OBAFIT: Physical Activity Observatory of Castilla-La Mancha

Sponsor
University of Castilla-La Mancha (Other)
Overall Status
Recruiting
CT.gov ID
NCT04994340
Collaborator
Consejería de Educación, Cultura y Deportes de Castilla-La Mancha (Other), Dirección General de Juventud y Deportes de Castilla-La Mancha (Other)
3,280
1
57.5
57.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3280 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Physical Activity Observatory of Castilla-La Mancha
    Actual Study Start Date :
    Sep 8, 2017
    Actual Primary Completion Date :
    Jun 23, 2018
    Anticipated Study Completion Date :
    Jun 23, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Subjective physical activity levels [2017/2018 to 2021/2022]

      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.

    2. Device-measured physical activity levels [2017/2018 to 2021/2022]

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

    3. Sedentary behavior [2017/2018 to 2021/2022]

      Sedentary behavior assessed by self-report (YLSBQ)

    4. Sedentary behavior [2017/2018 to 2021/2022]

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

    5. Health-related physical fitness [2017/2018 to 2021/2022]

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

    Secondary Outcome Measures

    1. Socioeconomic status [2017/2018 to 2021/2022]

      Socioeconomic status assessed by the Family Affluence Scale III. The scale ranged from 0 to 13, where higher values indicate a greater socioeconomic status.

    Other Outcome Measures

    1. Age [2017/2018 to 2021/2022]

      Age assessed by self-report

    2. Gender [2017/2018 to 2021/2022]

      Gender assessed by self-report

    3. Body mass index [2017/2018 to 2021/2022]

      Body mass calculated through height and weight measurements

    4. Type of school [2017/2018 to 2021/2022]

      Public/private schools or urban/semirural/rural schools extracted from the registry of Castilla-La Mancha

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universidad Castilla-La Mancha Toledo Spain 45004

    Sponsors and Collaborators

    • University of Castilla-La Mancha
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Javier Valenciano, Principal Investigator, University of Castilla-La Mancha
    ClinicalTrials.gov Identifier:
    NCT04994340
    Other Study ID Numbers:
    • 2020/01/007
    First Posted:
    Aug 6, 2021
    Last Update Posted:
    Aug 6, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Javier Valenciano, Principal Investigator, University of Castilla-La Mancha

    Study Results

    No Results Posted as of Aug 6, 2021