Mixed and Match vs One-size-fits-all

Smoking Cessation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05297370
• Other study ID #: SDTM-adult
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: The Hong Kong Polytechnic University
• Contact: Katherine Lam, PhD
• Phone: 27666420
• Email: kwkatlam[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Mixed and match Intervention
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.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Screening rate	calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available	at day 1
Secondary	Eligibility rate	calculated by dividing the number of smokers who are eligible by the number who are screened.	at day 1
Secondary	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
Secondary	Attendance rate	calculated by dividing the number of smokers who complete the intervention by those who are randomized.	Immediately after the training workshop
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Missing data at 1-week follow-up	calculated as the percentage of missing values in the dataset	At 1-week follow-up
Secondary	Missing data at 1-month follow-up	calculated as the percentage of missing values in the dataset	At 1-month follow-up
Secondary	Missing data at 3-month follow-up	calculated as the percentage of missing values in the dataset	At 3-month follow-up
Secondary	Missing data at 6-month follow-up	calculated as the percentage of missing values in the dataset	At 6-month follow-up
Secondary	Adverse events at 6-month follow-up	Participants will report any unfavorable and unintended events	At 6-month follow-up
Secondary	Adverse events at 1-week follow-up	Participants will report any unfavorable and unintended events	At 1-week follow-up
Secondary	Adverse events at 1-month follow-up	Participants will report any unfavorable and unintended events	At 1-month follow-up
Secondary	Adverse events at 3-month follow-up	Participants will report any unfavorable and unintended events	At 3-month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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