Mobile Health (mHealth) Application for Smoking Cessation Among Adolescents in Indonesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-15
SponsorGadjah Mada University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Adolescents aged 13-15 years
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
mHealth Smoking Cessation Application
BehavioralParticipants 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 Materials
BehavioralParticipants 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
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: mHealth Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Self-reported smoking abstinence measured through questionnaire (Yes/No response where Yes = abstinent, No = not abstinent)
Time frame
1, 3, and 6 months post-interventionSecondary outcomes
1
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
Time frame
Baseline, 1, 2, 3, and 6 months2
Motivation assessed via Richmond Test
Scale range: 0-10, where higher scores indicate greater motivation to quit smoking
Time frame
Baseline, 1, 2, 3, and 6 months3
Social support measured through Multidimensional Scale of Perceived Social Support (MSPSS)
Scale range: 12-84, where higher scores indicate greater perceived social support
Time frame
Baseline, 1, 2, 3, and 6 months4
Dependence level using Fagerström Test for Nicotine Dependence (FTND)
Scale range: 0-10, where higher scores indicate greater nicotine dependence
Time frame
Baseline, 1, 2, 3, and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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