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An Integrated Smoking Cessation and Alcohol Intervention for Young People

An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People: A Feasibility Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05627765
Enrollment
150
Registered
2022-11-28
Start date
2022-07-01
Completion date
2024-12-31
Last updated
2025-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Smoking Cessation

Keywords

Smoking cessation, Alcohol, Integrated intervention, Young adults, Feasibility, Randomized controlled trial

Brief summary

The specific objectives of this study are to investigate the (1) feasibility, (2) preliminary effectiveness and (3) effect sizes of the integrated smoking cessation and alcohol intervention when compared to standalone smoking cessation (ST) and control among young adults in Hong Kong.

Interventions

BEHAVIORALStandard treatment (ST) arm

participants who are ready to quit smoking: a brief smoking cessation intervention based on the 5A models and STAR method as quitting skills. participants who are not yet ready to quit smoking: a brief smoking cessation intervention based on the 5R models.

BEHAVIORALIntegrated Intervention (II) arm

brief advice on alcohol use based on the FRAMES model and the brief smoking cessation intervention based on the 5A and 5R models.

Sponsors

Food and Health Bureau, Hong Kong
CollaboratorOTHER_GOV
The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* aged 18 to 25 years * smoked at least one traditional cigarette in the past 30 days * consumed at least one alcohol unit (one alcohol unit contains 10g of pure alcohol) in the past 30 days * speak Cantonese.

Exclusion criteria

* have a compromised mental status and/or communication problems * participating in other smoking cessation and/or alcohol interventions

Design outcomes

Primary

MeasureTime frameDescription
completion rateFrom screening to the end of treatment after 6 monthsthe number of participants who complete the questionnaire divided by the number of questionnaires distributed
adherence to interventionFrom screening to the end of treatment after 6 monthsthe number of participants in the two treatment arms who practice the skills learned during the intervention divided by the number of participants in the two treatment arms
retention rateFrom screening to the end of treatment after 6 monthsthe number of participants who remain in the study divided by the number of participants randomized
missing dataFrom screening to the end of treatment after 6 monthsthe percentage of missing data
adverse eventsFrom screening to the end of treatment after 6 monthsunfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline
screening rateFrom screening to the end of treatment after 6 monthsthe number of smokers screened divided by the number of smokers available for screening
eligibility rateFrom screening to the end of treatment after 6 monthsthe number of eligible smokers divided by the number of screened people
consent rateFrom screening to the end of treatment after 6 monthsthe number of eligible smokers who agree to participate divided by the number of eligible smokers
randomization rateFrom screening to the end of treatment after 6 monthsthe number of participants who are randomized divided by the number of eligible smokers who consent to participate
attendance rateFrom screening to the end of treatment after 6 monthsthe number of participants who complete the intervention divided by the number of participants who are randomized into the treatment arms (ST and II)

Secondary

MeasureTime frameDescription
alcohol quit rateFrom screening to the end of treatment after 6 monthsthe effect size of II on self-reported quit rate for alcohol at 6 months relative to ST and Control
Smoking quit rateFrom screening to the end of treatment after 6 monthsthe effect size of II on self-reported and biochemically validated quit rates for smoking at 6 months relative to ST and Control.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026