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The PACO Study "Pedalea y Anda al COlegio" (PACO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937336
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Palma Chillón Garzón, Universidad de Granada

Brief Summary:
The aim of the PACO (Pedalea y Anda al COlegio) study is to design, implement and examine effects of 3 school-based interventions for promoting active commuting to and from school (hereinafter refered as to school) on transport to school patterns and physical activity levels in Spanish adolescents.

Condition or disease Intervention/treatment Phase
Physical Activity Sedentary Lifestyle Behavior Behavioral: Bike Intervention Group Behavioral: Walk Intevention Group Behavioral: Parents Intervention Group Not Applicable

Detailed Description:

Obesity in young people is a serious problem in the society. Low physical activity levels and a high sedentary time are unhealthy lifestyles among children and adolescents. To find opportunities where young people might adquire active behaviour is necessary. The mode of commuting to school is a behavior performed daily by young people at least twice during the way to and from school. This behavior can be performed using active modes, which means walking or cycling mainly, which has several health implications among youth. Young people who walk or cycle to school have higher physical activity levels, better cardiorespiratory fitness and there is evidence about a better academic performance compared to those who use motorized or passive modes of commuting. In the other hand, it is necessary to emphasize the socio-environmental effect of using modes of commuting that no produce pollution and that allow to interact with their peers.

The results will orienter researchers and policy makers about future studies and intervention intiatives respectively, that may be succesull on promotion active commuting to school behaviours and may be a public health strategy for benefing a society with higher health levels and, in general, higher quality of life.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized control trials
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The PACO Study "Pedalea y Anda al COlegio": Retrospective Analysis of Commuting to School in Spain and Implemention of Interventions to Promote Active Commuting Among Young People.
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
No Intervention: Control Group
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

Experimental: Walk Intevention Group
A 1-month walking-based program (1 session/week)
Behavioral: Walk Intevention Group
A 1-month walking-based program. The walking program consists of 4 sessions/month of 60 min at physical education lessons in school, and will focus on promote walking using a gamified mobile app called "Mystic School", where the steps that participants walk are kept and exchanged for movements into the game to reach the end.

Experimental: Parents Intervention Group
A 1-month perception parent-based program (1 message/week)
Behavioral: Parents Intervention Group
A 1-month perception parent-based program. The parent program consist on to promote active commuting focusing on parenting participation using an app mobile to find safe routes and social networks of Facebook and WhatsApp to communicate.




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 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 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. Change in anthropometry [ Time Frame: 1 day during both measurement points (baseline and Post-evaluation) ]
    Assessment of waist circumference in centimetres.

  12. Change in anthropometry [ Time Frame: 1 day during both measurement points (baseline and Post-evaluation) ]
    Assessment of neck circumference in centimetres.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.



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Ages Eligible for Study:   13 Years to 17 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937336


Contacts
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Contact: Palma Chillón, Doctor 958244374 ext +34 pchillon@ugr.es
Contact: Manuel Herrador, Doctor mhc@ugr.es

Locations
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Spain
Palma Chillón Garzón Recruiting
Granada, Spain, 18071
Contact: Palma Chillón, Doctor    958244374 ext +34    pchillon@ugr.es   
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
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Responsible Party: Palma Chillón Garzón, Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03937336    
Other Study ID Numbers: DEP2016-75598-R
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Palma Chillón Garzón, Universidad de Granada:
Active Commuting
Health behaviour
Design
Intervention
Technology
Children
Adolescents
Parents
Mobility