Physical ActivityNCT04194580
Physical Activiy Intervention Programm
A study testing Phisical activity intervention in people with Physical Activity and Fitness, run by Universidad Autónoma de Chile at 1 site in Chile.
Trial summary
The purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention for reducing the prevalence of overweight/obesity and other cardiovascular risk factors Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Fitness, Overweight and Obesity
- What is being tested?
- Phisical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChile
- Study dates
- 3 Dec 2019to 20 Dec 2020
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The parents of the children will be informed about the objectives and methods of the study, and will give their written consent to the participation of the children. Similarly, the study will introduce children from classroom to class and their oral consent will be obtained
Who cannot join
- Participating children will be free from serious learning difficulties, or physical or mental disorders, that could prevent participation in scheduled physical activities.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Laboratorio Fisiología del Ejercicio
Temuco, La Araucanía, 4780000
Andrés Godoy, Prof., +56932259064, andres.godoy@uautonoma.cl
About this study
Official title: Effectiveness of a Physical Activity Intervention on the Overweight and Obesity of Chilean Schoolchildren
The purpose of this study is to evaluate the effectiveness of a recreational physical activity intervention for reducing the prevalence of overweight/obesity and other cardiovascular risk factors
Read the detailed description
A greater intensity of the intervention, and a longer weekly duration that extends until the weekend, could improve the efficiency in obesity.
- Conditions
- Physical Activity, Fitness, Overweight and Obesity
- Being tested
- Phisical activity intervention
- Medical subject headings
- Motor Activity, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phisical activity interventionBehavioural
The prevalence of overweight in chilean children in the among the highest in the world and increasing quickly. The investigators recently evaluated an after-school program of recreational physical activity to control overweight, obesity and other cardiovascular risk factors in primary school children Temuco. This program reduced adiposity and increased the fitness.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | In the program we will perform a recreational physical activity intervention during one year that include standardized recreative and non competitive activities conducted by sports instructors Receives: Behavioral: Phisical activity intervention |
| Physical activity control | No intervention | This group will not participate in the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Capacity
By using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 4 years.
Measured: 1 year
Muscle Strength
By using standing long jump test
Measured: 1 year
Flexibility
By using the sit and reach test
Measured: 1 year
Speed-agility
By using 4x10 meters shuttle run test
Measured: 1 year
Secondary outcomes (1)
Health-related quality of life
By using the instrument for assessing Health-Related Quality of Life for children and adolescents aged 4-17 years (KINDL), in its version validated in Spanish. The KINDLR questionnaire consists of 24 Likert-scaled items associated with six dimensions: physical well-being, emotional well-being, self-esteem, family, friends and everyday functioning (school or nursery school/kindergarten). The sub-scales of these six dimensions can be combined to produce a total score. the score ranges from 0 to 100. Higher scores indicate better health-related quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start3 Dec 2019
- Primary completion20 Jul 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrés Godoy Cumillaf, Universidad Autónoma de Chile
- Investigators
- José Bruneau, PhD, Study director, Universidad Autónoma de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194580
- Sponsor's protocol ID
- UAChile
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Godoy-Cumillaf A, Fuentes-Merino P, Giakoni-Ramirez F, Duclos-Bastias D, Merellano-Navarro E. Effectiveness of a physical activity intervention on the overweight and obesity of Chilean schoolchildren. Medicine (Baltimore). 2022 Sep 30;101(39):e30908. doi: 10.1097/MD.0000000000030908.
PubMed 36181063
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Physical Activity Intervention on the Overweight and Obesity of Chilean Schoolchildren
- ClinicalTrials.gov ID
- NCT04194580
- Acronym / sponsor ID
- UAChile
- Conditions
- Physical Activity, Fitness, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Universidad Autónoma de ChileUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 20 Jul 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 11 Dec 2019 (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 evaluate the effectiveness of a recreational physical activity intervention for reducing the prevalence of overweight/obesity and other cardiovascular risk factors
Detailed description
A greater intensity of the intervention, and a longer weekly duration that extends until the weekend, could improve the efficiency in obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Phisical activity interventionIn the program we will perform a recreational physical activity intervention during one year that include standardized recreative and non competitive activities conducted by sports instructors |
| Physical activity control | No intervention | –This group will not participate in the intervention |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The parents of the children will be informed about the objectives and methods of the study, and will give their written consent to the participation of the children. Similarly, the study will introduce children from classroom to class and their oral consent will be obtained
Key exclusion criteria (1 listed)
- Participating children will be free from serious learning difficulties, or physical or mental disorders, that could prevent participation in scheduled physical activities.
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 |
|---|---|---|
| Phisical activity interventionThe prevalence of overweight in chilean children in the among the highest in the world and increasing quickly. The investigators recently evaluated an after-school program of recreational physical activity to control overweight, obesity and other cardiovascular risk factors in primary school children Temuco. This program reduced adiposity and increased the fitness. | Behavioural | Physical activity |
Primary outcome
Aerobic Capacity
Time frame: 1 year
By using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 4 years.
Muscle Strength
Time frame: 1 year
By using standing long jump test
Flexibility
Time frame: 1 year
By using the sit and reach test
Speed-agility
Time frame: 1 year
By using 4x10 meters shuttle run test
1 secondary outcome
Health-related quality of life
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Derived from this study: PubMed 36181063Godoy-Cumillaf A, Fuentes-Merino P, Giakoni-Ramirez F, Duclos-Bastias D, Merellano-Navarro E. Effectiveness of a physical activity intervention on the overweight and obesity of Chilean schoolchildren. Medicine (Baltimore). 2022 Sep 30;101(39):e30908. doi: 10.1097/MD.0000000000030908.
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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.
José Bruneau, PhD study director
Universidad Autónoma de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phisical activity intervention in people with Physical Activity and Fitness, run by Universidad Autónoma 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 1 inclusion and 1 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 11 Dec 2019. 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?
Contact Andrés Godoy, Prof. (+56932259064, andres.godoy@uautonoma.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Capacity (time frame: 1 year). The study lists 4 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 NCT04194580, which also lists 1 linked publication.
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 11 Dec 2019.