NCT07103343

Brief Summary

This study will evaluate the effectiveness of MOVI-OLE! (Open Learning Environment), a school-based intervention designed to reduce sedentary time and enhance multiple aspects of child development, including cognitive function, physical fitness, body composition, psychological well-being, and student engagement. The intervention combines dynamic classroom furniture with student-centered teaching practices. Additionally, a qualitative component will explore how students, teachers, and families perceive the feasibility and acceptability of implementing MOVI-OLE! in real-world school settings.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress26%
Sep 2025Aug 2028

First Submitted

Initial submission to the registry

July 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

July 19, 2025

Last Update Submit

April 9, 2026

Conditions

Keywords

Sedentary timeOpen Learning EnvironmentPhysical activityExecutive functionAcademic achievementPsychological well-beingStudent engagementBody compositionAdiposityCardiorespiratory fitnessPrimary school childrenActive learningEducational spacesMixed methods

Outcome Measures

Primary Outcomes (11)

  • Sedentary time in classroom

    measured using accelerometers to record sitting/lying, standing, and walking time during classroom activities. Data are expressed as minutes per child during classroom time; higher values of sedentary time indicate greater inactivity.

    Two academic years

  • Sedentary Behavior in Classroom

    measured in a randomly selected subsample using the Portable Ergonomic Observation Method. Observers will record and classify postures (sitting, standing, walking) during classroom time using real-time coding and/or video recordings. Minutes per child per posture category; higher sitting time indicates more sedentary behavior.

    Two academic years

  • Inhibition/Attention

    inhibitory control and attention will be measured using the Flanker Inhibitory Control and Attention Test. Children complete practice trials followed by a block of congruent and incongruent trials. Outcomes include reaction time, accuracy, and raw scores, with higher scores indicating better inhibitory control and attentional performance.

    Two academic years

  • Working memory

    working memory will be assessed using the List Sorting Working Memory Test. Children are required to recall and sequence items presented visually and orally, with task difficulty increasing progressively. Outcomes include raw scores, with higher scores indicating better working memory performance.

    Two academic years

  • Cognitive flexibility

    cognitive flexibility will be assessed using the Dimensional Change Card Sort Test. Children classify stimuli based on color or shape, with blocks assessing both pre-switch and post-switch performance. Outcomes include reaction time, accuracy, and raw scores, with higher scores reflecting greater cognitive flexibility.

    Two academic years

  • Academic performance

    academic grades provided by the school in various subjects, comparing the year prior to the intervention and during the intervention years.

    Two academic years

  • Mental health

    measured with questionnaire such as Revised Children's Anxiety and Depression Scale. This standardized questionnaire assesses a range of anxiety and depression symptoms in children. Responses are rated on a 4-point Likert scale, and scores are converted to age- and sex-normed T-scores. T-scores ≥65 indicate borderline clinical levels, and scores ≥70 indicate clinically significant symptoms.

    Two academic years

  • Health-related quality of life

    measured with questionnaire KIDSCREEN. This standardized instrument evaluates physical, psychological, and social dimensions of well-being in children and adolescents. Items are rated on 5-point Likert scales, and scores are transformed into T-scores. Higher T-scores indicate better HRQoL.

    Two academic years

  • Engagement in the teaching-learning process in students

    student engagement (based on the Achievement Beliefs Scale for Children). This self-report instrument evaluates motivational and cognitive components of academic engagement in children, such as effort, persistence, and beliefs about success. Items are rated on Likert-type scales, with higher scores indicating greater levels of engagement.

    Two academic years

  • Engagement in the teaching-learning process in teachers

    teacher personal efficacy (Utrecht Work Engagement Scale; UWES). This self-report questionnaire measures work engagement through three dimensions: vigor, dedication, and absorption. Items are rated on a 7-point Likert scale. Higher scores indicate greater work engagement and perceived efficacy.

    Two academic years

  • Energy expenditure in classroom in different postures

    estimation of oxigen (O2) consumption during lessons in traditional seated, dynamically seated and standing desks will be assessed in a a randomly selected subsample. It wil be estimated the O2/hour consumption using a K5 COSMED (Oxycon Mobile system; CareFusion) wireless portable metabolic analyzer.

    Two academic years

Secondary Outcomes (15)

  • Weight

    Two academic years

  • Height

    Two academic years

  • Body mass index (BMI)

    Two academic years

  • Body composition

    Two academic years

  • Blood pressure.

    Two academic years

  • +10 more secondary outcomes

Study Arms (2)

Traditional Classroom (Control Group)

NO INTERVENTION

Students in the control group will continue with their usual classroom activities and teaching methodology, without any changes to the furniture or pedagogical approaches during the first year of the study. Teachers in the control group schools will be asked to maintain their standard teaching practices throughout the control period. Traditional classrooms consist of conventional desks and chairs arranged in rows facing the front, with teaching generally teacher-centered. Students usually work individually on assigned tasks. For ethical and motivational reasons, this control group will receive the intervention starting in the second academic year.

MOVI-OLE! -Open Learning Environment- (Intervention Group)

EXPERIMENTAL

Students in the intervention group will experience a classroom environment modified with furniture designed to promote physical activity, alongside the implementation of student-centered teaching methodologies (MOVI-OLE!). Teachers in the intervention group schools will be trained and supported to apply these new methodologies during the school day throughout the study period. The research team will monitor the implementation and provide ongoing assistance to ensure fidelity to the intervention.

Behavioral: MOVI-OLE intervention

Interventions

In the MOVI-OLE! classrooms, traditional desks and chairs will be replaced by three dynamic learning zones: A) Dynamic seating: an area with traditional wheeled desks combined with dynamic seats such as fitballs, stools, pedal desks, etc.; B) Standing desks: an area with manually adjustable high desks to allow standing work. Students will also have stools with small backrests and footrests for when they need to sit; C) Vertical boards: vertical boards (vinyl, paper, chalkboard paint, etc.) installed on walls for standing work. To facilitate use and adapt to classroom routines, teachers will decide how to distribute students among the different zones, with the requirement that all students spend at least 20 minutes per school day in zone B. In addition to the workstations, teachers will receive training and didactic support materials focused on student-centered methodologies and the use of open learning spaces.

Also known as: MOVI-OLE
MOVI-OLE! -Open Learning Environment- (Intervention Group)

Eligibility Criteria

Age9 Years - 13 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Schools in Ciudad Real (Castilla-La Mancha region) with at least one classroom in both 5rd and 6th grades of Primary Education.
  • Schools currently involved in educational innovation projects that aim to transform classrooms and apply student-centered pedagogical approaches.
  • Schools whose School Council has approved participation in the MOVI-OLE! intervention and in baseline and final evaluations.
  • Students enrolled in 5rd or 6th grade of Primary Education.
  • Students without any condition that, according to families, pediatricians, or teachers, prevents participation in the MOVI-OLE! intervention.
  • Students with signed informed consent from a parent or legal guardian for participation in the study activities and assessments.
  • Students who verbally agree to participate in baseline and final physical assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Social and Health Research Center. Universidad de Castilla-La Mancha

Cuenca, Cuenca, 16071, Spain

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor ActivityPsychological Well-BeingPediatric ObesityObesity

Condition Hierarchy (Ancestors)

BehaviorPersonal SatisfactionOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mairena Sánchez-López, PhD

    University of Castilla-La Mancha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Stepped-wedge cluster randomized trial within a parallel design framework.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2025

First Posted

August 5, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations