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

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ClinicalTrials.gov Identifier: NCT04875546
Recruitment Status : Not yet recruiting
First Posted : May 6, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Eva Ho, The Hong Kong Polytechnic University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Adolescent Behavior Behavioral: Standard treatment Behavioral: Integrated Intervention Other: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Completion rate at baseline [ Time Frame: At baseline ]
    The number of participants who complete the questionnaire divided by the number of questionnaires distributed.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Missing data at baseline [ Time Frame: At baseline ]
    The percentage of missing data.

  19. Missing data at 1-week follow-up [ Time Frame: At 1-week follow-up ]
    The percentage of missing data.

  20. Missing data at 1-month follow-up [ Time Frame: At 1-month follow-up ]
    The percentage of missing data.

  21. Missing data at 3-month follow-up [ Time Frame: At 3-month follow-up ]
    The percentage of missing data.

  22. Missing data at 6-month follow-up [ Time Frame: At 6-month follow-up ]
    The percentage of missing data.

  23. 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

  24. Screen rate [ Time Frame: Immediately after the training workshop ]
    The number of people screened divided by the number of people available for screening.

  25. 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

  26. Eligibility rate [ Time Frame: Immediately after the training workshop ]
    The number of eligible smokers divided by the number of screened people.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04875546


Contacts
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Contact: Ka Yan Ho, Phd 27666417 kyeva.ho@polyu.edu.hk

Locations
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Hong Kong
Ka Yan Ho
Hong Kong, Hong Kong,China, Hong Kong, 0000
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Ka Yan Ho, Phd The Hong Kong Polytechnic University
More Information
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Responsible Party: Dr Eva Ho, Assistant Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04875546    
Other Study ID Numbers: Smk_AI-RCT
First Posted: May 6, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Eva Ho, The Hong Kong Polytechnic University:
smoking
alcohol
adolescents