NCT05468216

Brief Summary

The study assesses the effects of long-term movement integration intervention in academic lessons of primary education (6th grade) on physical activity levels and sedentary behaviour, executive functions, academic achievement and on-task behaviour. To achieve it, a cluster randomized controlled trial design will be adopted, where schools will be the clusters.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 21, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

May 9, 2022

Last Update Submit

November 8, 2022

Conditions

Keywords

exerciseeducationsedentary behaviourmovement integrationexecutive functionsacademic performance

Outcome Measures

Primary Outcomes (5)

  • Physical activity measures change: time and intensity

    Accelerometers will be used to measure and quantify the physical activity levels of students. Accelerometers have already been demonstrated as a valid and objective measure to quantify body posture and activity patterns during free-living conditions in children and adults.

    Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)

  • Sedentary behaviour measures change: time

    Accelerometers will be used to measure and quantify sedentary behaviour of students. Accelerometers have already been demonstrated as a valid and objective measure to quantify body posture and activity patterns during free-living conditions in children and adults.

    Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks).

  • Executive functions measures change

    Three core EFs will be assessed with validated tests from the NIH toolbox battery for the population aged between 3 and 85 years old. Inhibition control and attention: Flanker Inhibitory Control and Attention test; Working memory: List Sorting Working Memory test; Cognitive flexibility: Dimensional Change Card Sort test.

    Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)

  • Academic achievement measures change

    The Catalan national standardized test consists of evaluating the degree of achievement of basic competences at the end of primary education (sixth grade).

    Baseline, and end of the intervention (after 16 weeks)

  • On-task behaviour measures change

    The Direct Behaviour Rating Scale assesses students' behaviour and engagement by rating the percentage of time that the student does the desired behaviour. High scores on the Direct Behavior Rating scales (Academically engaged, Respectful and Disruptive) indicate high levels, with 10 being the maximum value. On the other hand, low scores on the Direct Behavior Rating scales (Academically engaged, Respectful and Disruptive) indicate low levels, with 0 being the minimum value.

    Baseline, 8 weeks after starting intervention, end of the intervention (after 16 weeks)

Other Outcomes (3)

  • Socioeconomic status

    Baseline

  • General Physical activity levels

    Baseline

  • Body Mass Index

    Baseline

Study Arms (2)

MovIn-Lessons group

EXPERIMENTAL

The schools which will implement the movement integration in the learning activities of primary education subjects (maths, natural science and English).

Other: MovIn-Lessons group

Control group

NO INTERVENTION

Schools which will continues applying the same methodology in the realization of the learning activities.

Interventions

The MovIn-Lessons intervention will consist of infusing PA in math, English and natural sciences lessons in primary education. The movement will be integrated in the learning activities for at least 20 minutes per session, at different physical intensities.

MovIn-Lessons group

Eligibility Criteria

Age11 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children in sixth grade of primary education

You may not qualify if:

  • children who require special educational needs and it is not following the whole-group classes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Vic- Central University of Catalonia

Vic, Barcelona, 08500, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Anna M Señé Mir, PhD

    University of Vic- Central University of Vic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna M Señé Mir, PhD

CONTACT

Anna M Señé Mir, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Only an allocation concealment mechanism will be used to prevent clusters' selection bias
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Lecturer and researcher

Study Record Dates

First Submitted

May 9, 2022

First Posted

July 21, 2022

Study Start

September 1, 2023

Primary Completion

June 2, 2024

Study Completion

June 20, 2024

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations