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Trial registered on ANZCTR


Registration number
ACTRN12625000148471
Ethics application status
Approved
Date submitted
25/11/2024
Date registered
7/02/2025
Date last updated
7/02/2025
Date data sharing statement initially provided
7/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Mobile App versus Conventional Methods in Imparting Knowledge of Adolescents' Sexual and Reproductive Health in Sarawak: A Community-Based Randomized Controlled Trial
Scientific title
Comparing The Effectiveness of Mobile App with Conventional Methods in Imparting Knowledge among Adolescents Sexual and Reproductive Health in Southern Sarawak.
Secondary ID [1] 313379 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexually Transmitted Infections (STIs) 335746 0
Mentally Unsound 336518 0
Condition category
Condition code
Public Health 332301 332301 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention will be done within one (1) day training and will be conducted by the researcher. The mode of training will be a groups of 15 participants. The participants will use the mobile app in one-off throughout the 1-day training program (for 3 hours training) and continously use it for 3 months (the usage is daily for 30 minutes). The mobile app is a web-based app that consists of four modules, which cover:
1. Sexual Growth and Development
2. Sexuality, Teenage Pregnancy and Abortion
3. Sexually Risky Behaviour, Sexually Transmitted Diseases (STDs) and Contraception
4. Communication Skills
Every module covers information including short videos, written articles, short question in the quiz section, interactive graphics, quizzes, and puzzles. This web-based mobile app has been designed specifically for this study. To monitor the adherence of the app, we have linked the website with google analytics to monitor the usage by the participants. However, participants still have the right to withdraw from the study at any time.
Intervention code [1] 329958 0
Behaviour
Comparator / control treatment
One (1) day training programme will be conducted at the beginning of the study. The activities in the programme consist of lectures through ppt slides, group discussions, and group activities that will be delivered by the researcher. The mode of training will be a group of 15 participants. The duration of the training program is 3 hours. The content of the lecture covers the topics of:
1. Sexual Growth and Development
2. Sexuality, Teenage Pregnancy and Abortion
3. Sexually Risky Behaviour, Sexually Transmitted Diseases (STDs) and Contraception
4. Communication Skills
However, participants still have the right to withdraw from the study at any time.
Control group
Active

Outcomes
Primary outcome [1] 339877 0
Positive changes in adolescents' knowledge, attitude, intention, and behaviour on sexual and reproductive health. (Note: this is the composite outcome)
Timepoint [1] 339877 0
Baseline, 1 month (primary timepoint) and 3 months follow-up (post-commencement of intervention)
Primary outcome [2] 339878 0
Positive changes among adolescents' communication with parents on the topic of sexual and reproductive health.
Timepoint [2] 339878 0
Baseline, 1 month (primary timepoint) and 3 months follow-up (post-commencement of intervention)
Secondary outcome [1] 441736 0
Measurement of the efficacy of mobile apps as a learning tool for sexual and reproductive health
Timepoint [1] 441736 0
Immediately after the 1-day training session

Eligibility
Key inclusion criteria
The study will focus on healthy adolescents between 16 and 19 years old, regardless of gender and ethnicity, living in Kuching and Serian divisions and having a mobile phone
Minimum age
16 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Being a guest or non-resident, not having a mobile phone that supports apps, and having a known mental health problem.

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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods - Minimisation method which ensures each group is as similar as possible.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired sample tests, One-way and two-way repeated measure ANOVA will also be performed, along with Per-protocol analysis to determine intervention efficacy.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2024
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
300
Accrual to date
219
Final
Recruitment outside Australia
Country [1] 26726 0
Malaysia
State/province [1] 26726 0
Sarawak

Funding & Sponsors
Funding source category [1] 317820 0
University
Name [1] 317820 0
Universiti Malaysia Sarawak
Country [1] 317820 0
Malaysia
Primary sponsor type
University
Name
Universiti Malaysia Sarawak
Address
Country
Malaysia
Secondary sponsor category [1] 320149 0
None
Name [1] 320149 0
Address [1] 320149 0
Country [1] 320149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316504 0
Medical Research Ethics Committee, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak
Ethics committee address [1] 316504 0
Professor Dr. Mohammad Zulkarnaen bin Ahmad Narihan, Chairman, Medical Ethics Committee
Ethics committee country [1] 316504 0
Malaysia
Date submitted for ethics approval [1] 316504 0
06/04/2023
Approval date [1] 316504 0
17/08/2023
Ethics approval number [1] 316504 0
FME/23/58

Summary
Brief summary
This study examines the effectiveness of a mobile app compared to conventional methods in improving adolescents' sexual and reproductive health (SRH) knowledge in Southern Sarawak. Adolescents aged 16-19 will be randomly assigned to receive SRH education via a mobile app or traditional approaches like presentations and talks. The study hypothesises that the mobile app will be more effective in enhancing SRH knowledge, that adolescents' sexual behaviours will improve after gaining SRH knowledge, and that closer parent-adolescent relationships will promote positive SRH behaviours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138102 0
Prof Dr Md Mizanur Rahman
Address 138102 0
Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak. Jln Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia
Country 138102 0
Malaysia
Phone 138102 0
+6082587666
Fax 138102 0
Email 138102 0
[email protected]
Contact person for public queries
Name 138103 0
Gerraint Gillan Anak Ahi
Address 138103 0
Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak. Jln Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia
Country 138103 0
Malaysia
Phone 138103 0
+60138187548
Fax 138103 0
Email 138103 0
[email protected]
Contact person for scientific queries
Name 138104 0
Gerraint Gillan Anak Ahi
Address 138104 0
Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak. Jln Datuk Mohammad Musa, 94300 Kota Samarahan, Sarawak, Malaysia
Country 138104 0
Malaysia
Phone 138104 0
+60138187548
Fax 138104 0
Email 138104 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
All records and data are to be kept strictly confidential and can only be used for the purpose of this study. All precautions are to be taken to maintain data confidentiality.


What supporting documents are/will be available?

No Supporting Document Provided



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.