Physical FitnessNCT07597460
Active Schools in Chile: Impact on Fitness, Physical Activity, and Sports Participation
A study testing Active Schools Program and Regular Physical Education in people with Physical Fitness and Physical Activity, run by Universidad de Santiago de Chile at 1 site in Chile.
Trial summary
Study Rationale: Currently, a significant proportion of children in Chile do not meet recommended physical activity levels, which may adversely affect their health and development. The school environment provides an ideal setting to promote healthy habits. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fitness, Physical Activity, Sedentary Behaviors
- What is being tested?
- Active Schools Program and Regular Physical Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteChile
- Study dates
- 11 Dec 2023to 2 Mar 2026
- 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 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students enrolled in the third grade of elementary school at the selected schools.
- Minimum enrollment period of at least one year at the current school.
- Residing in the same municipality where the school is located.
- Open to all students regardless of migration status.
Who cannot join
- Students following any type of restrictive diet related to previously diagnosed chronic diseases.
- Diagnosis of chronic conditions that require dietary or physical limitations (e.g., diabetes, celiac disease, renal disease, among others).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a School-based Intervention on Physical Activity, Fitness, and Sports Participation in Chilean Children: a Single-arm Cluster Study
Study Rationale:
Currently, a significant proportion of children in Chile do not meet recommended physical activity levels, which may adversely affect their health and development. The school environment provides an ideal setting to promote healthy habits. This study was designed to evaluate whether a school-based program incorporating physical activity, sports, and health education can improve physical fitness and increase the time children dedicate to physical activity practice.
Read more
Objective:
The primary objective of this study is to evaluate the impact of a two-year school-based intervention on physical activity levels, muscular fitness (measured by upper body, lower body, and abdominal muscular strength), and sports participation among Chilean schoolchildren.
How the study works:
This is a single-arm cluster intervention study incorporating a pre-post design. Participating schools were allocated in a specialized program focused on physical activity and the promotion of sports practice throughout two school years.
What was measured:
At baseline and after the two-year intervention, the following outcomes were assessed:
Physical Activity Levels: Measured via accelerometry; Muscular Fitness: Assessed through muscular strength tests, including upper limb strength (handgrip strength using a dynamometer), lower limb strength (standing long jump test), and abdominal strength (60-second curl-up test).
Sports Participation: Evaluated through self-reports of involvement in organized sports.
Researchers compared pre- and post-intervention data between the intervention to determine if children in the special program showed significantly greater improvements compared to those in the standard routine.
Read the detailed description
This is a a single-arm school-based intervention study designed to address the growing concern about low levels of physical activity among schoolchildren. Currently, a significant proportion of children in Chile do not meet global physical activity recommendations, which can lead to long-term health problems. Since children spend a large part of their day at school, this environment offers a unique opportunity to promote healthier lifestyles and sustainable physical habits.
The main objective of this intervention is to evaluate whether a comprehensive, two-year, multi-component program can effectively increase physical activity levels, improve physical fitness, and encourage sports participation. Unlike traditional programs that focus solely on physical education classes, this study uses a holistic approach based on three main pillars:
Active Recess: Transforming school breaks into opportunities for movement through structured and supervised activities, thus reducing sedentary time during the school day.
Enhanced Physical Education: Implementing high-engagement strategies within the existing curriculum to maximize benefits for students.
Health Education: Involving the entire school community-including students, teachers, and families-through workshops that highlight the importance of an active life and the practice of organized sports.
To ensure rigorous results, schools were randomly assigned to either an Intervention Group, which implemented the program over two school years (2024-2025). Children who did not participate in specific intervention activities continued their usual school routine and regular physical education classes; however, they were not considered a control group for analytical purposes.
The program's effectiveness was evaluated through a pre-post analysis. Using high-precision tools such as ActiGraph accelerometers for objective movement tracking and standardized muscle strength tests, researchers monitored changes in children's physical health. Additionally, the study investigates the frequency of sports participation to verify whether a more active school environment leads to greater interest in organized sports.
Ultimately, this study aims to provide evidence-based strategies that can be replicated in other schools in Chile and in similar contexts, contributing to the formation of a healthier and more active future generation.
- Conditions
- Physical Fitness, Physical Activity, Sedentary Behaviors, Health Promotion, Child Health, Sports
- Being tested
- Active Schools Program, Regular Physical Education
- Keywords
- School-based intervention, Accelerometry, Physical activity, Sedentary behavior, Sports participation, Children
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Schools ProgramBehavioural
The intervention was conducted two to three times per week, depending on the specific schedule of each school. In addition to enhanced physical education classes, educational content related to the benefits of healthy behaviors was integrated across various academic subjects to increase students' awareness. During physical education classes, activities designed to maximize PA levels and improve muscular strength were implemented. Additionally, strategies to foster active recess were established, including the provision of equipment such as jump ropes, medicine balls, and resistance bands for recreational and playful activities. Specific areas were also organized for PA during breaks, featuring floor and wall markings for game and exercise stations, accompanied by instructional posters suggesting activities. These actions aimed to encourage movement and increase students' engagement in PA throughout the school day.
