NCT06590103

Brief Summary

Study based on a school-based physically active learning intervention during the school day on physical activity, fitness, health and education outcomes in adolescents.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 2, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 6, 2024

Last Update Submit

September 6, 2024

Conditions

Keywords

Physuca active learningMotivational variablesSedentary timeAcademic indicators

Outcome Measures

Primary Outcomes (1)

  • Physical activity and sedentary time

    Physical activity and sedentary time will be measured by the Fitbit activity wristband version 6.0.

    8 months

Secondary Outcomes (13)

  • Cardiorespiratory capacity

    8 months

  • Musculoskeletal capacity of Upper body

    8 months

  • Musculoskeletal capacity of lower body

    8 months

  • Body mass index

    8 months

  • Health status

    8 months

  • +8 more secondary outcomes

Study Arms (2)

Physically Active Lessons.

EXPERIMENTAL

Physically Active Learning: consists of incorporating physical activity (usually of moderate-vigorous intensity) into the educational content taught in non-physical education academic classes.

Behavioral: Physically Active Lessons

Control group

NO INTERVENTION

The control group will receive the usual academic classes without any methodological modification during the intervention period.

Interventions

Physically active learning: this type of intervention is carried out once a week for 1 hour outside the classroom. The teachers of the corresponding subject (with the support of the Physical Education teacher) are in charge of designing and delivering the physically active classes.

Physically Active Lessons.

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents in 1st, 2nd, 3rd and 4th year of ESO.
  • Adolescents with informed consent signed by the family/guardian.
  • Schools with at least 210 students enrolled in 1st, 2nd, 3rd and 4th year of ESO.
  • Schools belonging to the Autonomous Community of Extremadura.

You may not qualify if:

  • Adolescents with any physical disability or health condition that may limit physical activity levels.
  • Schools participating in any other physical activity or health promotion program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Extremadura

Cáceres, 10003, Spain

RECRUITING

MeSH Terms

Conditions

Motor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

David Sánchez-Oliva, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 19, 2024

Study Start

September 2, 2024

Primary Completion

June 15, 2025

Study Completion

June 15, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations