SchoolNCT05949463
Activity Wristband-based Intermittent Teaching Unit and Students Physical Activity and Its Psychological Mediators
A study testing Intermittent teaching unit in people with School, run by University of Valladolid at 1 site in Spain.
Trial summary
Objective: The main objective of the present study was to examine the effects of an intermittent teaching unit based on the use of activity wristbands and behavior modification strategies on high school students perceptions of autonomy support, satisfaction of basic psychological needs, motivation toward Physical… Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- School
- What is being tested?
- Intermittent teaching unit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to 31 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being enrolled in the seventh to tenth grade at the secondary education level
- Participating in the normal Physical Education lessons
- Being exempt of any health problem that would make them unable to engage in physical activity normally
- Presenting the corresponding signed written consent by their legal tutors
- Presenting their own corresponding signed written assent
Who cannot join
- Not having performed the evaluation of the dependent variables correctly at the pre-intervention, post-intervention and/or follow-up measures following the administration rules (being removed only for incomplete variables and not for the overall study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Activity Wristband-based Intermittent Teaching Unit in Physical Education on Students Physical Activity and Its Psychological Mediators: A Cluster-randomized Controlled Trial. School-Fit Study
Objective: The main objective of the present study was to examine the effects of an intermittent teaching unit based on the use of activity wristbands and behavior modification strategies on high school students perceptions of autonomy support, satisfaction of basic psychological needs, motivation toward Physical Education and physical activity, intention to be physically active, and habitual physical activity levels.
Materials and methods: An initial sample of 353 high school students (final sample = 175; 45.7% females; mean age = 13.3 ± 1.2 years) from two public high schools were cluster-randomly assigned into the intermittent (n = 100) and control (n = 75) groups. The intermittent group performed an intermittent teaching unit twice a week for eight weeks. Specifically, the last 15 minutes of each lesson were used. As the main strategy to promote the practice of regular physical activity, students wore an activity wristband the whole day during the intervention period. Additionally, other behavior modification strategies were also applied (e.g., educational counseling, physical activity goals or reminders). The control group also performed two Physical Education sessions a week during the intervention period, but without using wristbands or other behavior modification strategies. Before and after the intervention, as well as at the end of the follow-up period (six weeks), students' physical activity practice mediators and physical activity levels were measured by validated questionnaires.
- Conditions
- School
- Being tested
- Intermittent teaching unit, No intervention group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent teaching unitOther
The intermittent group students performed an intermittent teaching unit twice a week for eight weeks aimed at promoting healthy physical activity habits. Specifically, the last 15 minutes of each lesson were used. The rest of lessons' time other contents were worked on with no relation to any health physical activity habit (i.e., acrosport, badminton, basketball, volleyball, soccer and athletics).
No intervention groupOther
The control group students also carried out two Physical Education lessons a week during the intervention period. During these lessons, contents of handball, basketball, alternative sports and traditional games were developed. However, this group did not wear physical activity activity wristbands or receive any behavior modification specific strategy.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent group | Experimental | The intermittent group students performed an intermittent teaching unit twice a week for eight weeks aimed at promoting healthy physical activity habits. Specifically, the last 15 minutes of each lesson were used. The rest of lessons' time other contents were worked on with no relation to any health physical activity habit (i.e., acrosport, badminton, basketball, volleyball, soccer and athletics). Receives: Other: Intermittent teaching unit |
| Control group | Active comparator | The control group students also carried out two Physical Education lessons a week during the intervention period. During these lessons, contents of handball, basketball, alternative sports and traditional games were developed. However, this group did not wear physical activity activity wristbands or receive any behavior modification specific strategy developed in the intermittent group. Receives: Other: No intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived autonomy support
The Physical Education teacher autonomy-support was assessed through the Spanish version of the Multi-Dimensional Perceived Autonomy Support Scale for Physical Education (MD-PASS-PA). It consists of 15 items (five items per factor) that assessed organizational, procedural, and cognitive autonomy support. The items were preceded by the statement "My Physical Education teacher...". The Spanish version of MD-PASS-PA has shown adequate psychometric properties among adolescents.
Measured: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Change in Basic psychological needs
Students' perceptions of autonomy, competence, and relatedness satisfaction in Physical Education and physical exercise were assessed using the Spanish version of the Basic Psychological Needs in Exercise Scale (BPNES). It consists of 12 items (four items per factor) that assessed autonomy, competence and relatedness. The items were preceded by the statement "When I do physical activity…". The Spanish version of BPNES has shown adequate psychometric properties among adolescents.
