Reducing and Breaking up School-related Sedentary Behaviour Among Adolescents Using Co-creation

NCT07036276 | Not Yet Recruiting

• 1 other identifier: ONZ-2025-0184
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Sedentary Behaviour

Keywords

Adolescents; Youth; Student; School; Classroom; Sedentary behaviour; Participatory research; Co-creation; Co-adaptation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Assessed at baseline (pre-intervention) and immediately after the intervention period.

Secondary Outcomes (2)

• Sleeping time

  Assessed at baseline (pre-intervention) and immediately after the intervention period. The GENEActiv will be worn during one week.

• Mental well-being

  Assessed at baseline (pre-intervention) and immediately after the intervention period.

Study Arms (3)

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.

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.

Behavioral: Standard intervention

Control group

NO INTERVENTION

No intervention will be implemented.

Interventions

Co-adapted intervention BEHAVIORAL

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.

Co-adaptation intervention group

Standard intervention BEHAVIORAL

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.

Standard intervention group

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Secondary schools need to have at least 150 pupils in the first two grades (Grade 7 and 8).

You may not qualify if:

• None

Sponsors & Collaborators

• University Ghent: lead

Central Study Contacts

Veerle Van Oeckel

CONTACT

+32 9 332 83 61; veerle.vanoeckel@ugent.be

Maïté Verloigne, Prof. dr.

CONTACT

+3293328336; maite.verloigne@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be published together with the publishing of manuscripts.
• Access Criteria: This depends on the journal. The investigators will deposit the data into a data repository (i.e., OSF) or publish the data as supplementary file along with the manuscript in a journal.