An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People

May 3, 2021 updated by: Dr Eva Ho, The Hong Kong Polytechnic University
Current smoking cessation interventions are focused only on smoking behaviors, and drinking habits are generally overlooked. The aims of the project is to examine the feasibility of implementing an integrated smoking cessation and alcohol abstinence intervention in young Hong Kong Chinese smokers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

Detailed Description

The study is a three-arm randomized controlled trial. (1)The standard treatment group , participants will receive a brief smoking cessation intervention based on the '5A' and '5R' model, then the RA will assist the participants to quit smoking using the STAR method. (2) For the alcohol intervention group, participants will also receive a brief smoking cessation intervention with the models as the ST group. After that they will receive a brief advice on alcohol use based on the FRAMES model. Then the RA will invite participants to complete the Alcohol Use Disorders Identification Test(AUDIT). (3) For the Control group, participants will be provide with two leaflets, one for smoking cessation and another for alcohol abstinence. All the data collection will be conducted at baseline, 1 week, 1 month , 3 months and 6 months for follow up.

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 (Anticipated)

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 Locations

  • Hong Kong
    • Hong Kong,China
      • Hong Kong, Hong Kong,China, Hong Kong, 0000
        • Ka Yan Ho

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

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • smoked at least one cigarette in the past 30 days.
  • have consumed at least one cup of alcohol in the past 30 days.
  • speak Cantonese

Exclusion Criteria:

  • have a compromised mental status and/or communication problems.
  • participating in other smoking cessation 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial 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.
Active Comparator: Standard treatment
  • A 5'A' and '5'R' models
  • STAR method for quitting
Behavioral: Standard treatment
Adolescent will receive a brief smoking cessation intervention based on the '5A' and '5R' models. Then the research assistant will ask about their tobacco use and assist them to quit using the STAR method. A booster intervention will be given over the phone at 1-week, 1month, 3-month, and 6 month follow-up.
Active Comparator: Integrated Intervention
  • A 5'A' and '5'R' models
  • Receive brief advice on alcohol use based on the FRAMES model
  • Complete the Alcohol Use Disorders Identification Test
Behavioral: Integrated Intervention
In addition to the brief smoking cessation intervention based on the '5A' and '5R' models, the participants will receive brief advice on alcohol use based on the FRAMES model. Then the RA will invite participants to complete the Alcohol Use Disorders Identification Test and provide personalized feedback. There will be a one to one, 20-30 minutes semi-structured interviews with 30 participants. Participants with high(N=15) and low (N=15) adherence will be purposively selected. A booster intervention will be given over the phone at 1-week, 1month, 3-month, and 6 month follow-up.
Sham Comparator: Control
Participants will receive two leaflets.
Other: Control
The adolescents will receive the leaflets for smoking cessation and alcohol abstinence. A booster intervention will be given over the phone at 1-week, 1month, 3-month, and 6 month follow-up.

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
The biochemical validation
Time Frame: At the 6-month follow-up
Measuring the level of carbon monoxide in expired air and level of cotinine in saliva
At the 6-month follow-up
Structured questionnaire
Time Frame: At baseline
The questionnaire will include six areas: smoking profile, cessation history, readiness to quit, self-efficacy to quit, alcohol use and demographics.
At baseline

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
Randomization rate
Time Frame: Immediately after the training workshop
The number of participants who randomized divided by the number of eligible smokers who consent to participate
Immediately after the training workshop
Attendance rate
Time Frame: Immediately after the training workshop
The number of participants who complete intervention divided by the number of participants who are randomized into the treatment arms participants who are randomized into the treatment arms
Immediately after the training workshop
Adherence to intervention at baseline
Time Frame: At baseline
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 during the intervention divided by the number of participants in the two treatment arm.
At baseline
Adherence to intervention at 1-week follow-up
Time Frame: At 1-week follow-up
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 during the intervention divided by the number of participants in the two treatment arm.
At 1-week follow-up
Adherence to intervention at 1-month follow-up
Time Frame: At 1-month follow-up
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 during the intervention divided by the number of participants in the two treatment arm.
At 1-month follow-up
Adherence to intervention at 3-month follow-up
Time Frame: At 3-month follow-up
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 during the intervention divided by the number of participants in the two treatment arm.
At 3-month follow-up
Adherence to intervention at 6-month follow-up
Time Frame: At 6-month follow-up
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 during the intervention divided by the number of participants in the two treatment arm.
At 6-month follow-up
Retention rate at baseline
Time Frame: At baseline
The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated for each arm at baseline and follow-ups.
At baseline
Retention rate at 1-week follow-up
Time Frame: At 1-week follow-up
The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated for each arm at baseline and follow-ups.
At 1-week follow-up
Retention rate at 1-month follow-up
Time Frame: At 1-month follow-up
The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated for each arm at baseline and follow-ups.
At 1-month follow-up
Retention rate at 3-month follow-up
Time Frame: At 3-month follow-up
The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated for each arm at baseline and follow-ups.
At 3-month follow-up
Retention rate at 6 month follow-up
Time Frame: At 6-month follow-up
The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated for each arm at baseline and follow-ups.
At 6-month follow-up
Completion rate at baseline
Time Frame: At baseline
The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
At baseline
Completion rate at 1-week follow-up
Time Frame: At 1-week follow-up
The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
At 1-week follow-up
Completion rate at 1-month follow-up
Time Frame: At 1-month follow-up
The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
At 1-month follow-up
Completion rate at 3-month follow-up
Time Frame: At 3-month follow-up
The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
At 3-month follow-up
Completion rate at 6-month follow-up
Time Frame: At 6-month follow-up
The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
At 6-month follow-up
Missing data at baseline
Time Frame: At baseline
The percentage of missing data.
At baseline
Missing data at 1-week follow-up
Time Frame: At 1-week follow-up
The percentage of missing data.
At 1-week follow-up
Missing data at 1-month follow-up
Time Frame: At 1-month follow-up
The percentage of missing data.
At 1-month follow-up
Missing data at 3-month follow-up
Time Frame: At 3-month follow-up
The percentage of missing data.
At 3-month follow-up
Missing data at 6-month follow-up
Time Frame: At 6-month follow-up
The percentage of missing data.
At 6-month follow-up
Adverse events
Time Frame: At the 6 months follow up
Unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline
At the 6 months follow up
Screen rate
Time Frame: Immediately after the training workshop
The number of people screened divided by the number of people available for screening.
Immediately after the training workshop
Consent rate
Time Frame: Immediately after the training workshop
The number of eligible smokers who agree to participate divided by the number of eligible smokers
Immediately after the training workshop
Eligibility rate
Time Frame: Immediately after the training workshop
The number of eligible smokers divided by the number of screened people.
Immediately after the training workshop

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

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, phd, 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 (Anticipated)

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 (Anticipated)

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.
July 1, 2024

Study Completion (Anticipated)

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.
July 1, 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 20, 2021

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.
May 3, 2021

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.
May 6, 2021

Study Record Updates

Last Update Posted (Actual)

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.
May 6, 2021

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.
May 3, 2021

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.
May 1, 2021

More Information

Terms related to this study

Keywords

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.
  • Smk_AI-RCT

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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