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Completed

NCT Number: NCT03937336

The PACO RCT Study

The aim of this school-based cycling intervention called "Cycling and Walk to School" (PACO, for its Spanish acronym) will be to examine their effects on adolescent's cycling to and from school and physical activity (PA). This study will also examine the effects of this intervention in several active commuting to and from school (ACS)-related variables belonging to Self-Determination Theory (SDT) and Social-Ecological Model (SEM).

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Key information

Conditions

Physical Activity Behavior Motor Activity Sedentary Behavior Sedentary Lifestyle

Age range

14 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palma Chillón Garzón

Granada, 18071, Spain

About this study

This study will also examine the effects of this intervention in several active commuting to and from school (ACS)-related variables belonging to SDT and SEM. In this randomized controlled trial will participate 360 adolescents, belonging to six secondary schools (three experimental and three control) from three Spanish cities. The intervention will be conducted by both the research staff and the physical education (PE) teacher through four cycling sessions (one per week). PA levels will be measured by accelerometers, and the other study variables by using self-reported scales, before and after the intervention programme. The primary outcomes will be: cycling to school, ACS, and PA levels. The secondary outcomes will be: SDT (Self-Determination Theory) -related variables in ACS and individual, interpersonal, communittal and environmental variables related to ACS belonging to SEM (Social-Ecological Model). The findings of this study will provide a comprehensive understanding of the effects of this short-term school-based intervention on cycling to school and PA levels of Spanish adolescents.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have at least one group of 3º ESO with a minimum of 15 students.
  • Obtain a minimum of 15 informed consent to carry out the project in the school.
  • That the students of 3rd ESO had not participated in other interventions in the center on active commuting during the ESO stage.
  • Not having public school transport for students; in this case, the project can not be carried out.

Treatment and study plan

Bike Intervention Group

Behavioral

A 1-month biking-based program. The biking program consists of 4 sessions/month of 120 min at physical education lessons in school, and will focus on promote biking through theory and practice lessons about cycle training skills including on-road training

Primary outcomes

  1. Change of the self-reported Mode of commuting

    Time frame: 1 week during both measurement points (baseline and Post-evaluation)

    Assessment of the mode of commuting using "Mode and Frequency of Commuting To and From School Questionnaire".

  2. Change of the objective Mode of commuting

    Time frame: 1 week during both measurement points (baseline and Post-evaluation)

    Assessment of the mode of commuting using GPS.

  3. Change of the objective Mode of commuting

    Time frame: 1 week during both measurement points (baseline and Post-evaluation)

    Assessment of the mode of commuting using accelerometers.

  4. Change in physical activity levels

    Time frame: 1 week during both measurement points (baseline and Post-evaluation)

    Assessment of physical activity levels using accelerometers.

  5. Change in self-reported physical activity levels

    Time frame: 1 week during both measurement points (baseline and Post-evaluation)

    Assessment of physical activity levels using YAP questionnaire.

Secondary outcomes

  1. Change in Children´s behaviours

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of mode of commuting to/from school using Mode and Frequency of Commuting To and From School Questionnaire. Scale range: active, passive or mix.

  2. Change in Children´s behaviours

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of sleep duration using UP and DOWN Study questionnaire.

  3. Change in Children´s behaviours

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of breakfast consumption using ENERGY Spanish questionnaire and enKids study. Scale range: Healthy or Not Healthy (subscale: yes/no, sum of groups of aliment).

  4. Change in Children´s behaviours

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of accompaniment to school using the question extracted of Herrador-Colmenero et al, 2017.

  5. Change in Children´s behaviours

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of individual factors of Social-Ecological model (Sociodemographics; health status; psychosocial; perception; behaviour) using motivation and behaviour change techniques (MBCTs) used in Self Determination Theory -based interventions (Teixeira et al., 2020).

  6. Change in Children´s behaviours

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of interpersonal factors of Social-Ecological model (Parent's Sociodemography, perception and behaviour; Peer social support; Family SES) using motivation and behaviour change techniques (MBCTs) used in Self Determination Theory -based interventions (Teixeira et al., 2020).

  7. Change in Children´s behaviours

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of community factors of Social-Ecological model (School characteristics; city characteristics) using motivation and behaviour change techniques (MBCTs) used in Self Determination Theory -based interventions (Teixeira et al., 2020).

  8. Change in Children´s behaviours

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of environment factors of Social-Ecological model (Route home-school; home neighbourhood; distance home-school; school neighbourhood) using motivation and behaviour change techniques (MBCTs) used in Self Determination Theory -based interventions (Teixeira et al., 2020).

  9. Change in Children´s perceptions

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of perceived environment using ALPHA environmental ((Instruments for Assessing Levels of PHysical Activity and Fitness) questionnaire. Score is extracted of average of differents items include in the questionnaire.

  10. Change in Children´s perceptions

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of barriers to active commuting to/from school using BATACE(BArreras en el Transporte Activo al Centro Educativo) questionnaire. Score is extracted of average of items include in the questionnaire.

  11. Change in children's psychosocial variables

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of autonomy using BPNES questionnaire (Basic Psychological Needs in Exercise Scale) subscales 1-5. Score is extracted of average of questionnaire.

  12. Change in children's psychosocial variables

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of motivation using BREQ questionnaire (Behavioural Regulation in Exercise Questionnaire) subscales 0 - 4. Score is extracted of average of questionnaire.

  13. Change in children's psychosocial variables

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of relatedness and competence to active commuting to school BPNES questionnaire (Basic Psychological Needs in Exercise Scale) subscales 1-5. Score is extracted of average of questionnaire.

  14. Change in anthropometry

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of height and weight, (e.g., weight and height will be combined to report BMI in kg/m^2).

  15. Change in anthropometry

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of waist circumference in centimetres.

  16. Change in anthropometry

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of neck circumference in centimetres.

  17. Change in parent´s behaviours

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of parent's physical activity using IPAQ (International Physical Activity Questionnaire) short form. Score is extracted of sum of time of physical activity.

  18. Change in parent´s behaviours

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of parent's mode of commuting to work using SRTS (Safe Route to School) questionnaire. Score scale is Active, Pasive or Mix.

  19. Change in parent´s perceptions

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of barriers to active commuting to/from school of their children using PABACS (parental perception of barriers towards active commuting to school) questionnaire. Score is extracted of average of items. Subscale is 0 - 4.

  20. Change in parent´s perceptions

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of perceived environment using ALPHA environmental(Instruments for Assessing Levels of PHysical Activity and Fitness) questionnaire. Score is extracted of average of different items include in the questionnaire.

  21. Change in parent´s perceptions

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of children´s distance to allow them to active commute to/from school using Family questionnaire. Score range is between none - >5km.

  22. Change in parent´s perceptions

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of children´s age to allow them to active commute to/from school using Family questionnaire. Score range is between <7y - >18y.

  23. Change in parent´s perceptions

    Time frame: 1 day during both measurement points (baseline and Post-evaluation)

    Assessment of social support using Family questionnaire. Score range is: none; few; many; everyone.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Ministerio de Economía y Competitividad, Spain
  • Pontificia Universidad Catolica de Valparaiso
  • University of Castilla-La Mancha
  • University of Jaén
  • University of Otago
  • University of Valencia

Registry information

Official study title

A School-based Randomized Controlled Trial to Promote Cycling to School and Physical Activity in Adolescents: The PACO RCT Study

Acronym: PACO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 3, 2019
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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