SmokingNCT02763527
Effectiveness of Negotiating Self-determination to Reduce Cigarette Consumption
A study testing Smoking reduction and Smoking Cessation in people with Smoking, run by The University of Hong Kong.
Trial summary
Background: Smokers attended to outpatient clinics present an excellent 'teachable moment' for smoking cessation interventions. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of negotiating self-determination to reduce cigarette… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Smoking reduction and Smoking Cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,566 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- smokers
- who are Chinese
- aged 18 years or above
- who smoke at least two cigarettes per day
- with moderate to severe nicotine dependence, and
- have no intention to quit smoking ≤7 days, but are interested in reducing the number of cigarettes smoked per day .
Who cannot join
- smokers
- with unstable medical conditions as advised by the doctor in charge,
- with poor cognitive state or mental illness,
- who participate in other smoking cessation programmes or services,
- with mild nicotine dependence, or
- who claim that they can quit ≤7 days
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of Negotiating Self-Determination to Reduce Cigarette Consumption (NSD-RCC) Among Smokers Attending Outpatient Clinics: A Cluster Randomized Controlled Trial
Background: Smokers attended to outpatient clinics present an excellent 'teachable moment' for smoking cessation interventions. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of negotiating self-determination to reduce cigarette consumption among smokers attending outpatient clinics
Methods: A randomized controlled trial will be conducted in 10 out-patient clinics in Hong Kong. Subjects in the intervention group will receive a brief intervention on smoking reduction plus a smoking reduction leaflet. Additionally, subjects will be asked to think about a smoking reduction schedule for themselves after the negotiation with the counsellor. Subjects in the control group will receive a brief advice on quitting plus a leaflet on smoking cessation. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted. The primary outcome measure is biochemically validated abstinence at 6 months. Secondary outcomes are: (i) biochemically validated abstinence at 12 months, (ii) self-reported 7-day point prevalence of abstinence at 6 and 12 months, (iii) self-reported reduction of ≥ 50% in cigarette consumption at 6 and 12 months, and (iv) self-efficacy against tobacco at 6 and 12 months.
Read the detailed description
This study aims to test the effectiveness of negotiating self-determination to reduce cigarette consumption (NSD-RCC) among smokers attending outpatient clinics.
Intervention Group (QP) Subjects in this group will receive a brief intervention on smoking reduction with a warning message plus a smoking reduction leaflet (the content will include a roadmap of smoking reduction strategy and information on how to cope with nicotine withdrawal symptoms). The whole intervention will last about 1 minute or slightly longer if necessary. In addition, subjects will be asked to think about a tailored smoking reduction schedule for themselves after the negotiation with the trained counsellor. For the subsequent telephone follow up in the intervention group, information on reduction and cessation will be collected, followed by a "booster" intervention, which will repeat the health warning to positively encourage them to reinforce their efforts and the next reduction target.
Control Group (QI) Subjects in the QI group will always be advised to quit immediately rather than to quit progressively. Subjects will receive a brief advice on quitting with a warning message similar to subjects in the QP group. In addition, subjects will receive a self-help quitting pamphlet published by the Hong Kong Council on Smoking and Health (COSH). Unlike the QP group, subjects in the QI group will not receive smoking reduction intervention and leaflet, and "booster" intervention during telephone follow-ups. However, they will undergo a similar schedule of telephone follow-up as those in the QP group.
Data collection
After completing the baseline questionnaire, subjects will receive proposed intervention according to their group assignment. Four consecutive follow-ups (at 1, 3, 6 and 12 months) will be conducted over the telephone by trained interviewers. Interviewers will first carry out outcome assessments with blinding to group status. Then, the group status will be disclosed so that the intervention group will receive the booster intervention and the control group will not. Smokers who have successfully quit smoking at 6-month will be invited to come back to the out-patient clinic and have biochemical validation tests (saliva cotinine test and exhaled CO test).
Analysis Data analysis will be performed using the Statistical Package for Social Science. We will compare the baseline characteristics of the participants by chi-square test for categorical variables and F-test for continuous variables between the intervention and the control group. We shall use the chi-square test to assess the effect of intervention and calculate the crude odds ratio (OR) with 95% confidence interval (CI) for the primary and secondary outcomes. Those who are lost to follow-up or refuse to participate in the validation tests, will be treated as smokers with no reduction in cigarette consumption compared with (a) baseline, as the main analysis (by intention to treat), (b) the most recent level and (c) complete case (per protocol) analysis by excluding subjects with missing data as a sensitivity analysis.