Measured: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Change in Motivation toward Physical Education
Participants' self-determined motivation toward Physical Education was measured by the Spanish version of the Revised Perceived Locus of Causality Scale (PLOC-R). It consists of of 23 items spread over six dimensions (four items each except external regulation) that measure intrinsic motivation, amotivation, integrated, identified, introjected, and external regulation. This questionnaire was preceded by the statement "I participate in Physical Education lessons…". The autonomous (i.e., averaging intrinsic, integrated, and identified regulation) and controlled (i.e., averaging introjected and external) motivations were also calculated. The Spanish version of the PLOC-R has shown adequate psychometric properties among adolescents.
Measured: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Change in Self-determined motivation towards physical activity
Students' motivation towards physical activity was measured using the Spanish version of the Behavioral Regulation in Exercise Questionnaire (BREQ-3). It consists of 23 items distributed into six dimensions (four items each except identified regulation) that measure intrinsic motivation, amotivation, integrated, identified, introjected, and external regulation. This questionnaire was preceded by the statement: "I do physical activity...". The autonomous and controlled motivations were also calculated. The Spanish version of the BREQ-3 has shown adequate psychometric properties among high-school students.
Measured: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Change in Intention to be physically active
Students' intention to be physically active in their free time was measured using the Spanish version of the Intention to partake in leisure-time physical activity questionnaire. It is composed of three items. The items were preceded by the sentence: "In my free time, after school ...". The Spanish version of this questionnaire has shown adequate psychometric properties among adolescents.
Measured: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Change in Habitual physical activity
Students' habitual physical activity was measured using the Physician-based Assessment and Counseling for Exercise questionnaire (PACE). It consists of two questions that measure how many days in the last week and in a habitual week at least 60 minutes of physical activity are performed. A 7-point Likert-type scale, ranging from 0 to 7 was used. The PACE questionnaire has shown adequate psychometric properties among high-school students.
Measured: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start10 Jan 2022
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchoolStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Granada
- Responsible party
- Principal investigator, Santiago Guijarro-Romero, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949463
- Sponsor's protocol ID
- 1252/CEIH/2020
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guijarro-Romero S, Mayorga-Vega D, Casado-Robles C, Viciana J. Effect of an activity wristband-based intermittent teaching unit in Physical Education on students' physical activity and its psychological mediators: a cluster-randomized controlled trial. School-fit study. Front Psychol. 2023 Sep 20;14:1228925. doi: 10.3389/fpsyg.2023.1228925. eCollection 2023.
PubMed 37799526
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Activity Wristband-based Intermittent Teaching Unit in Physical Education on Students Physical Activity and Its Psychological Mediators: A Cluster-randomized Controlled Trial. School-Fit Study
- ClinicalTrials.gov ID
- NCT05949463
- Acronym / sponsor ID
- 1252/CEIH/2020
- Conditions
- School
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Universidad de Granada
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 18 Jul 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.
Objective: The main objective of the present study was to examine the effects of an intermittent teaching unit based on the use of activity wristbands and behavior modification strategies on high school students perceptions of autonomy support, satisfaction of basic psychological needs, motivation toward Physical Education and physical activity, intention to be physically active, and habitual physical activity levels.
Materials and methods: An initial sample of 353 high school students (final sample = 175; 45.7% females; mean age = 13.3 ± 1.2 years) from two public high schools were cluster-randomly assigned into the intermittent (n = 100) and control (n = 75) groups. The intermittent group performed an intermittent teaching unit twice a week for eight weeks. Specifically, the last 15 minutes of each lesson were used. As the main strategy to promote the practice of regular physical activity, students wore an activity wristband the whole day during the intervention period. Additionally, other behavior modification strategies were also applied (e.g., educational counseling, physical activity goals or reminders). The control group also performed two Physical Education sessions a week during the intervention period, but without using wristbands or other behavior modification strategies. Before and after the intervention, as well as at the end of the follow-up period (six weeks), students' physical activity practice mediators and physical activity levels were measured by validated questionnaires.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent group | Experimental | Other: Intermittent teaching unitThe intermittent group students performed an intermittent teaching unit twice a week for eight weeks aimed at promoting healthy physical activity habits. Specifically, the last 15 minutes of each lesson were used. The rest of lessons' time other contents were worked on with no relation to any health physical activity habit (i.e., acrosport, badminton, basketball, volleyball, soccer and athletics). |
| Control group | Active comparator | Other: No intervention groupThe control group students also carried out two Physical Education lessons a week during the intervention period. During these lessons, contents of handball, basketball, alternative sports and traditional games were developed. However, this group did not wear physical activity activity wristbands or receive any behavior modification specific strategy developed in the intermittent group. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being enrolled in the seventh to tenth grade at the secondary education level