Regular Physical EducationOther
Children who did not participate in specific intervention activities continued their usual school routine and regular physical education classes, as mandated by the Ministry of Education of Chile; however, they were not considered a control group for analytical purposes.
| Study group | Role | What they receive |
|---|---|---|
| School-based Intervention Program | Active comparator | Students participated in a two-year, multicomponent school-based program designed to promote physical activity and sports participation. The intervention consisted of three core elements: (1) Active Recesses, involving structured and supervised physical activities during school breaks; (2) Enhanced Physical Education, utilizing high-engagement pedagogical strategies; and (3) Health Education workshops for students and the school community focused on active lifestyles. All activities were integrated into the regular school calendar. Receives: Behavioral: Active Schools Program; Other: Regular Physical Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the levels of physical activity.
Average daily minutes spent at different levels of physical activity, objectively measured using ActiGraph accelerometers worn over 7 consecutive days.
Measured: Baseline (Month 2-3) and End of Intervention (Month 27-30)
Secondary outcomes (5)
Change from Baseline in Upper Limb Strength
Handgrip strength (absolute strength) will be assessed using a Smedley-type handheld dynamometer, with results recorded in kilograms (kg). The participants will perform the test in a standing position with their arms extended alongside the body. Following a demonstration and a familiarization trial, two measurements will be taken for each hand, alternating between the right and left sides to allow for adequate recovery. The final score for each participant will be calculated as the mean of the two trials for each hand.
Measured: Baseline (Month 2-3) and End of Intervention (Month 27-30)
Change from Baseline in Sports Participation Frequency
Measured by the Physical Activity Questionnaire for Children (PAQ-C), a self-reported instrument designed to assess general levels of physical activity, with a particular focus on participation in sports and organized activities. The full title of the instrument is the Physical Activity Questionnaire for Children (PAQ-C). It consists of nine items scored on a 5-point Likert scale. The final score is the mean of these items, ranging from 1 to 5, where higher scores represent greater involvement in physical activity and sports.
Measured: Baseline (Month 2-3) and End of Intervention (Month 27-30)
Change from Baseline in Sedentary Behavior
Average daily minutes of sedentary behavior, measured objectively via ActiGraph accelerometry.
Measured: Baseline (Month 2-3) and End of Intervention (Month 27-30).
Change from Baseline in Lower Limb Strength
Evaluated using the standing long jump test, with results recorded in centimeters (cm). Participants will stand behind a starting line and perform a jump as far as possible, landing with both feet simultaneously. The distance is measured from the starting line to the heel of the foot that lands closest to the line. After a familiarization trial, two official attempts will be performed, and the final score will be recorded as the mean of the two trials.
Measured: Baseline (Month 2-3) and End of Intervention (Month 27-30)
Change from Baseline in Abdominal Muscle Strength
Measured using the 60-second curl-up test, recording the maximum number of correct repetitions performed within the time limit. Participants lie in a supine position with knees bent at 90 degrees and feet flat on the floor. On the signal 'Go', they perform as many controlled curl-ups as possible. The final result is recorded as the total number of successfully completed repetitions in one minute.
Measured: Baseline (Month 2-3) and End of Intervention (Month 27-30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start11 Dec 2023
- Primary completion15 Dec 2025
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical FitnessStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Santiago de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubenyta Martins Podmelle, Universidad de Santiago de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597460
- Sponsor's protocol ID
- 256/2023
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a School-based Intervention on Physical Activity, Fitness, and Sports Participation in Chilean Children: a Single-arm Cluster Study
- ClinicalTrials.gov ID
- NCT07597460
- Acronym / sponsor ID
- 256/2023
- Conditions
- Physical Fitness, Physical Activity, Sedentary Behaviors, Health Promotion, Child Health, Sports
- Keywords
- School-based intervention, Accelerometry, Physical activity, Sedentary behavior, Sports participation, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Universidad de Santiago de ChileUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 19 May 2026 (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.
Study Rationale:
Currently, a significant proportion of children in Chile do not meet recommended physical activity levels, which may adversely affect their health and development. The school environment provides an ideal setting to promote healthy habits. This study was designed to evaluate whether a school-based program incorporating physical activity, sports, and health education can improve physical fitness and increase the time children dedicate to physical activity practice.
Objective:
The primary objective of this study is to evaluate the impact of a two-year school-based intervention on physical activity levels, muscular fitness (measured by upper body, lower body, and abdominal muscular strength), and sports participation among Chilean schoolchildren.
How the study works:
This is a single-arm cluster intervention study incorporating a pre-post design. Participating schools were allocated in a specialized program focused on physical activity and the promotion of sports practice throughout two school years.
What was measured:
At baseline and after the two-year intervention, the following outcomes were assessed:
Physical Activity Levels: Measured via accelerometry; Muscular Fitness: Assessed through muscular strength tests, including upper limb strength (handgrip strength using a dynamometer), lower limb strength (standing long jump test), and abdominal strength (60-second curl-up test).
Sports Participation: Evaluated through self-reports of involvement in organized sports.
