Mobile Health (mHealth) Application for Smoking Cessation Among Adolescents in Indonesia

NCT07198828 | Not Yet Recruiting DMC

• 1 other identifier: KE-FK-0864-EC-2025
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Tobacco Use Disorder; Smoking Cessation; Adolescent Smoking

Outcome Measures

Primary Outcomes (1)

• Self-reported smoking abstinence measured through questionnaire (Yes/No response where Yes = abstinent, No = not abstinent)

  1, 3, and 6 months post-intervention

Secondary Outcomes (6)

• Smoking cessation self-efficacy using SEQ-12 (12-item Smoking Self-Efficacy Questionnaire)

  Baseline, 1, 2, 3, and 6 months

• Motivation assessed via Richmond Test

  Baseline, 1, 2, 3, and 6 months

• Social support measured through Multidimensional Scale of Perceived Social Support (MSPSS)

  Baseline, 1, 2, 3, and 6 months

• Dependence level using Fagerström Test for Nicotine Dependence (FTND)

  Baseline, 1, 2, 3, and 6 months

• App usage engagement measured through usage logs

  Baseline, 1, 2, 3, and 6 months

Study Arms (2)

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

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

Behavioral: Paper-based Control Materials

Interventions

mHealth Smoking Cessation Application BEHAVIORAL

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

mHealth Intervention Group

Paper-based Control Materials BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Multiple junior high schools and community health centers

Padang, West Sumatra, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 41734925 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Central Study Contacts

Radian Ilmaskal, MPH

CONTACT

+6285272803477; radianilmaskal@mail.ugm.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 30, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to yayisuryo@ugm.ac.id. Data requestors will need to sign a data access agreement.

Locations

ID (1)