- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937336
The PACO RCT Study (PACO)
September 29, 2021 updated by: Palma Chillón Garzón, Universidad de Granada
A School-based Randomized Controlled Trial to Promote Cycling to School and Physical Activity in Adolescents: The PACO RCT Study
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
360
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Granada, Spain, 18071
- Palma Chillón Garzón
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
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Experimental: Bike Intervention Group
A 1-month bike-based program (1 session/week)
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
1 week during both measurement points (baseline and Post-evaluation)
|
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.
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1 week during both measurement points (baseline and Post-evaluation)
|
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.
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1 week during both measurement points (baseline and Post-evaluation)
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Change in physical activity levels
Time Frame: 1 week during both measurement points (baseline and Post-evaluation)
|
Assessment of physical activity levels using accelerometers.
|
1 week during both measurement points (baseline and Post-evaluation)
|
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.
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1 week during both measurement points (baseline and Post-evaluation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day during both measurement points (baseline and Post-evaluation)
|
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.
|
1 day during both measurement points (baseline and Post-evaluation)
|
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).
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1 day during both measurement points (baseline and Post-evaluation)
|
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.
|
1 day during both measurement points (baseline and Post-evaluation)
|
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).
|
1 day during both measurement points (baseline and Post-evaluation)
|
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).
|
1 day during both measurement points (baseline and Post-evaluation)
|
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).
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1 day during both measurement points (baseline and Post-evaluation)
|
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).
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1 day during both measurement points (baseline and Post-evaluation)
|
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.
|
1 day during both measurement points (baseline and Post-evaluation)
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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.
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1 day during both measurement points (baseline and Post-evaluation)
|
Change in children's psychosocial variables
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
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Assessment of autonomy using BPNES questionnaire (Basic Psychological Needs in Exercise Scale) subscales 1-5.
Score is extracted of average of questionnaire.
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1 day during both measurement points (baseline and Post-evaluation)
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Change in children's psychosocial variables
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
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Assessment of motivation using BREQ questionnaire (Behavioural Regulation in Exercise Questionnaire) subscales 0 - 4. Score is extracted of average of questionnaire.
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1 day during both measurement points (baseline and Post-evaluation)
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Change in children's psychosocial variables
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
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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.
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1 day during both measurement points (baseline and Post-evaluation)
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Change in anthropometry
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
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Assessment of height and weight, (e.g., weight and height will be combined to report BMI in kg/m^2).
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1 day during both measurement points (baseline and Post-evaluation)
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Change in anthropometry
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
|
Assessment of waist circumference in centimetres.
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1 day during both measurement points (baseline and Post-evaluation)
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Change in anthropometry
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
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Assessment of neck circumference in centimetres.
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1 day during both measurement points (baseline and Post-evaluation)
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Change in parent´s behaviours
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
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Assessment of parent's physical activity using IPAQ (International Physical Activity Questionnaire) short form.
Score is extracted of sum of time of physical activity.
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1 day during both measurement points (baseline and Post-evaluation)
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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.
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1 day during both measurement points (baseline and Post-evaluation)
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Change in parent´s perceptions
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
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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)
|
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.
|
1 day during both measurement points (baseline and Post-evaluation)
|
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.
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1 day during both measurement points (baseline and Post-evaluation)
|
Change in parent´s perceptions
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
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Assessment of children´s age to allow them to active commute to/from school using Family questionnaire.
Score range is between <7y - >18y.
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1 day during both measurement points (baseline and Post-evaluation)
|
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.
|
1 day during both measurement points (baseline and Post-evaluation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 22, 2018
Primary Completion (Actual)
July 30, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
April 10, 2019
First Submitted That Met QC Criteria
May 2, 2019
First Posted (Actual)
May 3, 2019
Study Record Updates
Last Update Posted (Actual)
September 30, 2021
Last Update Submitted That Met QC Criteria
September 29, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DEP2016-75598-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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