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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Smoking Cessation
• Intervention / Treatment: Behavioral: Standard treatment (ST) arm; Behavioral: Integrated Intervention (II) arm

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hongkong, Hong Kong
    • The Hong Kong Polytechnic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 21 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Participants will be provided with two leaflets designed by Department of health: one for smoking cessation and another for alcohol abstinence.
Experimental: Standard treatment (ST) arm; 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; 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.
Experimental: Integrated Intervention (II) arm; 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; brief advice on alcohol use based on the "FRAMES" model and the brief smoking cessation intervention based on the "5A" and "5R" models.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking quit rate	the effect size of II on self-reported and biochemically validated quit rates for smoking at 6 months relative to ST and Control.	From screening to the end of treatment after 6 months
alcohol quit rate	the effect size of II on self-reported quit rate for alcohol at 6 months relative to ST and Control	From screening to the end of treatment after 6 months

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Food and Health Bureau, Hong Kong
• Investigators: Principal Investigator: Ka Yan Ho, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Feasibility; Randomized controlled trial; Smoking cessation; Alcohol; Young adults; Integrated intervention
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 19200161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No