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Trial registered on ANZCTR


Registration number
ACTRN12619000091101
Ethics application status
Approved
Date submitted
29/11/2018
Date registered
22/01/2019
Date last updated
9/07/2021
Date data sharing statement initially provided
22/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A school-based intervention to promote physical activity among adolescents
Scientific title
The effectiveness of a school-based intervention to promote physical activity among high school students in Bangladesh
Secondary ID [1] 296945 0
Nil known
Universal Trial Number (UTN)
U1111-1215-5539
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 308319 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307315 307315 0 0
Physiotherapy
Public Health 309565 309565 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve 70-minutes supervised physical activity session by the researcher in the presence of the physical education teacher, in addition to 10 minutes of classroom discussion per week during 12 weeks intervention. This length is segmented as – first 10 minutes for classroom discussion with the distribution of IEC materials, followed by 30-minutes supervised physical activity during the formal physical education class and 40 minutes supervised physical activity during recess time. Examples of the details are as follows:

Physical activity session-
A total of 70 minutes physical activity session per week will be offered in each interventional school during physical education class and recess time. During this physical activity session, the participants will do sports activities as per their most preferred (e.g., football, cricket), which will be sorted out from the formative research. However, most sports activities will be considered from the students’ preference list by the researcher. After this, participating students from the intervention schools will participate in 30-minutes supervised activities following warm-up and cool-down session during the formal physical education class. Firstly, the warm-up (e.g., light stretching) will be performed for about 5 minutes before the activities to prepare the body and mind for the activities; secondly, the preferred activities will be for 20 minutes followed by a cool-down session for 5 minutes to allow the heart rate to return to normal after the participation of the activities. Furthermore, 40-minutes supervised physical activity session will be offered during recess time. The supervised recess time physical activity session will utilize some sports equipment (e.g. soccer balls, Frisbee), which will be made available for the students during each of the recess sessions. The students will be encouraged to use the sports equipment and be physically active during recess time. The class captains will be asked to keep a log of equipment used during recess and number of children playing the sport or game. This will be done under the supervision of the physical education teachers.

Classroom discussion/session-
The researcher will give a total of 12 health education lectures (once a week) for 10 minutes before physical activity session in the intervention schools. A brief power point presentation will be delivered each of the 12 weeks on physical activity (e.g., intensity, duration, reducing sedentary time) and healthy eating (e.g., increasing consumption of vegetables and fruits, reducing consumption of meat, snacks, western fast foods).

Information, education and communication (IEC) materials-
The IEC materials such as infograph and a sticker will be developed with the aim to promote active lifestyles. The “infograph” will be a graphic visual representation of information or knowledge on some important aspects of physical activity (e.g., benefits of physical activity in children and adolescents, recommended the level of daily physical activity, fun ways to be the physical activity). The “sticker” will be a simplified form of key messages on children and adolescents’ physical activity. With prior permission from participating schools, these materials will be distributed by the research team to the students. Copies of these materials will also be provided to the class teachers and school principals who will be encouraged to distribute them to their students and their families. If schools permit, stickers will be pasted within the schools (e.g., notice board, school gate).

Intervention code [1] 301522 0
Lifestyle
Comparator / control treatment
No intervention will be provided in the control groups
Control group
Active

Outcomes
Primary outcome [1] 306276 0
Physical activity will be assessed using the International Physical Activity Questionnaire (short version)
Timepoint [1] 306276 0
At baseline, information related to vigorous and moderate PA including walking and sitting status of the respondents will be collected for last 7 days at timepoint 1 (Week 1), intervention will be provided to the participants from week 1 to 12 and selected intervention school will get intervention each week till 12. After completion of the intervention immediately the same information will be collected from the same participants (Week 13) and the same information will be collected again after 3 months (Week 24).
Primary outcome [2] 306277 0
Sedentary behaviour will be assessed using the Adolescent Sedentary Activity Questionnaire
Timepoint [2] 306277 0
There were three rounds of data collection: baseline (Wave 1: pre-intervention), mid-point at 8
weeks (Wave 2) and immediately after the intervention (Wave 3: end-line).
Secondary outcome [1] 348050 0
Khan et al. (2017) collated and used a set of dietary behaviour questions (includes consumption of fresh fruits & eat fresh vegetables during the past 30 days; also the consumption of fast food, sugar-sweetened soft-drink & eat breakfast in the morning during the past 7 days) in their research among adolescents in Bangladesh. This set of questions will be used the current study.

Fresh fruits during the past 30 days as assessed by Khan et al 2017 questionnaire.

Khan A, Burton NW, Trost SG. (2017) Patterns and correlates of physical activity in adolescents in Dhaka city, Bangladesh. Public Health 145:75-82.
Timepoint [1] 348050 0
At baseline (before the intervention-Wave 1), mid-point (Wave 2) and immediately after the 12-weeks intervention (Wave 3).

