NCT07597460

Brief 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. 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, physical fitness (measured by upper body, lower body, and abdominal muscular strength), and sports participation among Chilean schoolchildren. How the study works: This study is a cluster-randomized clinical trial incorporating a control group and a pre-post design. Participating schools were allocated into two groups: Intervention Group: Participated in a specialized program focused on physical activity and the promotion of sports practice throughout two school years. Control Group: Continued with the standard school curriculum and regular physical education classes for the same period. What was measured: At baseline and after the two-year intervention, the following outcomes were assessed: Physical Activity Levels: Measured via accelerometry; Physical 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 and control groups to determine if children in the special program showed significantly greater improvements compared to those in the standard routine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 11, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

School-based interventionAccelerometryPhysical activitySedentary behaviorSports participationChildren

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (Month 2-3) and End of Intervention (Month 27-30)

Secondary Outcomes (5)

  • Change from Baseline in Upper Limb Strength

    Baseline (Month 2-3) and End of Intervention (Month 27-30)

  • Change from Baseline in Sports Participation Frequency

    Baseline (Month 2-3) and End of Intervention (Month 27-30)

  • Change from Baseline in Sedentary Behavior

    Baseline (Month 2-3) and End of Intervention (Month 27-30).

  • Change from Baseline in Lower Limb Strength

    Baseline (Month 2-3) and End of Intervention (Month 27-30)

  • Change from Baseline in Abdominal Muscle Strength

    Baseline (Month 2-3) and End of Intervention (Month 27-30)

Study Arms (2)

Control Group

OTHER

Students followed the standard Chilean school curriculum, including mandated physical education classes (twice weekly) and unstructured recess. This group did not receive any additional intervention, specialized equipment, or health workshops provided by the research team throughout the two-year study period. All school activities for this group remained consistent with the national educational guidelines.

Other: Regular Physical Education

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.

Behavioral: Active Schools Program

Interventions

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.

School-based Intervention Program

Participants in the control group followed the standard Chilean school curriculum, as mandated by the Ministry of Education. This included the regular Physical Education program (typically two sessions per week) and standard school recess periods, without any additional structured physical activity, specialized equipment, or health education workshops provided by the research team. No specific intervention was implemented to modify physical activity levels, muscular strength, or sports participation patterns during the study period.

Control Group

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Santiago de Chile

Santiago, Chile

Location

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 19, 2026

Study Start

December 11, 2023

Primary Completion

December 15, 2025

Study Completion

March 2, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations