ClinicalTrials.gg
CompletedNCT03717051Updated May 16, 2024Results posted

Use of Nicotine Replacement Therapy (NRT) Sample and Brief Smoking Cessation Advice for Recruiting Smokers

An interventional study of Nicotine replacement therapy (NRT) sampling and Medication counseling in Smoking Cessation, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
834
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Background More than 60% of the daily smokers in Hong Kong have never tried and have no intention to quit smoking. About 30.8% of daily smokers attempted to quit but failed. Nicotine replacement therapy (NRT) is a safe and effective pharmacotherapy to reduce withdrawal symptoms during early stage of tobacco abstinence and increase quit rate. However, the prevalence of using NRT in Hong Kong is lower than most of the developed countries. The proposed project aims to test if providing free NRT sampling to smokers can increase quit attempt, the use of smoking cessation (SC) services and abstinence.

Methods University undergraduate students will be trained, and will invite smokers at outdoor smoking hotspots to quit smoking and enroll into SC services. Eligible smokers will be randomized to experimental or control group according to a cluster randomization, using recruitment session as the randomization unit. The experimental group will be provided with 1-week free NRT sampling and medication counselling, whereas the control group will be provided medication counselling. Both groups are advised to enroll in the SC services. The primary outcome is the proportion of smokers who report quit attempts at 1 month follow-up

Discussions The findings will inform the feasibility and effectiveness of delivering free NRT sampling to increase quit attempt, the use of smoking cessation services and abstinence. It will yield more information on smokers' adherence to the NRT sampling, side effect and safety issue of the usage.

Read the detailed description

Study design

The proposed project has 4 phases: (1) Training of SC ambassadors (SCAs) for the SC promotion; (2) SC promotion sessions to deliver the medication counselling and NRT sampling (experimental group), or the advice to use NRT only (control group); (3) Follow-up of the recruited smokers; (4) Evaluation of the effectiveness of training, promotions, and use of NRT sampling. To examine the effectiveness of NRT sampling for recruitment and quitting, a multi-site cluster RCT (allocation ratio 2:1) will be used. All promotion sessions will be randomly allocated to either the experimental or the control group. The experimental group will receive medication counselling and NRT samples, while the control group only receive the advice to use NRT. Both groups are advised to enroll in any smoking cessation service in Hong Kong. Because smokers who receive NRT sampling will be more likely to participate in the study, the experimental sessions will then recruit more smokers than the control sessions. Hence, the allocation ratio of participants is arbitrarily set at 2:1. To increase comparability between the two groups, the promotion sessions of one hotspot will be randomly allocated to either group. All recruitment and quitting outcomes in the smokers between the experimental and control group will be compared.

Subjects

Smokers with the following inclusion criteria will be invited to participate in our RCT: (1) Hong Kong residents, (2) aged 18 to 65 years, (3) have used any tobacco products in the past month, (4) able to read and speak Chinese, (5) have not used NRT for the past month, (6) no severe angina, serious cardiac arrhythmias and hypertension, (7) have not suffered acute myocardial event in the past 4 weeks, (8) neither pregnant nor breastfeeding, (9) not under medication and treatment due to mental illness. To confirm the smoking status, in those who use conventional cigarettes, smokers' exhaled carbon monoxide will be measured on-site. Nurses will measure the blood pressure if smoker is aged over 50 years old, obese by observation, or upon patient requests.

The inclusion criterion no. 3 was "smoke 10 cigarettes or more per day in the past week" and is amended to "have used any tobacco products in the past month". The initial intention of setting the inclusion criteria of at least 10 cigarettes per day (CPD) is to recruit smokers who have moderate to strong level of craving and a greater need for NRT. However, we also recognize that one of the objectives of the research is to promote the use of NRT for quit attempts with NRT sampling. In fact, smokers who smoke less than 10 CPD can also benefit from using NRT gums. Therefore, the change in the inclusion criteria does not deviate from our research aim. In contrast, with the removal of the criterion for CPD, we will be able to reach out to a larger group of smoking population and encourage more smokers to use NRT to quit smoking.

