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An Integrated Smoking Cessation and Alcohol Intervention for Young People

Primary Purpose

Smoking Cessation, Alcohol Drinking

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard treatment (ST) arm
Integrated Intervention (II) arm
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Smoking Cessation

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: smoked at least one cigarette in the past 30 days have consumed at least one cup of alcohol (10 ounces of beer, 4 ounces of wine, or 1 ounce of liquor) in the past 30 days speak Cantonese. Exclusion Criteria: have a compromised mental status and/or communication problems participating in other smoking cessation interventions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Standard treatment (ST) arm

    Integrated Intervention (II) arm

    Control arm

    Arm Description

    Participants will receive a brief smoking cessation intervention based on the asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit,Assisting in quitting, and Arranging for follow-up and relevance, risks, rewards, roadblocks and repetition models at baseline. Booster interventions will be provided to ST arm at 1-week, 1-month, 3-month, and 6-month follow-up.

    Participants in the II arm will receive brief advice on alcohol use based on the FRAMES model in addition to the brief smoking cessation intervention at baseline. Booster interventions will be provided to ST arm at 1-week, 1-month, 3-month, and 6-month follow-up.

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

    Outcomes

    Primary Outcome Measures

    screening rate
    the number of people screened divided by the number of people available for screening
    eligibility rate
    the number of eligible smokers divided by the number of screened people.
    consent rate
    the number of eligible smokers who agree to participate divided by the number of eligible smokers
    randomization rate
    the number of participants who are randomized divided by the number of eligible smokers who consent to participate
    attendance rate
    the number of participants who complete the intervention divided by the number of participants who are randomized into the treatment arms
    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
    retention rate
    the number of participants who remain in the study
    completion rate
    the number of participants who complete the questionnaire
    missing data
    the percentage of missing data
    adverse events
    unfavorable or unintended events

    Secondary Outcome Measures

    self-reported quit rate
    self-report no use of any tobacco products
    biochemically validated quit rate
    biochemically verified

    Full Information

    First Posted
    April 13, 2022
    Last Updated
    November 24, 2022
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05627765
    Brief Title
    An Integrated Smoking Cessation and Alcohol Intervention for Young People
    Official Title
    An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People: A Feasibility Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study will be a three-arm randomized controlled trial in a convenience sample of 150 smokers aged 18-25 years with a drinking habit who will be recruited from smoking hotspots in Mong Kok. Participants will be randomized into a standard treatment (ST), II, or control arm. Participants in the ST arm will receive a brief smoking cessation intervention based on the Asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit, Assisting in quitting, and Arranging for follow-up and Relevance, Risks, Rewards, Roadblocks and Repetition models. Participants in the II arm will receive brief advice on alcohol use based on the FRAMES model in addition to the brief smoking cessation intervention. Booster interventions will be provided to both ST and II arms at 1-week, 1-month, 3-month, and 6-month follow-up. Participants in the control arm will receive leaflets on smoking cessation and alcohol abstinence. Data collection will be done at baseline and at 1-week, 1-month, 3-month, and 6-month follow-ups. Self-reported quitters at 6-month follow-up will be invited for biochemical validation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Smoking Cessation, Alcohol Drinking

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard treatment (ST) arm
    Arm Type
    Experimental
    Arm Description
    Participants will receive a brief smoking cessation intervention based on the asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit,Assisting in quitting, and Arranging for follow-up and relevance, risks, rewards, roadblocks and repetition models at baseline. Booster interventions will be provided to ST arm at 1-week, 1-month, 3-month, and 6-month follow-up.
    Arm Title
    Integrated Intervention (II) arm
    Arm Type
    Experimental
    Arm Description
    Participants in the II arm will receive brief advice on alcohol use based on the FRAMES model in addition to the brief smoking cessation intervention at baseline. Booster interventions will be provided to ST arm at 1-week, 1-month, 3-month, and 6-month follow-up.
    Arm Title
    Control arm
    Arm Type
    No Intervention
    Arm Description
    Participants will be provided with two leaflets designed by Department of health: one for smoking cessation and another for alcohol abstinence.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard treatment (ST) arm
    Intervention Description
    Participants will receive a brief smoking cessation intervention based on the asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit,Assisting in quitting, and Arranging for follow-up and relevance, risks, rewards, roadblocks and repetition models at baseline. Booster interventions will be provided to ST arm at 1-week, 1-month, 3-month, and 6-month follow-up.
    Intervention Type
    Other
    Intervention Name(s)
    Integrated Intervention (II) arm
    Intervention Description
    Participants will receive brief advice on alcohol use based on the FRAMES model, which is a well-established and effective brief intervention for drinking.
    Primary Outcome Measure Information:
    Title
    screening rate
    Description
    the number of people screened divided by the number of people available for screening
    Time Frame
    24 months
    Title
    eligibility rate
    Description
    the number of eligible smokers divided by the number of screened people.
    Time Frame
    24 months
    Title
    consent rate
    Description
    the number of eligible smokers who agree to participate divided by the number of eligible smokers
    Time Frame
    24 months
    Title
    randomization rate
    Description
    the number of participants who are randomized divided by the number of eligible smokers who consent to participate
    Time Frame
    24 months
    Title
    attendance rate
    Description
    the number of participants who complete the intervention divided by the number of participants who are randomized into the treatment arms
    Time Frame
    24 months
    Title
    adherence to intervention
    Description
    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
    Time Frame
    24 months
    Title
    retention rate
    Description
    the number of participants who remain in the study
    Time Frame
    24 months
    Title
    completion rate
    Description
    the number of participants who complete the questionnaire
    Time Frame
    24 months
    Title
    missing data
    Description
    the percentage of missing data
    Time Frame
    24 months
    Title
    adverse events
    Description
    unfavorable or unintended events
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    self-reported quit rate
    Description
    self-report no use of any tobacco products
    Time Frame
    6 month
    Title
    biochemically validated quit rate
    Description
    biochemically verified
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: smoked at least one cigarette in the past 30 days have consumed at least one cup of alcohol (10 ounces of beer, 4 ounces of wine, or 1 ounce of liquor) in the past 30 days speak Cantonese. Exclusion Criteria: have a compromised mental status and/or communication problems participating in other smoking cessation interventions
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ka Yan HO
    Phone
    27666417
    Email
    kyeva.ho@polyu.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ka Yan HO
    Organizational Affiliation
    The Hong Kong Polytechnic University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    An Integrated Smoking Cessation and Alcohol Intervention for Young People

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