- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05949463
Activity Wristband-based Intermittent Teaching Unit and Students Physical Activity and Its Psychological Mediators
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Valladolid, Spain, 47011
- Santiago Guijarro-Romero
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
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.
|
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1252/CEIH/2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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