Procedures

In the experimental sessions, the SCAs will approach and distribute souvenirs (e.g. a pen) or leaflets to the smokers at outdoor smoking hotspots for 3-4 hours. The souvenirs and leaflets will have SC messages, quitline number and other SC services. If a smoker is willing to accept them and talk to the SCAs, the SCAs will advise the smoker to quit using the AWARD protocol. The AWARD protocol includes (1) Ask the smoking history, (2) Warn about the high risk (i.e., half of the smokers will die of smoking-related diseases), (3) Advise to quit, (4) Refer to the SC clinics of TWGHs and (5) Repeat the above advice (Do-it-again) [4]. Our previous studies have shown that the AWARD protocol is a feasible and appropriate tool used by non-healthcare professionals to promote smoking cessation [4-6]. If the smoker is interested in smoking cessation, the SCAs will introduce NRT to the smoker and conduct a preliminary assessment of his/her eligibility for enrolling in the "NRT sampling" programme. The SCAs will invite him/her to go to the smoking cessation truck nearby to receive counselling by an onsite nurse. If the smoker is not eligible, he/she can still enroll in the cessation service provided by the SC clinics. The intervention and assessment will mostly be taken place in a smoking cessation truck when the recruitment venues allow us to park the truck nearby, or at outdoor areas when a parking space for a truck is not available.

Intervention: NRT sampling and medication counselling

In the experimental sessions, an onsite nurse will assess whether each participant is fit for using NRT with further assessment on his/her current physical status, medication and blood pressure. If the participant is willing to use NRT to quit smoking and pass the nurse's assessment, he/she will be prescribed the NRT sample, regardless of whether they use NRT for smoking reduction and when the quit day is. The nurse will help the participant decide which type of NRT product (gum: 2mg, patch: 14mg or 21mg) that he/she can use and advise him/her on how to use the NRT based on his/her smoking habit and daily cigarette consumption. In addition, the nurse will deliver medication counselling which addresses five main components: (1) the benefits for using NRT in quitting, (2) withdrawal symptoms due to smoking cessation, (3) side effects of NRT, (4) instructions for using NRT, and (5) making appointments for TWGHs SC clinics. An instruction card for using NRT will be given. Afterwards, the participant will receive 1-week free NRT. Our research staff will send the NRT sample via mail within 2 days.

In the control sessions, all the above procedures for the experimental group will be applied, except that they will not receive an NRT sample and an instruction card about the use of NRT. Instead, they will be advised to obtain free NRT by enrolling in the SC clinics. Both groups will receive a one-page leaflet provided by the SC clinics, and encouraged to make service appointments with the SC clinics. The leaflet briefly introduced this RCT, the use of NRT and the service provided by the smoking cessation clinics.

When the participant has finished the above procedures, the research assistant or trained ambassadors (under supervision of the research staff) or the nurse will introduce the trial of evaluating the effect of NRT sample and the outreach service and screen the eligibility of participating in the trial. If the participant is eligible, the research assistant will seek his/her consent to participate in the trial, and complete a baseline questionnaire.

Some smokers are willing to participate in the RCT, but they have no time to receive all intervention or complete all recruitment procedures at the hotspots. In these cases, the SCAs will only briefly introduce the RCT, ask the participants to give written consent. A nurse will contact these participants to complete the baseline questionnaire and deliver the intervention (medication advice and NRT prescription) within the same day. If the participants are in the experimental group, after the telephone counselling by the nurse, our research staff will send the NRT sample via mail within 2 days.

Randomization

We will use cluster randomization based on promotion session as the cluster unit because the procedures of individual randomization are difficult in outdoor areas as found in our pilot RCT. The PI will randomly allocate the promotion sessions within a hotspot to the 2 groups by a list of group allocation which is based on a list of random numbers from Excel programme. Each hotspot will have 2 or more promotion sessions, and each session will last for about 3-4 hours. If a hotspot has 2 promotion sessions on 1 single day, the 2 sessions will be allocated into the same RCT group, and we will organize 2 more promotion sessions in this hotspot on another day.

