 2025 and January 2026, the intervention will be co-adapted in the co-adaptation intervention schools. Researchers facilitating the co-adaptation process will complete a reflection form after each co-adaptation session with pupils and teachers to conduct a process evaluation of the co-adaptation process. In addition, focus groups with participating pupils and teachers will be conducted after the co-adaptation process. Before implementing the interventions in both intervention arms (co-adaptation intervention arm and standard intervention arm), a pre-test will be conducted in January-February 2026 in all six schools. From January to April 2026, the intervention will be implemented in both intervention arms over a six-week period. A post-test will be conducted after intervention implementation in March-April 2026. The pre-test and post-test will take place during school hours, at a time that is convenient for the school, in the presence of a researcher. During these visits, pupils will be given a GENEActiv to measure their sedentary and sleep time. They will then be asked to complete a questionnaire measuring determinants of reducing and regularly interrupting sedentary time and mental well-being. To evaluate intervention implementation, all pupils and teachers exposed to the intervention will be asked to complete an additional questionnaire during the post-test, supplemented by focus groups organised after the implementation. Further details on the measurements, are provided below.
- Measurements
4.1. Process evaluation of the co-adaptation process and implementation of the interventions After each design session with pupils or teachers, researchers facilitating the session will complete a reflection form. These forms are used to reflect on the group process (e.g., if everyone participated) and the facilitators' role (e.g., if facilitators involved everyone). This way, facilitators can identify areas for improvement in subsequent sessions.
A trained female researcher with expertise in qualitative research will conduct 12 focus groups-6 with pupils and 6 with teachers. A second researcher will co-facilitate these focus groups and take notes. In the co-adaptation intervention schools, separate focus groups will be held with pupils and teachers after the co-adaptation process and after implementation. In the standard intervention schools, focus groups will be conducted only after the intervention has been implemented. At the start of each focus group, the interviewer will outline the goal of the focus group. Next, a semi-structured focus group will be conducted using an interview guide. Topics that will be discussed include: delivery (the extent to which the co-adaptation process and/or intervention was implemented as planned), participation (the level of engagement and participation of individuals or groups in the co-adaptation process and/or intervention), experience (subjective perceptions and evaluation of the co-adaptation process and/or intervention), context (social, cultural, economic, and political factors influencing the success or failure of the intervention), impact (the extent to which the co-adaptation process and/or intervention achieved its intended outcome(s), such as the impact on sedentary behaviour, but also the perceived impact on aspects such as pupils' classroom behaviour), and maintenance (the degree to which the relationships and/or outcomes formed during the co-adaptation process and/or intervention are sustained). Focus groups will be recorded and transcribed verbatim for analysis. In addition to the focus groups, a questionnaire will be administered to pupils and teachers after the implementation of the intervention, covering the delivery of the intervention and the participation of pupils in the intervention.
4.2 Effect evaluation Sedentary time and sleep duration will be measured using the GENEActiv accelerometer (ActivInsights Ltd., Kimbolton, UK), a waterproof tri-axial accelerometer (43 mm × 40 mm × 13 mm, 16 g). The accelerometer will be worn at the non-dominant wrist continuously over seven days using a 24-hour protocol. Data will be downloaded using the GENEActiv software and subsequently processed and analysed in R (R Development Core Team, 2010) using the GGIR package. Raw tri-axial acceleration values will be converted into a single omnidirectional measure of body acceleration using the Euclidean norm minus one (ENMO) metric. Data will then be reduced by averaging values over 1-second epochs. To determine physical activity intensity, the investigators will apply validated cut-points, classifying sedentary behaviour as values below 56.3 mg, light-intensity physical activity as values ranging from 56.3 to 191.6 mg, moderate-intensity physical activity as values between 191.6 and 695.8 mg, and vigorous-intensity physical activity as values exceeding 695.8 mg. Sedentary time and sedentary behaviour patterns, will be analysed across the entire day, during class hours, outside class hours (e.g., recess), and outside school hours.
To detect sleep, GGIR identifies periods of sustained inactivity. Sustained inactivity is defined as a period in which there is a change in arm angle of less than five degrees over a five-minute period. These thresholds have shown good accuracy for detecting sleep without the use of an activity diary compared to polysomnography, the gold standard sleep measure.
