An Integrated Smoking Cessation and Alcohol Intervention for Young People

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Drinking; Smoking Cessation
• Intervention / Treatment: Behavioral: Standard treatment (ST) arm; Other: Integrated Intervention (II) arm

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ka Yan HO; Phone Number: 27666417; Email: kyeva.ho@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 23 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
No Intervention: Control arm; Participants will be provided with two leaflets designed by Department of health: one for smoking cessation and another for alcohol abstinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
screening rate	the number of people screened divided by the number of people available for screening	24 months
eligibility rate	the number of eligible smokers divided by the number of screened people.	24 months
consent rate	the number of eligible smokers who agree to participate divided by the number of eligible smokers	24 months
randomization rate	the number of participants who are randomized divided by the number of eligible smokers who consent to participate	24 months
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
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
retention rate	the number of participants who remain in the study	24 months
completion rate	the number of participants who complete the questionnaire	24 months
missing data	the percentage of missing data	24 months
adverse events	unfavorable or unintended events	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-reported quit rate	self-report no use of any tobacco products	6 month
biochemically validated quit rate	biochemically verified	6 month

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Ka Yan HO, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: 19200161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No