Activity, MotorNCT03974607
Program to Promote Physical Activity and Healthy Habits in Adolescents
A study testing Physical Activity Program (PAP) in people with Activity, Motor, run by University of Extremadura at 1 site in Spain.
Trial summary
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 multidisciplinary intervention program of physical activity to promote healthier lifestyles . Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Activity, Motor
- What is being tested?
- Physical Activity Program (PAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2018to 28 Jul 2020
- 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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: 10 - 16 años
- Nor engaged in regular physical activity > 20 min on > 3 days/week
- 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, understand exclusion criteria and accept the randomized group assignment.
- 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: Multidisciplinary Training Program for the Promotion of Physical Activity and Other Healthy Habits in Inactive Adolescents
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 multidisciplinary intervention program of physical activity to promote healthier lifestyles . This program will follow the principles of the Theory of Self-determination, using Information and Communication Technologies (ICTs), a training plan for monitors, teachers and parents, with the aim of achieving greater adherence to the sports practice of adolescents from Extremadura, with the benefits at a psychosocial, cognitive and biological level that this entails.
Read the detailed description
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 multidisciplinary intervention program of physical activity to promote healthier lifestyles . This program will follow the principles of the Theory of Self-determination, using Information and Communication Technologies (ICTs), a training plan for monitors, teachers and parents, with the aim of achieving greater adherence to the sports practice of adolescents from Extremadura, with the benefits at a psychosocial, cognitive and biological level that this entails.
Students of 1st and 2nd year of E.S.O would be part of this project. of different educational centers of the Autonomous Community of Extremadura and the set of professors of the mentioned centers. Through the initial measurement made to 1st and 2nd year students of E.S.O, children who do not perform sufficient physical activity and can be part of the intervention study will be identified. In this way, identified young people who do not perform physical activity or do not reach minimum recommendable values, will be grouped by means of the sampling of random selection by conglomerates in a control group and an experimental group. Overall, the investigatos would expect to have a total of about 240 male and female students, with ages between 11 and 15 years, where about 120 students would be part of the experimental group and another 120 students would form the control group. Indirectly, parents of students and teachers in the area of Physical Education who will collaborate in different activities and events would also participate.
To achieve the objectives of the project, a quasi-experimental methodology would be carried out, with an ABA'-A'' design, formed by a first phase of initial evaluation of the psychosocial and biological variables that the investigators are going to try to optimize, a second phase that would consist of the intervention based on different procedures developed throughout an academic course, a third phase of final evaluation of the different variables that aims to assess the effects of the intervention and the usefulness of the program, and a fourth phase with an extinction measure, aimed at evaluating the stability of the effects caused by the program.
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 Program (PAP)
- 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 Program (PAP)Behavioural
A Physical Activity Program (PAP) will be carried out. Previously an initial measure will be made to know the little active adolescents. At the end of the PAF a retention measure will be carried out to know the scope and persistence of the variables analyzed. The PAF 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 we 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. During the sessions, basic physical abilities and motor skills will be worked on with playful proposals focused on the improvement of physical and psychosocial parameters. They will always have the same monitor Graduate in Physical Activity and Sports Sciences, which will be responsible for developing the PAF.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | Physical Activity Programme (PAP) was planned for the promotion of PA and other healthy habits in inactive adolescents as an agent of change intervention, in which a trained staff actively disseminates effective practices to improve the PA's habits of adolescents. Receives: Behavioral: Physical Activity Program (PAP) |
| No Physical Activity | No intervention | The control group will be selected in a targeted manner according to the availability of the center. You will not be given any information about healthy habits nor will any physical training program be applied to you, so that you do not give indications that may produce a variation of your habitual behavior. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of physical activity levels
The levels of PA of adolescents were assessed using a scale designed by the WHO and developed in many countries called the International Physical Activity Questionnaire (IPAQ - A: Hagströmer et al., 2008).
Measured: 3 Months
Type of motivation towards sports
The motivation of the students will be evaluated when doing physical exercise through the versioned Spanish version (BREQ-2: Moreno-Murcia Cervelló, and Martínez, 2007) of the Behavioral Regulation in Exercise Questionnaire (BREQ-3: Wilson Rodgers, Loitz , and Scime, 2006).
Measured: 3 Months
Satisfaction of basic psychological needs: scale
The perception of body image and the desired body image of the students will be analyzed, using the scale of Stunkard, Sørensen, and Schulsinger (1983).
Measured: 3 Months
Levels of physical activity
The level of physical activity will be measured with Actigraph wGT3X-BT accelerometers will be used, with high reliability and information storage capacity.
Measured: 3 Months
Body Image Dimensional Assessment
The dimension of the body image of adolescents will be analyzed with the BIDA questionnaire (Segura-García et al., 2012).
Measured: 3 Months
Physical condition
The physical condition (strength, endurance and agility) will be evaluated by the Alpha Fitness test battery (Ruiz et al., 2011).
Measured: 4 Months
Body composition
The body fat percentage will be assessed through the subscapular and triciple pligues using the Holtain plicter.
Measured: 4 Months
Body Mass Index (BMI)
The BMI of the participants will be evaluated. To do this, all young students will be measured and weighed and the BMI calculated using the following formula: BMI = Weight (Kg) / Height2 (Mt). For this, the Scale (SECA 877), and a Leicester Height Measure brand stadiometer, Marsden Group, will be used.
