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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
      • Granada, Spain, 18071
        • Palma Chillón Garzón

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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.
1 week during both measurement points (baseline and Post-evaluation)
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.
1 week during both measurement points (baseline and Post-evaluation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
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).
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).
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)
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.
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)
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)
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.
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)
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)
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).
1 day during both measurement points (baseline and Post-evaluation)
Change in anthropometry
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
Assessment of waist circumference in centimetres.
1 day during both measurement points (baseline and Post-evaluation)
Change in anthropometry
Time Frame: 1 day during both measurement points (baseline and Post-evaluation)
Assessment of neck circumference in centimetres.
1 day during both measurement points (baseline and Post-evaluation)
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.
1 day during both measurement points (baseline and Post-evaluation)
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.
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 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.
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 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)
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Otago
University of Jaén
University of Valencia
Ministerio de Economía y Competitividad, Spain
University of Castilla-La Mancha
Pontificia Universidad Catolica de Valparaiso

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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