Allocation concealment

All recruitment staff will know the group allocation before each promotion session, so no group concealment can be done.

Blinding

Participants, recruitment staff and nurses cannot and will not be blinded to the intervention. Assessors of the follow-up outcomes and the research analysts will not be involved in the recruitment and intervention delivery, and will be blinded to the group allocation (single blindness).

Baseline assessments

Baseline information includes socio-demographics, current use of conventional and new tobacco products, such as heat-not-burn tobacco products and electronic cigarettes, history of quit attempts, and intention to quit. Nicotine dependence will be assessed by the Fagerström Test for Nicotine Dependence.24 Participants will also be asked about their self-efficacy in quitting, based on the perceived importance, difficulty and confidence to quit smoking on a Likert scale from 0 to 10.

Follow-up

All the smokers who consent to the follow-up will be contacted via telephone or WhatsApp around one week by a nurse or a trained research staff after recruitment. The aim of this follow-up is (1) to enquire if there is any progress towards smoking cessation and (2) encourage the use of NRT for a quit attempt and/or enrollment in SC services as soon as possible. If participants show no interest to quit, the nurse/research staff will use the "5R" approach to re-motivate the quitting intention. The "5R" approach is being adopted by the local and international smoking cessation guideline including the discussion on why quitting is important (relevance), hazards of smoking (risk), benefits of quitting (rewards), difficulties (roadblocks) and repeated quit attempts (repetition). If participants report any contra-indication(s) to NRT, the nurse/research staff will discuss the reasons with them, and, if necessary, refer the participants to the physician in the smoking cessation clinic.

At 1-, 3- and 6-month follow-up, the quitting outcomes will be assessed by a trained interviewer through telephone who is blinded to the subject's group status. A small amount (HK$50=US$6.4) of cash voucher will be offered to those who completed a follow-up survey. At 6-month follow-up, participants who reported no smoking in past 7 days will be invited for a biochemical validation of the abstinence. Participants with exhaled carbon monoxide 4ppm or below and saliva cotinine level below 10ng/ml will be considered as validated abstinence. Participants of the biochemical validation, no matter the abstinence status is confirmed, will be offered a HK$50 (US$6.4) cash voucher for the travel compensation.

Sample size determination

As we predicted that the recruitment sessions of providing free NRT samples will recruit more smokers, participant ratio of the 2 trial groups is arbitrarily set at 2:1. At the time we designed this trial, our preliminary analysis of the aforementioned pilot RCT showed that the rate of quit attempt in the intervention and control group was 26% and 12% at 3-month follow-up, respectively. We arbitrarily reduced these rates to 20% and 8% for 1-month follow-up. To detect a significant difference with normal test and a power of 95% and 5% significance level, we need 485 subjects in the RCT (allocation ratio 2:1; 323 vs 162). Based on the method of Eldridge et al. (2006),29 conservatively assuming that we could recruit 8 participants per session on average and the intra-cluster correlation coefficient was 0.1, the design effect is estimated to be 1.7. Thus, the minimum sample size required for the trial is 825 (=1.7 X 485) participants and 104 sessions in total. With the similar calculation, the required sample size for detecting a significant difference in the proportion of using any smoking cessation service is 421.

Statistical analysis

An independent data analyst will perform the data check of missing, duplication and validity on the completed dataset before analysis is done. All data will be de-identified in the data analysis. To assess the effect of NRT sampling to the process outcomes, the number of smokers who accept the brief advice or consent the RCT in each recruitment session will be the outcome variables of Poisson regression model, with group allocation as the predictor, and total number of approached smokers in that promotion session as the offset variable. Considering the possibility of correlated outcomes of participants within the recruitment session, an analysis by generalized estimating equations model, assigning session as a random effect, will be used to summarize the intervention effect on the primary outcome. The analysis adopted a longitudinal approach with an exchangeable structure for the correlation matrix of the outcome. Other secondary outcomes will be analyzed with either generalized estimating equations models (binary outcomes; e.g. tobacco abstinence) or linear mixed model (continuous outcomes; e.g. perceived importance to quit smoking). Both intention-to-treat (treating participants as smokers without quit attempts and no use of cessation services if they are lost to follow-up) and per protocol analysis will be done. Subgroup analysis of comparing the primary and secondary outcomes between participants receiving the nurse-led intervention onsite and those receiving the intervention via telephone will be done.

02

Conditions studied

  • Smoking Cessation

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Keywords

  • intervention
  • nicotine replacement sample
  • smoking cessation
  • smoking hotspots
03

In context

Smoking Cessation

350 studies on the registry are indexed under Smoking Cessation; 145 are open to participants now.

This study's enrollment of 834 is above the median of 150 across 326 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hong Kong residents
  • aged 18 to 65 years
  • have used any tobacco products in the past month
  • able to read and speak Chinese
  • have not used NRT for the past month

Exclusion criteria

Exclusion Criteria:

  • Have severe angina, serious cardiac arrhythmias and hypertension
  • Have suffered from acute myocardial event in the past 4 weeks
  • Pregnant nor breastfeeding
  • Under medication and treatment due to mental illness

One of the inclusion criteria was "smoke 10 cigarettes or more per day in the past week" and is amended to "have used any tobacco products in the past month". The initial intention of setting the inclusion criteria of at least 10 cigarettes per day (CPD) is to recruit smokers who have moderate to strong level of craving and a greater need for NRT. However, we also recognize that one of the objectives of the research is to promote the use of NRT for quit attempts with NRT sampling. In fact, smokers who smoke less than 10 CPD can also benefit from using NRT gums. Therefore, the change in the inclusion criteria does not deviate from our research aim. In contrast, with the removal of the criterion for CPD, we will be able to reach out to a larger group of smoking population and encourage more smokers to use NRT to quit smoking

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
834 participants (actual)

Study arms

  • Experimental
    Intervention

    The intervention group will receive nicotine replacement therapy (NRT) sampling and medication counseling. The nurse will help the subject to decide which NRT product (patch or gum) he/she can use and advise how to use the NRT based on his/her smoking habit and amount of cigarette consumption. In addition, the nurse will deliver medication counselling which addresses five main components: (1) the benefits for using NRT in quitting, (2) withdrawal symptoms due to smoking cessation, (3) side effects of NRT, (4) instructions for using NRT, and (5) making appointments for TWGHs SC clinics. Afterwards, the participant will receive 1-week free NRT, an education card about NRT and a one-page leaflet provided by the SC clinics.

    Drug: Nicotine replacement therapy (NRT) sampling · Behavioral: Medication counseling

  • Active comparator
    Control

    The control group subjects will receive medication counseling. They will be advised to obtain free NRT by enrolling in the smoking cessation services, but will not be given the sampling. The same one-page leaflet will be provided by the SC clinics.

    Behavioral: Medication counseling

Interventions

  • DrugNicotine replacement therapy (NRT) sampling

    1-week free NRT samples (patch or gum)

