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Activity, MotorNCT05789693

School-based Intervention to Promote Physical Activity in Adolescents in Spain: the Promoting Physical Activity in Secondary School For Health Project

A study testing Physical activity changes in people with Activity, Motor, run by Universidad de Zaragoza 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 goal of this study is to design, adapt and implement a strategies and a teaching intervention programme to improve the adolescents physical activity in a little city of Spain, in an educational context. Read more about this study

Who is it for?
Ages 12 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Activity, Motor
What is being tested?
Physical activity changes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSpain
Study dates
1 Feb 2022to 4 May 2022
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 12 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age
  • Not participating in a weight loss programme
  • Provide informed consent by parents, mothers or legal guardians
  • Participants must be capable and willing to provide consent
  • Participants must attend at least 80% of the sessions.

Who cannot join

  • Unwillingness to either complete the study requirements or to be randomized into control or training group.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hisham

    Huesca, 22001

Other trials in Spain

About this study

Official title: Dissemination, Implementation, and Evaluation of an Effective School-based Intervention to Promote Physical Activity in Adolescents

The goal of this study is to design, adapt and implement a strategies and a teaching intervention programme to improve the adolescents physical activity in a little city of Spain, in an educational context.

Students will be divided in two groups (control and intervention) and we will apply in the intervention in one group and we will develop different strategies aimed at improve the active lifestyles in the adolescents. Researchers will compare both groups taking in to account: levels of physical activity, sedentary time, healthy diet, self-concept or different psychosocial outcomes

Read the detailed description

The purpose of the project is the development of a healthy environment from educational centers. Healthy behaviors and perceptions of healthy environments of members of the educational community will be analyzed. The data processing process will be anonymous in all students. The center will receive the information corresponding to the project through the person in charge of the investigation. The center will send a letter voluntarily accepting your participation (attached) to the principal investigator (PI) of the project. The main objective of the research project presented is to improve physical activity levels in adolescents who present rates of diagnosed active impairment through the design, development and evaluation of a multilevel and multicomponent intervention program to promote healthier lifestyles. This program will follow the principles of the Socio-ecological model, teachers and parents perceptions and beliefs, with the aim of achieving greater adherence to the sports practice of adolescents.

Students of 2nd year of E.S.O would be part of this intervention program of two educational centers of a Spanish region. Through the initial measurement made to 2nd year students of E.S.O. Overall, the investigatos would expect to have a total of about 80 male and female students, with ages between 12 and 15 years. Indirectly, parents of students and teachers would also participate. In this way, identified young people who do not perform physical activity or do not reach minimum recommendable values (recommendations of World Health Organization), will be grouped in control and experimental schools.

The study variables will be:

  • Qualitative data: Collected through focus groups: personal opinions about their educational center and the development of healthy environments. Estimated completion time: 45 minutes.
  • Quantitative data: The data that will be required for the students in the questionnaires (students): age, gender, place of residence and data on healthy behaviors (levels of physical activity, hours of sleep, food, hours spent on screen, substance use). and influences for a healthy environment and self-concept). Estimated completion time: 45 minutes.

The focus groups and the questionnaires will be applied once the approval of the Ethical Commitee of the region has been obtained for the application of the project. Once obtained, the following day the informed consent will be provided to the families, it will be collected in 7 days and the following week the initial questionnaires will be carried out. At the end of the research in May 2022, the same questionnaires will be passed again to assess the evolution of the group in the different study variables.

Students who do not participate in the study will be invited to non-curricular activities since participation will be voluntary. When the questionnaires are completed, the center will enable a teacher "on duty" to attend to the students during the hour that the questionnaires last.

Statistical analysis: Comparisons will be made to verify that there are no differences in the baseline, using the "t" test and the χ2 test. After verifying the assumptions of normality and homoscedasticity, an analysis of covariance with three repeated measures (ANCOVA) will be performed on the outcome variables, by intention to treat (ITT), using the last observation carried forward (LOCF) method. Age, sex, and baseline scores will be included as covariates to examine differences between groups, eliminating their possible influence. The effect size will be calculated using the partial eta square value (η2). Values ≤ 0.01 correspond to a small effect size, = 0.06 with a medium size, and ≥ 0.14 with a large size. Contrasts will be made between the pretest and posttest measurements, using the corresponding "t" test. The significance level adopted will be α< 0.05.

Limitations of the study: It is a study with a reduced sample that does not want to be representative, only to see the evaluation of the variables in that context during a specific time to help the centers make decisions about their health promoting school project.The benefits of this project would be framed in different levels. In the first place, the main benefit would be obtained by the direct recipients of the project, that is, the adolescents who would see their physical activity levels increased with the positive consequences that this entails and with the development of healthier living habits. Secondly, Physical Education teachers could have new methodological and motivational tools to encourage more physical activity among their students; and the parents of these, could value the importance of physical activity and lead an active lifestyle, collaborating from the family environment to promote the objectives of this project.

Conditions
Activity, Motor
Being tested
Physical activity changes
Keywords
Physical activity
Medical subject headings
Motor Activity

What participants receive

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

  • Physical activity changesBehavioural

    Also called Promote active lifestyles, Physical activity in adolescents

    Previously an initial measure (qualitative and qualitative) will be made to know the little active adolescents. At the end of the physical activity program a retention measure will be carried out to know the scope and persistence of the variables analyzed. The intervention will be developed with a frequency of three weekly sessions, of 60 minutes, in the period of the intervention, with the exception of weeks in which there is a public holiday, where there will take measures to recover the class. A schedule for the sessions will be set according to the interests of the participants and will be the same for all.

Study groups in NCT05789693
Study groupRoleWhat they receive
InterventionExperimentalPhysical activity changes expected Description: * Develop four sessions in the Tutorial Action Plan of the school * Connect several subjects aligned with the messages from the tutory * Physical education teachers provide some insights about healty behaviours
Receives: Behavioral: Physical activity changes
No interventionNo interventionNo Physical activity changes expected Descrption: - No intervention

What is being measured

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

  1. Physical activity and sedentary time (objectively)

    ActiGraph accelerometer

    Measured: 4 months

  2. Physical activity and sedentary time (subjectively)

    Questionnaire: Youth Activity Profile - Spain Likert scale (worst score) 0-4 (best score)

    Measured: 4 months

  3. Future intention to practice physical activity

    Questionnaire: Ad-hoc questions about Theory of Planned Behaviour Likert scale (worst score) 1-7 (best score)

    Measured: 4 months

Secondary outcomes (3)
  1. Healthy and unhealthy nutrition

    Questionnaire: Health Behavior in School Children Survey Likert scale (worst score) 0-4 (best score)

    Measured: 4 months

  2. Self-concept

    Questionnaire: Self-concept form 5 Likert scale (worst score) 1-10 (best score)

    Measured: 4 months

  3. Motivation to do exercise

    Questionnaire: Behavioral Regulation in Exercise Questionnaire - 3 Likert scale (worst score) 0-4 (best score)

    Measured: 4 months

Timeline

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

  1. First posted29 Mar 2023
  2. Study start1 Feb 2022
  3. Primary completion4 May 2022
  4. Study completion4 May 2022

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05789693
Sponsor's protocol ID
UZPI21/502
Other IDs
622733-EPP-1-2020-1-FR-SPO-SCP
Status last verified
Mar 2023
First submitted
3 Mar 2023
Last updated
31 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We are planning to publish several research papers related to this intervention

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity changes in people with Activity, Motor, run by Universidad de Zaragoza 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 5 inclusion and 1 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 31 Mar 2023. 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?

Physical activity and sedentary time (objectively) (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Mar 2023.

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