NCT02457754

Brief Summary

Several studies have shown a high association between physical fitness and present and future health. Two of the main epidemics of the industrialized world are obesity and osteoporosis, diseases that could be prevented with early interventions from childhood. Both, physical activity and physical fitness have shown an association with these diseases, but tools for assessing them in early ages are still in development. Moreover, there is a lack of physical fitness reference values in preschool children and the relation of pathologies with physical fitness in these ages is still to be demonstrated. Therefore, through a simple and precise methodology displayed in the school and adapted for the younger we intend to: Provide a combination of safe and precise field tests to evaluate health related physical fitness in preschool children. Analyze body composition, risk of overweight, obesity and low mineral density and their relation with physical activity. The evaluation of these health-related physical fitness variables in early ages is of great interest to clinic and public health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

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

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

11 months

First QC Date

March 20, 2015

Last Update Submit

March 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of physical fitness in preschool children

    4 months evaluation

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy 3 to 5 year-old children

You may qualify if:

  • Healthy
  • to 5 years old

You may not qualify if:

  • Unhealthy
  • Taking drugs affecting bone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Zaragoza

Zaragoza, 50009, Spain

Location

Study Officials

  • German Vicente-Rodríguez, PhD

    Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 20, 2015

First Posted

May 29, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

March 26, 2025

Record last verified: 2025-03

Locations