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

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.

Read the 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

Conditions: Smoking Cessation
Being tested: Mixed and match Intervention, Control
Keywords: self-determination theory, adult smokers, Mixed and match, one-size-fits-all, feasibility, abstinence, quit
Medical subject headings: Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mixed and match InterventionBehavioural
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.
ControlOther
Participants in the control group will receive a self-help quitting leaflet issued by the TACO

Study groups in NCT05297370
Study group	Role	What they receive
Mixed and Match	Other	Participants can choose to receive their own smoking cessation treatment options from our menu. Receives: Behavioral: Mixed and match Intervention
Control	Other	Participants will receive a self-help quitting leaflet Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Self-reported abstinence at 6-month follow-up
participants will be asked about their self-reported abstinence in the past 7 and 30 days
Measured: 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
Measured: 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.
Measured: At 6-month follow-up

Secondary outcomes (30)

Screening rate
calculated as the number of smokers screened at smoking hotspots by the RA divided by number of smokers available
Measured: at day 1
Eligibility rate
calculated by dividing the number of smokers who are eligible by the number who are screened.
Measured: 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.
Measured: at day 1
Attendance rate
calculated by dividing the number of smokers who complete the intervention by those who are randomized.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 6-month follow-up
Missing data at 1-week follow-up
calculated as the percentage of missing values in the dataset
Measured: At 1-week follow-up
Missing data at 1-month follow-up
calculated as the percentage of missing values in the dataset
Measured: At 1-month follow-up
Missing data at 3-month follow-up
calculated as the percentage of missing values in the dataset
Measured: At 3-month follow-up
Missing data at 6-month follow-up
calculated as the percentage of missing values in the dataset
Measured: At 6-month follow-up
Adverse events at 6-month follow-up
Participants will report any unfavorable and unintended events
Measured: At 6-month follow-up
Adverse events at 1-week follow-up
Participants will report any unfavorable and unintended events
Measured: At 1-week follow-up
Adverse events at 1-month follow-up
Participants will report any unfavorable and unintended events
Measured: At 1-month follow-up
Adverse events at 3-month follow-up
Participants will report any unfavorable and unintended events
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202231 Dec 2023

First posted28 Mar 2022
Study start1 Jul 2022 (estimated)
Primary completion31 Dec 2023 (estimated)
Study completion31 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Smoking CessationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05297370
Sponsor's protocol ID: SDTM-adult
Status last verified: Mar 2022
First submitted: 18 May 2021
Last updated: 28 Mar 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Katherine Lam, PhD

27666420

kwkatlam@polyu.edu.hk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation

All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05297370
Acronym / sponsor ID: SDTM-adult
Conditions: Smoking Cessation
Keywords: self-determination theory, adult smokers, Mixed and match, one-size-fits-all, feasibility, abstinence, quit
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 500 participants (estimated)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 1 Jul 2022 (estimated)
Primary completion: 31 Dec 2023 (estimated)
Study completion: 31 Dec 2023 (estimated)
First posted: 28 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mixed and Match	Other	Behavioral: Mixed and match InterventionParticipants can choose to receive their own smoking cessation treatment options from our menu.
Control	Other	Other: ControlParticipants will receive a self-help quitting leaflet

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

have smoking in the previous 30 days.
be above 25 years old
able to speak Cantonese and read Chinese

Key exclusion criteria (3 listed)

who are receiving current smoking cessation services
report psychological disorders
at risk of suicide

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mixed and match InterventionParticipants 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.	Behavioural	Mixed and Match
ControlParticipants in the control group will receive a self-help quitting leaflet issued by the TACO	Other	Control

Primary outcome

Self-reported abstinence at 6-month follow-up
Time frame: At 6-month follow-up
participants will be asked about their self-reported abstinence in the past 7 and 30 days
Biochemically validated abstinence
Time frame: 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
Self-efficacy at 6-month follow-up
Time frame: 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.

30 secondary outcomes

Screening rate
Time frame: at day 1
Eligibility rate
Time frame: at day 1
Randomization rate
Time frame: at day 1
Attendance rate
Time frame: Immediately after the training workshop
Retention rate at 1-week follow-up
Time frame: At 1-week follow-up
Retention rate at 1-month follow-up
Time frame: At 1-month follow-up
Retention rate at 6-month follow-up
Time frame: At 6-month follow-up
Retention rate at 3-month follow-up
Time frame: At 3-month follow-up
Adherence to intervention protocol at 1-week follow-up
Time frame: At 1-week follow-up
Adherence to intervention protocol at 1-month follow-up
Time frame: At 1-month follow-up
Adherence to intervention protocol at 3-month follow-up
Time frame: At 3-month follow-up
Adherence to intervention protocol at 6-month follow-up
Time frame: At 6-month follow-up
Complete rate at 1-week follow-up
Time frame: At 1-week follow-up
Complete rate at 1-month follow-up
Time frame: At 1-month follow-up
Complete rate at 3-month follow-up
Time frame: At 3-month follow-up
Complete rate at 6-month follow-up
Time frame: At 6-month follow-up
Missing data at 1-week follow-up
Time frame: At 1-week follow-up
Missing data at 1-month follow-up
Time frame: At 1-month follow-up
Missing data at 3-month follow-up
Time frame: At 3-month follow-up
Missing data at 6-month follow-up
Time frame: At 6-month follow-up
Adverse events at 6-month follow-up
Time frame: At 6-month follow-up
Adverse events at 1-week follow-up
Time frame: At 1-week follow-up
Adverse events at 1-month follow-up
Time frame: At 1-month follow-up
Adverse events at 3-month follow-up
Time frame: At 3-month follow-up
Self-reported abstinence at 1-week follow-up
Time frame: At 1-week follow-up
Self-reported abstinence at 1-month follow-up
Time frame: At 1-month follow-up
Self-reported abstinence at 3-month follow-up
Time frame: At 3-month follow-up
Self-efficacy at 1-week follow-up
Time frame: at 1-week follow-up
Self-efficacy at 1-month follow-up
Time frame: at 1-month follow-up
Self-efficacy at 3-month follow-up
Time frame: at 3-month follow-up

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
Individual participant dataSharing planned: No

Related trials for Smoking Cessation

Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Katherine Lam, PhD contact

27666420

kwkatlam@polyu.edu.hk

Eva Ho, PhD contact

27666417

kyeva.ho@polyu.edu.hk

Katherine Lam, PhD principal investigator

The Hong Kong Polytechnic University

Questions about this trial

What is this clinical trial studying?

A study testing Mixed and match Intervention in people with Smoking Cessation, run by The Hong Kong Polytechnic University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Katherine Lam, PhD (27666420, kwkatlam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported abstinence at 6-month follow-up (time frame: At 6-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05297370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.