An Integrated Smoking Cessation and Alcohol Intervention for Young People

Smoking Cessation Clinical Trial

Official title:

An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People: A Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05627765
• Other study ID #: 19200161
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2022
• Source: The Hong Kong Polytechnic University
• Contact: Ka Yan HO
• Phone: 27666417
• Email: kyeva.ho[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Smoking Cessation

Intervention

Behavioral:
• 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.

Other:
• Integrated Intervention (II) arm
Participants will receive brief advice on alcohol use based on the FRAMES model, which is a well-established and effective brief intervention for drinking.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	screening rate	the number of people screened divided by the number of people available for screening	24 months
Primary	eligibility rate	the number of eligible smokers divided by the number of screened people.	24 months
Primary	consent rate	the number of eligible smokers who agree to participate divided by the number of eligible smokers	24 months
Primary	randomization rate	the number of participants who are randomized divided by the number of eligible smokers who consent to participate	24 months
Primary	attendance rate	the number of participants who complete the intervention divided by the number of participants who are randomized into the treatment arms	24 months
Primary	adherence to intervention	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	24 months
Primary	retention rate	the number of participants who remain in the study	24 months
Primary	completion rate	the number of participants who complete the questionnaire	24 months
Primary	missing data	the percentage of missing data	24 months
Primary	adverse events	unfavorable or unintended events	24 months
Secondary	self-reported quit rate	self-report no use of any tobacco products	6 month
Secondary	biochemically validated quit rate	biochemically verified	6 month