Physical Activity Observatory of Castilla-La Mancha (OBAFIT)

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).

Study Overview

• Status: Recruiting
• Conditions: Exercise; Sedentary Behavior; Physical Fitness

Detailed Description

The OBAFIT project was designed to provide a public tool where PA habits, sedentary behaviors and the health-related physical fitness of school children from Castilla-La Mancha (a Spanish region) could be visualized. OBAFIT also allows physical education teachers at participating schools to monitor and observe the evolution of these variables in their students.

For this, the schooling data provided by the Consejería de Educación, Cultura y Deportes de la Junta de Comunidades de Castilla-La Mancha (Ministry of Education, Culture and Sports of the Community Board of Castilla-La Mancha) are considered: the population enrolled in the region from the first to the sixth year of Primary Education amounts to 131,903 students (63,488 girls; 68,415 boys) distributed in the five provinces (Albacete 24,143; Ciudad Real 31,053; Cuenca 11,001; Guadalajara 17,560; Toledo 48,146) both in public (106,366) and private (25,537) schools.

In the case of Secondary Education and the first year of high school, the number of students stands at 98,745 (50,807 men and 49,267 women) from the five provinces of the region (Albacete 19,016; Ciudad Real 23,599; Cuenca 8,971; Guadalajara 12,827; Toledo 34,332) of public centers (80,996) and private (19,078).

The sample size, calculated through the Edidat 4.2 software, is 631 subjects for the Primary sample and 631 for the Secondary sample (assuming normal distribution). A confidence level of 95% and a margin of error of 3% have been considered, and the CVR associated with low CRC with a prevalence of 18% is assumed as the parameter of greater variance. If the same level of confidence and margin of error for both sexes are considered, the sample would amount to 1,262 for each educational level. Assuming a non-response rate of 30%, the final sample size is estimated at 1640 students in Primary Education and 1640 for Secondary Education.

The participants that will make up the sample will be selected from the 724 Castilian-La Mancha schools with education in the Primary Education stage, and from 373 Secondary Education centers. Both public and private centers will be selected. The sample will be multistage, randomized and stratified according to province (Albacete, Ciudad Real, Cuenca, Guadalajara and Toledo), area (urban, semi-urban, rural), gender (men, women) and age (one group for each section of age).

Once the sample size has been determined, a lottery of schools classified based on the aforementioned criteria is carried out, considering in all cases the proportionality in the number of students. For this, a multistage method with proportional probability will be used using SPSS 24.0 software. Approximately 48 centers for Primary Education and 55 for Secondary Education will be selected, taking into account that there are 6 Primary courses and 4 in E.S.O. (Spanish system) in addition to 1st year of high school In the selected schools, three boys and three girls will be randomly chosen per group-class and level, on which the different instruments will be applied. A priori, due to pedagogical and operational issues in the administration, proportional age preselection will not be carried out (for the same group-class). Since all students in the same class-group will have the same probability of being selected, the age and sex quotas will be corrected at the end of data collection by a weighting system.

• Study Type: Observational
• Enrollment (Anticipated): 3280

Contacts and Locations

• Study Contact: Name: Javier Valenciano, PhD; Phone Number: +34 925268800; Email: javier.valenciano@uclm.es
• Study Contact Backup: Name: Alejandro Jiménez-Loaisa, PhD; Phone Number: +34 648622088; Email: alejandro.jloaisa@uclm.es

Study Locations

• Spain
  • Toledo, Spain, 45004
    • Recruiting
    • Universidad Castilla-La Mancha
    • Contact: Javier Valenciano, PhD; Phone Number: +34 925268800; Email: javier.valenciano@uclm.es
    • Contact: Alejandro Jiménez-Loaisa; Phone Number: +34 648622088; Email: alejandro.jloaisa@uclm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Socioeconomic status	Socioeconomic status assessed by the Family Affluence Scale III. The scale ranged from 0 to 13, where higher values indicate a greater socioeconomic status.	2017/2018 to 2021/2022

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age assessed by self-report	2017/2018 to 2021/2022
Gender	Gender assessed by self-report	2017/2018 to 2021/2022
Body mass index	Body mass calculated through height and weight measurements	2017/2018 to 2021/2022
Type of school	Public/private schools or urban/semirural/rural schools extracted from the registry of Castilla-La Mancha	2017/2018 to 2021/2022

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Consejería de Educación, Cultura y Deportes de Castilla-La Mancha; Dirección General de Juventud y Deportes de Castilla-La Mancha
• Investigators: Principal Investigator: Javier Valenciano, PhD, University of Castilla-La Mancha; Principal Investigator: Juan Gregorio Fernández-Bustos, PhD, University of Castilla-La Mancha

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• OBAFIT website

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2017
• Primary Completion (ACTUAL): June 23, 2018
• Study Completion (ANTICIPATED): June 23, 2022

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (ACTUAL): August 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Physical activity; Health; Childhood; School; Surveillance
• Other Study ID Numbers: 2020/01/007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No