NCT04875546

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

April 20, 2021

Last Update Submit

May 3, 2021

Conditions

Keywords

smokingalcoholadolescents

Outcome Measures

Primary Outcomes (2)

  • The biochemical validation

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

    At the 6-month follow-up

  • Structured questionnaire

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

    At baseline

Secondary Outcomes (26)

  • Randomization rate

    Immediately after the training workshop

  • Attendance rate

    Immediately after the training workshop

  • 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

  • +21 more secondary outcomes

Study Arms (3)

Standard treatment

ACTIVE COMPARATOR

* A 5'A' and '5'R' models * STAR method for quitting

Behavioral: Standard treatment

Integrated Intervention

ACTIVE COMPARATOR

* A 5'A' and '5'R' models * Receive brief advice on alcohol use based on the FRAMES model * Complete the Alcohol Use Disorders Identification Test

Behavioral: Integrated Intervention

Control

SHAM COMPARATOR

Participants will receive two leaflets.

Other: Control

Interventions

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.

Standard treatment

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.

Integrated Intervention
ControlOTHER

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.

Control

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • have a compromised mental status and/or communication problems.
  • participating in other smoking cessation interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ka Yan Ho

Hong Kong, Hong Kong,China, 0000, Hong Kong

Location

MeSH Terms

Conditions

Adolescent BehaviorSmoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ka Yan Ho, Phd

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka Yan Ho, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 20, 2021

First Posted

May 6, 2021

Study Start

July 1, 2022

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations