NCT07070154

Brief Summary

The goal of this study is to evaluate the efficacy of a culture specific text-messaging based shisha smoking cessation intervention for young adults in Hong Kong. Participants in the intervention group will receive smartphone text messaging-based intervention and support that contained personalised messages with both text and visual elements over 6 weeks under a manualised programme. Participants in the control group will only receive a leaflet about the health risks of shisha smoking (the exact identical contents received by the participants in the intervention group at a session). All participants will complete a self-administered questionnaire at baseline, 6th- and 12th-week on their self-reported shisha abstinences, knowledge on risk, readiness to quit and attitudes on shisha smoking

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jul 2025Jul 2026

First Submitted

Initial submission to the registry

June 18, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

July 20, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

June 18, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

shisha smokingtext-messaging basedcessation interventionmHealth

Outcome Measures

Primary Outcomes (1)

  • shisha abstinences

    To compare the self-reported shisha abstinences between intervention and control group to evaluate the efficacy of the culture specific text-messaging based shisha smoking cessation intervention. Shisha abstinence is determined by self-reported last use 1) in the past 7 days using the Timeline Followback Method for active use, 2) in the past 30 days to determine current use, and 3) in the past 90 days to determine early remission in accordance with the criteria from the Diagnostic and Statistical Manual for Mental Disorders, 5th Edition.

    From enrollment, 6-week (after treatment) and 12-week follow-up

Secondary Outcomes (4)

  • Level of dependency

    From enrolment, 6-week (after treatment) and 12-week follow-up

  • Knowledge on risk

    From enrolment, 6-week (after treatment) and 12-week follow-up

  • Readiness to quit

    From enrolment, 6-week (after treatment) and 12-week follow-up

  • Attitudes on shisha smoking

    From enrolment, 6-week (after treatment) and 12-week follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive smartphone text messaging-based intervention and support that contained personalised messages with both text and visual elements over 6 weeks under a manualised programme. The contents of the messages within the intervention is developed based on the results of a Delphi study that identified 32 behaviour change techniques by 46 tobacco/ substance use control policy experts and mental health professionals in Hong Kong.

Behavioral: text-messaging based intervention

Control

NO INTERVENTION

Participants in the control group will only receive a leaflet about the health risks of shisha smoking in either Chinese or English. The information of the leaflet will be with the exact identical contents on the leaflet received by the participants in the intervention group at Session 2.

Interventions

The 6-week, culture specific, text-messaging based cessation intervention for young adults in Hong Kong consists of 6 sessions: 1) Programme overview, 2) Psychoeducation on the health risks, 3) Social support, 4) Stress management, 5) Craving and withdrawal symptoms management, and 6) Summary and relapse prevention.

Intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • young adults aged 18 to 35 years who are interested in quitting shisha
  • smoked shisha within the 30 days at the time of enrolment (current smoker)
  • smoked for more than twelve times in 12 months (i.e., on a monthly basis)22
  • able to read and communicate in Chinese or English
  • agree to utilise his/her own personal mobile or smartphone to send and receive messages

You may not qualify if:

  • scored 10 (''have already quitted'') on Contemplation Ladder assessment at baseline
  • unable to provide consent
  • unable to read and communicate in Chinese or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Room 212, New Clinical Building, Queen Mary Hospital, 102 Pokfulam Road

Hong Kong, 0000000, Hong Kong

Location

Study Officials

  • Johnson Kai Chun Law, MSc

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johnson Kai Chun Law, MSc

CONTACT

Albert Kar Kin Chung, MBBS(HK) & FHKCPsych

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

June 18, 2025

First Posted

July 17, 2025

Study Start

July 20, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The dataset without personal identifiers and contact information will be available upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
The dataset will be available from May 2026 for 5 years following the principles from the HKSAR Personal Data (Privacy) Ordinance (Cap. 486) and the principles from the Policy on the Management of Research Data and Records, the University of Hong Kong.
Access Criteria
The IPD and supporting information will be available from the PI of this study Mr Law Kai Chun Johnson upon reaonalbe request.
More information

Locations