Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000712707
Ethics application status
Approved
Date submitted
7/05/2022
Date registered
18/05/2022
Date last updated
18/05/2022
Date data sharing statement initially provided
18/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the Effect of a Technology-Supported Physical Education Course on the Physical Activity Levels of University Students
Scientific title
Investigating the Effect of a Technology-Supported Physical Education Course on the Physical Activity Levels of University Students: A Randomised Controlled Trial
Secondary ID [1] 307072 0
Nil known
Universal Trial Number (UTN)
U1111-1278-0602
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 326229 0
Condition category
Condition code
Public Health 323531 323531 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Description of Intervention
1. Brief name:
A Technology-Supported Physical Education Course to Increase the Physical Activity Levels of University Students

2. Materials
A 16-week physical education course incorporating the modified prototype Learning Management System (LMS) as lecturers’ website and students’ mobile app. The lecturers’ website is entitled PESSPA (Physical Education Supporting Site for Physical Activity), while the student’s app is entitled PESAPA (Physical Education Supporting App for Physical Activity). The PESSPA includes the following features (1) Learning management system features such as uploading course materials (text, pdf, picture, video, direct link), creating quizzes, creating assignments, creating discussions for every lesson week (2). Reviewing students goal settings, physical fitness test results, dietary and physical activity records; and (3). Uploading exercise examples and exercise video guidelines. The PESAPA includes the following features: (1) Access course materials (informative texts, pdfs, pictures, videos, etc.), quizzes, assignments submission, and weekly discussions; (2) goal settings opportunities, physical fitness testing protocols, dietary and physical activity recording opportunities; and (3). Access exercise examples and exercise video guidelines.

3. Procedures, Activities, and/or Processes Used in the Intervention
The six lecturers who agree to participate will be randomly assigned to intervention or control and will be asked to invite the students who enrol in their physical education course. The intervention lecturer will have lecturer training and implement the technology-supported physical education course for one semester (16 weeks, 100 minutes per week). Students in the intervention group will attend weekly 100-minutes classes where lecturers will deliver the course content and discuss the assigned tasks. These will all be administered via a mobile app. Students are then expected to spend 2 hours of their own time during the week completing their homework and assignments such as goal-setting, as well as undertaking physical exercise. Weeks 8 and 16 will consist of exams to test the knowledge delivered in the previous weeks. The outcome will be assessed at pre-test (1st week of physical education course after students agree to participate) and post-test (last week of the physical education course). Students will also be invited to participate in a focus group about their experience using the technology at the end of the course for a single 1-hour session. All students in the intervention group will receive an invitation and the first 6 to respond will form the focus group. The principal investigator will conduct the focus group. The exercises prescribed for students as part of this intervention are based-on course content assignments. For example, in week 10, students will receive a demonstration of aerobic dance guided by the mobile app in the class. The lecturer then will give the assignment to practise the aerobic dance outside class two times that week and then record the time, and duration of the activity on the mobile app.
Table 1. Course content for intervention and control group
Week Intervention Group and Control Group
1 Course Introduction
2 Physical activity, Healthy and active lifestyle knowledge
3 Health-related physical fitness knowledge
4 Goal setting in Physical activity and fitness
5 Body composition
6 Aerobic fitness
7 Muscular fitness and flexibility
8 Midsemester exam
9 Nutrition: Healthy eating
10 Aerobic activity- aerobic dance
11 Aerobic activity- GPS-Based activity
12 Muscular strengthening
13 Flexibility training
14 Create an individual fitness training
15 Overcome the physical activity barrier
16 Final exam

4. Who provided
The lecturer will be eligible to deliver intervention if he/she meets the following inclusion criteria: 1) run two classes of the physical education course; 2) willing to take part in lecturer training before the physical education course class begins; and 3) willing to invite their students to take part in the Randomised Controlled Trial.
The lecturer training includes:
a) Training on how to use the PESSPA website.
b) Principal investigator will be administering the training.
c) 2-hour sessions for 4 days.
d) Mode of training is interactive activities online over Zoom.

5. Mode of delivery
Due to the pandemic situation, the course will be conducted fully online. There will be no face-to-face contact with students.

6. Number of times
The intervention group will receive 16 weeks (100-minutes per week) of the physical education course incorporated with the prototype of technology-supported physical education course implemented by their lecturer. To clarify, there is also university courses called Physical Education Teacher Education (PETE) programs that aim to educate preservice physical education teachers to prepare them to become beginning teachers in school settings. However, the physical activity education course (herein now called physical education course) in this study is unit of study with the main outcome is to promote active lifestyles or lifelong physical activity for all undergraduate students. Based on the higher education system in Indonesia, the workload used in the physical education course is a semester credit unit. In this system, one credit is equivalent to 48 hours/semester, 16 meetings, and 3 hours for each meeting consisting of scheduled lecture activities, structured, and independent assignments. The credit system is different from European Credit Transfer and Accumulation System (ECTS) which has a workload of 25 hours of study or 2.5 hours for 10 meetings per semester. When the credit system is changed to the ECTS, the students' workloads for this course is 48:25 x 2 credits = 3.84 ECTS.

7. Location
This study will be conducted at the Universitas Pendidikan Indonesia (Indonesia University of Education) located in Bandung, West Java, Indonesia (www.upi.edu). The physical activity education course of interest is offered to first year and second-year undergraduate students as required (mandatory) learning or as an elective.

