NCT03937336

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

April 10, 2019

Last Update Submit

September 29, 2021

Conditions

Physical ActivitySedentary LifestyleBehavior

Keywords

Active CommutingHealth behaviourDesignSchool-based interventionChildrenYouthSelf-Determination TheoryWalking

Outcome Measures

Primary Outcomes (5)

  • Change of the self-reported Mode of commuting

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

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

  • Change of the objective Mode of commuting

    Assessment of the mode of commuting using GPS.

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

  • Change of the objective Mode of commuting

    Assessment of the mode of commuting using accelerometers.

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

  • Change in physical activity levels

    Assessment of physical activity levels using accelerometers.

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

  • Change in self-reported physical activity levels

    Assessment of physical activity levels using YAP questionnaire.

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

Secondary Outcomes (23)

  • Change in Children´s behaviours

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

  • Change in Children´s behaviours

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

  • Change in Children´s behaviours

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

  • Change in Children´s behaviours

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

  • Change in Children´s behaviours

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

  • +18 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Bike Intervention Group

EXPERIMENTAL

A 1-month bike-based program (1 session/week)

Behavioral: Bike Intervention Group

Interventions

Bike Intervention GroupBEHAVIORAL

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

Bike Intervention Group

Eligibility Criteria

Age14 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palma Chillón Garzón

Granada, 18071, Spain

Location

Related Publications (1)

  • Herrador-Colmenero M, Perez-Garcia M, Ruiz JR, Chillon P. Assessing modes and frequency of commuting to school in youngsters: a systematic review. Pediatr Exerc Sci. 2014 Aug;26(3):291-341. doi: 10.1123/pes.2013-0120. Epub 2014 Apr 10.

    PMID: 24722834RESULT

MeSH Terms

Conditions

Motor ActivitySedentary BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Control Trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2019

First Posted

May 3, 2019

Study Start

October 22, 2018

Primary Completion

July 30, 2021

Study Completion

September 30, 2021

Last Updated

September 30, 2021

Record last verified: 2021-09

Locations

ES(1)