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AzTrials

Healthy ChildrenNCT07029685

Physical Activity Intervention

A study testing Physical in people with Healthy Children, run by Andrés Godoy Cumillaf at 1 site in Chile.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Obesity is a problem that affects almost every region of the world. In Chile, data indicate that the prevalence of obesity in preschool children aged 4 to 6 years is 58%, which increases as they reach adolescence and adulthood. Read more about this study

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Children
What is being tested?
Physical
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteChile
Study dates
1 Aug 2025to 15 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Be enrolled in the selected establishment Have the consent of the parents or legal guardian to participate in the activity Have the consent of the child when asked to participate

Who cannot join

  • Health impairments that limit participation in the physical activity intervention Have completed less than 80% of the intervention program

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Andrés Godoy, PhD contact

56953534223

andres.godoy@uautonoma.cl

Chile1 site
  • Facultad de Educacion

    Temuco

    Andrés Godoy, PhD, +56953534223, andres.godoy@uautonoma.cl

Other trials in Chile

About this study

Official title: Effect of an Ecological Model-Based Physical Activity Intervention on Improving Obesity Parameters and Quality of Life in Preschoolers 4 to 6 Years of Age

Obesity is a problem that affects almost every region of the world. In Chile, data indicate that the prevalence of obesity in preschool children aged 4 to 6 years is 58%, which increases as they reach adolescence and adulthood. The role played by physical inactivity in the development of obesity is so relevant that it has been established that in children it is one of the factors that most contributes to the development of obesity. Among factors that influence adherence to healthy lifestyles are motor competence (CM) and physical condition (CF); Both CM and CF are factors that generate an underlying mechanism that decreases the risk of obesity and promotes health. Health-related quality of life [HRQoL] refers to an individual's subjective perception of the impact of health status on their physical, psychological, and social functioning. Overweight and obesity influence HRQoL. Physical activity interventions applied from an early age have proven to be a useful means of preventing childhood obesity, being more effective when implemented in the school environment and is key to achieving long-term results. The ecological model of physical activity favors modifying active lifestyle behaviors including intrapersonal, interpersonal, organizational, community, physical-environmental and political factors. Using the ecological model, physical activity interventions have managed to increase the levels of physical activity since the child and the entire environment that surrounds him or her are involved, that is, they have included the biological and behavioral, along with the motivational, school, in addition to taking into account environmental, cultural and socioeconomic aspects. The general objective of the project is to determine the effect of a physical activity intervention based on the ecological model, in the improvement of obesity parameters and quality of life in preschoolers from 4 to 6 years old. The study is experimental through a cluster-randomized clinical trial; of pre and postest.

The methodological approach is mixed. Physical Condition will be measured through the PREFIT battery with the following components:

body composition (weight, waist circumference; hip circumference, BMI); Musculoskeletal capacity (upper body strength, lower body strength; speed/agility); Cardiorespiratory capacity. Motor competence will be measured through the Children's Movement Assessment Battery (MABC-2) with the following components: Manual dexterity; Marksmanship and catch; Balance. Health-related quality of life will be assessed through the KINDL-R questionnaire for parents, in the validated version in Spanish; Sedentary behaviour and physical activity ActiGraph wGT3X-BT accelerometers will be used. To determine the effect, statistical tests will be applied for intragroup analysis and intrasubject repeated measures, considering p <.05 as significance. When statistically significant differences are found, the effect size will be calculated. In addition, the use of mixed regression models is contemplated where the models will be adjusted for baseline values and age. It is hypothesized that the physical activity intervention based on the ecological model will lead to a 3% decrease in body fat, improves anthropometric measurements, physical condition, improved competence and health-related quality of life.

Being tested
Physical
Keywords
Physical activity, Body composition, preschool, physical fitness
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhysicalOther

    Also called Exercise

    They will carry out a physical activity intervention based on the ecological model

Study groups in NCT07029685
Study groupRoleWhat they receive
oneExperimentalNot described
Receives: Other: Physical
twoNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat Mass

    body fat measurement

    Measured: From enrollment to the end of treatment at 16 weeks

  2. Fat Mass

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion10 Aug 2025 (estimated)
  4. Study completion15 Dec 2025 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Model Description
Masking
Single blind
Who is masked
Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07029685
Sponsor's protocol ID
UAutonomaEFI
Other IDs
22-25
Status last verified
Jun 2025
First submitted
4 Jun 2025
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical in people with Healthy Children, run by Andrés Godoy Cumillaf 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: opening soon, as of the sponsor's last update on 19 Jun 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Andrés Godoy, PhD (56953534223, andres.godoy@uautonoma.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat Mass (time frame: From enrollment to the end of treatment at 16 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?
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 19 Jun 2025.

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