Tobacco Use DisorderNCT07198828
Mobile Health (mHealth) Application for Smoking Cessation Among Adolescents in Indonesia
A study testing mHealth Smoking Cessation Application in people with Tobacco Use Disorder and Smoking Cessation, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
This mixed-methods study develops and evaluates a mobile health (mHealth) application for smoking cessation among Indonesian adolescents aged 13-15 years. The study uses a sequential exploratory approach with three phases: (1) qualitative research to inform app design; (2) app development using Rapid Application… Read more about this study
- Who is it for?
- Ages 13 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Smoking Cessation, Adolescent Smoking
- What is being tested?
- mHealth Smoking Cessation Application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Phase 1 (Qualitative Study):
- Adolescent smokers aged 13-15 years
- Smoking at least one cigarette or vaping once per week
- Key informants: teachers, parents, peers, healthcare workers with relevant experience
- Phase 3 (RCT):
- Adolescents aged 13-15 years
Show all 11Show fewer
- Smoking at least 1 cigarette in the past week
- Own smartphone with internet access
- Living in Padang City during study period
- Willing to participate until study completion
- Desire to quit smoking
Who cannot join
- Phase 3 (RCT):
- Currently using other smoking cessation apps or programs
- Planning to change schools or relocate outside Padang during study period
- Have severe psychiatric or medical conditions requiring intensive treatment
- Unable to use smartphone applications due to literacy or technical limitations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Multiple junior high schools and community health centers
Padang, West Sumatra
Multiple junior high schools and community health centers, +6285272803477, radianilmaskal@mail.ugm.ac.id
About this study
Official title: Development and Evaluation of a Mobile Health (mHealth) Application for Smoking Cessation Among Adolescents in Indonesia: A Mixed Methods Randomized Controlled Trial
This mixed-methods study develops and evaluates a mobile health (mHealth) application for smoking cessation among Indonesian adolescents aged 13-15 years. The study uses a sequential exploratory approach with three phases: (1) qualitative research to inform app design; (2) app development using Rapid Application Development (RAD) model; and (3) a single-blind, two-arm randomized controlled trial comparing the mHealth intervention to paper-based materials. The intervention is grounded in the Unified Theory of Acceptance and Use of Technology (UTAUT2) and Transtheoretical Model (TTM). Primary outcome is smoking abstinence at 1-, 3-, and 6-month follow-ups measured through self-report questionnaires.
Read the detailed description
Adolescent smoking is a growing public health concern worldwide, and it is particularly prevalent in low- and middle-income countries (LMICs) such as Indonesia. According to the World Health Organization (WHO), nearly 6.5% of adolescents aged 13-15 years globally use tobacco, with Southeast Asia, including Indonesia, contributing a significant proportion of this population. The prevalence of smoking among Indonesian adolescents has escalated over the past decade, with national surveys indicating a sharp increase from 7.2% in 2013 to 9.1% in 2018 and even higher figures reported by the 2019 Global Youth Tobacco Survey (GYTS) at 19.2%. Although more recent estimates suggest a slight reduction to 7.4% in 2023, smoking among adolescents remains a major public health challenge in Indonesia. Especially since Indonesia is the only country in Asia that has not ratified the WHO Framework Convention on Tobacco Control (FCTC).
This condition is especially concerning given the strong empirical evidence of the detrimental effects of smoking on individual health, societal well-being, and the environment. Adolescent smoking is associated with numerous long-term health risks, including respiratory diseases, cardiovascular problems, and an increased likelihood of continuing smoking into adulthood. Furthermore, smoking during adolescence has been linked to mental health issues such as depression, anxiety, and suicidal ideation. Moreover, tobacco-related mortality is alarmingly high, with over 8 million deaths annually worldwide due to active smoking and exposure to secondhand smoke. In Indonesia, tobacco-related diseases contribute significantly to mortality, with an estimated 225,700 deaths annually attributed to smoking. Despite various tobacco control measures implemented in Indonesia, such as raising taxes on tobacco products, free smoking cessation consultation services, and establishing smoke-free zones, smoking rates among adolescents have remained persistently high.