- Conditions
- Smoking
- Being tested
- Smoking reduction, Smoking Cessation
- Keywords
- smoking cessation
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking reductionBehavioural
A brief intervention on smoking reduction plus a smoking reduction leaflet
Smoking CessationBehavioural
A brief advice on quitting plus a leaflet on smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Smoking reduction | Experimental | Subjects will receive a brief intervention on smoking reduction with a warning message plus a smoking reduction leaflet. They will be asked to think about a tailored smoking reduction schedule for themselves after the negotiation with the trained counsellor. The trained counsellor will negotiate a schedule with subjects to reduce their smoking over an acceptable level. For the subsequent telephone follow up in the intervention group, information on reduction and cessation will be collected, followed by a "booster" intervention, which will repeat the health warning to positively encourage them to reinforce their efforts and the next reduction target. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted over the telephone by trained interviewers. Receives: Behavioral: Smoking reduction |
| Smoking Cessation | Placebo comparator | Subjects in the QI group will always be advised to quit immediately rather than to quit progressively. Subjects will receive a brief advice on quitting with a warning message similar to subjects in the QP group. In addition, subjects will receive a self-help quitting pamphlet published by the Hong Kong Council on Smoking and Health (COSH). Unlike the QP group, subjects in the QI group will not receive smoking reduction intervention and leaflet, and "booster" intervention during telephone follow-ups. However, they will undergo a similar schedule of telephone follow-up as those in the QP group. Receives: Behavioral: Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
biochemically validated abstinence using exhaled CO test
Measured: 6 months
Secondary outcomes (9)
biochemically validated abstinence using exhaled CO test
Measured: 12 months
self-reported 7-day point prevalence of abstinence
Measured: 6 months
self-reported 7-day point prevalence of abstinence
Measured: 12 months
self-reported reduction of ≥ 50% in cigarette consumption
Measured: 6 months
self-reported reduction of ≥ 50% in cigarette consumption
Measured: 12 months
self-efficacy against tobacco
Subjects' self-efficacy against tobacco was assessed by using 12-item Smoking Self-efficacy Questionnaire (SEQ-12). SEQ-12 is a valid and reliable scale, which has been used in both research and clinical setting.
Measured: 6 months
self-efficacy against tobacco
Subjects' self-efficacy against tobacco was assessed by using 12-item Smoking Self-efficacy Questionnaire (SEQ-12). SEQ-12 is a valid and reliable scale, which has been used in both research and clinical setting.
Measured: 12 months
biochemically validated abstinence using saliva cotinine test
Measured: 6 months
biochemically validated abstinence using saliva cotinine test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startJun 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,566 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William, Ho Cheung LI, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763527
- Sponsor's protocol ID
- GRF
- Status last verified
- Oct 2020
- First submitted
- 26 Apr 2016
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Negotiating Self-Determination to Reduce Cigarette Consumption (NSD-RCC) Among Smokers Attending Outpatient Clinics: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02763527
- Acronym / sponsor ID
- GRF
- Conditions
- Smoking
- Keywords
- smoking cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,566 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 May 2016 (estimated)
- 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.
Background: Smokers attended to outpatient clinics present an excellent 'teachable moment' for smoking cessation interventions. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of negotiating self-determination to reduce cigarette consumption among smokers attending outpatient clinics
Methods: A randomized controlled trial will be conducted in 10 out-patient clinics in Hong Kong. Subjects in the intervention group will receive a brief intervention on smoking reduction plus a smoking reduction leaflet. Additionally, subjects will be asked to think about a smoking reduction schedule for themselves after the negotiation with the counsellor. Subjects in the control group will receive a brief advice on quitting plus a leaflet on smoking cessation. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted. The primary outcome measure is biochemically validated abstinence at 6 months. Secondary outcomes are: (i) biochemically validated abstinence at 12 months, (ii) self-reported 7-day point prevalence of abstinence at 6 and 12 months, (iii) self-reported reduction of ≥ 50% in cigarette consumption at 6 and 12 months, and (iv) self-efficacy against tobacco at 6 and 12 months.
Detailed description
This study aims to test the effectiveness of negotiating self-determination to reduce cigarette consumption (NSD-RCC) among smokers attending outpatient clinics.
Intervention Group (QP) Subjects in this group will receive a brief intervention on smoking reduction with a warning message plus a smoking reduction leaflet (the content will include a roadmap of smoking reduction strategy and information on how to cope with nicotine withdrawal symptoms). The whole intervention will last about 1 minute or slightly longer if necessary. In addition, subjects will be asked to think about a tailored smoking reduction schedule for themselves after the negotiation with the trained counsellor. For the subsequent telephone follow up in the intervention group, information on reduction and cessation will be collected, followed by a "booster" intervention, which will repeat the health warning to positively encourage them to reinforce their efforts and the next reduction target.