Secondary outcome [2] 366012 0
Fresh vegetables during the past 30 days as assessed by Khan et al 2017 questionnaire'
Timepoint [2] 366012 0
At baseline (before the intervention-Wave 1), mid-point (Wave 2) and immediately after the 12-weeks intervention (Wave 3).

Secondary outcome [3] 366013 0
Sugar-sweetened soft-drink in last 7 days as assessed by Khan et al 2017 questionnaire
Timepoint [3] 366013 0
At baseline (before the intervention-Wave 1), mid-point (Wave 2) and immediately after the 12-weeks intervention (Wave 3).
Secondary outcome [4] 366014 0
Breakfast in the morning during the past 7 days as assessed by Khan et al 2017 questionnaire
Timepoint [4] 366014 0
At baseline (before the intervention-Wave 1), mid-point (Wave 2) and immediately after the 12-weeks intervention (Wave 3).

Secondary outcome [5] 366015 0
Fast Food in last 7 days as assessed by Khan et al 2017 questionnaire
Timepoint [5] 366015 0
At baseline (before the intervention-Wave 1), mid-point (Wave 2) and immediately after the 12-weeks intervention (Wave 3).
Secondary outcome [6] 366016 0
Depressive symptoms will be measured by using the 10-item Center for Epidemiologic Studies Depression Scale
Timepoint [6] 366016 0
At baseline (before the intervention-Wave 1), mid-point (Wave 2) and immediately after the 12-weeks intervention (Wave 3).

Secondary outcome [7] 366017 0
Anthropometric measurement is a composite secondary outcome. That is why an anthropometric measurement (e.g., height, weight, BMI) will be assessed by the researcher. Height and weight will be measured using height scale, weighing machine and the measurement tape.
Timepoint [7] 366017 0
At baseline (before the intervention-Wave 1), mid-point (Wave 2) and immediately after the 12-weeks intervention (Wave 3).

Eligibility
Key inclusion criteria
Healthy participants aged 13-17 years
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants those havewith physical disability that hampered PA orand mentally challenged will be excluded from the study.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation))
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
To obtain the descriptive profile of the study participants, descriptive statistics (e.g., frequencies, averages, standard deviations) will be produced for socio-demographic and -economic characteristics. These variables will be used in subsequent analyses to address the objectives of the research project.
Primary Objective: To evaluate the effectiveness of the multi-component school-based intervention on habitual levels of physical activity and sedentary behaviour among secondary school children in Bangladesh; pre and post-intervention data from baseline (Wave 1) to end-line (Wave 3) data will be used. To assess the effectiveness of the intervention, Generalized Estimating Equations (GEEs) will be implemented to compare between- and within-group comparison. Total MET-minutes/day will be used as outcome variables while comparing the intervention with the control groups. GEE, which is an extension of the generalised linear model, is useful in studies with repeated measures and is often used to analyse longitudinal as well as other correlated data. Baseline characteristics (e.g., gender, age groups, weight status, family level socioeconomic status) will be examined to identify any group differences and hence the variables with demonstrated group differences will be considered as adjusting variables in the multivariable assessment of the intervention effects. In the event of non-normal outcome variables, which were collected across three-time points, GEE with gamma distribution and log link will be used to examine possible group differences.