  • BehavioralMedication counseling

    Medication counseling

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong

    Number of participants who enroll in any smoking cessation service in Hong Kong

    Time frame: 1 month

  2. Number of Participants With Self-reported Quit Attempt

    No smoking for at least 24 hours in the past month

    Time frame: 1 month

Secondary outcomes

  1. Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong

    Number of participants who enroll in any smoking cessation service in Hong Kong

    Time frame: 3 months

  2. Number of Participants With Self-reported Quit Attempt

    No smoking for at least 24 hours in the past month

    Time frame: 3 months

  3. Number of Participants With Self-reported Use of NRT in Past Week/Month

    self-reported use of NRT in past week/month

    Time frame: 1 month

  4. Number of Participants With Self-reported Use of NRT in Past Week/Month

    self-reported use of NRT in past week/month

    Time frame: 3 months

  5. Number of Participants With Self-reported Tobacco Abstinence in Past 7 Days

    self-reported tobacco abstinence in past 7 days

    Time frame: 3 months

  6. Number of Participants With Self-reported Tobacco Abstinence in Past 30 Days

    self-reported tobacco abstinence in past 30 days

    Time frame: 3 months

  7. Number of Participants With Self-reported Tobacco Abstinence in Past 7 Days

    self-reported tobacco abstinence in past 7 days

    Time frame: 6 months

  8. Number of Participants With Self-reported Tobacco Abstinence in Past 30 Days

    self-reported tobacco abstinence in past 30 days

    Time frame: 6 months

  9. Biochemically Validated Abstinence at 6-month Follow-up

    measurement of exhaled carbon monoxide using a Smokerlyzer, and a saliva cotinine test

    Time frame: 6 months

  10. Perceived Importance, Difficulty and Confidence to Quit Smoking

    Self-efficacy will be evaluated according to the importance of quitting on a scale of 0 to 10 (0, least important; 10, most important), the difficulty of quitting on a scale of 0 to 10 (0, least difficult; 10, most difficult), and confidence in quitting on a scale of 0 to 10 (0, least confident; 10, most confident). For the scale of measuring quitting importance and confidence, higher scores mean a better outcome and for the scale of measuring difficulty, higher scores mean a worse outcome.

    Time frame: 1 month

  11. Perceived Importance, Difficulty and Confidence to Quit Smoking

    Self-efficacy will be evaluated according to the importance of quitting on a scale of 0 to 10 (0, least important; 10, most important), difficulty of quitting on a scale of 0 to 10 (0, least difficult; 10, most difficult), and confidence in quitting on a scale of 0 to 10 (0, least confident; 10, most confident)

    Time frame: 3 months

  12. Perceived Importance, Difficulty and Confidence to Quit Smoking

    Self-efficacy will be evaluated according to the importance of quitting on a scale of 0 to 10 (0, least important; 10, most important), difficulty of quitting on a scale of 0 to 10 (0, least difficult; 10, most difficult), and confidence in quitting on a scale of 0 to 10 (0, least confident; 10, most confident)

    Time frame: 6 months

  13. Progression Towards Smoking Cessation

    progression towards smoking cessation as measured by Incremental Behavior Change toward Smoking cessation (IBC-S). The minimum value is 3 and the maximum value is 27. Higher scores mean a better outcome.

    Time frame: 1 month

  14. Progression Towards Smoking Cessation

    progression towards smoking cessation as measured by Incremental Behavior Change toward Smoking cessation (IBC-S). The minimum value is 3 and the maximum value is 27. Higher scores mean a better outcome.

    Time frame: 3 months

  15. Progression Towards Smoking Cessation

    progression towards smoking cessation as measured by Incremental Behavior Change toward Smoking cessation (IBC-S). The minimum value is 3 and the maximum value is 27. Higher scores mean a better outcome.

    Time frame: 6 months

07

Results

Posted Jul 1, 2021

Participant flow

The recruitment started from July 1st, 2018 to June 30th, 2020. Participants of this study were recruited at outdoor smoking hotspots in Hong Kong.

Participant flow — Overall Study
MilestoneControlIntervention
Started352482
Completed352482
Not completed00

Outcome measures

PrimaryNumber of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong

Number of participants who enroll in any smoking cessation service in Hong Kong

Time frame:
1 month
Reported as:
Count of participants · Participants
Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong
ParticipantsInterventionControl
Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong156158
PrimaryNumber of Participants With Self-reported Quit Attempt

No smoking for at least 24 hours in the past month

Time frame:
1 month
Reported as:
Count of participants · Participants
Number of Participants With Self-reported Quit Attempt
ParticipantsInterventionControl
Number of Participants With Self-reported Quit Attempt214153
SecondaryNumber of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong

Number of participants who enroll in any smoking cessation service in Hong Kong

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong
ParticipantsInterventionControl
Number of Participants Who Enroll in Any Smoking Cessation Service in Hong Kong247213
SecondaryNumber of Participants With Self-reported Quit Attempt

