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Enrolling by invitationNCT06362655ACTIBESEUpdated Apr 12, 2024

ACTIBESE Project - Active Behaviour in School Education

An interventional study of Intervention in Physical Inactivity, Child Behavior and Family Support, sponsored by Pontificia Universidad Catolica de Valparaiso. Enrolling by invitation at 1 site in Chile. Open to participants aged 9 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Pontificia Universidad Catolica de Valparaiso · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Apr 2023, registered Mar 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
9 Years to 17 Years
Sex
All
01

Study summary

The ACtive BEhaviour in School Education (ACTIBESE) project aims to assess and intervene in Chilean schoolchildren's active behaviours by examining the influence of personal, interpersonal, and school factors. This study includes a cross-sectional and intervention study involving 152 schools in the Valparaíso and Araucanía Regions, representing urban and rural areas. Participants, divided into children (8-11 years old) and adolescents (12-17 years old), will undergo a comprehensive evaluation, including sociodemographic characteristics, physical activity (PA) levels, parental and peer support, teaching styles of the teachers, and school environment characteristics.

For the cross-sectional study, questionnaires, interviews, accelerometry, and pedometry will be used to collect data on various factors influencing PA in schoolchildren. In the intervention study, a 5-month continuous training program for teachers will be implemented, focusing on improving teaching styles and enhancing teaching competencies related to physical education and health classes. The program aims to positively affect schoolchildren's PA indirectly through improved teaching practices.

The research will use mixed models, ANCOVA (Analysis of Covariance) , and logistic regressions for data analysis, incorporating multilevel logistic regressions to account for school-level dependencies. The study's outcomes will contribute valuable insights into the complex interactions between school, interpersonal, and personal factors influencing schoolchildren's PA, aiding the development of targeted interventions. This comprehensive approach aligns with the project's goal of fostering a physically active lifestyle among Chilean schoolchildren.

Read the detailed description

ACTIve BEhaviour in School Education project (ACTIBESE) is a project funded by the National Agency for Research and Development (ANID) of the Chilean government (Code Nº: 1230801), which seeks to investigate and propose useful tools to increase levels of Physical Activity (PA) in schools. The project will consist of two parts: a cross-sectional study (first and second years) and an intervention study (third year), over a period of three years.

Recruitment

An invitation to participate will be sent to the principals of the participating schools. Once the schools agree to take part and are selected, a meeting will be held with both the representatives of the administrative management authorities and the schoolteachers to explain in detail the aims and stages of the project.

Subsequently, an informative meeting will be held with parents and schoolchildren using the same terms. The groups will be divided by age: children from grades 3-6 of primary school (8-11 years old) and adolescents from grade 7 of primary school to grade 2 of secondary school (12-16 years old).

Cross-sectional study

This study will determine the school factors associated with Active Behaviour (AB) in schoolchildren. These include teaching styles, teaching training, teacher perception of Physical Education (PE), and characteristics of the school and curriculum: school-environmental, spaces to play, infrastructure, recess, time dedicated and weekly frequency of PE, contents, topics, etc. This information will be obtained through qualitative questionnaires administered to schoolteachers. Additionally, the association between social factors and AB in schoolchildren will be studied. This will be determined through standardized questionnaires for parents. In addition, personal factors (i.e., motivation for PE, perception of PE, built-environment perception, and barriers to PA) will be evaluated using qualitative instruments (questionnaires). The outcomes of AB in schoolchildren will be evaluated using device-based methods (accelerometers and pedometers).

Intervention study

  1. Assessment: This consists of applying the evaluation instruments to schoolteachers: Need-Supportive Teaching Style Scale (NSTSS), interviews, and focus group and schoolchildren: Young Activity Profile (YAP) questionnaire, "Pedalea y Anda al Cole" (PACO) questionnaire, accelerometry, pedometry, and barriers, both in the pre-test and post-test, to the intervention and control groups. In addition, instruments for parents (regarding interpersonal factors) will be used. The pre-test and post-test 1 correspond to the evaluation of the intervention process. Post-test 2 will evaluate the effect of the intervention through a follow-up process.
  2. Intervention: The "teaching training" program consists of weekly class sessions addressed to teachers, where topics will be discussed to improve educational practices in Physical Education and Health (PEaH) classes, such as teaching strategies, teaching styles (productive style), recommendations for PA for children and the inclusion of the socioecological model, incorporating all the actors of the school educational environment. In addition, strategies are incorporated to stimulate the self-determination theory (SDT). This activity will be conducted in person; however, it will be changed to an online format according to the circumstances of the distance between cities. The "application of learning" will be carried out, where the teachers must apply the knowledge acquired in the teaching training to courses selected with a weekly frequency of one or two days. The application will take place over a semester (four months). To assess this implementation, pre-and post-tests will be carried out as defined in the methodology. Additionally, the teachers will keep a "field notebook" consisting of a record of the activities that go wrong or of complex situations that require a solution when the Teaching Training is applied in the chosen courses. Parallel to the problem, a solution or activity must be proposed to solve the difficulties that have arisen. Additionally, in the Teaching Training classes, teachers will be asked to attend various "workshops" on topics associated with AB and PEaH to diversify learning. To strengthen the process of applying these lessons, at least two mentoring sessions will be presented to the PEaH classes to resolve doubts, see the implementation of the changes, and understand the reality that schoolteachers face.

