Multicomponent 16-week Program Comprised of a Goal Setting, Wearable Activity Tracker Feedback, Physical Exercising, and Motivating Students to be ActiveNCT07393789
A Multicomponent Physical Activity Intervention Effect on Weekly Steps and Physical Fitness in Preadolescents
A study testing Multicomponent Physical Activity Program in people with Multicomponent 16-week Program Comprised of a Goal Setting, Wearable Activity Tracker Feedback, Physical Exercising, and Motivating Students to be Active, run by University of Belgrade at 2 sites in 2 countries.
Trial summary
This study examines the effects of a 16-week structured physical activity program on physical fitness, steps number, and body mass index in children aged 8 to 10 years. Participants were randomly assigned to either an intervention group that participated in the physical activity program or a control group that… Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Multicomponent 16-week Program Comprised of a Goal Setting, Wearable Activity Tracker Feedback, Physical Exercising, and Motivating Students to be Active
- What is being tested?
- Multicomponent Physical Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Oct 2022to 3 Mar 2023
- 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
- Children aged 8 to 10 years.
- Enrollment in regular primary school.
- Written informed consent obtained from parent or legal guardian.
- Ability to participate in physical education and physical activity.
Who cannot join
- Medical conditions or physical disabilities that limit participation in physical activity.
- Acute illness or injury at the time of testing.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Serbia1 site
University of Belgrade - Faculty of Sport and Physical Education
Belgrade, 11000
About this study
Official title: A Multicomponent Physical Activity Intervention Effect on Weekly Steps and Physical Fitness in Preadolescents: A Pretest-Posttest Study and Randomized Control Trial
This study examines the effects of a 16-week structured physical activity program on physical fitness, steps number, and body mass index in children aged 8 to 10 years.
Participants were randomly assigned to either an intervention group that participated in the physical activity program or a control group that continued with their usual daily activities without additional intervention.
Read more
Physical fitness outcomes include standing broad jump, handgrip strength, and 20-meter shuttle run performance. Body mass index is calculated from measured height and body mass.
The goal of the study is to determine whether participation in a multicomponent physical activity intervention leads to greater improvements in physical fitness, steps number, and body composition compared with no additional intervention.
Read the detailed description
This randomized controlled trial investigated the effects of a multicomponent physical activity intervention on physical fitness, steps number, and body mass index in preadolescent children.
Children aged 8 to 10 years were recruited from a primary school setting and randomly allocated to either an intervention group or a control group. The intervention group participated in a structured physical activity program and motivational strategies lasting 16 weeks, while the control group continued their regular daily routines and school activities without additional intervention activities provided by the study.
The physical activity program consisted of planned sessions designed to develop muscular strength, cardiorespiratory endurance, speed, and coordination through age-appropriate exercises and games.
Assessments were conducted before and after the intervention period. Physical fitness was evaluated using the standing broad jump (lower-body muscular power), handgrip strength (upper-body muscular strength), and the 20-meter shuttle run test (cardiorespiratory fitness). Body mass index was calculated using measured body mass and height.
The primary objective of the study was to determine whether children participating in the intervention demonstrate greater improvements in physical fitness and body mass index compared with children in the control group.
- Being tested
- Multicomponent Physical Activity Program
- Keywords
- Pretest-Posttest Study, Randomized Control Trial, physical activity intervention, children, preadolescents, physical fitness, body mass index, school-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Physical Activity ProgramBehavioural
Structured physical activity sessions and motivational procedures designed to improve muscular strength, cardiorespiratory fitness, speed, and coordination.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention Group | Experimental | Participants receive a 16-week structured multicomponent physical activity program. Receives: Behavioral: Multicomponent Physical Activity Program |
| Control Group | No intervention | Participants continue their usual daily activities without additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip Strength
Handgrip Strength in kg
Measured: Baseline and 16 weeks
Standing Broad Jump Distance
Assessment of lower-body muscular power measured in centimeters
Measured: Baseline and 16 weeks
20-Meter Shuttle Run Performance
20-Meter Shuttle Run result in seconds
Measured: Baseline and 16 weeks
Secondary outcomes (1)
Body Mass Index (BMI)
BMI is calculated by dividing weight in kilograms by height in meters squared.
