Activity Wristband-based Intermittent Teaching Unit and Students Physical Activity and Its Psychological Mediators

July 13, 2023 updated by: Santiago Guijarro-Romero, University of Valladolid

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
175

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valladolid, Spain, 47011
        • Santiago Guijarro-Romero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criterion:

- 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intermittent group
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).
Other: Intermittent teaching unit
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).
Active Comparator: Control group
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.
Other: No intervention group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention, immediately post-intervention, and after 6-week follow-up
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.
Pre-intervention, immediately post-intervention, and after 6-week follow-up
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.
Pre-intervention, immediately post-intervention, and after 6-week follow-up
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.
Pre-intervention, immediately post-intervention, and after 6-week follow-up
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.
Pre-intervention, immediately post-intervention, and after 6-week follow-up
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.
Pre-intervention, immediately post-intervention, and after 6-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valladolid

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1252/CEIH/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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