GGIR also estimates non-wear time by identifying periods of sustained low acceleration. Non-wear time will be determined when, for at least two out of three axes, the standard deviation of raw accelerometer data is less than 13 milligravity units (mg) and the data range is below 50 mg over 60-minute blocks, assessed every 15 minutes. GGIR provides two estimates to determine data validity: the number of valid hours and the fraction (%) of the night identified as invalid. In this study, the investigators will convert the fraction of the night identified as invalid to percentage of the night identified as valid (e.g., when 25% of the night is identified as invalid, this will be converted to 75% of the night identified as valid). Pupils will be included if they have at least 9 valid hours on four days for the sedentary time analysis, and at least 50% valid sleep data for five nights for the sleep duration analysis.
Next to the GENEActiv accelerometer, pupils will complete a questionnaire including items on determinants of reducing and regularly interrupting sedentary time in general (e.g., "I think it is important for my health to reduce my sitting time and to take regular breaks"), in the classroom (e.g., "I would rather sit in class than stand up"), and while making homework (e.g., "I prefer to do my schoolwork sitting down rather than standing up"). All items will be answered using a 5-point Likert scale (e.g., "totally disagree" to "totally agree"). Secondly, the questionnaire will assess adolescents' mental well-being using the World Health Organization-Five Well-Being Index (WHO-5). This scale consists of five statements relating to the past two weeks. Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being.
- Conditions
- Sedentary Behaviour
- Being tested
- Co-adapted intervention, Standard intervention
- Keywords
- Adolescents, Youth, Student, School, Classroom, Sedentary behaviour, Participatory research, Co-creation, Co-adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-adapted interventionBehavioural
An existing co-created intervention will be adapted by researchers and 7th and 8th grade pupils and teachers during 3 to 5 design sessions in both co-adaptation intervention schools.
Standard interventionBehavioural
The existing co-created intervention will be implemented in the standard intervention schools. So, adolescents and school staff from the standard intervention schools will not be involved in adapting the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Co-adaptation intervention group | Experimental | Co-adapted intervention: An existing co-created intervention will be adapted by researchers and 7th and 8th grade pupils and teachers during 3 to 5 design sessions in both co-adaptation intervention schools. Receives: Behavioral: Co-adapted intervention |
| Standard intervention group | Active comparator | Standard intervention: The existing co-created intervention will be implemented in the standard intervention schools. So, adolescents and school staff from the standard intervention schools will not be involved in adapting the intervention. Receives: Behavioral: Standard intervention |
| Control group | No intervention | No intervention will be implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sitting time and patterns of sitting time
Sitting time and patterns of sitting time will be derived from a GENEActiv accelerometer that will be worn on the non-dominant wrist.
Measured: Assessed at baseline (pre-intervention) and immediately after the intervention period. The GENEActiv will be worn during one week.
Determinants of reducing and regularly interrupting sedentary time in general, in the classroom, and while making homework
These determinants will be measured using a questionnaire including items that will be answered on a 5-point Likert scale.
Measured: Assessed at baseline (pre-intervention) and immediately after the intervention period.
Secondary outcomes (2)
Sleeping time
Sleeping time will be derived from a GENEActiv accelerometer that will be worn on the non-dominant wrist.
Measured: Assessed at baseline (pre-intervention) and immediately after the intervention period. The GENEActiv will be worn during one week.
Mental well-being
Mental well-being will be measured using the the World Health Organization-Five Well-Being Index (WHO-5).
Measured: Assessed at baseline (pre-intervention) and immediately after the intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviourStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Model description
- A three-arm clustered controlled trial will be conducted, including a co-adaptation intervention group, a standard intervention group and a control group. In September 2025, six schools will be recruited with immediate allocation to the 3 conditions. Pupils from Grade 7 and 8 will be informed about our study and provide an information letter for their parents. It will be specified that the co-adapted and standard intervention will be delivered to all adolescents as part of their curriculum, but that they are free to participate in the measurements. In September 2025 - January 2026, the co-adaptation process will take place in the co-adaptation intervention group. Between January and April 2026, the intervention will be implemented in the co-adaptation and standard intervention group. For the effect evaluation, there will be a pre-test after the co-adaptation process but before the implementation phase (January-February 2026), and a post-test after the implementation (March-April 2026).
