Clinical trial NCT03937336: The PACO RCT Study
Official title: A School-based Randomized Controlled Trial to Promote Cycling to School and Physical Activity in Adolescents: The PACO RCT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Sedentary Lifestyle
Behavior
Keywords: Active Commuting
Health behaviour
Design
School-based intervention
Children
Youth
Self-Determination Theory
Walking
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: University of Jaén
name: University of Valencia
name: University of Castilla-La Mancha
name: Pontificia Universidad Catolica de Valparaiso
name: University of Otago
First posted: 2019-05-03
Enrollment: 360
Sex: ALL
Minimum age (years): 14
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trials
Primary purpose: PREVENTION

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).

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.

Eligibility 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.

Primary outcomes:
measure: Change of the self-reported Mode of commuting
timeFrame: 1 week during both measurement points (baseline and Post-evaluation)
measure: Change of the objective Mode of commuting
timeFrame: 1 week during both measurement points (baseline and Post-evaluation)
measure: Change of the objective Mode of commuting
timeFrame: 1 week during both measurement points (baseline and Post-evaluation)
measure: Change in physical activity levels
timeFrame: 1 week during both measurement points (baseline and Post-evaluation)
measure: Change in self-reported physical activity levels
timeFrame: 1 week during both measurement points (baseline and Post-evaluation)
Secondary outcomes:
measure: Change in Children´s behaviours
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in Children´s behaviours
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in Children´s behaviours
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in Children´s behaviours
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in Children´s behaviours
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in Children´s behaviours
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in Children´s behaviours
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in Children´s behaviours
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in Children´s perceptions
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in Children´s perceptions
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in children's psychosocial variables
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in children's psychosocial variables
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in children's psychosocial variables
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in anthropometry
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in anthropometry
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in anthropometry
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in parent´s behaviours
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in parent´s behaviours
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in parent´s perceptions
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in parent´s perceptions
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in parent´s perceptions
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in parent´s perceptions
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
measure: Change in parent´s perceptions
timeFrame: 1 day during both measurement points (baseline and Post-evaluation)
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Palma Chillón Garzón
Study officials:
References:
citation: 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.