Mixed and Match vs One-size-fits-all

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Mixed and match Intervention; Other: Control

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

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine Lam, PhD; Phone Number: 27666420; Email: kwkatlam@polyu.edu.hk
• Study Contact Backup: Name: Eva Ho, PhD; Phone Number: 27666417; Email: kyeva.ho@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Katherine Lam, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: feasibility; abstinence; self-determination theory; quit; adult smokers; Mixed and match; one-size-fits-all
• Other Study ID Numbers: SDTM-adult

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No