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036276
- Sponsor's protocol ID
- ONZ-2025-0184
- Acronym
- G072223N
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing and Breaking Up School-related Sedentary Behaviour Among Adolescents Using Co-creation
- ClinicalTrials.gov ID
- NCT07036276
- Acronym / sponsor ID
- G072223N / ONZ-2025-0184
- Conditions
- Sedentary Behaviour
- Keywords
- Adolescents, Youth, Student, School, Classroom, Sedentary behaviour, Participatory research, Co-creation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Jun 2025 (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.
Adolescents spend the majority of the day sedentary, especially at school whilst sitting in class and at home when performing school-related tasks. As high levels of sedentary time are associated with adverse health effects, effective interventions are needed. To improve effectiveness, literature recommends a co-creative approach in which adolescents and other key stakeholders (such as teachers) are actively involved in the choice and development of intervention strategies. Therefore, this project aims to co-adapt a previously co-created intervention targeting adolescents' school-related sedentary behaviour. Further, the effect of this co-adapted intervention on adolescents' sedentary behaviour and related determinants, sleep, and mental wellbeing will be evaluated via a three-arm clustered controlled trial, including a co-adaptation intervention arm, a standard intervention arm (including schools that were not involved in co-adapting the intervention) and a control arm (continuing their curriculum as usual). By comparing these three arms, the investigators can evaluate the added value of co-creation compared to not involving adolescents or stakeholders in the development of an intervention. Lastly, the investigators will conduct a process evaluation of (1) the co-adaptation approach used to adapt the co-created intervention and (2) the implementation of both the co-adapted and standard interventions. Studies that evaluate co-created interventions are scarce. However, if such interventions prove to be more effective, this approach could be promising to change adolescents' health behaviour.
Detailed description
- Introduction This research project aims to co-adapt a co-created intervention targeting school-related sedentary behaviour. In this research, co-adaptation refers to the use of co-creation principles to adapt a co-created intervention to a new context (i.e., another school). The original intervention targeting school-related sedentary behaviour was co-created with Flemish secondary school pupils, teachers, and researchers in 2021-2022. In the current study, secondary school pupils and teachers from two schools, and researchers will be involved in the co-adaptation process. Next to co-adapting the intervention, this study aims to conduct an effect evaluation of the co-adapted intervention using a three-arm clustered controlled trial. Two schools will be allocated to each arm. In the first arm, the intervention will be co-adapted and implemented (co-adaptation intervention group); in the second arm, the original intervention will be implemented (standard intervention group); and the third arm is a control condition, which schools will continue their curriculum as usual. Finally, the investigators will conduct a process evaluation, which will evaluate (1) the co-adaptation process and (2) the implementation of the intervention in both the co-adaptation and standard intervention schools.
- Participants Schools will be recruited in September 2025. The researcher will contact all secondary schools that are reachable within 40 minutes from the researcher's home town (Lier, Belgium) via e-mail and, if necessary, subsequently via telephone. If more than six schools show interest to participate, schools will be selected based on similar demographic characteristics (number of pupils and sex distribution) and education-related characteristics (such as the type of educational network). The focus of the study is on pupils and teachers in the first stage of secondary education (Grades 7 and 8, typically for ages 12-14). All pupils in these grades will be invited to participate in the study. A researcher will visit these classes to explain the study and distribute information and consent letters. Active consent will be asked from the pupils and at least one of their parents or legal representatives.
