An Integrated Smoking Cessation and Alcohol Intervention for Young People

Not Applicable

• Conditions: Alcohol Drinking; Smoking Cessation
• Interventions: Behavioral: Standard treatment (ST) arm; Other: Integrated Intervention (II) arm

• Registration Number: NCT05627765
• Lead Sponsor: The Hong Kong Polytechnic University

Brief Summary

The study will be a three-arm randomized controlled trial in a convenience sample of 150 smokers aged 18-25 years with a drinking habit who will be recruited from smoking hotspots in Mong Kok. Participants will be randomized into a standard treatment (ST), II, or control arm. Participants in the ST arm will receive a brief smoking cessation intervention based on the Asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit, Assisting in quitting, and Arranging for follow-up and Relevance, Risks, Rewards, Roadblocks and Repetition models. Participants in the II arm will receive brief advice on alcohol use based on the FRAMES model in addition to the brief smoking cessation intervention. Booster interventions will be provided to both ST and II arms at 1-week, 1-month, 3-month, and 6-month follow-up. Participants in the control arm will receive leaflets on smoking cessation and alcohol abstinence. Data collection will be done at baseline and at 1-week, 1-month, 3-month, and 6-month follow-ups. Self-reported quitters at 6-month follow-up will be invited for biochemical validation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-11-24
• Last Update Submitted: 2022-11-24
• Study First Posted: 2022-11-28
• Last Update Posted: 2022-11-28
• Study Start: 2023-04-01
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

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 (10 ounces of beer, 4 ounces of wine, or 1 ounce of liquor) 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: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment (ST) arm	Standard treatment (ST) arm	Participants will receive a brief smoking cessation intervention based on the asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit,Assisting in quitting, and Arranging for follow-up and relevance, risks, rewards, roadblocks and repetition models at baseline. Booster interventions will be provided to ST arm at 1-week, 1-month, 3-month, and 6-month follow-up.
Integrated Intervention (II) arm	Integrated Intervention (II) arm	Participants in the II arm will receive brief advice on alcohol use based on the FRAMES model in addition to the brief smoking cessation intervention at baseline. Booster interventions will be provided to ST arm at 1-week, 1-month, 3-month, and 6-month follow-up.

Primary Outcome Measures

Name	Time	Method
screening rate	24 months	the number of people screened divided by the number of people available for screening
eligibility rate	24 months	the number of eligible smokers divided by the number of screened people.
consent rate	24 months	the number of eligible smokers who agree to participate divided by the number of eligible smokers
randomization rate	24 months	the number of participants who are randomized divided by the number of eligible smokers who consent to participate
attendance rate	24 months	the number of participants who complete the intervention divided by the number of participants who are randomized into the treatment arms
adherence to intervention	24 months	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
retention rate	24 months	the number of participants who remain in the study
completion rate	24 months	the number of participants who complete the questionnaire
missing data	24 months	the percentage of missing data
adverse events	24 months	unfavorable or unintended events

Secondary Outcome Measures

Name	Time	Method
self-reported quit rate	6 month	self-report no use of any tobacco products
biochemically validated quit rate	6 month	biochemically verified