Clinical trial NCT05297370: Mixed and Match vs One-size-fits-all
Official title: Mixed and Match Versus One-size-fits-all: A Randomized Controlled Trial of Self-determination Theory on a Menu of Smoking Cessation Options (SDTM) Among Adult Smokers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking Cessation
Keywords: self-determination theory
adult smokers
Mixed and match
one-size-fits-all
feasibility
abstinence
quit
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 500
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A randomized controlled trial (RCT) will be conducted. One-hundred adult smokers aged 25 or above will be recruited from smoking hotspots in Hong Kong. Participants in the intervention group will be contacted by our trained research assistant to receive a telephone counselling session at baseline. Participants can choose to receive their own smoking cessation treatment options from our menu. Control group participants will only receive a self-help quitting leaflet

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Self-reported abstinence at 6-month follow-up
timeFrame: At 6-month follow-up
measure: Biochemically validated abstinence
timeFrame: At 6 months follow-up
measure: Self-efficacy at 6-month follow-up
timeFrame: At 6-month follow-up
Secondary outcomes:
measure: Screening rate
timeFrame: at day 1
measure: Eligibility rate
timeFrame: at day 1
measure: Randomization rate
timeFrame: at day 1
measure: Attendance rate
timeFrame: Immediately after the training workshop
measure: Retention rate at 1-week follow-up
timeFrame: At 1-week follow-up
measure: Retention rate at 1-month follow-up
timeFrame: At 1-month follow-up
measure: Retention rate at 6-month follow-up
timeFrame: At 6-month follow-up
measure: Retention rate at 3-month follow-up
timeFrame: At 3-month follow-up
measure: Adherence to intervention protocol at 1-week follow-up
timeFrame: At 1-week follow-up
measure: Adherence to intervention protocol at 1-month follow-up
timeFrame: At 1-month follow-up
measure: Adherence to intervention protocol at 3-month follow-up
timeFrame: At 3-month follow-up
measure: Adherence to intervention protocol at 6-month follow-up
timeFrame: At 6-month follow-up
measure: Complete rate at 1-week follow-up
timeFrame: At 1-week follow-up
measure: Complete rate at 1-month follow-up
timeFrame: At 1-month follow-up
measure: Complete rate at 3-month follow-up
timeFrame: At 3-month follow-up
measure: Complete rate at 6-month follow-up
timeFrame: At 6-month follow-up
measure: Missing data at 1-week follow-up
timeFrame: At 1-week follow-up
measure: Missing data at 1-month follow-up
timeFrame: At 1-month follow-up
measure: Missing data at 3-month follow-up
timeFrame: At 3-month follow-up
measure: Missing data at 6-month follow-up
timeFrame: At 6-month follow-up
measure: Adverse events at 6-month follow-up
timeFrame: At 6-month follow-up
measure: Adverse events at 1-week follow-up
timeFrame: At 1-week follow-up
measure: Adverse events at 1-month follow-up
timeFrame: At 1-month follow-up
measure: Adverse events at 3-month follow-up
timeFrame: At 3-month follow-up
measure: Self-reported abstinence at 1-week follow-up
timeFrame: At 1-week follow-up
measure: Self-reported abstinence at 1-month follow-up
timeFrame: At 1-month follow-up
measure: Self-reported abstinence at 3-month follow-up
timeFrame: At 3-month follow-up
measure: Self-efficacy at 1-week follow-up
timeFrame: at 1-week follow-up
measure: Self-efficacy at 1-month follow-up
timeFrame: at 1-month follow-up
measure: Self-efficacy at 3-month follow-up
timeFrame: at 3-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Katherine Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References: