An Integrated Smoking Cessation and Alcohol Intervention for Young People

July 2, 2025 updated by: Dr Eva Ho, The Hong Kong Polytechnic University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
screening rate
Time Frame: From screening to the end of treatment after 6 months
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
Time Frame: From screening to the end of treatment after 6 months
the number of eligible smokers divided by the number of screened people
From screening to the end of treatment after 6 months
consent rate
Time Frame: From screening to the end of treatment after 6 months
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
Time Frame: From screening to the end of treatment after 6 months
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
Time Frame: From screening to the end of treatment after 6 months
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
Time Frame: From screening to the end of treatment after 6 months
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
Time Frame: From screening to the end of treatment after 6 months
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
Time Frame: From screening to the end of treatment after 6 months
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
Time Frame: From screening to the end of treatment after 6 months
the percentage of missing data
From screening to the end of treatment after 6 months
adverse events
Time Frame: From screening to the end of treatment after 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Smoking quit rate
Time Frame: From screening to the end of treatment after 6 months
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
Time Frame: From screening to the end of treatment after 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Food and Health Bureau, Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ka Yan Ho, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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