No smoking for at least 24 hours in the past month

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants With Self-reported Quit Attempt
ParticipantsInterventionControl
Number of Participants With Self-reported Quit Attempt300243
SecondaryNumber of Participants With Self-reported Use of NRT in Past Week/Month

self-reported use of NRT in past week/month

Time frame:
1 month
Reported as:
Count of participants · Participants
Number of Participants With Self-reported Use of NRT in Past Week/Month
ParticipantsInterventionControl
Number of Participants With Self-reported Use of NRT in Past Week/Month192121
SecondaryNumber of Participants With Self-reported Use of NRT in Past Week/Month

self-reported use of NRT in past week/month

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants With Self-reported Use of NRT in Past Week/Month
ParticipantsInterventionControl
Number of Participants With Self-reported Use of NRT in Past Week/Month9286
SecondaryNumber of Participants With Self-reported Tobacco Abstinence in Past 7 Days

self-reported tobacco abstinence in past 7 days

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants With Self-reported Tobacco Abstinence in Past 7 Days
ParticipantsInterventionControl
Number of Participants With Self-reported Tobacco Abstinence in Past 7 Days9579
SecondaryNumber of Participants With Self-reported Tobacco Abstinence in Past 30 Days

self-reported tobacco abstinence in past 30 days

Time frame:
3 months
Reported as:
Count of participants · Participants
Number of Participants With Self-reported Tobacco Abstinence in Past 30 Days
ParticipantsInterventionControl
Number of Participants With Self-reported Tobacco Abstinence in Past 30 Days6852
SecondaryNumber of Participants With Self-reported Tobacco Abstinence in Past 7 Days

self-reported tobacco abstinence in past 7 days

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants With Self-reported Tobacco Abstinence in Past 7 Days
ParticipantsInterventionControl
Number of Participants With Self-reported Tobacco Abstinence in Past 7 Days10492
SecondaryNumber of Participants With Self-reported Tobacco Abstinence in Past 30 Days

self-reported tobacco abstinence in past 30 days

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants With Self-reported Tobacco Abstinence in Past 30 Days
ParticipantsInterventionControl
Number of Participants With Self-reported Tobacco Abstinence in Past 30 Days9377
SecondaryBiochemically Validated Abstinence at 6-month Follow-up

measurement of exhaled carbon monoxide using a Smokerlyzer, and a saliva cotinine test

Time frame:
6 months
Reported as:
Count of participants · Participants
Biochemically Validated Abstinence at 6-month Follow-up
ParticipantsInterventionControl
Biochemically Validated Abstinence at 6-month Follow-up2210
SecondaryPerceived Importance, Difficulty and Confidence to Quit Smoking

Self-efficacy will be evaluated according to the importance of quitting on a scale of 0 to 10 (0, least important; 10, most important), the difficulty of quitting on a scale of 0 to 10 (0, least difficult; 10, most difficult), and confidence in quitting on a scale of 0 to 10 (0, least confident; 10, most confident). For the scale of measuring quitting importance and confidence, higher scores mean a better outcome and for the scale of measuring difficulty, higher scores mean a worse outcome.

Time frame:
1 month
Reported as:
Mean · score on a scale
Perceived Importance, Difficulty and Confidence to Quit Smoking
score on a scaleInterventionControl
Importance7.60 ± 2.307.88 ± 2.09
Difficulty7.02 ± 2.427.38 ± 2.33
Confidence6.39 ± 2.666.97 ± 2.43
SecondaryPerceived Importance, Difficulty and Confidence to Quit Smoking

Self-efficacy will be evaluated according to the importance of quitting on a scale of 0 to 10 (0, least important; 10, most important), difficulty of quitting on a scale of 0 to 10 (0, least difficult; 10, most difficult), and confidence in quitting on a scale of 0 to 10 (0, least confident; 10, most confident)

