Smoking CessationNCT02370147
Very Brief Smoking Reduction Intervention
A study testing Smoking reduction intervention in people with Smoking Cessation, run by Chinese PLA General Hospital.
Trial summary
A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be proposed in outpatient department clinics of People's Liberation Army General Hospital in Beijing, China. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking reduction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 2017
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years old;
- Smoked more than 10 cigarettes per day in the past month.
- Have no intent to smoking cessation now.
- Agreed to participate in the follow-up, offer telephone number and signed an informed consent form.
Who cannot join
- Smoked less than 10 cigarettes per day in the past month.
- Had some diseases that let the physician think that it would be unethical not to advise him to quit smoking as soon as possible.
- Cognitively impaired (such as those with deafness or who could not understand and complete the questionnaire reliably).
- Pregnant females.
About this study
Official title: The Effect of Very Brief Smoking Reduction Intervention in Smokers Who Having no Intention to Quit: Study Protocol for a Randomized Controlled Trial
A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be proposed in outpatient department clinics of People's Liberation Army General Hospital in Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief face-to-face individual smoking reduction intervention lasted about one minute, and five follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and also five follow-up interventions lasted for one minute each with different intervention contents.
- Conditions
- Smoking Cessation
- Being tested
- Smoking reduction intervention, Exercise and diet advice control
- Keywords
- smoking reduction intervention, no intention to quit, randomized controlled trial, telephone follow-up intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking reduction interventionBehavioural
Smokers was informed that many harmful effects were proved to be related with smoking, such as cancer, coronary heart disease, respiratory disease and many other health problems, and one out of two smokers will be killed by smoking. Smokers will be advised to reduce smoking consumption for at least half of their total consumption in the next month. Finally, all smokers were warned to keep in mind that the current attempt to reduce smoking is an intermediate step before the complete cessation.
Exercise and diet advice controlBehavioural
Smokers will be asked to do regular activities for three or four times per week, and to have a healthy and balanced diet, having more fruit and vegetables which are rich in vitamins, high in nutrition yet low in calories. In the whole process, advises will not refer to smoking cessation or smoking reduction.
| Study group | Role | What they receive |
|---|---|---|
| Smoking reduction intervention arm | Experimental | Smoking reduction intervention arm (SRI) consisting of a minimal face-to-face individual smoking reduction intervention lasted for about one minute, and five follow-up interventions lasted for about one minute each. Receives: Behavioral: Smoking reduction intervention |
| Control arm | Active comparator | Control arm (UC) consisting of a brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and five follow-up interventions lasted for about one minute each with different intervention contents. Receives: Behavioral: Exercise and diet advice control |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported 7-day point prevalence quit rate
Measured: at 12 months follow-up
prolonged abstinence quit rate
Measured: at 12 months follow-up
Secondary outcomes (1)
smoking reduction rates
number of cigarettes smoked per day reduced at least 50%
Measured: baseline and at 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao He, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370147
- Sponsor's protocol ID
- ChinaPLAGHW
- Status last verified
- Feb 2015
- First submitted
- 10 Feb 2015
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wu L, He Y, Jiang B, Zhang D, Tian H, Zuo F, Lam TH, Cheung YT. The effect of a very brief smoking-reduction intervention in smokers who have no intention to quit: study protocol for a randomized controlled trial. BMC Public Health. 2015 Apr 25;15:418. doi: 10.1186/s12889-015-1749-7.
PubMed 25944023
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Very Brief Smoking Reduction Intervention in Smokers Who Having no Intention to Quit: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02370147
- Acronym / sponsor ID
- ChinaPLAGHW
- Conditions
- Smoking Cessation
- Keywords
- smoking reduction intervention, no intention to quit, randomized controlled trial, telephone follow-up intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 24 Feb 2015 (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.
A two-arm randomized controlled trial for smokers who are not intent to quit smoking will be proposed in outpatient department clinics of People's Liberation Army General Hospital in Beijing, China. Smoking reduction intervention arm (SRI) consisting of a very brief face-to-face individual smoking reduction intervention lasted about one minute, and five follow-up interventions lasted for about minute each. Control arm (EDA) consisting of a very brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and also five follow-up interventions lasted for one minute each with different intervention contents.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking reduction intervention arm | Experimental | Behavioral: Smoking reduction interventionSmoking reduction intervention arm (SRI) consisting of a minimal face-to-face individual smoking reduction intervention lasted for about one minute, and five follow-up interventions lasted for about one minute each. |
| Control arm | Active comparator | Behavioral: Exercise and diet advice controlControl arm (UC) consisting of a brief face-to-face individual exercise and dietetic advices lasted for the same intervention time as SRI, and five follow-up interventions lasted for about one minute each with different intervention contents. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18 years old;
- Smoked more than 10 cigarettes per day in the past month.
- Have no intent to smoking cessation now.
- Agreed to participate in the follow-up, offer telephone number and signed an informed consent form.
Key exclusion criteria (4 listed)
- Smoked less than 10 cigarettes per day in the past month.
- Had some diseases that let the physician think that it would be unethical not to advise him to quit smoking as soon as possible.
- Cognitively impaired (such as those with deafness or who could not understand and complete the questionnaire reliably).
- Pregnant females.
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 reduction interventionSmokers was informed that many harmful effects were proved to be related with smoking, such as cancer, coronary heart disease, respiratory disease and many other health problems, and one out of two smokers will be killed by smoking. Smokers will be advised to reduce smoking consumption for at least half of their total consumption in the next month. Finally, all smokers were warned to keep in mind that the current attempt to reduce smoking is an intermediate step before the complete cessation. | Behavioural | Smoking reduction intervention arm |
| Exercise and diet advice controlSmokers will be asked to do regular activities for three or four times per week, and to have a healthy and balanced diet, having more fruit and vegetables which are rich in vitamins, high in nutrition yet low in calories. In the whole process, advises will not refer to smoking cessation or smoking reduction. | Behavioural | Control arm |
Primary outcome
self-reported 7-day point prevalence quit rate
Time frame: at 12 months follow-up
prolonged abstinence quit rate
Time frame: at 12 months follow-up
1 secondary outcome
smoking reduction rates
Time frame: baseline and at 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
- Derived from this study: PubMed 25944023Wu L, He Y, Jiang B, Zhang D, Tian H, Zuo F, Lam TH, Cheung YT. The effect of a very brief smoking-reduction intervention in smokers who have no intention to quit: study protocol for a randomized controlled trial. BMC Public Health. 2015 Apr 25;15:418. doi: 10.1186/s12889-015-1749-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking reduction intervention in people with Smoking Cessation, run by Chinese PLA General Hospital.
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 4 inclusion and 4 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 24 Feb 2015. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-reported 7-day point prevalence quit rate (time frame: at 12 months follow-up). The study lists 2 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 NCT02370147, which also lists 1 linked publication.
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 24 Feb 2015.