Health BehaviorActiva-MenteNCT05403996
Effects of an Active Break Program at Primary School
A study testing Activa-Mente in people with Health Behavior and Behavior, Child, run by Universidad de La Frontera at 1 site in Chile.
Trial summary
The purpose of this study is to assess the effectiveness of an active break program at school on physical activity levels and enjoyment, and on-task behavior in children. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Behavior, Child
- What is being tested?
- Activa-Mente
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 1 Nov 2022to 30 Apr 2024
- 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 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Schoolchildren aged 8 to 10 years old (third to fourth grade of primary education).
Who cannot join
- Children with school attendance lower than 90 per cent (excluded from data analysis).
- Any medical condition that impedes physical activity breaks.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Facultad de Ciencias de la Actividad Física y del Deporte
Valparaíso
About this study
Official title: Effects of an Active Break Program at School on Physical Activity and On-task Behavior in Children From 6 to 12 Years Old
The purpose of this study is to assess the effectiveness of an active break program at school on physical activity levels and enjoyment, and on-task behavior in children.
Read the detailed description
The protocol will include third and fourth-grade students (children aged 8 to 10 years) from elementary schools in the Valparaíso Region, Chile. Four school classes from two schools (intervention and control school) will be included. The intervention school will carry out the active break program, ACTIVA-MENTE This program consists of the application of a 4-and-a-half-minute video with moderate to vigorous-intensity physical activity. These breaks will take place 6 times a day in classes for 6 weeks.
- Conditions
- Health Behavior, Behavior, Child
- Being tested
- Activa-Mente
- Keywords
- physical activity, physical activity enjoyment, on-task behavior
- Medical subject headings
- Health Behavior, Child Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activa-MenteBehavioural
Active break program
| Study group | Role | What they receive |
|---|---|---|
| Activa-Mente (Intervention) | Experimental | The active break program involves the presentation of video (4.5 min) with moderate-to-vigorous physical activities. These active breaks will be performed 6 times per day during 6 weeks. Receives: Behavioral: Activa-Mente |
| Control group | No intervention | This group of students will not be exposed to the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Physical activity will be measured with waist-worn ActiGraph GT3X+ accelerometers for seven days. Physical activity intensities will be derived from the accelerometer counts. Evenson cut points will be used to classify counts into physical activity intensities. Physical activity will be classified as light, moderate-to-vigorous and total physical activity.
Measured: 6 weeks
On-task behavior
The Direct Behaviour Rating Scale will be used to measure on-task behavior at the individual level. This scale measures academically engaged, respectful and disruptive behavior. For each domain, the scale uses a per cent grading system in which 0% indicates 'never' while 100% indicates 'always'. At the group level, the Classroom Behaviour and Assets Survey will be used teachers who will be asked to indicate the proportion of the class displaying on-task behavior as defined by the individual behavior tool. Response options include: 0 (0 students), 1 (1-2 students), 2 (a few students), 3 (about ¼ of the class), 4 (about ½ of the class), 5 (about ¾ of the class), 6 (most of the class), and 7 (all of the class).
Measured: 6 weeks
Secondary outcomes (1)
Physical activity enjoyment
The Physical Activity Enjoyment Scale (PACES) will be used to measure enjoyment during the active breaks. Each of the 14 items of this instrument includes a Likert-type scale that ranges from 1 (Disagree a lot) to 5 (Agree a lot).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Nov 2022
- Primary completion20 Oct 2023
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot cluster randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Collaborators
- Playa Ancha University, Universidad Metropolitana de Ciencias de la Educacion
- Responsible party
- Principal investigator, Nicolas Aguilar Farias, Universidad de La Frontera
- Investigators
- Tomas Reyes, PhD, Principal investigator, Playa Ancha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403996
- Sponsor's protocol ID
- UPLA-005-2022
- Acronym
- Activa-Mente
- Status last verified
- Dec 2023
- First submitted
- 31 May 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The anonymized and raw data supporting the conclusions of this study will be made available by the principal investigator, upon reasonable request.
Publications
Reyes-Amigo T, Grao-Cruces A, Sanchez-Oliva D, Garcia-Hermoso A, Reyes-Molina D, Yanez-Sepulveda R, Olivares-Arancibia J, Hurtado-Almonacid J, Paez-Herrera J, Salinas-Gallardo G, Mendoza E, Ovalle-Fernandez C, Sepulveda-Figueroa F, Ibarra-Mora J. Acute effect of school-based active breaks on physical activity level and on-task classroom behavior in primary schoolchildren. Front Public Health. 2025 Oct 30;13:1644819. doi: 10.3389/fpubh.2025.1644819. eCollection 2025.
PubMed 41246058Reyes-Amigo T, Ibarra-Mora J, Aguilar-Farias N, Gomez-Alvarez N, Carrasco-Beltran H, Zapata-Lamana R, Hurtado-Almonacid J, Paez-Herrera J, Yanez-Sepulveda R, Cortes G, Rolle-Caceres G, Bezerra A. An active break program (ACTIVA-MENTE) at elementary schools in Chile: study protocol for a pilot cluster randomized controlled trial. Front Public Health. 2024 Jan 8;11:1243592. doi: 10.3389/fpubh.2023.1243592. eCollection 2023.
PubMed 38259740
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Active Break Program at School on Physical Activity and On-task Behavior in Children From 6 to 12 Years Old
- ClinicalTrials.gov ID
- NCT05403996
- Acronym / sponsor ID
- Activa-Mente / UPLA-005-2022
- Conditions
- Health Behavior, Behavior, Child
- Keywords
- physical activity, physical activity enjoyment, on-task behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Collaborators
- Playa Ancha University, Universidad Metropolitana de Ciencias de la Educacion
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 3 Jun 2022 (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.
The purpose of this study is to assess the effectiveness of an active break program at school on physical activity levels and enjoyment, and on-task behavior in children.
Detailed description
The protocol will include third and fourth-grade students (children aged 8 to 10 years) from elementary schools in the Valparaíso Region, Chile. Four school classes from two schools (intervention and control school) will be included. The intervention school will carry out the active break program, ACTIVA-MENTE This program consists of the application of a 4-and-a-half-minute video with moderate to vigorous-intensity physical activity. These breaks will take place 6 times a day in classes for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Activa-Mente (Intervention) | Experimental | Behavioral: Activa-MenteThe active break program involves the presentation of video (4.5 min) with moderate-to-vigorous physical activities. These active breaks will be performed 6 times per day during 6 weeks. |
| Control group | No intervention | –This group of students will not be exposed to the intervention. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Schoolchildren aged 8 to 10 years old (third to fourth grade of primary education).
Key exclusion criteria (2 listed)
- Children with school attendance lower than 90 per cent (excluded from data analysis).
- Any medical condition that impedes physical activity breaks.
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 |
|---|---|---|
| Activa-MenteActive break program | Behavioural | Activa-Mente (Intervention) |
Primary outcome
Physical activity
Time frame: 6 weeks
Physical activity will be measured with waist-worn ActiGraph GT3X+ accelerometers for seven days. Physical activity intensities will be derived from the accelerometer counts. Evenson cut points will be used to classify counts into physical activity intensities. Physical activity will be classified as light, moderate-to-vigorous and total physical activity.
On-task behavior
Time frame: 6 weeks
The Direct Behaviour Rating Scale will be used to measure on-task behavior at the individual level. This scale measures academically engaged, respectful and disruptive behavior. For each domain, the scale uses a per cent grading system in which 0% indicates 'never' while 100% indicates 'always'. At the group level, the Classroom Behaviour and Assets Survey will be used teachers who will be asked to indicate the proportion of the class displaying on-task behavior as defined by the individual behavior tool. Response options include: 0 (0 students), 1 (1-2 students), 2 (a few students), 3 (about ¼ of the class), 4 (about ½ of the class), 5 (about ¾ of the class), 6 (most of the class), and 7 (all of the class).
1 secondary outcome
Physical activity enjoyment
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Derived from this study: PubMed 41246058Reyes-Amigo T, Grao-Cruces A, Sanchez-Oliva D, Garcia-Hermoso A, Reyes-Molina D, Yanez-Sepulveda R, Olivares-Arancibia J, Hurtado-Almonacid J, Paez-Herrera J, Salinas-Gallardo G, Mendoza E, Ovalle-Fernandez C, Sepulveda-Figueroa F, Ibarra-Mora J. Acute effect of school-based active breaks on physical activity level and on-task classroom behavior in primary schoolchildren. Front Public Health. 2025 Oct 30;13:1644819. doi: 10.3389/fpubh.2025.1644819. eCollection 2025.
- Derived from this study: PubMed 38259740Reyes-Amigo T, Ibarra-Mora J, Aguilar-Farias N, Gomez-Alvarez N, Carrasco-Beltran H, Zapata-Lamana R, Hurtado-Almonacid J, Paez-Herrera J, Yanez-Sepulveda R, Cortes G, Rolle-Caceres G, Bezerra A. An active break program (ACTIVA-MENTE) at elementary schools in Chile: study protocol for a pilot cluster randomized controlled trial. Front Public Health. 2024 Jan 8;11:1243592. doi: 10.3389/fpubh.2023.1243592. eCollection 2023.
- Individual participant dataSharing planned: Undecided. The anonymized and raw data supporting the conclusions of this study will be made available by the principal investigator, upon reasonable request.
Related trials for Health Behavior
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Active, not recruiting
Improving Emotional Wellbeing of University Students: Emotion Regulation
Emotion Regulation
Not yet recruiting
Effects of the 11 for Health Program on Physical Fitness and Health-Related Outcomes in Schoolchildren
Physical Fitness, Health
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
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.
Tomas Reyes, PhD principal investigator
Playa Ancha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activa-Mente in people with Health Behavior and Behavior, Child, run by Universidad de La Frontera at 1 site in Chile.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Jan 2024. 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 Chile. 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?
Results are not available in the source record.
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?
Physical activity (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT05403996, which also lists 2 linked publications.
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 2 Jan 2024.