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Clinical Trials/NCT04875546
NCT04875546
Unknown
Not Applicable

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

The Hong Kong Polytechnic University1 site in 1 country150 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Behavior
Sponsor
The Hong Kong Polytechnic University
Enrollment
150
Locations
1
Primary Endpoint
Structured questionnaire
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
July 1, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Eva Ho

Assistant Professor

The Hong Kong Polytechnic University

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

Outcomes

Primary Outcomes

Structured questionnaire

Time Frame: At baseline

The questionnaire will include six areas: smoking profile, cessation history, readiness to quit, self-efficacy to quit, alcohol use and demographics.

The biochemical validation

Time Frame: At the 6-month follow-up

Measuring the level of carbon monoxide in expired air and level of cotinine in saliva

Secondary Outcomes

  • Retention rate at baseline(At baseline)
  • Retention rate at 1-month follow-up(At 1-month follow-up)
  • Adherence to intervention at baseline(At baseline)
  • Adherence to intervention at 1-week follow-up(At 1-week follow-up)
  • Adherence to intervention at 1-month follow-up(At 1-month follow-up)
  • Retention rate at 3-month follow-up(At 3-month follow-up)
  • Completion rate at 1-month follow-up(At 1-month follow-up)
  • Eligibility rate(Immediately after the training workshop)
  • Retention rate at 1-week follow-up(At 1-week follow-up)
  • Completion rate at 3-month follow-up(At 3-month follow-up)
  • Missing data at 1-month follow-up(At 1-month follow-up)
  • Missing data at 3-month follow-up(At 3-month follow-up)
  • Missing data at 6-month follow-up(At 6-month follow-up)
  • Randomization rate(Immediately after the training workshop)
  • Completion rate at 6-month follow-up(At 6-month follow-up)
  • Adverse events(At the 6 months follow up)
  • Consent rate(Immediately after the training workshop)
  • Attendance rate(Immediately after the training workshop)
  • Adherence to intervention at 3-month follow-up(At 3-month follow-up)
  • Adherence to intervention at 6-month follow-up(At 6-month follow-up)
  • Completion rate at 1-week follow-up(At 1-week follow-up)
  • Screen rate(Immediately after the training workshop)
  • Retention rate at 6 month follow-up(At 6-month follow-up)
  • Completion rate at baseline(At baseline)
  • Missing data at baseline(At baseline)
  • Missing data at 1-week follow-up(At 1-week follow-up)

Study Sites (1)

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