Researchers compared pre- and post-intervention data between the intervention to determine if children in the special program showed significantly greater improvements compared to those in the standard routine.
Detailed description
This is a a single-arm school-based intervention study designed to address the growing concern about low levels of physical activity among schoolchildren. Currently, a significant proportion of children in Chile do not meet global physical activity recommendations, which can lead to long-term health problems. Since children spend a large part of their day at school, this environment offers a unique opportunity to promote healthier lifestyles and sustainable physical habits.
The main objective of this intervention is to evaluate whether a comprehensive, two-year, multi-component program can effectively increase physical activity levels, improve physical fitness, and encourage sports participation. Unlike traditional programs that focus solely on physical education classes, this study uses a holistic approach based on three main pillars:
Active Recess: Transforming school breaks into opportunities for movement through structured and supervised activities, thus reducing sedentary time during the school day.
Enhanced Physical Education: Implementing high-engagement strategies within the existing curriculum to maximize benefits for students.
Health Education: Involving the entire school community-including students, teachers, and families-through workshops that highlight the importance of an active life and the practice of organized sports.
To ensure rigorous results, schools were randomly assigned to either an Intervention Group, which implemented the program over two school years (2024-2025). Children who did not participate in specific intervention activities continued their usual school routine and regular physical education classes; however, they were not considered a control group for analytical purposes.
The program's effectiveness was evaluated through a pre-post analysis. Using high-precision tools such as ActiGraph accelerometers for objective movement tracking and standardized muscle strength tests, researchers monitored changes in children's physical health. Additionally, the study investigates the frequency of sports participation to verify whether a more active school environment leads to greater interest in organized sports.
Ultimately, this study aims to provide evidence-based strategies that can be replicated in other schools in Chile and in similar contexts, contributing to the formation of a healthier and more active future generation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| School-based Intervention Program | Active comparator | Behavioral: Active Schools Program, Other: Regular Physical EducationStudents participated in a two-year, multicomponent school-based program designed to promote physical activity and sports participation. The intervention consisted of three core elements: (1) Active Recesses, involving structured and supervised physical activities during school breaks; (2) Enhanced Physical Education, utilizing high-engagement pedagogical strategies; and (3) Health Education workshops for students and the school community focused on active lifestyles. All activities were integrated into the regular school calendar. |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Students enrolled in the third grade of elementary school at the selected schools.
- Minimum enrollment period of at least one year at the current school.
- Residing in the same municipality where the school is located.
- Open to all students regardless of migration status.
Key exclusion criteria (2 listed)
- Students following any type of restrictive diet related to previously diagnosed chronic diseases.
- Diagnosis of chronic conditions that require dietary or physical limitations (e.g., diabetes, celiac disease, renal disease, among others).
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 |
|---|---|---|
| Active Schools ProgramThe intervention was conducted two to three times per week, depending on the specific schedule of each school. In addition to enhanced physical education classes, educational content related to the benefits of healthy behaviors was integrated across various academic subjects to increase students' awareness. During physical education classes, activities designed to maximize PA levels and improve muscular strength were implemented. Additionally, strategies to foster active recess were established, including the provision of equipment such as jump ropes, medicine balls, and resistance bands for recreational and playful activities. Specific areas were also organized for PA during breaks, featuring floor and wall markings for game and exercise stations, accompanied by instructional posters suggesting activities. These actions aimed to encourage movement and increase students' engagement in PA throughout the school day. | Behavioural | School-based Intervention Program |
| Regular Physical EducationChildren who did not participate in specific intervention activities continued their usual school routine and regular physical education classes, as mandated by the Ministry of Education of Chile; however, they were not considered a control group for analytical purposes. | Other | School-based Intervention Program |
Primary outcome
Change from Baseline in the levels of physical activity.
Time frame: Baseline (Month 2-3) and End of Intervention (Month 27-30)
Average daily minutes spent at different levels of physical activity, objectively measured using ActiGraph accelerometers worn over 7 consecutive days.
5 secondary outcomes
Change from Baseline in Upper Limb Strength
Time frame: Baseline (Month 2-3) and End of Intervention (Month 27-30)
Change from Baseline in Sports Participation Frequency
Time frame: Baseline (Month 2-3) and End of Intervention (Month 27-30)
Change from Baseline in Sedentary Behavior
Time frame: Baseline (Month 2-3) and End of Intervention (Month 27-30).
Change from Baseline in Lower Limb Strength
Time frame: Baseline (Month 2-3) and End of Intervention (Month 27-30)
Change from Baseline in Abdominal Muscle Strength
Time frame: Baseline (Month 2-3) and End of Intervention (Month 27-30)
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 30 Jul 2026.
- Individual participant dataSharing planned: No
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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 Active Schools Program and Regular Physical Education in people with Physical Fitness and Physical Activity, run by Universidad de Santiago de Chile 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 4 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: finished, as of the sponsor's last update on 30 Jul 2026. 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?
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?
Change from Baseline in the levels of physical activity. (time frame: Baseline (Month 2-3) and End of Intervention (Month 27-30)). 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 30 Jul 2026.