- Procedure Between September 2025 and January 2026, the intervention will be co-adapted in the co-adaptation intervention schools. Researchers facilitating the co-adaptation process will complete a reflection form after each co-adaptation session with pupils and teachers to conduct a process evaluation of the co-adaptation process. In addition, focus groups with participating pupils and teachers will be conducted after the co-adaptation process. Before implementing the interventions in both intervention arms (co-adaptation intervention arm and standard intervention arm), a pre-test will be conducted in January-February 2026 in all six schools. From January to April 2026, the intervention will be implemented in both intervention arms over a six-week period. A post-test will be conducted after intervention implementation in March-April 2026. The pre-test and post-test will take place during school hours, at a time that is convenient for the school, in the presence of a researcher. During these visits, pupils will be given a GENEActiv to measure their sedentary and sleep time. They will then be asked to complete a questionnaire measuring determinants of reducing and regularly interrupting sedentary time and mental well-being. To evaluate intervention implementation, all pupils and teachers exposed to the intervention will be asked to complete an additional questionnaire during the post-test, supplemented by focus groups organised after the implementation. Further details on the measurements, are provided below.
- Measurements
4.1. Process evaluation of the co-adaptation process and implementation of the interventions After each design session with pupils or teachers, researchers facilitating the session will complete a reflection form. These forms are used to reflect on the group process (e.g., if everyone participated) and the facilitators' role (e.g., if facilitators involved everyone). This way, facilitators can identify areas for improvement in subsequent sessions.
A trained female researcher with expertise in qualitative research will conduct 12 focus groups-6 with pupils and 6 with teachers. A second researcher will co-facilitate these focus groups and take notes. In the co-adaptation intervention schools, separate focus groups will be held with pupils and teachers after the co-adaptation process and after implementation. In the standard intervention schools, focus groups will be conducted only after the intervention has been implemented. At the start of each focus group, the interviewer will outline the goal of the focus group. Next, a semi-structured focus group will be conducted using an interview guide. Topics that will be discussed include: delivery (the extent to which the co-adaptation process and/or intervention was implemented as planned), participation (the level of engagement and participation of individuals or groups in the co-adaptation process and/or intervention), experience (subjective perceptions and evaluation of the co-adaptation process and/or intervention), context (social, cultural, economic, and political factors influencing the success or failure of the intervention), impact (the extent to which the co-adaptation process and/or intervention achieved its intended outcome(s), such as the impact on sedentary behaviour, but also the perceived impact on aspects such as pupils' classroom behaviour), and maintenance (the degree to which the relationships and/or outcomes formed during the co-adaptation process and/or intervention are sustained). Focus groups will be recorded and transcribed verbatim for analysis. In addition to the focus groups, a questionnaire will be administered to pupils and teachers after the implementation of the intervention, covering the delivery of the intervention and the participation of pupils in the intervention.
4.2 Effect evaluation Sedentary time and sleep duration will be measured using the GENEActiv accelerometer (ActivInsights Ltd., Kimbolton, UK), a waterproof tri-axial accelerometer (43 mm × 40 mm × 13 mm, 16 g). The accelerometer will be worn at the non-dominant wrist continuously over seven days using a 24-hour protocol. Data will be downloaded using the GENEActiv software and subsequently processed and analysed in R (R Development Core Team, 2010) using the GGIR package. Raw tri-axial acceleration values will be converted into a single omnidirectional measure of body acceleration using the Euclidean norm minus one (ENMO) metric. Data will then be reduced by averaging values over 1-second epochs. To determine physical activity intensity, the investigators will apply validated cut-points, classifying sedentary behaviour as values below 56.3 mg, light-intensity physical activity as values ranging from 56.3 to 191.6 mg, moderate-intensity physical activity as values between 191.6 and 695.8 mg, and vigorous-intensity physical activity as values exceeding 695.8 mg. Sedentary time and sedentary behaviour patterns, will be analysed across the entire day, during class hours, outside class hours (e.g., recess), and outside school hours.
To detect sleep, GGIR identifies periods of sustained inactivity. Sustained inactivity is defined as a period in which there is a change in arm angle of less than five degrees over a five-minute period. These thresholds have shown good accuracy for detecting sleep without the use of an activity diary compared to polysomnography, the gold standard sleep measure.
GGIR also estimates non-wear time by identifying periods of sustained low acceleration. Non-wear time will be determined when, for at least two out of three axes, the standard deviation of raw accelerometer data is less than 13 milligravity units (mg) and the data range is below 50 mg over 60-minute blocks, assessed every 15 minutes. GGIR provides two estimates to determine data validity: the number of valid hours and the fraction (%) of the night identified as invalid. In this study, the investigators will convert the fraction of the night identified as invalid to percentage of the night identified as valid (e.g., when 25% of the night is identified as invalid, this will be converted to 75% of the night identified as valid). Pupils will be included if they have at least 9 valid hours on four days for the sedentary time analysis, and at least 50% valid sleep data for five nights for the sleep duration analysis.
