Mixed and Match vs One-size-fits-all

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Mixed and match Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Mixed and Match<br>Participants can choose to receive their own smoking cessation treatment options from our menu. | Behavioral: Mixed and match Intervention<br>* 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.<br>|
| Other: Control<br>Participants will receive a self-help quitting leaflet | Other: Control<br>* Participants in the control group will receive a self-help quitting leaflet issued by the TACO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening rate | calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available | at day 1 | 
| Eligibility rate | calculated by dividing the number of smokers who are eligible by the number who are screened. | at day 1 | 
| Randomization rate | calculated by dividing the number of smokers who are randomized into intervention and control groups by those who provide consent. | at day 1 | 
| Attendance rate | calculated by dividing the number of smokers who complete the intervention by those who are randomized. | Immediately after the training workshop | 
| Retention rate at 1-week follow-up | calculated by dividing the number of smokers who remain in the study by those who are randomized | At 1-week follow-up | 
| Retention rate at 1-month follow-up | calculated by dividing the number of smokers who remain in the study by those who are randomized | At 1-month follow-up | 
| Retention rate at 6-month follow-up | calculated by dividing the number of smokers who remain in the study by those who are randomized | At 6-month follow-up | 
| Retention rate at 3-month follow-up | calculated by dividing the number of smokers who remain in the study by those who are randomized | At 3-month follow-up | 
| Adherence to intervention protocol 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 | At 1-week follow-up | 
| Adherence to intervention protocol 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 | At 1-month follow-up | 
| Adherence to intervention protocol 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 | At 3-month follow-up | 
| Adherence to intervention protocol 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 | At 6-month follow-up | 
| Complete rate at 1-week follow-up | calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed | At 1-week follow-up | 
| Complete rate at 1-month follow-up | calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed | At 1-month follow-up | 
| Complete rate at 3-month follow-up | calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed | At 3-month follow-up | 
| Complete rate at 6-month follow-up | calculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed | At 6-month follow-up | 
| Missing data at 1-week follow-up | calculated as the percentage of missing values in the dataset | At 1-week follow-up | 
| Missing data at 1-month follow-up | calculated as the percentage of missing values in the dataset | At 1-month follow-up | 
| Missing data at 3-month follow-up | calculated as the percentage of missing values in the dataset | At 3-month follow-up | 
| Missing data at 6-month follow-up | calculated as the percentage of missing values in the dataset | At 6-month follow-up | 
| Adverse events at 6-month follow-up | Participants will report any unfavorable and unintended events | At 6-month follow-up | 
| Adverse events at 1-week follow-up | Participants will report any unfavorable and unintended events | At 1-week follow-up | 
| Adverse events at 1-month follow-up | Participants will report any unfavorable and unintended events | At 1-month follow-up | 
| Adverse events at 3-month follow-up | Participants will report any unfavorable and unintended events | At 3-month follow-up | 
| Self-reported abstinence at 1-week follow-up | Participants will be asked about their self-reported abstinence in the past 7 and 30 days | At 1-week follow-up | 
| Self-reported abstinence at 1-month follow-up | participants will be asked about their self-reported abstinence in the past 7 and 30 days | At 1-month follow-up | 
| Self-reported abstinence at 3-month follow-up | participants will be asked about their self-reported abstinence in the past 7 and 30 days | At 3-month follow-up | 
| Self-efficacy 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. | at 1-week follow-up | 
| Self-efficacy 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. | at 1-month follow-up | 
| Self-efficacy 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. | at 3-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-determination theory, adult smokers, Mixed and match, one-size-fits-all, feasibility, abstinence, quit