8. Adherence
To ensure the fidelity of the intervention, the intervention teacher will reflect on each session and provide a fidelity check on what they able to do in the online class.
Intervention code [1] 323526 0
Lifestyle
Comparator / control treatment
The control group also will receive 16 weeks of physical education course. However, the control group accesses their course content via the University’s existing LMS and will have no access to students mobile app. While the intervention group will access their content via the developed prototype LMS integrated into a mobile app. The course outcomes and content topics are the same.
Control group
Active

Outcomes
Primary outcome [1] 331287 0
Difference in physical activity levels at 16 weeks’ time point compared to physical activity levels measures at baseline.
The International Physical Activity Questionnaire-Short Form (IPAQ) was used to measure the student’s physical activity levels. IPAQ is internationally recognised as a valid and reliable questionnaire for measuring physical activity levels. The IPAQ is publicly available, it is open access, and no permissions are required to use it. The IPAQ is suitable for adults between 15 and 69 years of age and is primarily used for population surveillance of physical activity levels. The IPAQ short form records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting.
Timepoint [1] 331287 0
Baseline (pre-intervention) and 16 weeks post commencement of the intervention
Primary outcome [2] 331288 0
Difference in physical activity motivation at 16 weeks’ time point compared to physical activity motivation measures at baseline.
to measure students’ motivation, the Behavioural Regulation Exercise Questionnaire (BREQ-2) was used which has 19 questions using a 5-point Likert scale for responses. BREQ-2 is a valid and reliable measure of five subscales of physical activity motivation: Amotivation, External Regulation, Introjected Regulation, Identified Regulation, and Intrinsic Regulation within the university students population.
Timepoint [2] 331288 0
Baseline (pre-intervention) and 16 weeks post commencement of the intervention.
Primary outcome [3] 331289 0
Difference in physical activity knowledge at 16 weeks compared to baseline assessed via study-specific physical activity knowledge quizzes.
Timepoint [3] 331289 0
Baseline (pre-intervention) and 16 weeks post commencement of the intervention.
Secondary outcome [1] 409430 0
Student’s experience using technology-supported physical education app measured by Focus Group Discussion
Timepoint [1] 409430 0
Focus Group Discussion will be conducted 17 weeks after the intervention commencement.

Eligibility
Key inclusion criteria
Students will be included in the RCT if they meet the following inclusion criteria: 1) students enrolled in a physical education course with a lecturer who will participate in the RCT; 2) voluntarily participate in the RCT; and 3) owns an android smartphone.
Minimum age
18 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students with medical condition

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed as the randomisation is will be at the class level
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Quasi-randomisation allocation procedure.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be presented (mean and standard deviation) for each group separately. A series of Analysis of Covariate (ANCOVAs) were used to analyse the difference between groups on all outcomes at post-test, using pre-test data as the covariate. ANCOVA adjusted for pre-test results was employed to compare the post-test results of the two groups (Tabachnick & Fidell, 2014). ANCOVA was used because these models usually provides a more appropriate and informative analysis (Dugard & Todman, 1995). To perform ANCOVA, two assumptions are needed. Firstly, we assume that pre-test scores were not significantly different between each group. The other assumption is homogeneity of regression slopes. All analyses were conducted using SPSS 28.0 (Chicago, IL, USA). The level of significance was set at P < 0.05. Then to demonstrate effects and trends, Cohen’s d standardised effect sizes were calculated with values 0.2 (small), 0.5 (medium) and 0.8 (large) using Microsoft Excel (Cohen, 1988).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
14/09/2022
Actual
Date of last data collection
Anticipated
13/01/2023
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 24752 0
Indonesia
State/province [1] 24752 0
Jawa Barat

Funding & Sponsors
Funding source category [1] 311383 0
Government body
Name [1] 311383 0
Indonesian Ministry of Finance
Country [1] 311383 0
Indonesia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, Camperdown, NSW 2006, Australia
Country
Australia
Secondary sponsor category [1] 312772 0
Individual
Name [1] 312772 0
Wayne Cotton
Address [1] 312772 0
A35 - Education Building, The University of Sydney, Camperdown, NSW 2006, Australia
Country [1] 312772 0
Australia
Secondary sponsor category [2] 312773 0
Individual
Name [2] 312773 0
Louisa Peralta
Address [2] 312773 0
A35 - Education Building, The University of Sydney, Camperdown, NSW 2006, Australia
Country [2] 312773 0
Australia
Secondary sponsor category [3] 312813 0
Individual
Name [3] 312813 0
Kuston Sultoni
Address [3] 312813 0
Universitas Pendidikan Indonesia, Jln Dr Setiabudhi 259, Bandung Jawa barat, Indonesia
Country [3] 312813 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310867 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 310867 0
Ethics committee country [1] 310867 0
Australia
Date submitted for ethics approval [1] 310867 0
19/11/2021
Approval date [1] 310867 0
03/05/2022
Ethics approval number [1] 310867 0
2021/935

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119154 0
A/Prof Wayne Cotton
Address 119154 0
Education Building, The University of Sydney, Camperdown, NSW 2006, Australia
Country 119154 0
Australia
Phone 119154 0
+61 293516278
Fax 119154 0
Email 119154 0
[email protected]
Contact person for public queries
Name 119155 0
Kuston Sultoni
Address 119155 0
Gedung FPOK Universitas Pendidikan Indonesia, Jl. Dr. Setiabudi No.229, Isola, Kec. Sukasari, Kota Bandung, Jawa Barat 40154, Indonesia
Country 119155 0
Indonesia
Phone 119155 0
+6281586261988
Fax 119155 0
Email 119155 0
[email protected]
Contact person for scientific queries
Name 119156 0
Kuston Sultoni
Address 119156 0
Gedung FPOK Universitas Pendidikan Indonesia, Jl. Dr. Setiabudi No.229, Isola, Kec. Sukasari, Kota Bandung, Jawa Barat 40154, Indonesia
Country 119156 0
Indonesia
Phone 119156 0
+6281586261988
Fax 119156 0
Email 119156 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.