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

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

Tracking Information

• First Submitted Date: April 20, 2021
• First Posted Date: May 6, 2021
• Last Update Posted Date: May 6, 2021
• Estimated Study Start Date: July 1, 2022
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 3, 2021)

• 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
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 3, 2021)

• 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
• 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
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Completion rate at baseline [ Time Frame: At baseline ]
  The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
• 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.
• 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.
• 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.
• 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.
• Missing data at baseline [ Time Frame: At baseline ]
  The percentage of missing data.
• Missing data at 1-week follow-up [ Time Frame: At 1-week follow-up ]
  The percentage of missing data.
• Missing data at 1-month follow-up [ Time Frame: At 1-month follow-up ]
  The percentage of missing data.
• Missing data at 3-month follow-up [ Time Frame: At 3-month follow-up ]
  The percentage of missing data.
• Missing data at 6-month follow-up [ Time Frame: At 6-month follow-up ]
  The percentage of missing data.
• 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
• Screen rate [ Time Frame: Immediately after the training workshop ]
  The number of people screened divided by the number of people available for screening.
• 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
• Eligibility rate [ Time Frame: Immediately after the training workshop ]
  The number of eligible smokers divided by the number of screened people.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People
• Official Title: An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People
• 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.
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Adolescent Behavior

Intervention

• 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.
• 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.
• 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.

Study Arms

• Active Comparator: Standard treatment
  • A 5'A' and '5'R' models
  • STAR method for quitting
  Intervention: Behavioral: Standard treatment
• 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
  Intervention: Behavioral: Integrated Intervention
• Sham Comparator: Control
  Participants will receive two leaflets.
  Intervention: Other: Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: May 3, 2021): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2024
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 25 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT04875546
• Other Study ID Numbers: Smk_AI-RCT
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr Eva Ho, The Hong Kong Polytechnic University
• Original Responsible Party: Same as current
• Current Study Sponsor: The Hong Kong Polytechnic University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ka Yan Ho, Phd; The Hong Kong Polytechnic University

• PRS Account: The Hong Kong Polytechnic University
• Verification Date: May 2021