CClinicalTrials.gg
Not yet recruitingNCT07029685Updated Jun 19, 2025

Physical Activity Intervention

An interventional study of Physical in Healthy Children, sponsored by Andrés Godoy Cumillaf. Not yet recruiting at 1 site in Chile. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-19.

Sponsored by Andrés Godoy Cumillaf · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy Children

Keywords

  • Physical activity
  • Body composition
  • preschool
  • physical fitness
03

In context

Lead sponsor

This is the only study on the registry with Andrés Godoy Cumillaf as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    one

    Other: Physical

  • No intervention
    two

Interventions

  • OtherPhysical

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

    Also known as: Exercise

06

What researchers measure

Primary outcomes

  1. Fat Mass

    body fat measurement

    Time frame: From enrollment to the end of treatment at 16 weeks

  2. Fat Mass

    Time frame: 16 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07029685
Lead sponsor
Andrés Godoy Cumillaf
Responsible party
Andrés Godoy Cumillaf (PhD scientist, Universidad Autónoma de Chile) — Sponsor-investigator
First posted
Jun 19, 2025
Start date
Aug 1, 2025 (estimated)
Primary completion
Aug 10, 2025 (estimated)
Completion
Dec 15, 2025 (estimated)
Last update
Jun 19, 2025

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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