The PACO RCT Study

Physical Activity Clinical Trial

— PACO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937336
• Other study ID #: DEP2016-75598-R
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2021
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: September 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior
• Physical Activity
• Sedentary Lifestyle

Intervention

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

Locations

Country	Name	City	State
Spain	Palma Chillón Garzón	Granada

Sponsors (7)

Lead Sponsor	Collaborator
Universidad de Granada	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

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Herrador-Colmenero M, Pérez-García M, Ruiz JR, Chillón 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Change in physical activity levels	Assessment of physical activity levels using accelerometers.	1 week during both measurement points (baseline and Post-evaluation)
Primary	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	Change in Children´s behaviours	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.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in Children´s behaviours	Assessment of sleep duration using UP and DOWN Study questionnaire.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in Children´s behaviours	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).	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in Children´s behaviours	Assessment of accompaniment to school using the question extracted of Herrador-Colmenero et al, 2017.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in Children´s behaviours	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).	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in Children´s behaviours	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).	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in Children´s behaviours	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).	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in Children´s behaviours	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).	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in Children´s perceptions	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.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in Children´s perceptions	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.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in children's psychosocial variables	Assessment of autonomy using BPNES questionnaire (Basic Psychological Needs in Exercise Scale) subscales 1-5. Score is extracted of average of questionnaire.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in children's psychosocial variables	Assessment of motivation using BREQ questionnaire (Behavioural Regulation in Exercise Questionnaire) subscales 0 - 4. Score is extracted of average of questionnaire.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in children's psychosocial variables	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.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in anthropometry	Assessment of height and weight, (e.g., weight and height will be combined to report BMI in kg/m^2).	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in anthropometry	Assessment of waist circumference in centimetres.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in anthropometry	Assessment of neck circumference in centimetres.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in parent´s behaviours	Assessment of parent's physical activity using IPAQ (International Physical Activity Questionnaire) short form. Score is extracted of sum of time of physical activity.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in parent´s behaviours	Assessment of parent's mode of commuting to work using SRTS (Safe Route to School) questionnaire. Score scale is Active, Pasive or Mix.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in parent´s perceptions	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.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in parent´s perceptions	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.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in parent´s perceptions	Assessment of children´s distance to allow them to active commute to/from school using Family questionnaire. Score range is between none - >5km.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in parent´s perceptions	Assessment of children´s age to allow them to active commute to/from school using Family questionnaire. Score range is between <7y - >18y.	1 day during both measurement points (baseline and Post-evaluation)
Secondary	Change in parent´s perceptions	Assessment of social support using Family questionnaire. Score range is: none; few; many; everyone.	1 day during both measurement points (baseline and Post-evaluation)