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

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: Not yet recruiting
• Conditions: Adolescent Behavior
• Intervention / Treatment: Behavioral: Standard treatment; Behavioral: Integrated Intervention; Other: Control

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
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The biochemical validation	Measuring the level of carbon monoxide in expired air and level of cotinine in saliva	At the 6-month follow-up
Structured questionnaire	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

Outcome Measure	Measure Description	Time Frame
Randomization rate	The number of participants who randomized divided by the number of eligible smokers who consent to participate	Immediately after the training workshop
Attendance rate	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	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	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	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	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	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	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	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	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	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	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	The number of participants who complete the questionnaire divided by the number of questionnaires distributed.	At baseline
Completion rate 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	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	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	The number of participants who complete the questionnaire divided by the number of questionnaires distributed.	At 6-month follow-up
Missing data at baseline	The percentage of missing data.	At baseline
Missing data at 1-week follow-up	The percentage of missing data.	At 1-week follow-up
Missing data at 1-month follow-up	The percentage of missing data.	At 1-month follow-up
Missing data at 3-month follow-up	The percentage of missing data.	At 3-month follow-up
Missing data at 6-month follow-up	The percentage of missing data.	At 6-month follow-up
Adverse events	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	The number of people screened divided by the number of people available for screening.	Immediately after the training workshop
Consent rate	The number of eligible smokers who agree to participate divided by the number of eligible smokers	Immediately after the training workshop
Eligibility rate	The number of eligible smokers divided by the number of screened people.	Immediately after the training workshop

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Ka Yan Ho, phd, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: alcohol; smoking; adolescents
• Other Study ID 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