NCT05297370

Brief Summary

Most existing smoking cessation services are based on '5A's' and '5R's' models which are recognized by the World Health Organization as a standardized tool for smoking cessation. While there are more techniques that are known to be effective and could be incorporated in existing smoking cessation interventions to further promote their effectiveness. This study is to examine the effectiveness SDTM in assisting adult smokers in Hong Kong to quit.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2021

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 28, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

May 18, 2021

Last Update Submit

March 22, 2022

Conditions

Keywords

self-determination theoryadult smokersMixed and matchone-size-fits-allfeasibilityabstinencequit

Outcome Measures

Primary Outcomes (3)

  • Self-reported abstinence at 6-month follow-up

    participants will be asked about their self-reported abstinence in the past 7 and 30 days

    At 6-month follow-up

  • Biochemically validated abstinence

    validate the self-reported abstinence if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests

    At 6 months follow-up

  • Self-efficacy at 6-month follow-up

    Participants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.

    At 6-month follow-up

Secondary Outcomes (30)

  • Screening rate

    at day 1

  • Eligibility rate

    at day 1

  • Randomization rate

    at day 1

  • Attendance rate

    Immediately after the training workshop

  • Retention rate at 1-week follow-up

    At 1-week follow-up

  • +25 more secondary outcomes

Study Arms (2)

Mixed and Match

OTHER

Participants can choose to receive their own smoking cessation treatment options from our menu.

Behavioral: Mixed and match Intervention

Control

OTHER

Participants will receive a self-help quitting leaflet

Other: Control

Interventions

Participants will receive a brief 15-minute counselling session based on the 5A's' and '5R's' models by our trained research assistant. Participants will be able to choose their smoking cessation treatment options from our menu.

Mixed and Match
ControlOTHER

Participants in the control group will receive a self-help quitting leaflet issued by the TACO

Control

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have smoking in the previous 30 days.
  • be above 25 years old
  • able to speak Cantonese and read Chinese

You may not qualify if:

  • who are receiving current smoking cessation services
  • report psychological disorders
  • at risk of suicide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Katherine Lam, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Lam, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 18, 2021

First Posted

March 28, 2022

Study Start

July 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share