Clinical trial NCT04875546: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Behavior
Keywords: smoking
alcohol
adolescents
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The biochemical validation
timeFrame: At the 6-month follow-up
measure: Structured questionnaire
timeFrame: At baseline
Secondary outcomes:
measure: Randomization rate
timeFrame: Immediately after the training workshop
measure: Attendance rate
timeFrame: Immediately after the training workshop
measure: Adherence to intervention at baseline
timeFrame: At baseline
measure: Adherence to intervention at 1-week follow-up
timeFrame: At 1-week follow-up
measure: Adherence to intervention at 1-month follow-up
timeFrame: At 1-month follow-up
measure: Adherence to intervention at 3-month follow-up
timeFrame: At 3-month follow-up
measure: Adherence to intervention at 6-month follow-up
timeFrame: At 6-month follow-up
measure: Retention rate at baseline
timeFrame: At baseline
measure: Retention rate at 1-week follow-up
timeFrame: At 1-week follow-up
measure: Retention rate at 1-month follow-up
timeFrame: At 1-month follow-up
measure: Retention rate at 3-month follow-up
timeFrame: At 3-month follow-up
measure: Retention rate at 6 month follow-up
timeFrame: At 6-month follow-up
measure: Completion rate at baseline
timeFrame: At baseline
measure: Completion rate at 1-week follow-up
timeFrame: At 1-week follow-up
measure: Completion rate at 1-month follow-up
timeFrame: At 1-month follow-up
measure: Completion rate at 3-month follow-up
timeFrame: At 3-month follow-up
measure: Completion rate at 6-month follow-up
timeFrame: At 6-month follow-up
measure: Missing data at baseline
timeFrame: At baseline
measure: Missing data at 1-week follow-up
timeFrame: At 1-week follow-up
measure: Missing data at 1-month follow-up
timeFrame: At 1-month follow-up
measure: Missing data at 3-month follow-up
timeFrame: At 3-month follow-up
measure: Missing data at 6-month follow-up
timeFrame: At 6-month follow-up
measure: Adverse events
timeFrame: At the 6 months follow up
measure: Screen rate
timeFrame: Immediately after the training workshop
measure: Consent rate
timeFrame: Immediately after the training workshop
measure: Eligibility rate
timeFrame: Immediately after the training workshop
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Ka Yan Ho
state: Hong Kong,China
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Ka Yan Ho, Phd
role: PRINCIPAL_INVESTIGATOR
References: