NCT05949463

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

June 30, 2023

Last Update Submit

July 13, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Pre-intervention, immediately post-intervention, and after 6-week follow-up

Study Arms (2)

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).

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.

Other: No intervention group

Interventions

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).

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.

Control group

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • \- 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santiago Guijarro-Romero

Valladolid, 47011, Spain

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 30, 2023

First Posted

July 18, 2023

Study Start

January 10, 2022

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations