NCT04863040

Brief Summary

Project which objective is a) to test the effectiveness, in preschool children, of an integrated physical activity intervention in the classroom based on intervallic training (MOVI-HIIT) on improving executive function, body composition, cardiorespiratory fitness and b) to evaluate teachers' perceptions of barriers and facilitating elements for the implementation and monitoring of MOVI-HIIT interventions in the classroom.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
522

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 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

June 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

March 30, 2021

Last Update Submit

June 3, 2024

Conditions

Keywords

Physical activityObesityChildrenCognitive functionAcademic achievementCardiorespiratory fitnessAdiposityCardiovascular fitnessAerobic capacityHigh Intensity Interval TrainingPreschool

Outcome Measures

Primary Outcomes (3)

  • VO2max

    Cardiorespiratory fitness, with the Course Navette or 20-m shuttle run test, validated to measure maximum aerobic capacity in children. It will be carried out according to the Léger protocol. This battery adapts the Course Navette test to children under the age of 6.

    One year

  • Executive function

    NIH toolbox battery. 1. Inhibition/Attention by means of the Flanker Inhibitory Control and Attention test. 2. Working memory with the List Sorting Working Memory test. 3. Cognitive flexibility through the DCCS (Dimensional Change Card Sort) test.

    One year

  • Body fat percent

    Body fat percentage measured by Bioimpedance analysis

    One year

Secondary Outcomes (10)

  • Health-related quality of life - Parents

    One year

  • Health-related quality of life - Children

    One year

  • Mothers' breastfeeding

    Baseline measurements

  • Questionnaire ad-hoc about pregnancy

    Baseline measurements

  • Eating habits

    One year

  • +5 more secondary outcomes

Study Arms (2)

Usual classroom teaching methodology

NO INTERVENTION

Students in the CG will receive mandatory lessons on Spain (one 45-minute session of Psychomotor/Physical Education), and the usual classroom teaching methodology. Teachers in the CG schools will be asked not to make any changes to their methodology during the time of the study, with the promise by the research team to share and explain the MOVI-HIIT materials once the interventions are completed.

Usual classroom teaching methodology + MOVI-HIIT intervention

EXPERIMENTAL

The design of the MOVI-HIIT intervention is framed within the socio-ecological model of behavior modification, in such a way that it will be designed to intervene in the individual, family and school environment. It will have a duration of one school year and will consist of two 5-minute daily physical activity breaks based on intervallic training, five days a week.

Behavioral: MOVI intervention

Interventions

Each HIIT break will last approximately 5 minutes and will not require any specific materials. The structure of the HIIT-Rest will be as follows: 1' to describe the work to be done; 3' of work following the HIIT protocol: 6 repetitions of a functional movement such as squats, Jumping Jack or running on site for 10" at high intensity (85-90% of HR max) followed by 20" of recovery (65-75% of HR max); and 1' to perform a return to calm in order to lower the activation and prepare the student body to return to class activities. To increase the workload, and after evaluation of cardiorespiratory capacity, after 12 weeks of program, the HIIT protocol will be changed to 20" of high intensity work alternating with 10" of recovery.

Also known as: MOVI-HIIT
Usual classroom teaching methodology + MOVI-HIIT intervention

Eligibility Criteria

Age4 Years - 6 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Schools in the province of Ciudad Real with at least one class (classroom) at each level (2nd and 3rd of preschool education), and in which the School Board gives its approval to the interventions and to the basal and final evaluations.
  • The participating schoolchildren must belong to the 2nd and 3rd year of preschool education, not have any malformation that prevents them from learning the Spanish language (or Spanish sign language), not have any type of physical or mental disorder that parents and/or teachers have identified that prevents the performance of physical activities, not suffer from any chronic disease such as heart disease, diabetes or asthma that, according to the criteria of their pediatrician - after analysis of the program of activities - prevents their participation in them.
  • As this is an intervention in the classroom, the school faculty will include the active breaks proposed in the center's programming, for which reason the intervention will be received by all the children in each IG school. However, we will consider school participants to be those who have the consent of the parent or guardian for participation in the study. In addition, schoolchildren must verbally express their willingness to participate in the baseline and final physical examinations.

You may not qualify if:

  • Children with severe Spanish language learning difficulties.
  • Children with serious physical or mental disorders identified by parents or teachers that would impede participation in the programme's activities.
  • Children diagnoses of chronic disorders, such as heart disease, diabetes or asthma, which in the opinion of their paediatricians would prevent their participation in the programme's activities (MOVI-HIIT).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cuenca, 16071, Spain

Location

MeSH Terms

Conditions

Motor ActivityObesity

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mairena Sanchez-Lopez, PhD

    University of Castilla-La Mancha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 28, 2021

Study Start

June 1, 2020

Primary Completion

June 1, 2023

Study Completion

June 1, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations