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Physical ActivityPACONCT03937336

The PACO RCT Study

A study testing Bike Intervention Group in people with Physical Activity and Sedentary Lifestyle, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 14 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Physical Activity, Sedentary Lifestyle, Behavior
What is being tested?
Bike Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
1 siteSpain
Study dates
22 Oct 2018to 30 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Palma Chillón Garzón

    Granada, 18071

Other trials in Spain

About this study

Official title: 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).

Read the 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.

Being tested
Bike Intervention Group
Keywords
Active Commuting, Health behaviour, Design, School-based intervention, Children, Youth, Self-Determination Theory, Walking
Medical subject headings
Motor Activity, Sedentary Behavior, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bike Intervention GroupBehavioural

    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

Study groups in NCT03937336
Study groupRoleWhat they receive
Control GroupNo interventionNot described
Bike Intervention GroupExperimentalA 1-month bike-based program (1 session/week)
Receives: Behavioral: Bike Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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".

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

  2. Change of the objective Mode of commuting

    Assessment of the mode of commuting using GPS.

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

  3. Change of the objective Mode of commuting

    Assessment of the mode of commuting using accelerometers.

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

  4. Change in physical activity levels

    Assessment of physical activity levels using accelerometers.

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

  5. Change in self-reported physical activity levels

    Assessment of physical activity levels using YAP questionnaire.

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

Secondary outcomes (23)

  1. 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.

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

  2. Change in Children´s behaviours

    Assessment of sleep duration using UP and DOWN Study questionnaire.

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

  3. 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).

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

  4. Change in Children´s behaviours

    Assessment of accompaniment to school using the question extracted of Herrador-Colmenero et al, 2017.

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

  5. 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).

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

  6. 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).

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

  7. 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).

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

  8. 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).

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

  14. Change in anthropometry

    Assessment of height and weight, (e.g., weight and height will be combined to report BMI in kg/m^2).

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

  15. Change in anthropometry

    Assessment of waist circumference in centimetres.

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

  16. Change in anthropometry

    Assessment of neck circumference in centimetres.

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

  17. 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.

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

  18. 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.

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

  19. 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.

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

  20. 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.

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

  21. 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.

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

  22. 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.

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

  23. Change in parent´s perceptions

    Assessment of social support using Family questionnaire. Score range is: none; few; many; everyone.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start22 Oct 2018
  3. Primary completion30 Jul 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Control Trials
Masking
Single blind
Who is masked
Participant
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03937336
Sponsor's protocol ID
DEP2016-75598-R
Acronym
PACO
Status last verified
Sep 2021
First submitted
10 Apr 2019
Last updated
30 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24722834

  • Campos-Garzon P, Huertas-Delgado FJ, Cadenas-Sanchez C, Molina-Garcia J, Barranco-Ruiz Y, Chillon P. Effects of a school-based cycling intervention on commuting to school behavior and device-measured activity in Spanish adolescents: the PACO cluster-randomized controlled trial. Int J Behav Nutr Phys Act. 2026 Feb 24;23(1):29. doi: 10.1186/s12966-026-01893-1.

    PubMed 41736046

Questions about this trial

What is this clinical trial studying?

A study testing Bike Intervention Group in people with Physical Activity and Sedentary Lifestyle, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of the self-reported Mode of commuting (time frame: 1 week during both measurement points (baseline and Post-evaluation)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03937336, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.

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