Next to the GENEActiv accelerometer, pupils will complete a questionnaire including items on determinants of reducing and regularly interrupting sedentary time in general (e.g., "I think it is important for my health to reduce my sitting time and to take regular breaks"), in the classroom (e.g., "I would rather sit in class than stand up"), and while making homework (e.g., "I prefer to do my schoolwork sitting down rather than standing up"). All items will be answered using a 5-point Likert scale (e.g., "totally disagree" to "totally agree"). Secondly, the questionnaire will assess adolescents' mental well-being using the World Health Organization-Five Well-Being Index (WHO-5). This scale consists of five statements relating to the past two weeks. Each statement is rated on a 6-point scale, with higher scores indicating better mental well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A three-arm clustered controlled trial will be conducted, including a co-adaptation intervention group, a standard intervention group and a control group. In September 2025, six schools will be recruited with immediate allocation to the 3 conditions. Pupils from Grade 7 and 8 will be informed about our study and provide an information letter for their parents. It will be specified that the co-adapted and standard intervention will be delivered to all adolescents as part of their curriculum, but that they are free to participate in the measurements. In September 2025 - January 2026, the co-adaptation process will take place in the co-adaptation intervention group. Between January and April 2026, the intervention will be implemented in the co-adaptation and standard intervention group. For the effect evaluation, there will be a pre-test after the co-adaptation process but before the implementation phase (January-February 2026), and a post-test after the implementation (March-April 2026).
| Arm | Type | Receives |
|---|---|---|
| Co-adaptation intervention group | Experimental | Behavioral: Co-adapted interventionCo-adapted intervention: An existing co-created intervention will be adapted by researchers and 7th and 8th grade pupils and teachers during 3 to 5 design sessions in both co-adaptation intervention schools. |
| Standard intervention group | Active comparator | Behavioral: Standard interventionStandard intervention: The existing co-created intervention will be implemented in the standard intervention schools. So, adolescents and school staff from the standard intervention schools will not be involved in adapting the intervention. |
| Control group | No intervention | –No intervention will be implemented. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Secondary schools need to have at least 150 pupils in the first two grades (Grade 7 and 8).
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Co-adapted interventionAn existing co-created intervention will be adapted by researchers and 7th and 8th grade pupils and teachers during 3 to 5 design sessions in both co-adaptation intervention schools. | Behavioural | Co-adaptation intervention group |
| Standard interventionThe existing co-created intervention will be implemented in the standard intervention schools. So, adolescents and school staff from the standard intervention schools will not be involved in adapting the intervention. | Behavioural | Standard intervention group |
Primary outcome
Sitting time and patterns of sitting time
Time frame: Assessed at baseline (pre-intervention) and immediately after the intervention period. The GENEActiv will be worn during one week.
Sitting time and patterns of sitting time will be derived from a GENEActiv accelerometer that will be worn on the non-dominant wrist.
Determinants of reducing and regularly interrupting sedentary time in general, in the classroom, and while making homework
Time frame: Assessed at baseline (pre-intervention) and immediately after the intervention period.
These determinants will be measured using a questionnaire including items that will be answered on a 5-point Likert scale.
2 secondary outcomes
Sleeping time
Time frame: Assessed at baseline (pre-intervention) and immediately after the intervention period. The GENEActiv will be worn during one week.
Mental well-being
Time frame: Assessed at baseline (pre-intervention) and immediately after the intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Co-adapted intervention and Standard intervention in people with Sedentary Behaviour, run by University Ghent.
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: opening soon, as of the sponsor's last update on 25 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veerle Van Oeckel (+32 9 332 83 61, veerle.vanoeckel@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sitting time and patterns of sitting time (time frame: Assessed at baseline (pre-intervention) and immediately after the intervention period. The GENEActiv will be worn during one week.). 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?
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 25 Jun 2025.