Secondary Objective (i): To explore students’ preferences for physical activity and sports, the qualitative data from pre-intervention FGDs (Phase 1) will be examined through descriptive statistics. The obtained information (e.g., the most preferred sports activities) will inform the development of physical activity session for the intervention group, which may enhance student motivation for and engagement in the school-based physical activity.
Secondary Objective (ii): To assess the level of knowledge on physical activity and sedentary behaviour (e.g., screen time); pre and post-intervention data from baseline (Wave 1) to end line (Wave 3) will be assessed. Univariate analyses (Chi-square test) will be performed to explore knowledge of physical activity (PA) and sedentary behaviour (SB) by a set of sociodemographic variables, including age, gender, BMI, parental education and employment/occupation status, monthly gross household income. The multilevel generalized linear model will be implemented to examine correlates of PA and SB knowledge.
Secondary Objective (iii): To determine patterns of dietary behaviours and their correlates; pre and post-intervention data from baseline (Wave 1) to end line (Wave 3) data will be used. Univariate analyses (Chi-square test) will be performed to explore patterns of dietary habit by a set of sociodemographic variables, including age, gender, BMI, parental education and employment/occupation status, monthly gross household income. The multilevel generalized linear model will be implemented to examine correlates of dietary behaviours. Outliers and other assumptions of the models will be checked and the model fit will be assessed before finalising the models.
Secondary Objective (iii): To examine possible relationships of physical activity and sedentary behaviours with health outcomes including obesity, psychosocial conditions, the analyses will include relevant data collected at all data points (Waves 1-3). The distributions of physical activity (average time and/or MET-minutes) and time spent in sedentary behaviour will be examined for normality. Patterns of participation in physical activity will be explored using Chi-square tests. Multilevel generalized linear models will be implemented to examine the associations of physical activity and sedentary behaviour with obesity, sleep difficulties and psychosocial conditions, adjusted for potential confounders (e.g., age, gender, BMI, fast food intake, fresh fruit and vegetable intake). Outliers and other assumptions of the models will be checked and the model fit will be assessed before finalising the models.
Secondary Objective (iv): To conduct a process evaluation to determine if the intervention was implemented as planned, its reach and how the implementation might have impacted on outcomes, post-intervention qualitative data (Phase 3) will be collected through FGDs and in-depth interviews (IDIs) of physical education teachers. Process evaluation data will be obtained from the recordings which will be analyzed, using an inductive content analysis approach. Initially, the qualitative data will be segregated and organized into different segments in a logical and meaningful manner. Next, the thematic analysis will be performed according to the methods described by Braun and Clarke. After receiving the transcriptions, then data will be imported to NVivo.for better data management. The thematic analysis will involve open coding system. Words, sentences, and/or paragraphs will be assigned to a theme. However, they could belong to more than one theme. Then sub-themes (generic categories) will be identified by collapsing or expanding the themes. Main outcome categories will be identified by analysing the sub-themes.
All statistical analyses will be performed using SPSS version 25 and the statistical significance will be set at p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2019
Actual
12/03/2019
Date of last participant enrolment
Anticipated
7/03/2019
Actual
14/03/2019
Date of last data collection
Anticipated
31/08/2019
Actual
7/07/2019
Sample size
Target
392
Accrual to date
Final
320
Recruitment outside Australia
Country [1] 10554 0
Bangladesh
State/province [1] 10554 0
Dhaka

Funding & Sponsors
Funding source category [1] 299766 0
University
Name [1] 299766 0
The University of Queensland
Country [1] 299766 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Therapies Annexe (84A), The University of Queensland, St Lucia QLD 4072, Australia.
Country
Australia
Secondary sponsor category [1] 299108 0
University
Name [1] 299108 0
Bangladesh University of Health Sciences
Address [1] 299108 0
125/1 Darus Salam, Mirpur, Dhaka-1216
Country [1] 299108 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300657 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [1] 300657 0
The University of Queensland Human Research Ethics Committee A
Level 3, Brian Wilson Chancellery
The University of Queensland
St Lucia QLD 4072, Australia
Ethics committee country [1] 300657 0
Australia
Date submitted for ethics approval [1] 300657 0
Approval date [1] 300657 0
21/12/2018
Ethics approval number [1] 300657 0
2018000885

Summary
Brief summary
Insufficient physical activity is a growing problem among school-going Bangladeshi adolescents. The objective of this study is to evaluate the effectiveness of a school-based intervention to promote physical activity among the mentioned target group. It will be a mixed-method design comprising of a clustered randomized control trial (RCT) with schools as clusters and focus group discussions. This study will have three phases: formative research; intervention; and process evaluation. The RCT will have three data points: baseline, mid-point and end-line immediately after the intervention. The intervention will be a 12-weeks with physical activity session, health education lectures and educational materials that will be delivered per week to the intervention schools, where no intervention will be provided to the control schools.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84366 0
A/Prof Asad Khan
Address 84366 0
School of Health and Rehabilitation Sciences. Faculty of Health and Behavioural Sciences. The University of Queensland
St Lucia QLD 4072, Australia
Country 84366 0
Australia
Phone 84366 0
+61 7 334 67456
Fax 84366 0
Email 84366 0
[email protected]
Contact person for public queries
Name 84367 0
Kazi Rumana Ahmed
Address 84367 0
School of Health and Rehabilitation Sciences. Faculty of Health and Behavioural Sciences. The University of Queensland
St Lucia QLD 4072, Australia
Country 84367 0
Australia
Phone 84367 0
+610469898880
Fax 84367 0
Email 84367 0
[email protected]
Contact person for scientific queries
Name 84368 0
Tracy Kolbe-Alexander
Address 84368 0
School of Health and Wellbeing, University of Southern Queensland, Ipswich Campus, 11 Salisbury Rd, Ipswich QLD 4305
Country 84368 0
Australia
Phone 84368 0
+61 7 3812 6178
Fax 84368 0
Email 84368 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
575Ethical approval    375327-(Uploaded-14-01-2019-00-09-36)-Study-related document.pdf



Results publications and other study-related documents

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