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NCT01098968 Clinical Trial

Education and Fitness: EDUFIT Study

Body Composition Clinical Trial

— EDUFIT  

Official title:
Effects of a Physical Education Program Focused on Improving Physical Fitness in Adolescents Aged 12-14 Years

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01098968
Other study ID # EDUFIT
Secondary ID
Status Completed
Phase N/A
First received April 2, 2010
Last updated September 7, 2011
Start date January 2007
Est. completion date September 2007

Study information
Verified date September 2010
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.

Description:

Physical fitness is a powerful marker of cardiovascular health already at early stages in life. To promote physical fitness enhancement from the school is therefore needed and this is the main aim of the EDUFIT study (EDUcation for FITness).

The participants were randomly allocated to control group (CG), experimental group 1 (EG1) and experimental group 2 (EG2). The CG received 2 physical education sessions/week, the EG1 received 4 physical education sessions/week (volume increased) and the EG2 received 4 physical education sessions/week of high intensity (volume+intensity increased). Several health-related parameters were assessed before and after a 16-weeks intervention: physical fitness (primary outcome), body composition (secondary), and lipid-metabolic profile, ventilatory parameters, blood pressure, and cognitive and academic performance (tertiary outcomes).

The hypothesis of the EDUFIT project was that to double the number of physical education classes will improve physical fitness in adolescents. The confirmation of the hypothesis could have important public health implications.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date September 2007
Est. primary completion date June 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 14 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Physical activity program
School intervention program specifically designed to increase health-related physical fitness

Locations
Country Name City State
Spain IES Alcántara (Consejería de Educación, Formación y Empleo de la Región de Murcia) Alcantarilla Murcia
Spain University of Granada Granada

Sponsors (1)
Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Ardoy DN, Fernández-Rodríguez JM, Chillón P, Artero EG, España-Romero V, Jiménez-Pavón D, Ruiz JR, Guirado-Escámez C, Castillo MJ, Ortega FB. [Physical fitness enhancement through education, EDUFIT study: background, design, methodology and dropout analys — View Citation

Ortega FB, Artero EG, Ruiz JR, España-Romero V, Jiménez-Pavón D, Vicente-Rodriguez G, Moreno LA, Manios Y, Béghin L, Ottevaere C, Ciarapica D, Sarri K, Dietrich S, Blair SN, Kersting M, Molnar D, González-Gross M, Gutiérrez A, Sjöström 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. — View Citation

Ortega FB, Artero EG, Ruiz JR, Vicente-Rodriguez G, Bergman P, Hagströmer M, Ottevaere C, Nagy E, Konsta O, Rey-López JP, Polito A, Dietrich S, Plada M, Béghin L, Manios Y, Sjöström 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. — View Citation

Ortega FB, Ruiz JR, Castillo MJ, Moreno LA, González-Gross M, Wärnberg J, Gutiérrez 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. — View Citation

Ortega FB, Ruiz JR, Castillo MJ, Sjöström M. Physical fitness in childhood and adolescence: a powerful marker of health. Int J Obes (Lond). 2008 Jan;32(1):1-11. Epub 2007 Dec 4. Review. — View Citation

Ortega FB, Ruiz JR, Hurtig-Wennlöf A, Sjöström 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. — View Citation

Ruiz JR, Castro-Piñero J, Artero EG, Ortega FB, Sjöström 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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Health-related physical fitness Cardiorespiratory fitness; musculoskeletal fitness; motor fitness. 4 months No
Secondary Cardiovascular disease risk factors Body composition; lipid-metabolic profile; blood pressure; ventilatory parameters. 4 months No
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