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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Physical 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 intervention | No intervention | No Physical activity changes expected Descrption: - No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity and sedentary time (objectively)
ActiGraph accelerometer
Measured: 4 months
Physical activity and sedentary time (subjectively)
Questionnaire: Youth Activity Profile - Spain Likert scale (worst score) 0-4 (best score)
Measured: 4 months
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)
Healthy and unhealthy nutrition
Questionnaire: Health Behavior in School Children Survey Likert scale (worst score) 0-4 (best score)
Measured: 4 months
Self-concept
Questionnaire: Self-concept form 5 Likert scale (worst score) 1-10 (best score)
Measured: 4 months
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.
- First posted29 Mar 2023
- Study start1 Feb 2022
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activity, MotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Bachouri-Muniesa, Universidad de Zaragoza
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination, Implementation, and Evaluation of an Effective School-based Intervention to Promote Physical Activity in Adolescents
- ClinicalTrials.gov ID
- NCT05789693
- Acronym / sponsor ID
- UZPI21/502
- Conditions
- Activity, Motor
- Keywords
- Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Physical activity changesPhysical 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 |
| No intervention | No intervention | –No Physical activity changes expected Descrption: - No intervention |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Unwillingness to either complete the study requirements or to be randomized into control or training group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity changesAlso: Promote active lifestyles, Physical activity in adolescentsPreviously 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. | Behavioural | Intervention |
Primary outcome
Physical activity and sedentary time (objectively)
Time frame: 4 months
ActiGraph accelerometer
Physical activity and sedentary time (subjectively)
Time frame: 4 months
Questionnaire: Youth Activity Profile - Spain Likert scale (worst score) 0-4 (best score)
Future intention to practice physical activity
Time frame: 4 months
Questionnaire: Ad-hoc questions about Theory of Planned Behaviour Likert scale (worst score) 1-7 (best score)
3 secondary outcomes
Healthy and unhealthy nutrition
Time frame: 4 months
Self-concept
Time frame: 4 months
Motivation to do exercise
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: Undecided. We are planning to publish several research papers related to this intervention
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.