Time frame:
3 months
Reported as:
Mean · score on a scale
Perceived Importance, Difficulty and Confidence to Quit Smoking
score on a scaleInterventionControl
Importance7.80 ± 2.157.53 ± 2.26
Difficulty7.25 ± 2.387.34 ± 2.18
Confidence6.58 ± 2.506.47 ± 2.49
SecondaryPerceived Importance, Difficulty and Confidence to Quit Smoking

Self-efficacy will be evaluated according to the importance of quitting on a scale of 0 to 10 (0, least important; 10, most important), difficulty of quitting on a scale of 0 to 10 (0, least difficult; 10, most difficult), and confidence in quitting on a scale of 0 to 10 (0, least confident; 10, most confident)

Time frame:
6 months
Reported as:
Mean · score on a scale
Perceived Importance, Difficulty and Confidence to Quit Smoking
score on a scaleInterventionControl
Importance7.36 ± 2.468.09 ± 2.02
Difficulty7.53 ± 2.197.22 ± 2.46
Confidence6.02 ± 2.876.47 ± 2.95
SecondaryProgression Towards Smoking Cessation

progression towards smoking cessation as measured by Incremental Behavior Change toward Smoking cessation (IBC-S). The minimum value is 3 and the maximum value is 27. Higher scores mean a better outcome.

Time frame:
1 month
Reported as:
Mean · score on a scale
Progression Towards Smoking Cessation
score on a scaleInterventionControl
Progression Towards Smoking Cessation16.04 ± 3.2415.12 ± 3.30
SecondaryProgression Towards Smoking Cessation

progression towards smoking cessation as measured by Incremental Behavior Change toward Smoking cessation (IBC-S). The minimum value is 3 and the maximum value is 27. Higher scores mean a better outcome.

Time frame:
3 months
Reported as:
Mean · score on a scale
Progression Towards Smoking Cessation
score on a scaleInterventionControl
Progression Towards Smoking Cessation14.60 ± 2.9914.42 ± 3.00
SecondaryProgression Towards Smoking Cessation

progression towards smoking cessation as measured by Incremental Behavior Change toward Smoking cessation (IBC-S). The minimum value is 3 and the maximum value is 27. Higher scores mean a better outcome.

Time frame:
6 months
Reported as:
Mean · score on a scale
Progression Towards Smoking Cessation
score on a scaleInterventionControl
Progression Towards Smoking Cessation13.94 ± 2.8514.58 ± 2.77

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention0/482 (0%)0/482 (0%)0/482 (0%)
Control0/352 (0%)0/352 (0%)0/352 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)InterventionControlTotal
Mean40.54 (18 to 74)41.33 (18 to 65)40.87 (18 to 74)
Sex: Female, Male
Sex: Female, Male(Participants)InterventionControlTotal
Female9957156
Male383295678
Race (NIH/OMB)
Race (NIH/OMB)(Participants)InterventionControlTotal
American Indian or Alaska Native000
Asian482352834
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
08

