NCT01098968

Brief Summary

EDUFIT is a group-Randomized Controlled Trial specifically designed to enhance physical fitness and other health-related factors in a school setting in adolescents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

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

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2010

Completed
Last Updated

September 8, 2011

Status Verified

September 1, 2010

Enrollment Period

5 months

First QC Date

April 2, 2010

Last Update Submit

September 7, 2011

Conditions

Physical FitnessBody CompositionLipid Metabolism

Outcome Measures

Primary Outcomes (1)

  • Health-related physical fitness

    Cardiorespiratory fitness; musculoskeletal fitness; motor fitness.

    4 months

Secondary Outcomes (1)

  • Cardiovascular disease risk factors

    4 months

Study Arms (3)

Normal PE

NO INTERVENTION

2 Physical Education sessions / week

PE Volume

EXPERIMENTAL

4 Physical Education sessions/week (increased volume)

Behavioral: Physical activity program

PE Volume + Intensity

EXPERIMENTAL

4 Physical Education sessions/week of high intensity (increased volume and intensity)

Behavioral: Physical activity program

Interventions

Physical activity programBEHAVIORAL

School intervention program specifically designed to increase health-related physical fitness

PE VolumePE Volume + Intensity

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents enrolled in the Spanish Educational System, free of any muscle-skeletal problem not allowing take part in Physical Education lessons or fitness testing.

You may not qualify if:

  • Clinical diagnosis of diabetes
  • Pregnancy
  • Drugs/alcohol abuse
  • In general, any chronic disease that does not permit the person to perform exercise and physical education lessons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Granada

Granada, Granada, 18071, Spain

Location

IES Alcántara (Consejería de Educación, Formación y Empleo de la Región de Murcia)

Alcantarilla, Murcia, 30820, Spain

Location

Related Publications (7)

  • Ortega FB, Ruiz JR, Castillo MJ, Moreno LA, Gonzalez-Gross M, Warnberg J, Gutierrez A; Grupo AVENA. [Low level of physical fitness in Spanish adolescents. Relevance for future cardiovascular health (AVENA study)]. Rev Esp Cardiol. 2005 Aug;58(8):898-909. Spanish.

    PMID: 16053823BACKGROUND

  • Ortega FB, Ruiz JR, Hurtig-Wennlof A, Sjostrom M. [Physically active adolescents are more likely to have a healthier cardiovascular fitness level independently of their adiposity status. The European youth heart study]. Rev Esp Cardiol. 2008 Feb;61(2):123-9. Spanish.

    PMID: 18364180BACKGROUND

  • Ortega FB, Ruiz JR, Castillo MJ, Sjostrom M. Physical fitness in childhood and adolescence: a powerful marker of health. Int J Obes (Lond). 2008 Jan;32(1):1-11. doi: 10.1038/sj.ijo.0803774. Epub 2007 Dec 4.

    PMID: 18043605BACKGROUND

  • Ruiz JR, Castro-Pinero J, Artero EG, Ortega FB, Sjostrom M, Suni J, Castillo MJ. Predictive validity of health-related fitness in youth: a systematic review. Br J Sports Med. 2009 Dec;43(12):909-23. doi: 10.1136/bjsm.2008.056499. Epub 2009 Jan 21.

    PMID: 19158130BACKGROUND

  • Ortega FB, Artero EG, Ruiz JR, Vicente-Rodriguez G, Bergman P, Hagstromer M, Ottevaere C, Nagy E, Konsta O, Rey-Lopez JP, Polito A, Dietrich S, Plada M, Beghin L, Manios Y, Sjostrom M, Castillo MJ; HELENA Study Group. Reliability of health-related physical fitness tests in European adolescents. The HELENA Study. Int J Obes (Lond). 2008 Nov;32 Suppl 5:S49-57. doi: 10.1038/ijo.2008.183.

    PMID: 19011654BACKGROUND

  • Ortega FB, Artero EG, Ruiz JR, Espana-Romero V, Jimenez-Pavon D, Vicente-Rodriguez G, Moreno LA, Manios Y, Beghin L, Ottevaere C, Ciarapica D, Sarri K, Dietrich S, Blair SN, Kersting M, Molnar D, Gonzalez-Gross M, Gutierrez A, Sjostrom M, Castillo MJ; HELENA study. Physical fitness levels among European adolescents: the HELENA study. Br J Sports Med. 2011 Jan;45(1):20-9. doi: 10.1136/bjsm.2009.062679. Epub 2009 Aug 20.

    PMID: 19700434BACKGROUND

  • Ardoy DN, Fernandez-Rodriguez JM, Chillon P, Artero EG, Espana-Romero V, Jimenez-Pavon D, Ruiz JR, Guirado-Escamez C, Castillo MJ, Ortega FB. [Physical fitness enhancement through education, EDUFIT study: background, design, methodology and dropout analysis]. Rev Esp Salud Publica. 2010 Mar-Apr;84(2):151-68. doi: 10.1590/s1135-57272010000200004. Spanish.

    PMID: 20571717RESULT

Related Links

Study Officials

  • Francisco B Ortega Porcel, PhD

    University of Granada (Spain)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 2, 2010

First Posted

April 5, 2010

Study Start

January 1, 2007

Primary Completion

June 1, 2007

Study Completion

September 1, 2007

Last Updated

September 8, 2011

Record last verified: 2010-09

Locations

ES(2)