Mixed and Match vs One-size-fits-all
- Conditions
- Smoking Cessation
- Interventions
- Behavioral: Mixed and match InterventionOther: Control
- Registration Number
- NCT05297370
- Lead Sponsor
- The Hong Kong Polytechnic University
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- have smoking in the previous 30 days.
- be above 25 years old
- able to speak Cantonese and read Chinese
- who are receiving current smoking cessation services
- report psychological disorders
- at risk of suicide
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mixed and Match Mixed and match Intervention Participants can choose to receive their own smoking cessation treatment options from our menu. Control Control Participants will receive a self-help quitting leaflet
- Primary Outcome Measures
Name Time Method Self-efficacy at 6-month follow-up 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.
Self-reported abstinence at 6-month follow-up At 6-month follow-up participants will be asked about their self-reported abstinence in the past 7 and 30 days
Biochemically validated abstinence At 6 months follow-up 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
- Secondary Outcome Measures
Name Time Method Missing data at 6-month follow-up At 6-month follow-up calculated as the percentage of missing values in the dataset
Screening rate at day 1 calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available
Randomization rate at day 1 calculated by dividing the number of smokers who are randomized into intervention and control groups by those who provide consent.
Retention rate at 3-month follow-up At 3-month follow-up calculated by dividing the number of smokers who remain in the study by those who are randomized
Adherence to intervention protocol at 6-month follow-up At 6-month follow-up calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
Attendance rate Immediately after the training workshop calculated by dividing the number of smokers who complete the intervention by those who are randomized.
Retention rate at 1-month follow-up At 1-month follow-up calculated by dividing the number of smokers who remain in the study by those who are randomized
Complete rate at 1-week follow-up At 1-week follow-up calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
Missing data at 3-month follow-up At 3-month follow-up calculated as the percentage of missing values in the dataset
Self-efficacy at 1-week follow-up at 1-week 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.
Retention rate at 1-week follow-up At 1-week follow-up calculated by dividing the number of smokers who remain in the study by those who are randomized
Complete rate at 1-month follow-up At 1-month follow-up calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
Eligibility rate at day 1 calculated by dividing the number of smokers who are eligible by the number who are screened.
Retention rate at 6-month follow-up At 6-month follow-up calculated by dividing the number of smokers who remain in the study by those who are randomized
Adherence to intervention protocol at 1-week follow-up At 1-week follow-up calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
Adherence to intervention protocol at 1-month follow-up At 1-month follow-up calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
Adherence to intervention protocol at 3-month follow-up At 3-month follow-up calculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
Adverse events at 3-month follow-up At 3-month follow-up Participants will report any unfavorable and unintended events
Self-reported abstinence at 1-week follow-up At 1-week follow-up Participants will be asked about their self-reported abstinence in the past 7 and 30 days
Self-reported abstinence at 3-month follow-up At 3-month follow-up participants will be asked about their self-reported abstinence in the past 7 and 30 days
Complete rate at 3-month follow-up At 3-month follow-up calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
Complete rate at 6-month follow-up At 6-month follow-up calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
Missing data at 1-month follow-up At 1-month follow-up calculated as the percentage of missing values in the dataset
Adverse events at 1-month follow-up At 1-month follow-up Participants will report any unfavorable and unintended events
Self-reported abstinence at 1-month follow-up At 1-month follow-up participants will be asked about their self-reported abstinence in the past 7 and 30 days
Missing data at 1-week follow-up At 1-week follow-up calculated as the percentage of missing values in the dataset
Adverse events at 1-week follow-up At 1-week follow-up Participants will report any unfavorable and unintended events
Self-efficacy at 1-month follow-up at 1-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.
Adverse events at 6-month follow-up At 6-month follow-up Participants will report any unfavorable and unintended events
Self-efficacy at 3-month follow-up at 3-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.