NCT03236337

Brief Summary

Project which objective is to test the effectiveness of an extracurricular physical activity intervention based on high intensity interval training (MOVI-daFit!) on improving cardiorespiratory fitness (CRF), cardiometabolic risk, executive function, and academic performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
570

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

Keywords

Physical activityObesityChildrenCognitive functionAcademic achievementCardiorespiratory fitnessAdiposityCardiovascular fitnessAtherosclerosisAerobic capacity

Outcome Measures

Primary Outcomes (1)

  • VO2 max

    It will be assessed by using 20-m shuttle run test, which is validated to measure maximal aerobic capacity in children from 5 years.

    One year

Secondary Outcomes (16)

  • BDNF blood determination

    One year

  • Health-related quality of life

    One year

  • Sleep behaviors and sleep problems by questionnaire

    One year

  • Sleep quality by accelerometry

    One year

  • Motor skills

    One year

  • +11 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

No intervention

MOVI intervention

EXPERIMENTAL

\- MOVI-da Fit! is a high intensity interval training intervention that consists on: a) 4 h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.

Behavioral: MOVI intervention

Interventions

MOVI-da Fit! is a multidimensional intervention that consists on: a) 4h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.

Also known as: MOVI-da Fit!
MOVI intervention

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Schools must have at least one full classrooms for both the 4th and 5th grade of primary school.
  • The approval of boards of governors will be necessary.
  • Children's parents or legal representatives will sign an informed consent to participate.
  • 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:

  • Severe Spanish language learning difficulties.
  • 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-daFit!).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health and Social Research Centre, University of Castilla-La Mancha

Cuenca, 16071, Spain

Location

Mairena Sánchez-López

Cuenca, 16071, Spain

Location

Related Publications (3)

  • Visier-Alfonso ME, Jimenez-Lopez E, Rodriguez-Gutierrez E, Mesas AE, Nunez de Arenas-Arroyo S, Diaz-Goni V, Alvarez-Bueno C, Martinez-Vizcaino V. Internal Consistency and Validity of a Short Spanish Version (10-Items) of the Center for Epidemiological Studies Depression Scale for Children and Adolescents (CES-DC). Depress Anxiety. 2024 Sep 25;2024:5409747. doi: 10.1155/2024/5409747. eCollection 2024.

  • Pozuelo-Carrascosa DP, Martinez-Vizcaino V, Torres-Costoso A, Martinez MS, Rodriguez-Gutierrez E, Garrido-Miguel M. "Fat but Fit" Paradox and Cardiometabolic Risk in Children: The Role of Physical Activity. Child Obes. 2023 Jun;19(4):282-291. doi: 10.1089/chi.2022.0073. Epub 2022 Jul 26.

  • Martinez-Vizcaino V, Garrido-Miguel M, Redondo-Tebar A, Notario-Pacheco B, Rodriguez-Martin B, Sanchez-Lopez M. The "Fat but Fit" Paradigm from a Children's Health-Related Quality of Life Perspective. Child Obes. 2021 Oct;17(7):449-456. doi: 10.1089/chi.2021.0041. Epub 2021 May 18.

MeSH Terms

Conditions

Motor ActivityObesityAtherosclerosis

Condition Hierarchy (Ancestors)

BehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Vicente Martínez-Vizcaíno, 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