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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04875546
Enrollment
150
Registered
2021-05-06
Start date
2022-07-01
Completion date
2024-07-01
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior

Keywords

smoking, alcohol, adolescents

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.

Interventions

BEHAVIORALStandard 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.

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.

OTHERControl

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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The biochemical validationAt the 6-month follow-upMeasuring the level of carbon monoxide in expired air and level of cotinine in saliva
Structured questionnaireAt baselineThe questionnaire will include six areas: smoking profile, cessation history, readiness to quit, self-efficacy to quit, alcohol use and demographics.

Secondary

MeasureTime frameDescription
Randomization rateImmediately after the training workshopThe number of participants who randomized divided by the number of eligible smokers who consent to participate
Attendance rateImmediately after the training workshopThe 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 baselineAt baselineThe 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-upThe 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-upThe 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-upAt 3-month follow-upThe 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-upThe 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 baselineAt baselineThe 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-upAt 1-week follow-upThe 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-upThe 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-upAt 3-month follow-upThe 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-upAt 6-month follow-upThe 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 baselineThe number of participants who complete the questionnaire divided by the number of questionnaires distributed.
Completion rate at 3-month follow-upAt 3-month follow-upThe number of participants who complete the questionnaire divided by the number of questionnaires distributed.
Completion rate at 6-month follow-upAt 6-month follow-upThe number of participants who complete the questionnaire divided by the number of questionnaires distributed.
Missing data at baselineAt baselineThe percentage of missing data.
Missing data at 1-week follow-upAt 1-week follow-upThe percentage of missing data.
Missing data at 1-month follow-upAt 1-month follow-upThe percentage of missing data.
Missing data at 3-month follow-upAt 3-month follow-upThe percentage of missing data.
Missing data at 6-month follow-upAt 6-month follow-upThe percentage of missing data.
Adverse eventsAt the 6 months follow upUnfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline
Screen rateImmediately after the training workshopThe number of people screened divided by the number of people available for screening.
Consent rateImmediately after the training workshopThe number of eligible smokers who agree to participate divided by the number of eligible smokers
Eligibility rateImmediately after the training workshopThe number of eligible smokers divided by the number of screened people.
Completion rate at 1-month follow-upAt 1-month follow-upThe number of participants who complete the questionnaire divided by the number of questionnaires distributed.
Completion rate at 1-week follow-upAt 1-week follow-upThe number of participants who complete the questionnaire divided by the number of questionnaires distributed.

Countries

Hong Kong

Contacts

Primary ContactKa Yan Ho, Phd
kyeva.ho@polyu.edu.hk27666417

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026