Technology-based interventions, particularly mobile health (mHealth) applications, have emerged as promising tools for promoting smoking cessation. The widespread use of smartphones among adolescents, with Indonesia being the fourth-largest smartphone market globally, presents a unique opportunity to leverage mHealth interventions to reduce smoking rates. However, the effectiveness of mHealth applications for smoking cessation has shown inconsistent results, particularly in LMICs where accessibility, engagement, and content relevance may differ from those in high-income countries.
Previous studies have demonstrated that while mHealth applications can help individuals quit smoking in the short term, their long-term effectiveness remains unclear, especially among adolescent populations. There is a growing body of literature highlighting the importance of tailoring interventions to the unique needs of adolescents, taking into account developmental stages, peer influence, and social media dynamics. However, there is a significant gap in the availability of mHealth applications designed specifically for adolescents in Indonesia, and the existing tools often fail to integrate critical elements such as behavioral change techniques, social support, and interactive features.
This study aims to address these gaps by developing an innovative mHealth intervention designed specifically for adolescent smokers in Indonesia. The intervention will be grounded in behavioral change theories such as the Unified Theory of Acceptance and Use of Technology (UTAUT2) and the Transtheoretical Model (TTM). UTAUT2 will ensure that the app is accepted, used, and engaging for adolescents, taking into account the influence of peers, ease of use, and intrinsic motivation factors. TTM will guide the app design by allowing it to adapt to the adolescent's specific stage in the smoking cessation process, providing tailored content and support. Together, these frameworks will make the mHealth app both effective, promoting long-term behavior change, relevant for adolescent smokers and better smoking cessation outcomes in Indonesia.
- Conditions
- Tobacco Use Disorder, Smoking Cessation, Adolescent Smoking
- Being tested
- mHealth Smoking Cessation Application, Paper-based Control Materials
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Smoking Cessation ApplicationBehavioural
Participants receive the mHealth smoking cessation application with:
- Educational content about smoking risks and cessation benefits
- Motivational messages and progress tracking
- Social support features
- Interactive elements and quizzes
- Monthly monitoring and support
Paper-based Control MaterialsBehavioural
Participants receive paper-based smoking cessation module containing equivalent content:
- Motivational content and cessation benefits
- Ex-smoker success stories
- Trigger identification and coping strategies
- Weekly quizzes with prizes (online access)
- Monthly check-ins
| Study group | Role | What they receive |
|---|---|---|
| mHealth Intervention Group | Experimental | Participants receive the mHealth smoking cessation application with:
* Educational content about smoking risks and cessation benefits
* Motivational messages and progress tracking
* Social support features
* Interactive elements and quizzes
* Monthly monitoring and support Receives: Behavioral: mHealth Smoking Cessation Application |
| Control Group | Active comparator | Participants receive paper-based smoking cessation module containing equivalent content:
* Motivational content and cessation benefits
* Ex-smoker success stories
* Trigger identification and coping strategies
* Weekly quizzes with prizes (online access)
* Monthly check-ins Receives: Behavioral: Paper-based Control Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported smoking abstinence measured through questionnaire (Yes/No response where Yes = abstinent, No = not abstinent)
Measured: 1, 3, and 6 months post-intervention
Secondary outcomes (6)
Smoking cessation self-efficacy using SEQ-12 (12-item Smoking Self-Efficacy Questionnaire)
Scale range: 12-60, where higher scores indicate greater self-efficacy for smoking cessation
Measured: Baseline, 1, 2, 3, and 6 months
Motivation assessed via Richmond Test
Scale range: 0-10, where higher scores indicate greater motivation to quit smoking
Measured: Baseline, 1, 2, 3, and 6 months
Social support measured through Multidimensional Scale of Perceived Social Support (MSPSS)
Scale range: 12-84, where higher scores indicate greater perceived social support
Measured: Baseline, 1, 2, 3, and 6 months
Dependence level using Fagerström Test for Nicotine Dependence (FTND)
Scale range: 0-10, where higher scores indicate greater nicotine dependence
Measured: Baseline, 1, 2, 3, and 6 months
App usage engagement measured through usage logs
Frequency and duration of app usage tracked through automated logging system. Measured as number of sessions per week and average session duration in minutes
Measured: Baseline, 1, 2, 3, and 6 months
mHealth app usability measured through mHealth Usability Questionnaire (MAUQ)
mHealth Usability Questionnaire (MAUQ) scores. Scale range: 18-126, where higher scores indicate better perceived usability of the mobile health application
Measured: Time Frame: 1, 2, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Mar 2026 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radian Ilmaskal, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198828
- Sponsor's protocol ID
- KE-FK-0864-EC-2025
- Status last verified
- Feb 2026
- First submitted
- 16 Sep 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie the results reported in this article, after deidentification.
Publications
Ilmaskal R, Prabandari YS, Oktaria V. Development and evaluation of a mobile health (mHealth) application for smoking cessation among adolescents in Indonesia: a mixed methods randomised controlled trial study protocol. BMJ Open. 2026 Feb 24;16(2):e112178. doi: 10.1136/bmjopen-2025-112178.
PubMed 41734925
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Mobile Health (mHealth) Application for Smoking Cessation Among Adolescents in Indonesia: A Mixed Methods Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07198828
- Acronym / sponsor ID
- KE-FK-0864-EC-2025
- Conditions
- Tobacco Use Disorder, Smoking Cessation, Adolescent Smoking
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This mixed-methods study develops and evaluates a mobile health (mHealth) application for smoking cessation among Indonesian adolescents aged 13-15 years. The study uses a sequential exploratory approach with three phases: (1) qualitative research to inform app design; (2) app development using Rapid Application Development (RAD) model; and (3) a single-blind, two-arm randomized controlled trial comparing the mHealth intervention to paper-based materials. The intervention is grounded in the Unified Theory of Acceptance and Use of Technology (UTAUT2) and Transtheoretical Model (TTM). Primary outcome is smoking abstinence at 1-, 3-, and 6-month follow-ups measured through self-report questionnaires.
Detailed description
Adolescent smoking is a growing public health concern worldwide, and it is particularly prevalent in low- and middle-income countries (LMICs) such as Indonesia. According to the World Health Organization (WHO), nearly 6.5% of adolescents aged 13-15 years globally use tobacco, with Southeast Asia, including Indonesia, contributing a significant proportion of this population. The prevalence of smoking among Indonesian adolescents has escalated over the past decade, with national surveys indicating a sharp increase from 7.2% in 2013 to 9.1% in 2018 and even higher figures reported by the 2019 Global Youth Tobacco Survey (GYTS) at 19.2%. Although more recent estimates suggest a slight reduction to 7.4% in 2023, smoking among adolescents remains a major public health challenge in Indonesia. Especially since Indonesia is the only country in Asia that has not ratified the WHO Framework Convention on Tobacco Control (FCTC).
This condition is especially concerning given the strong empirical evidence of the detrimental effects of smoking on individual health, societal well-being, and the environment. Adolescent smoking is associated with numerous long-term health risks, including respiratory diseases, cardiovascular problems, and an increased likelihood of continuing smoking into adulthood. Furthermore, smoking during adolescence has been linked to mental health issues such as depression, anxiety, and suicidal ideation. Moreover, tobacco-related mortality is alarmingly high, with over 8 million deaths annually worldwide due to active smoking and exposure to secondhand smoke. In Indonesia, tobacco-related diseases contribute significantly to mortality, with an estimated 225,700 deaths annually attributed to smoking. Despite various tobacco control measures implemented in Indonesia, such as raising taxes on tobacco products, free smoking cessation consultation services, and establishing smoke-free zones, smoking rates among adolescents have remained persistently high.
Technology-based interventions, particularly mobile health (mHealth) applications, have emerged as promising tools for promoting smoking cessation. The widespread use of smartphones among adolescents, with Indonesia being the fourth-largest smartphone market globally, presents a unique opportunity to leverage mHealth interventions to reduce smoking rates. However, the effectiveness of mHealth applications for smoking cessation has shown inconsistent results, particularly in LMICs where accessibility, engagement, and content relevance may differ from those in high-income countries.
