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

Not Applicable
Conditions
Adolescent Behavior
Interventions
Behavioral: Integrated Intervention
Behavioral: Standard treatment
Other: Control
Registration Number
NCT04875546
Lead Sponsor
The Hong Kong Polytechnic University
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
150
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 & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Integrated InterventionIntegrated 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
Standard treatmentStandard treatment* A 5'A' and '5'R' models * STAR method for quitting
ControlControlParticipants will receive two leaflets.
Primary Outcome Measures
NameTimeMethod
Structured questionnaireAt baseline

The questionnaire will include six areas: smoking profile, cessation history, readiness to quit, self-efficacy to quit, alcohol use and demographics.

The biochemical validationAt the 6-month follow-up

Measuring the level of carbon monoxide in expired air and level of cotinine in saliva

Secondary Outcome Measures
NameTimeMethod
Retention rate at baselineAt 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-month follow-upAt 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.

Missing data at 6-month follow-upAt 6-month follow-up

The percentage of missing data.

Adherence to intervention at baselineAt 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-upAt 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-upAt 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.

Retention rate at 3-month follow-upAt 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.

Completion rate at 1-month follow-upAt 1-month follow-up

The number of participants who complete the questionnaire divided by the number of questionnaires distributed.

Eligibility rateImmediately after the training workshop

The number of eligible smokers divided by the number of screened people.

Retention rate at 1-week follow-upAt 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.

Completion rate at 3-month follow-upAt 3-month follow-up

The number of participants who complete the questionnaire divided by the number of questionnaires distributed.

Missing data at 1-month follow-upAt 1-month follow-up

The percentage of missing data.

Missing data at 3-month follow-upAt 3-month follow-up

The percentage of missing data.

Randomization rateImmediately after the training workshop

The number of participants who randomized divided by the number of eligible smokers who consent to participate

Completion rate at 6-month follow-upAt 6-month follow-up

The number of participants who complete the questionnaire divided by the number of questionnaires distributed.

Adverse eventsAt 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

Consent rateImmediately after the training workshop

The number of eligible smokers who agree to participate divided by the number of eligible smokers

Missing data at baselineAt baseline

The percentage of missing data.

Missing data at 1-week follow-upAt 1-week follow-up

The percentage of missing data.

Attendance rateImmediately 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 3-month follow-upAt 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-upAt 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.

Completion rate at 1-week follow-upAt 1-week follow-up

The number of participants who complete the questionnaire divided by the number of questionnaires distributed.

Screen rateImmediately after the training workshop

The number of people screened divided by the number of people available for screening.

Retention rate at 6 month follow-upAt 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 baselineAt baseline

The number of participants who complete the questionnaire divided by the number of questionnaires distributed.

Trial Locations

Locations (1)

Ka Yan Ho

🇭🇰

Hong Kong, Hong Kong,China, Hong Kong

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