NCT05627765

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 13, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

April 13, 2022

Last Update Submit

July 2, 2025

Conditions

Smoking CessationAlcohol Drinking

Keywords

Smoking cessationAlcoholIntegrated interventionYoung adultsFeasibilityRandomized controlled trial

Outcome Measures

Primary Outcomes (10)

  • screening rate

    the number of smokers screened divided by the number of smokers available for screening

    From screening to the end of treatment after 6 months

  • eligibility rate

    the number of eligible smokers divided by the number of screened people

    From screening to the end of treatment after 6 months

  • consent rate

    the number of eligible smokers who agree to participate divided by the number of eligible smokers

    From screening to the end of treatment after 6 months

  • randomization rate

    the number of participants who are randomized divided by the number of eligible smokers who consent to participate

    From screening to the end of treatment after 6 months

  • attendance rate

    the number of participants who complete the intervention divided by the number of participants who are randomized into the treatment arms (ST and II)

    From screening to the end of treatment after 6 months

  • adherence to intervention

    the 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

    From screening to the end of treatment after 6 months

  • retention rate

    the number of participants who remain in the study divided by the number of participants randomized

    From screening to the end of treatment after 6 months

  • completion rate

    the number of participants who complete the questionnaire divided by the number of questionnaires distributed

    From screening to the end of treatment after 6 months

  • missing data

    the percentage of missing data

    From screening to the end of treatment after 6 months

  • adverse events

    unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline

    From screening to the end of treatment after 6 months

Secondary Outcomes (2)

  • Smoking quit rate

    From screening to the end of treatment after 6 months

  • alcohol quit rate

    From screening to the end of treatment after 6 months

Study Arms (3)

Standard treatment (ST) arm

EXPERIMENTAL

Participants will receive a brief smoking cessation intervention based on the "5A" and "5R" models proposed by the World Health Organization. The "STAR" method as quitting skills will also be provided. The "5A" model includes five steps to identify participants who are ready to quit smoking. For those who are ready to quit, a research assistant will assist them to quit using the "STAR" method: Set a quit date within 1 week, Tell the surrounding people that they have planned to quit and solicited their support, Anticipate challenges to quit attempt, and Remove all tobacco products. Otherwise, the "5R" model will be applied to those not yet ready to quit. After "5R" is applied, the research assistant will repeat the assessment of their willingness to quit. The booster interventions will be delivered by the research assistant through follow-ups arranged with the participants via phone.

Behavioral: Standard treatment (ST) arm

Integrated Intervention (II) arm

EXPERIMENTAL

In addition to the brief smoking cessation intervention based on the "5A" and "5R" models, participants in this arm received brief advice on alcohol use based on the "FRAMES" model. The booster interventions will be delivered by the research assistant through follow-ups arranged with the participants via phone.

Behavioral: Integrated Intervention (II) arm

Control arm

NO INTERVENTION

Participants will be provided with two leaflets designed by Department of health: one for smoking cessation and another for alcohol abstinence.

Interventions

Standard treatment (ST) armBEHAVIORAL

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.

Standard treatment (ST) arm
Integrated Intervention (II) armBEHAVIORAL

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

Integrated Intervention (II) arm

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Smoking CessationAlcohol Drinking

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorDrinking Behavior

Study Officials

  • Ka Yan HO

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 13, 2022

First Posted

November 28, 2022

Study Start

July 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)