NCT04994340

Brief Summary

The OBAFIT project aims to examine the patterns of physical activity, sedentary activity and health-related physical fitness of the boys and girls enrolled in schools of Primary Education and Secondary Education in Castilla-La Mancha (Spain). The design of the project is observational/cross-sectional. Through an epidemiological orientation, it proposes a representative sampling of a multistage type of the Castilian-La Mancha population aged 6 to 16 years. The subjects that will make up the sample will be selected from among the 724 Castilian-La Mancha schools with teachings in the Primary Education stage, and among 373 Secondary Education schools. To ensure the heterogeneity of the population, both public and private centers will be selected, and proportionally between centers that have Healthy School Programs (PES) from those that do not. The sample will be multistage, randomized and stratified according to province (Albacete, Ciudad Real, Cuenca, Guadalajara and Toledo), area (urban, semi-urban, rural), sex (men, women) and age (one group for each age group).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 8, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2022

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

July 28, 2021

Last Update Submit

August 5, 2021

Conditions

Sedentary BehaviorExercisePhysical Fitness

Keywords

ChildhoodPhysical activityHealthSchoolSurveillance

Outcome Measures

Primary Outcomes (5)

  • Subjective physical activity levels

    Physical activity assessed by self-report (PAQ-C or PAQ-A). The scales ranged from 0 to 5, where higher values indicate greater levels of physical activity.

    2017/2018 to 2021/2022

  • Device-measured physical activity levels

    Physical activity assessed by accelerometer (Measure carried out only in those schools that give consent)

    2017/2018 to 2021/2022

  • Sedentary behavior

    Sedentary behavior assessed by self-report (YLSBQ)

    2017/2018 to 2021/2022

  • Sedentary behavior

    Adolescents' sedentary behaviors assessed by self-report (ASAQ)

    2017/2018 to 2021/2022

  • Health-related physical fitness

    Health-related physical fitness assessed by the ALPHA-FITNESS test battery

    2017/2018 to 2021/2022

Secondary Outcomes (1)

  • Socioeconomic status

    2017/2018 to 2021/2022

Other Outcomes (4)

  • Age

    2017/2018 to 2021/2022

  • Gender

    2017/2018 to 2021/2022

  • Body mass index

    2017/2018 to 2021/2022

  • +1 more other outcomes

Study Arms (2)

Children

From a cross-sectional perspective, children will fill out questionnaires related to their subjective physical activity levels (PAQ-C), levels of sedentary activity (YLSBQ), and socio-economic status (Family Affluence Scale III) during school hours. Two sessions of physical education will be used to measure the health-related physical fitness of children through the ALPHA-Fitness battery test. The sequence to administer this battery will be: 1. Weight and height (BMI); 2. Waist circumference; 3. Skin folds; 4. Hand grip strength, long jump with feet together, and 4x10 m shuttle run test (these tests could be carried out alternately or simultaneously since there will always be 2 or more evaluators); 5. 20 m Course Navette test.

Adolescents

From a cross-sectional perspective, adolescents will fill out questionnaires related to their subjective physical activity levels (PAQ-A), levels of sedentary activity (YLSBQ), and socio-economic status (Family Affluence Scale III) during school hours. Two sessions of physical education will be used to measure the health-related physical fitness of adolescents through the ALPHA-Fitness battery test. The sequence to administer this battery will be: 1. Weight and height (BMI); 2. Waist circumference; 3. Skin folds; 4. Hand grip strength, long jump with feet together, and 4x10 m shuttle run test (these tests could be carried out alternately or simultaneously since there will always be 2 or more evaluators); 5. 20 m Course Navette test.

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Boys and girls aged 6 to 16 years enrolled in Primary and Secondary Education schools in Castilla La Mancha.

You may qualify if:

  • \- Be enrolled in any school in Castilla-La Mancha (primary or secondary, public or private, rural or urban).

You may not qualify if:

  • Temporary injury or disability that prevents physical testing.
  • Clinical diagnosis of diabetes or diseases not related to nutrition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Castilla-La Mancha

Toledo, 45004, Spain

RECRUITING

Related Publications (8)

  • Poitras VJ, Gray CE, Borghese MM, Carson V, Chaput JP, Janssen I, Katzmarzyk PT, Pate RR, Connor Gorber S, Kho ME, Sampson M, Tremblay MS. Systematic review of the relationships between objectively measured physical activity and health indicators in school-aged children and youth. Appl Physiol Nutr Metab. 2016 Jun;41(6 Suppl 3):S197-239. doi: 10.1139/apnm-2015-0663.

    PMID: 27306431BACKGROUND

  • Biddle SJ, Gorely T, Pearson N, Bull FC. An assessment of self-reported physical activity instruments in young people for population surveillance: Project ALPHA. Int J Behav Nutr Phys Act. 2011 Jan 2;8:1. doi: 10.1186/1479-5868-8-1.

    PMID: 21194492BACKGROUND

  • Benitez-Porres J, Lopez-Fernandez I, Raya JF, Alvarez Carnero S, Alvero-Cruz JR, Alvarez Carnero E. Reliability and Validity of the PAQ-C Questionnaire to Assess Physical Activity in Children. J Sch Health. 2016 Sep;86(9):677-85. doi: 10.1111/josh.12418.

    PMID: 27492937BACKGROUND

  • Cain KL, Sallis JF, Conway TL, Van Dyck D, Calhoon L. Using accelerometers in youth physical activity studies: a review of methods. J Phys Act Health. 2013 Mar;10(3):437-50. doi: 10.1123/jpah.10.3.437.

    PMID: 23620392BACKGROUND

  • Hidding LM, Chinapaw MJM, van Poppel MNM, Mokkink LB, Altenburg TM. An Updated Systematic Review of Childhood Physical Activity Questionnaires. Sports Med. 2018 Dec;48(12):2797-2842. doi: 10.1007/s40279-018-0987-0.

    PMID: 30298479BACKGROUND

  • 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

  • Ruiz JR, Espana Romero V, Castro Pinero J, Artero EG, Ortega FB, Cuenca Garcia M, Jimenez Pavon D, Chillon P, Girela Rejon MJ, Mora J, Gutierrez A, Suni J, Sjostrom M, Castillo MJ. [ALPHA-fitness test battery: health-related field-based fitness tests assessment in children and adolescents]. Nutr Hosp. 2011 Nov-Dec;26(6):1210-4. doi: 10.1590/S0212-16112011000600003. Spanish.

    PMID: 22411362BACKGROUND

  • Marasso D, Lupo C, Collura S, Rainoldi A, Brustio PR. Subjective versus Objective Measure of Physical Activity: A Systematic Review and Meta-Analysis of the Convergent Validity of the Physical Activity Questionnaire for Children (PAQ-C). Int J Environ Res Public Health. 2021 Mar 25;18(7):3413. doi: 10.3390/ijerph18073413.

    PMID: 33806106BACKGROUND

Related Links

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Javier Valenciano, PhD

    University of Castilla-La Mancha

    PRINCIPAL INVESTIGATOR

  • Juan Gregorio Fernández-Bustos, PhD

    University of Castilla-La Mancha

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Valenciano, PhD

CONTACT

925268800javier.valenciano@uclm.es

Alejandro Jiménez-Loaisa, PhD

CONTACT

648622088alejandro.jloaisa@uclm.es

Study Design

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

Study Record Dates

First Submitted

July 28, 2021

First Posted

August 6, 2021

Study Start

September 8, 2017

Primary Completion

June 23, 2018

Study Completion

June 23, 2022

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

ES(1)