NCT03236363

Brief Summary

Project which objective is to test the effectiveness of a classroom-based physical activity intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and executive function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 19, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

July 21, 2017

Last Update Submit

July 12, 2018

Conditions

Physical ActivityChildrenObesityCardiovascularCardiorespiratory Fitness

Keywords

Physical activityObesityChildrenCognitive functionAcademic achievementCardiorespiratory fitnessAdiposityCardiovascular fitnessAerobic capacity

Outcome Measures

Primary Outcomes (1)

  • Executive function

    Executive function will be measured by standardized test using the NIH toolbox

    One year

Secondary Outcomes (4)

  • VO2 max

    One year

  • Motor skills

    One year

  • Body fat%

    One year

  • Health-related quality of life

    One year

Study Arms (3)

MOVI-da 10! active breaks

EXPERIMENTAL

It is a physical activity intervention that consists on two daily physical activity active breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children

Behavioral: MOVI-da10! active breaks

Control

NO INTERVENTION

No intervention

MOVI-da10! integrated physical activity

EXPERIMENTAL

It is an integrated physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate \<150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children

Behavioral: MOVI-da10! integrated physical activity

Interventions

MOVI-da10! active breaksBEHAVIORAL

MOVI-da10! active breaks, is a physical activity intervention that consists on two daily physical activity breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children

MOVI-da 10! active breaks
MOVI-da10! integrated physical activityBEHAVIORAL

MOVI-da10! integrated lessons, is a physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate \<150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children

MOVI-da10! integrated physical activity

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Schools must have at least one full classrooms for the 3rd year of preschool.
  • The approval of boards of governors will be necessary to participate in the intervention and in the measurements at the beginning and end of academic year.
  • Children's parents or legal representatives will sign an informed consent to participate.
  • Children's parents will be invited to collaborate by filling in questionnaires with regard to family leisure habits, sleeping, eating and getting around town.

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-da10!).

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

Related Publications (1)

  • Sanchez-Lopez M, Ruiz-Hermosa A, Redondo-Tebar A, Visier-Alfonso ME, Jimenez-Lopez E, Martinez-Andres M, Solera-Martinez M, Soriano-Cano A, Martinez-Vizcaino V; MOVI group. Rationale and methods of the MOVI-da10! Study -a cluster-randomized controlled trial of the impact of classroom-based physical activity programs on children's adiposity, cognition and motor competence. BMC Public Health. 2019 Apr 18;19(1):417. doi: 10.1186/s12889-019-6742-0.

    PMID: 30999870DERIVED

MeSH Terms

Conditions

Motor ActivityObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Vicente Martinez-Vizcaino, PhD, MD

    Social and Health Care Research Center, 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

July 21, 2017

First Posted

August 1, 2017

Study Start

September 19, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

July 13, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)