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 posted5 Jun 2019
- Study start1 May 2018
- Primary completion21 Jan 2020 (estimated)
- Study completion28 Jul 2020 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PEDRO ANTONIO SÁNCHEZ MIGUEL, University of Extremadura
- Investigators
- Pedro Antonio Sánchez Miguel, Study director, University ExtremaduraMiguel Angel Tapia Serrano, Principal investigator, University Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974607
- Sponsor's protocol ID
- University of Extremadura
- Status last verified
- Jun 2019
- First submitted
- 22 May 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Training Program for the Promotion of Physical Activity and Other Healthy Habits in Inactive Adolescents
- ClinicalTrials.gov ID
- NCT03974607
- Acronym / sponsor ID
- University of Extremadura
- Conditions
- Activity, Motor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 21 Jan 2020 (estimated)
- Study completion
- 28 Jul 2020 (estimated)
- First posted
- 5 Jun 2019 (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 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 multidisciplinary intervention program of physical activity to promote healthier lifestyles . This program will follow the principles of the Theory of Self-determination, using Information and Communication Technologies (ICTs), a training plan for monitors, teachers and parents, with the aim of achieving greater adherence to the sports practice of adolescents from Extremadura, with the benefits at a psychosocial, cognitive and biological level that this entails.
Detailed description
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 multidisciplinary intervention program of physical activity to promote healthier lifestyles . This program will follow the principles of the Theory of Self-determination, using Information and Communication Technologies (ICTs), a training plan for monitors, teachers and parents, with the aim of achieving greater adherence to the sports practice of adolescents from Extremadura, with the benefits at a psychosocial, cognitive and biological level that this entails.
Students of 1st and 2nd year of E.S.O would be part of this project. of different educational centers of the Autonomous Community of Extremadura and the set of professors of the mentioned centers. Through the initial measurement made to 1st and 2nd year students of E.S.O, children who do not perform sufficient physical activity and can be part of the intervention study will be identified. In this way, identified young people who do not perform physical activity or do not reach minimum recommendable values, will be grouped by means of the sampling of random selection by conglomerates in a control group and an experimental group. Overall, the investigatos would expect to have a total of about 240 male and female students, with ages between 11 and 15 years, where about 120 students would be part of the experimental group and another 120 students would form the control group. Indirectly, parents of students and teachers in the area of Physical Education who will collaborate in different activities and events would also participate.
To achieve the objectives of the project, a quasi-experimental methodology would be carried out, with an ABA'-A'' design, formed by a first phase of initial evaluation of the psychosocial and biological variables that the investigators are going to try to optimize, a second phase that would consist of the intervention based on different procedures developed throughout an academic course, a third phase of final evaluation of the different variables that aims to assess the effects of the intervention and the usefulness of the program, and a fourth phase with an extinction measure, aimed at evaluating the stability of the effects caused by the program.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical Activity Program (PAP)Physical Activity Programme (PAP) was planned for the promotion of PA and other healthy habits in inactive adolescents as an agent of change intervention, in which a trained staff actively disseminates effective practices to improve the PA's habits of adolescents. |
| No Physical Activity | No intervention | –The control group will be selected in a targeted manner according to the availability of the center. You will not be given any information about healthy habits nor will any physical training program be applied to you, so that you do not give indications that may produce a variation of your habitual behavior. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age: 10 - 16 años
- Nor engaged in regular physical activity > 20 min on > 3 days/week
- 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, understand exclusion criteria and accept the randomized group assignment.
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 Program (PAP)A Physical Activity Program (PAP) will be carried out. Previously an initial measure will be made to know the little active adolescents. At the end of the PAF a retention measure will be carried out to know the scope and persistence of the variables analyzed. The PAF 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 we 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. During the sessions, basic physical abilities and motor skills will be worked on with playful proposals focused on the improvement of physical and psychosocial parameters. They will always have the same monitor Graduate in Physical Activity and Sports Sciences, which will be responsible for developing the PAF. | Behavioural | Physical Activity |
Primary outcome
Perception of physical activity levels
Time frame: 3 Months
The levels of PA of adolescents were assessed using a scale designed by the WHO and developed in many countries called the International Physical Activity Questionnaire (IPAQ - A: Hagströmer et al., 2008).
Type of motivation towards sports
Time frame: 3 Months
The motivation of the students will be evaluated when doing physical exercise through the versioned Spanish version (BREQ-2: Moreno-Murcia Cervelló, and Martínez, 2007) of the Behavioral Regulation in Exercise Questionnaire (BREQ-3: Wilson Rodgers, Loitz , and Scime, 2006).
Satisfaction of basic psychological needs: scale
Time frame: 3 Months
The perception of body image and the desired body image of the students will be analyzed, using the scale of Stunkard, Sørensen, and Schulsinger (1983).
Levels of physical activity
Time frame: 3 Months
The level of physical activity will be measured with Actigraph wGT3X-BT accelerometers will be used, with high reliability and information storage capacity.
Body Image Dimensional Assessment
Time frame: 3 Months
The dimension of the body image of adolescents will be analyzed with the BIDA questionnaire (Segura-García et al., 2012).
Physical condition
Time frame: 4 Months
The physical condition (strength, endurance and agility) will be evaluated by the Alpha Fitness test battery (Ruiz et al., 2011).
Body composition
Time frame: 4 Months
The body fat percentage will be assessed through the subscapular and triciple pligues using the Holtain plicter.
Body Mass Index (BMI)
Time frame: 4 Months
The BMI of the participants will be evaluated. To do this, all young students will be measured and weighed and the BMI calculated using the following formula: BMI = Weight (Kg) / Height2 (Mt). For this, the Scale (SECA 877), and a Leicester Height Measure brand stadiometer, Marsden Group, will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Pedro Antonio Sánchez Miguel study director
University Extremadura
Miguel Angel Tapia Serrano principal investigator
University Extremadura
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 Program (PAP) in people with Activity, Motor, run by University of Extremadura 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 6 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: status not confirmed, as of the sponsor's last update on 20 Aug 2019. 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?
Results are not available in the source record.
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?
Perception of physical activity levels (time frame: 3 Months). The study lists 8 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 20 Aug 2019.