Control Group (QI) Subjects in the QI group will always be advised to quit immediately rather than to quit progressively. Subjects will receive a brief advice on quitting with a warning message similar to subjects in the QP group. In addition, subjects will receive a self-help quitting pamphlet published by the Hong Kong Council on Smoking and Health (COSH). Unlike the QP group, subjects in the QI group will not receive smoking reduction intervention and leaflet, and "booster" intervention during telephone follow-ups. However, they will undergo a similar schedule of telephone follow-up as those in the QP group.
Data collection
After completing the baseline questionnaire, subjects will receive proposed intervention according to their group assignment. Four consecutive follow-ups (at 1, 3, 6 and 12 months) will be conducted over the telephone by trained interviewers. Interviewers will first carry out outcome assessments with blinding to group status. Then, the group status will be disclosed so that the intervention group will receive the booster intervention and the control group will not. Smokers who have successfully quit smoking at 6-month will be invited to come back to the out-patient clinic and have biochemical validation tests (saliva cotinine test and exhaled CO test).
Analysis Data analysis will be performed using the Statistical Package for Social Science. We will compare the baseline characteristics of the participants by chi-square test for categorical variables and F-test for continuous variables between the intervention and the control group. We shall use the chi-square test to assess the effect of intervention and calculate the crude odds ratio (OR) with 95% confidence interval (CI) for the primary and secondary outcomes. Those who are lost to follow-up or refuse to participate in the validation tests, will be treated as smokers with no reduction in cigarette consumption compared with (a) baseline, as the main analysis (by intention to treat), (b) the most recent level and (c) complete case (per protocol) analysis by excluding subjects with missing data as a sensitivity analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking reduction | Experimental | Behavioral: Smoking reductionSubjects will receive a brief intervention on smoking reduction with a warning message plus a smoking reduction leaflet. They will be asked to think about a tailored smoking reduction schedule for themselves after the negotiation with the trained counsellor. The trained counsellor will negotiate a schedule with subjects to reduce their smoking over an acceptable level. For the subsequent telephone follow up in the intervention group, information on reduction and cessation will be collected, followed by a "booster" intervention, which will repeat the health warning to positively encourage them to reinforce their efforts and the next reduction target. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted over the telephone by trained interviewers. |
| Smoking Cessation | Placebo comparator | Behavioral: Smoking CessationSubjects in the QI group will always be advised to quit immediately rather than to quit progressively. Subjects will receive a brief advice on quitting with a warning message similar to subjects in the QP group. In addition, subjects will receive a self-help quitting pamphlet published by the Hong Kong Council on Smoking and Health (COSH). Unlike the QP group, subjects in the QI group will not receive smoking reduction intervention and leaflet, and "booster" intervention during telephone follow-ups. However, they will undergo a similar schedule of telephone follow-up as those in the QP group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- smokers
- who are Chinese
- aged 18 years or above
- who smoke at least two cigarettes per day
- with moderate to severe nicotine dependence, and
Key exclusion criteria (6 listed)
- smokers
- with unstable medical conditions as advised by the doctor in charge,
- with poor cognitive state or mental illness,
- who participate in other smoking cessation programmes or services,
- with mild nicotine dependence, or
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 |
|---|---|---|
| Smoking reductionA brief intervention on smoking reduction plus a smoking reduction leaflet | Behavioural | Smoking reduction |
| Smoking CessationA brief advice on quitting plus a leaflet on smoking cessation | Behavioural | Smoking Cessation |
Primary outcome
biochemically validated abstinence using exhaled CO test
Time frame: 6 months
9 secondary outcomes
biochemically validated abstinence using exhaled CO test
Time frame: 12 months
self-reported 7-day point prevalence of abstinence
Time frame: 6 months
self-reported 7-day point prevalence of abstinence
Time frame: 12 months
self-reported reduction of ≥ 50% in cigarette consumption
Time frame: 6 months
self-reported reduction of ≥ 50% in cigarette consumption
Time frame: 12 months
self-efficacy against tobacco
Time frame: 6 months
self-efficacy against tobacco
Time frame: 12 months
biochemically validated abstinence using saliva cotinine test
Time frame: 6 months
biochemically validated abstinence using saliva cotinine test
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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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.
William, Ho Cheung LI, PhD principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Smoking reduction and Smoking Cessation in people with Smoking, run by The University of Hong Kong.
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 6 inclusion and 6 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 4 Nov 2020. 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. Some participants in this study may receive a placebo. 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 William, Ho Cheung LI, PhD (39176634, william3@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemically validated abstinence using exhaled CO test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2020.