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start31 Oct 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multicomponent 16-week Program Comprised of a Goal Setting, Wearable Activity Tracker Feedback, Physical Exercising, and Motivating Students to be ActiveStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either an intervention group or a control group.
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Milošević, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393789
- Sponsor's protocol ID
- COMPASS-2022
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 6 Feb 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicomponent Physical Activity Intervention Effect on Weekly Steps and Physical Fitness in Preadolescents: A Pretest-Posttest Study and Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07393789
- Acronym / sponsor ID
- COMPASS-2022
- Keywords
- Pretest-Posttest Study, Randomized Control Trial, physical activity intervention, children, preadolescents, physical fitness, body mass index, school-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 6 Feb 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.
This study examines the effects of a 16-week structured physical activity program on physical fitness, steps number, and body mass index in children aged 8 to 10 years.
Participants were randomly assigned to either an intervention group that participated in the physical activity program or a control group that continued with their usual daily activities without additional intervention.
Physical fitness outcomes include standing broad jump, handgrip strength, and 20-meter shuttle run performance. Body mass index is calculated from measured height and body mass.
The goal of the study is to determine whether participation in a multicomponent physical activity intervention leads to greater improvements in physical fitness, steps number, and body composition compared with no additional intervention.
Detailed description
This randomized controlled trial investigated the effects of a multicomponent physical activity intervention on physical fitness, steps number, and body mass index in preadolescent children.
Children aged 8 to 10 years were recruited from a primary school setting and randomly allocated to either an intervention group or a control group. The intervention group participated in a structured physical activity program and motivational strategies lasting 16 weeks, while the control group continued their regular daily routines and school activities without additional intervention activities provided by the study.
The physical activity program consisted of planned sessions designed to develop muscular strength, cardiorespiratory endurance, speed, and coordination through age-appropriate exercises and games.
Assessments were conducted before and after the intervention period. Physical fitness was evaluated using the standing broad jump (lower-body muscular power), handgrip strength (upper-body muscular strength), and the 20-meter shuttle run test (cardiorespiratory fitness). Body mass index was calculated using measured body mass and height.
The primary objective of the study was to determine whether children participating in the intervention demonstrate greater improvements in physical fitness and body mass index compared with children in the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either an intervention group or a control group.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention Group | Experimental | Behavioral: Multicomponent Physical Activity ProgramParticipants receive a 16-week structured multicomponent physical activity program. |
| Control Group | No intervention | –Participants continue their usual daily activities without additional intervention. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 8 to 10 years.
- Enrollment in regular primary school.
- Written informed consent obtained from parent or legal guardian.
- Ability to participate in physical education and physical activity.
Key exclusion criteria (2 listed)
- Medical conditions or physical disabilities that limit participation in physical activity.
- Acute illness or injury at the time of testing.
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 |
|---|---|---|
| Multicomponent Physical Activity ProgramStructured physical activity sessions and motivational procedures designed to improve muscular strength, cardiorespiratory fitness, speed, and coordination. | Behavioural | Physical Activity Intervention Group |
Primary outcome
Handgrip Strength
Time frame: Baseline and 16 weeks
Handgrip Strength in kg
Standing Broad Jump Distance
Time frame: Baseline and 16 weeks
Assessment of lower-body muscular power measured in centimeters
20-Meter Shuttle Run Performance
Time frame: Baseline and 16 weeks
20-Meter Shuttle Run result in seconds
1 secondary outcome
Body Mass Index (BMI)
Time frame: Baseline and 16 weeks
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 6 Feb 2026.
- Individual participant dataSharing planned: No
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Physical Activity Program in people with Multicomponent 16-week Program Comprised of a Goal Setting, Wearable Activity Tracker Feedback, Physical Exercising, and Motivating Students to be Active, run by University of Belgrade at 2 sites in 2 countries.
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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Serbia. 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?
Handgrip Strength (time frame: Baseline and 16 weeks). The study lists 3 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 6 Feb 2026.