    This activity will be conducted in person; however, if the circumstances prohibit in-person meetings, it will be changed to an online format. In addition, regular "online meetings" will be established for schoolteachers to resolve questions and establish approaches, share ideas and concerns, and jointly resolve difficulties imposed on schoolwork or how to implement the different strategies learned in teaching training. This activity will take place every two weeks.

  3. Follow-up: In this phase, teaching materials will be delivered to teachers to be applied during classes. In addition, there will be an observational follow-up to the process, a field notebook will be used, and two process evaluations will be conducted every six weeks from Post-test 1 through "mentoring." Additionally, a support web page will be created with help materials, and an app will be created for schoolteachers and schoolchildren to allow us to monitor the intervention.
02

Conditions studied

  • Physical Inactivity
  • Child Behavior
  • Family Support

Keywords

  • Physical activity
  • School-based intervention
  • Exercise
  • Health
  • Well-being
03

In context

Sedentary Behavior

1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.

This study's planned enrollment of 144 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.

Browse Sedentary Behavior studies →

Lead sponsor

Pontificia Universidad Catolica de Valparaiso is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • At least two PEaH classes per week, at least in selected grades.
  • Grades between the 4th of primary and the 2nd of secondary .
  • Each class had to include at least 15 schoolchildren.
  • At least 15 forms per class for schoolchildren and 15 parents or guardians.
  • At least two physical Education and Health (PEaH) schoolteachers.

Exclusion criteria

Exclusion Criteria:

  • No physical or mental disability
  • Schoolteachers, schoolchildren, and parents cannot participate in other programs promoting physical activity (PA).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    ACTIBESE Invervention Group

    Group that will receive the intervention from teachers to improve physical activity behaviors.

    Behavioral: Intervention

  • No intervention
    Traditional Physical Education Classes Group (Comparative group)

    Group that won't receive the intervention from teachers for improving physical activity behaviours. This group will receive traditional physical education classes according to the national curriculum.

Interventions

  • BehavioralIntervention

    Intervention study. In this intervention study for teachers, a 5-month continuous training program will be included that will improve teaching style and promote teaching training. It will also strengthen teaching competencies to create teaching improvement strategies affecting PEaH and interpersonal and personal factors. This is expected to improve schoolchildren's AB, even when they are not directly influenced. The program will be designed according to the results of the cross-sectional study. The greatest associations found between the three proposed factors (school, interpersonal and personal factors) and schoolchildren AB will be sought. In addition, the characteristics of the schools and the possibilities of time and physical spaces available will be taken into account. This information will be recorded through validated questionnaires and interviews in the pre-test, post-test 1 and after follow-up post-test 2.

06

What researchers measure

Primary outcomes

  1. Physical activity levels

    Physical activity levels carried out inside school and outside school measured through the Young Activity Profile (YAP) questionnaire in the cross sectional stage and through the YAP questionnaire and accelerometry in the intervention stage.

    Time frame: 3 years

07

Study locations

1 site
  • IRyS Group, School of Physical Education, Pontificia Universidad Católica de Valparaíso, Valparaíso, Chile.
    Viña Del Mar, Valparaiso 2300000, Chile
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06362655
Lead sponsor
Pontificia Universidad Catolica de Valparaiso
Collaborators
Universidad de La Frontera
Responsible party
Carlos Cristi Montero (Fernando Rodriguez-Rodriguez, Pontificia Universidad Catolica de Valparaiso) — Principal investigator
First posted
Apr 12, 2024
Start date
Apr 1, 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2025 (estimated)
Last update
Apr 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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