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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05297370
Enrollment
500
Registered
2022-03-28
Start date
2022-07-01
Completion date
2023-12-31
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

self-determination theory, adult smokers, Mixed and match, one-size-fits-all, feasibility, abstinence, quit

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

Interventions

BEHAVIORALMixed 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.

OTHERControl

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

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Self-reported abstinence at 6-month follow-upAt 6-month follow-upparticipants will be asked about their self-reported abstinence in the past 7 and 30 days
Biochemically validated abstinenceAt 6 months follow-upvalidate 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
Self-efficacy at 6-month follow-upAt 6-month follow-upParticipants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.

Secondary

MeasureTime frameDescription
Attendance rateImmediately after the training workshopcalculated by dividing the number of smokers who complete the intervention by those who are randomized.
Retention rate at 1-week follow-upAt 1-week follow-upcalculated by dividing the number of smokers who remain in the study by those who are randomized
Retention rate at 1-month follow-upAt 1-month follow-upcalculated by dividing the number of smokers who remain in the study by those who are randomized
Retention rate at 6-month follow-upAt 6-month follow-upcalculated by dividing the number of smokers who remain in the study by those who are randomized
Retention rate at 3-month follow-upAt 3-month follow-upcalculated by dividing the number of smokers who remain in the study by those who are randomized
Adherence to intervention protocol at 1-week follow-upAt 1-week follow-upcalculated 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-upAt 1-month follow-upcalculated 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-upAt 3-month follow-upcalculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
Adherence to intervention protocol at 6-month follow-upAt 6-month follow-upcalculated by dividing the number of smokers who follow and practice the chosen treatment options by those who are randomized
Complete rate at 1-week follow-upAt 1-week follow-upcalculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
Complete rate at 1-month follow-upAt 1-month follow-upcalculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
Complete rate at 3-month follow-upAt 3-month follow-upcalculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
Complete rate at 6-month follow-upAt 6-month follow-upcalculated by dividing the number of smokers who returned questionnaires by the number of questionnaires distributed
Screening rateat day 1calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available
Missing data at 1-month follow-upAt 1-month follow-upcalculated as the percentage of missing values in the dataset
Missing data at 3-month follow-upAt 3-month follow-upcalculated as the percentage of missing values in the dataset
Missing data at 6-month follow-upAt 6-month follow-upcalculated as the percentage of missing values in the dataset
Adverse events at 6-month follow-upAt 6-month follow-upParticipants will report any unfavorable and unintended events
Adverse events at 1-week follow-upAt 1-week follow-upParticipants will report any unfavorable and unintended events
Adverse events at 1-month follow-upAt 1-month follow-upParticipants will report any unfavorable and unintended events
Adverse events at 3-month follow-upAt 3-month follow-upParticipants will report any unfavorable and unintended events
Self-reported abstinence at 1-week follow-upAt 1-week follow-upParticipants will be asked about their self-reported abstinence in the past 7 and 30 days
Self-reported abstinence at 1-month follow-upAt 1-month follow-upparticipants will be asked about their self-reported abstinence in the past 7 and 30 days
Self-reported abstinence at 3-month follow-upAt 3-month follow-upparticipants will be asked about their self-reported abstinence in the past 7 and 30 days
Self-efficacy at 1-week follow-upat 1-week follow-upParticipants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
Self-efficacy at 1-month follow-upat 1-month follow-upParticipants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
Self-efficacy at 3-month follow-upat 3-month follow-upParticipants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.
Missing data at 1-week follow-upAt 1-week follow-upcalculated as the percentage of missing values in the dataset
Eligibility rateat day 1calculated by dividing the number of smokers who are eligible by the number who are screened.
Randomization rateat day 1calculated by dividing the number of smokers who are randomized into intervention and control groups by those who provide consent.

Contacts

Primary ContactKatherine Lam, PhD
kwkatlam@polyu.edu.hk27666420
Backup ContactEva Ho, PhD
kyeva.ho@polyu.edu.hk27666417

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026