- Participating in the normal Physical Education lessons
- Being exempt of any health problem that would make them unable to engage in physical activity normally
- Presenting the corresponding signed written consent by their legal tutors
- Presenting their own corresponding signed written assent
Key exclusion criteria (1 listed)
- Not having performed the evaluation of the dependent variables correctly at the pre-intervention, post-intervention and/or follow-up measures following the administration rules (being removed only for incomplete variables and not for the overall study)
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 |
|---|---|---|
| Intermittent teaching unitThe intermittent group students performed an intermittent teaching unit twice a week for eight weeks aimed at promoting healthy physical activity habits. Specifically, the last 15 minutes of each lesson were used. The rest of lessons' time other contents were worked on with no relation to any health physical activity habit (i.e., acrosport, badminton, basketball, volleyball, soccer and athletics). | Other | Intermittent group |
| No intervention groupThe control group students also carried out two Physical Education lessons a week during the intervention period. During these lessons, contents of handball, basketball, alternative sports and traditional games were developed. However, this group did not wear physical activity activity wristbands or receive any behavior modification specific strategy. | Other | Control group |
Primary outcome
Change in Perceived autonomy support
Time frame: Pre-intervention, immediately post-intervention, and after 6-week follow-up
The Physical Education teacher autonomy-support was assessed through the Spanish version of the Multi-Dimensional Perceived Autonomy Support Scale for Physical Education (MD-PASS-PA). It consists of 15 items (five items per factor) that assessed organizational, procedural, and cognitive autonomy support. The items were preceded by the statement "My Physical Education teacher...". The Spanish version of MD-PASS-PA has shown adequate psychometric properties among adolescents.
Change in Basic psychological needs
Time frame: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Students' perceptions of autonomy, competence, and relatedness satisfaction in Physical Education and physical exercise were assessed using the Spanish version of the Basic Psychological Needs in Exercise Scale (BPNES). It consists of 12 items (four items per factor) that assessed autonomy, competence and relatedness. The items were preceded by the statement "When I do physical activity…". The Spanish version of BPNES has shown adequate psychometric properties among adolescents.
Change in Motivation toward Physical Education
Time frame: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Participants' self-determined motivation toward Physical Education was measured by the Spanish version of the Revised Perceived Locus of Causality Scale (PLOC-R). It consists of of 23 items spread over six dimensions (four items each except external regulation) that measure intrinsic motivation, amotivation, integrated, identified, introjected, and external regulation. This questionnaire was preceded by the statement "I participate in Physical Education lessons…". The autonomous (i.e., averaging intrinsic, integrated, and identified regulation) and controlled (i.e., averaging introjected and external) motivations were also calculated. The Spanish version of the PLOC-R has shown adequate psychometric properties among adolescents.
Change in Self-determined motivation towards physical activity
Time frame: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Students' motivation towards physical activity was measured using the Spanish version of the Behavioral Regulation in Exercise Questionnaire (BREQ-3). It consists of 23 items distributed into six dimensions (four items each except identified regulation) that measure intrinsic motivation, amotivation, integrated, identified, introjected, and external regulation. This questionnaire was preceded by the statement: "I do physical activity...". The autonomous and controlled motivations were also calculated. The Spanish version of the BREQ-3 has shown adequate psychometric properties among high-school students.
Change in Intention to be physically active
Time frame: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Students' intention to be physically active in their free time was measured using the Spanish version of the Intention to partake in leisure-time physical activity questionnaire. It is composed of three items. The items were preceded by the sentence: "In my free time, after school ...". The Spanish version of this questionnaire has shown adequate psychometric properties among adolescents.
Change in Habitual physical activity
Time frame: Pre-intervention, immediately post-intervention, and after 6-week follow-up
Students' habitual physical activity was measured using the Physician-based Assessment and Counseling for Exercise questionnaire (PACE). It consists of two questions that measure how many days in the last week and in a habitual week at least 60 minutes of physical activity are performed. A 7-point Likert-type scale, ranging from 0 to 7 was used. The PACE questionnaire has shown adequate psychometric properties among high-school students.
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 18 Jul 2023.
- Derived from this study: PubMed 37799526Guijarro-Romero S, Mayorga-Vega D, Casado-Robles C, Viciana J. Effect of an activity wristband-based intermittent teaching unit in Physical Education on students' physical activity and its psychological mediators: a cluster-randomized controlled trial. School-fit study. Front Psychol. 2023 Sep 20;14:1228925. doi: 10.3389/fpsyg.2023.1228925. eCollection 2023.
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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 Intermittent teaching unit in people with School, run by University of Valladolid 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 18 Jul 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?
Change in Perceived autonomy support (time frame: Pre-intervention, immediately post-intervention, and after 6-week follow-up). The study lists 6 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 NCT05949463, which also lists 1 linked publication.
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 18 Jul 2023.