Previous studies have demonstrated that while mHealth applications can help individuals quit smoking in the short term, their long-term effectiveness remains unclear, especially among adolescent populations. There is a growing body of literature highlighting the importance of tailoring interventions to the unique needs of adolescents, taking into account developmental stages, peer influence, and social media dynamics. However, there is a significant gap in the availability of mHealth applications designed specifically for adolescents in Indonesia, and the existing tools often fail to integrate critical elements such as behavioral change techniques, social support, and interactive features.
This study aims to address these gaps by developing an innovative mHealth intervention designed specifically for adolescent smokers in Indonesia. The intervention will be grounded in behavioral change theories such as the Unified Theory of Acceptance and Use of Technology (UTAUT2) and the Transtheoretical Model (TTM). UTAUT2 will ensure that the app is accepted, used, and engaging for adolescents, taking into account the influence of peers, ease of use, and intrinsic motivation factors. TTM will guide the app design by allowing it to adapt to the adolescent's specific stage in the smoking cessation process, providing tailored content and support. Together, these frameworks will make the mHealth app both effective, promoting long-term behavior change, relevant for adolescent smokers and better smoking cessation outcomes in Indonesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth Intervention Group | Experimental | Behavioral: mHealth Smoking Cessation ApplicationParticipants receive the mHealth smoking cessation application with: * Educational content about smoking risks and cessation benefits * Motivational messages and progress tracking * Social support features * Interactive elements and quizzes * Monthly monitoring and support |
| Control Group | Active comparator | Behavioral: Paper-based Control MaterialsParticipants receive paper-based smoking cessation module containing equivalent content: * Motivational content and cessation benefits * Ex-smoker success stories * Trigger identification and coping strategies * Weekly quizzes with prizes (online access) * Monthly check-ins |
Who may qualify
- Ages
- 13 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Phase 1 (Qualitative Study):
- Phase 3 (RCT):
Key exclusion criteria (5 listed)
- Currently using other smoking cessation apps or programs
- Planning to change schools or relocate outside Padang during study period
- Have severe psychiatric or medical conditions requiring intensive treatment
- Unable to use smartphone applications due to literacy or technical limitations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Smoking Cessation ApplicationParticipants receive the mHealth smoking cessation application with: * Educational content about smoking risks and cessation benefits * Motivational messages and progress tracking * Social support features * Interactive elements and quizzes * Monthly monitoring and support | Behavioural | mHealth Intervention Group |
| Paper-based Control MaterialsParticipants receive paper-based smoking cessation module containing equivalent content: * Motivational content and cessation benefits * Ex-smoker success stories * Trigger identification and coping strategies * Weekly quizzes with prizes (online access) * Monthly check-ins | Behavioural | Control Group |
Primary outcome
Self-reported smoking abstinence measured through questionnaire (Yes/No response where Yes = abstinent, No = not abstinent)
Time frame: 1, 3, and 6 months post-intervention
6 secondary outcomes
Smoking cessation self-efficacy using SEQ-12 (12-item Smoking Self-Efficacy Questionnaire)
Time frame: Baseline, 1, 2, 3, and 6 months
Motivation assessed via Richmond Test
Time frame: Baseline, 1, 2, 3, and 6 months
Social support measured through Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline, 1, 2, 3, and 6 months
Dependence level using Fagerström Test for Nicotine Dependence (FTND)
Time frame: Baseline, 1, 2, 3, and 6 months
App usage engagement measured through usage logs
Time frame: Baseline, 1, 2, 3, and 6 months
mHealth app usability measured through mHealth Usability Questionnaire (MAUQ)
Time frame: Time Frame: 1, 2, 3, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 41734925Ilmaskal R, Prabandari YS, Oktaria V. Development and evaluation of a mobile health (mHealth) application for smoking cessation among adolescents in Indonesia: a mixed methods randomised controlled trial study protocol. BMJ Open. 2026 Feb 24;16(2):e112178. doi: 10.1136/bmjopen-2025-112178.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie the results reported in this article, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Smoking Cessation Application in people with Tobacco Use Disorder and Smoking Cessation, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radian Ilmaskal, MPH (+6285272803477, radianilmaskal@mail.ugm.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported smoking abstinence measured through questionnaire (Yes/No response where Yes = abstinent, No = not abstinent) (time frame: 1, 3, and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07198828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.