About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

The PACO RCT Study

Clinicaltrials.gov identifier NCT03937336

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted July 27, 2020

Study Description

Brief summary:

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).

  • Condition or Disease:Physical Activity
    Sedentary Lifestyle
    Behavior
  • Intervention/Treatment: Behavioral: Bike Intervention Group
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 360 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Randomized Control Trials
  • Masking: Single (Participant)
  • Primary Purpose: Prevention
  • Official Title: A School-based Randomized Controlled Trial to Promote Cycling to School and Physical Activity in Adolescents: The PACO RCT Study
  • Actual Study Start Date: October 2018
  • Estimated Primary Completion Date: July 2021
  • Estimated Study Completion Date: September 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Bike Intervention Group
A 1-month bike-based program (1 session/week)
Behavioral: Bike Intervention Group
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
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 1. Change in anthropometry [ Time Frame: 1 day during both measurement points (baseline and Post-evaluation) ]
    Assessment of waist circumference in centimetres.
  • 2. 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).
  • 3. 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.
  • 4. 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.
  • 5. 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).
  • 6. 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.
  • 7. 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).
  • 8. 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).
  • 9. 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).
  • 10. 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).
  • 11. 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.
  • 12. 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.
  • 13. 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.
  • 14. 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.
  • 15. 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.
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 14 to 15 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria:

1. Have at least one group of 3º ESO with a minimum of 15 students.

2. Obtain a minimum of 15 informed consent to carry out the project in the school.

3. That the students of 3rd ESO had not participated in other interventions in the center
on active commuting during the ESO stage.

4. Not having public school transport for students; in this case, the project can not be
carried out.

Contacts and Locations
Contacts

Contact: Palma Chillón, Doctor 958244374 ext +34 pchillon@ugr.es

Contact: Patricia Gálvez, Graduada pgalvez@ugr.es

Locations

Spain
Palma Chillón Garzón
Granada

Sponsors and Collaborators

Universidad de Granada

Ministerio de Economía y Competitividad, Spain

University of Jaén

University of Valencia

University of Castilla-La Mancha

Pontificia Universidad Catolica de Valparaiso

University of Otago

More Information