Study locations

1 site
  • The University of Hong Kong
    Hong Kong, 00, Hong Kong
09

References and documents

Publications

  • Cropsey KL, Trent LR, Clark CB, Stevens EN, Lahti AC, Hendricks PS. How low should you go? Determining the optimal cutoff for exhaled carbon monoxide to confirm smoking abstinence when using cotinine as reference. Nicotine Tob Res. 2014 Oct;16(10):1348-55. doi: 10.1093/ntr/ntu085. Epub 2014 Jun 2. PubMed 24891552 ↗
  • Montalto NJ, Wells WO. Validation of self-reported smoking status using saliva cotinine: a rapid semiquantitative dipstick method. Cancer Epidemiol Biomarkers Prev. 2007 Sep;16(9):1858-62. doi: 10.1158/1055-9965.EPI-07-0189. PubMed 17855706 ↗
  • Chan SSC, Cheung YTD, Wong YMB, Kwong A, Lai V, Lam TH. A Brief Smoking Cessation Advice by Youth Counselors for the Smokers in the Hong Kong Quit to Win Contest 2010: a Cluster Randomized Controlled Trial. Prev Sci. 2018 Feb;19(2):209-219. doi: 10.1007/s11121-017-0823-z. PubMed 28755244 ↗
  • Chan SS, Wong DC, Cheung YT, Leung DY, Lau L, Lai V, Lam TH. A block randomized controlled trial of a brief smoking cessation counselling and advice through short message service on participants who joined the Quit to Win Contest in Hong Kong. Health Educ Res. 2015 Aug;30(4):609-21. doi: 10.1093/her/cyv023. Epub 2015 Jun 25. PubMed 26116584 ↗
  • Cheung YTD, Lam TH, Li WHC, Wang MP, Chan SSC. Feasibility, Efficacy, and Cost Analysis of Promoting Smoking Cessation at Outdoor Smoking "Hotspots": A Pre-Post Study. Nicotine Tob Res. 2018 Nov 15;20(12):1519-1524. doi: 10.1093/ntr/ntx147. PubMed 28655173 ↗
  • Cheung YT, Wang MP, Li HC, Kwong A, Lai V, Chan SS, Lam TH. Effectiveness of a small cash incentive on abstinence and use of cessation aids for adult smokers: A randomized controlled trial. Addict Behav. 2017 Mar;66:17-25. doi: 10.1016/j.addbeh.2016.11.006. Epub 2016 Nov 10. PubMed 27863323 ↗
  • Abdullah AS, Hedley AJ, Chan SS, Lam TH. A randomized controlled trial of two different lengths of nicotine replacement therapy for smoking cessation. Biomed Res Int. 2013;2013:961751. doi: 10.1155/2013/961751. Epub 2013 Sep 9. PubMed 24089693 ↗
  • Census & Statistics Department (Hong Kong SAR government). Thematic Household Survey, Report No. 59: Pattern of Smoking. Hong Kong: Census & Statistics Department 2016.
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  • Leung DYP, Chan SSC, Jiang CQ, et al. Providing Smoking Cessation Services and Its Relationship with Knowledge and Attitudes: A Comparison of the Guangzhou and Hong Kong Nurses. Journal of Comparative Asian Development 2009;8(1):179-205.
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  • Leung DY, Chan SS, Chan V, Lam TH. Hardcore smoking after comprehensive smoke-free legislation and health warnings on cigarette packets in Hong Kong. Public Health. 2016 Mar;132:50-6. doi: 10.1016/j.puhe.2015.10.007. Epub 2015 Nov 21. PubMed 26612457 ↗
  • Chan SSC, Cheung YTD, Wan Z, Wang MP, Lam TH. Proactive and Brief Smoking Cessation Intervention for Smokers at Outdoor Smoking "Hotspots" in Hong Kong. J Cancer Educ. 2018 Apr;33(2):365-370. doi: 10.1007/s13187-016-1085-3. PubMed 27474113 ↗
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  • Cheung YT, Leung JP, Cheung CK, Li WH, Wang MP, Lam TH. Motivating smokers at outdoor public smoking hotspots to have a quit attempt with a nicotine replacement therapy sample: study protocol for a randomized controlled trial. Trials. 2016 Jul 26;17(1):355. doi: 10.1186/s13063-016-1485-z. PubMed 27456342 ↗
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Study documents

  • Protocol and statistical analysis plan · Jun 30, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Research data and documentation will be available upon request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Data will be available for 10 years.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2018 to primary completion in Dec 2019, 14 months.

Results were first posted in Jul 2021, 1 year 6 months after primary completion.

Of 187 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 14 months is below that.

Counting every sponsor, half of 190 studies reached it within 35 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2018
First posted
Oct 23, 2018
StartActual
Oct 13, 2018
Primary completionActual
Dec 31, 2019
CompletionActual
Jul 31, 2020
Results first posted
Jul 1, 2021
Last update
May 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03717051
Responsible party
Dr. Derek Yee-Tak Cheung (Research Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
Oct 23, 2018
Start date
Oct 13, 2018
Primary completion
Dec 31, 2019
Completion
Jul 31, 2020
Results posted
Jul 1, 2021
Last update
May 16, 2024

Study contacts

Yee Tak Derek Cheung, PhD
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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