Smoking CessationNCT03236025
A Video-led Smoking Cessation Intervention in Helping Male Smokers Whose Partners Got Pregnant to Quit Smoking
A study testing Video+brief smoking cessation+pamphlet, Text-message+brief smoking cessation+pamphlet and brief smoking cessation+pamphlet in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to use a three arms randomized clinical trial study to evaluate the effectiveness of a video-led intervention in helping male smokers whose partner got pregnant in Mainland China to quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Video+brief smoking cessation+pamphlet, Text-message+brief smoking cessation+pamphlet and brief smoking cessation+pamphlet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,023 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2017to 31 Mar 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male resident aged 18 or above;
- smoking at least one cigarette per day averagely during the past 1 months and validated by exhaled CO test (≥ 4ppm);
- have a pregnant partner whose embryo had been confirmed to not have any significant deformity;
- able to communicate in Mandarin (including reading Chinese);
- have a smart phone for intervention and follow-up
Who cannot join
- smokers who meet the above criteria but are currently involved in other smoking cessation programs or the pilot study;
- mentally or physically unfit for communication;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Video-led Smoking Cessation Intervention in Helping Male Smokers in Mainland China Whose Partner Got Pregnant to Quit Smoking: A Randomized Control Trial
This study aims to use a three arms randomized clinical trial study to evaluate the effectiveness of a video-led intervention in helping male smokers whose partner got pregnant in Mainland China to quit smoking.
Read the detailed description
With a globally growing number of smokers, up to about half of men and one tenth of women are becoming smokers and relatively few stopping, especially in Mainland China.
It has been proved that tobacco is responsible for even more deaths and diseases. Smokers have two to three times mortality in middle age among otherwise similar persons who had never smoked. According to the literature review, smoking has been confirmed to be an important risk factor to most chronic diseases and cancer.
For the male smokers at their reproductive ages, who is preparing to have a baby, smoking may negatively influence their reproductive capacity. Sufficient studies found that the quantity and duration of smoking, especially the current smoking is positively associated with the risk of erectile dysfunction. Smoking may increase the risk of a higher risk of developing oligospermia, asthenozoospermia and teratozoospermia for man in the reproductive years, which may lead to the inefficiency of fertilization and even give birth to abnormal fetus. Besides, secondhand Smoking (SHS) exposure also have further and longer negative effects on their female partner and their baby born in the future. The non-smoking population is much more sensitive to the nicotine in the passive smoking than smokers. The SHS may increase the risk of respiratory infections, ear problem, immediate adverse effects on cardiovascular system, lung cancer and so on to adults. For the children, the passive smoking make children have a higher chance to get severe asthma, slow lung growth. Hence, children and women live with smokers may have a higher risk of premature death and disease. Besides, newborns whose mothers were exposed to secondhand smoke showed significantly lower scores in the habituation cluster and motor system cluster, as well as the delay of neurobehavioral development regardless of socio-demographic, obstetric and pediatric factors. Conclusively, smoking has direct and indirect negative effect to male smokers in reproductive ages themselves and their family members.
Based on the official statistic figures in 2010, about one third of people in China were current smokers, and the number of young smokers is increasing. While most current smokers (83.9%) report having no intention to quit smoking (WHO, 2011). On average, between 60% and 70% of Chinese men continue to smoke into middle age, which is different with the western countries. Hence, finding out a solution to decrease the married reproductive male smoking rate is extremely crucial.
Overall awareness of the health hazards of tobacco has improved in the last 15 years in China, but is still relatively poor. Even there were several patterns of propaganda and education applied in China, the efficiency is not very satisfactory. Hence, an effective education interventions that delivery the health hazards of tobacco to male smokers and secondhand smoking to their wives and baby born in the future should be developed and implemented for reproductive male smokers in China.
Different patterns of interventions, such as counselling, advertising, leaflets and so on have been implemented, however the effect is not so well as we expected. Thus, a more efficient intervention should be developed. As the high usage rate of smart phone, interventions implemented by cellphone can be considered as a new approach. Watching video has been proven to be significantly associated with prevalence abstinence. Video, combining with the advantage of text, image, and tones, will take visual, auditory and reading stimulation to the brain, consequently, enhance the delivery and memory of information for people. Hence video is an efficient intervention medium for smoking cessation.
Given that, a video-led intervention will be applied to help male smokers whose partner got pregnant in Mainland China to quit or reduce the cigarette smoking.
- Conditions
- Smoking Cessation
- Being tested
- Video+brief smoking cessation+pamphlet, Text-message+brief smoking cessation+pamphlet, brief smoking cessation+pamphlet
- Keywords
- smoking cessation, video, male smoker
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video+brief smoking cessation+pamphletCombination product
The videos presented the health effects of smoking, especially emphasizing the importance of smoking cessation on pregnant women, fetuses, and newborns.
Text-message+brief smoking cessation+pamphletCombination product
The text -message contains the same content with the videos
brief smoking cessation+pamphletOther
The pamphlet showed the general information related to the smoking cessation, the brief smoking cessation only contains a sentence like "You'd better quit smoking."
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Video+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. The videos which presented the health effects of smoking, especially emphasizing the importance of smoking cessation on the fetal and pregnancy, will be sent in sequence through the smart phone to the participants in the experimental group. Receives: Combination Product: Video+brief smoking cessation+pamphlet |
| Conditional control group | Active comparator | Text-message+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. Text-message contains the same content with videos and will be sent in the same frequency with the videos through the smart phone to the participants in the Conditional control group. Receives: Combination Product: Text-message+brief smoking cessation+pamphlet |
| Placebo control group | Placebo comparator | Participants in the control group will be given a one-sentence smoking cessation advice during the baseline assessment. A leaflet showed the information related to the smoking cessation will be allocated to them at the same time. Receives: Other: brief smoking cessation+pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated smoking abstinence at the 6-month follow-up
The biochemically validated smoking abstinence was confirmed by an exhaled carbon monoxide level < 4 parts per million (p.p.m.)
Measured: 6-month follow-up
Secondary outcomes (2)
Self-reported 7-day point prevalence quit rate
Subjects report that they had not smoked within the recent 7 days.
Measured: 6-month follow-up
The level of readiness to quit
The readiness to quit is divided into pre-contemplation stage (attempt to quit more that 30 days later), contemplation stage (attempt to quit within 30 days but more than 7 days), preparation stage (attempt to quit within 7 days), and action stage (quitting)
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Jul 2017
- Primary completion31 Oct 2018
- Study completion31 Mar 2019
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,023 participants (actual)
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
- NCT03236025
- Sponsor's protocol ID
- UW17-269
- Status last verified
- Jan 2020
- First submitted
- 27 Jul 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xia W, Li HCW, Cai W, Song P, Zhou X, Lam KWK, Ho LLK, Cheung AT, Luo Y, Zeng C, Ho KY. Effectiveness of a video-based smoking cessation intervention focusing on maternal and child health in promoting quitting among expectant fathers in China: A randomized controlled trial. PLoS Med. 2020 Sep 29;17(9):e1003355. doi: 10.1371/journal.pmed.1003355. eCollection 2020 Sep.
PubMed 32991589
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Video-led Smoking Cessation Intervention in Helping Male Smokers in Mainland China Whose Partner Got Pregnant to Quit Smoking: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03236025
- Acronym / sponsor ID
- UW17-269
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, video, male smoker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 1 Aug 2017 (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.
This study aims to use a three arms randomized clinical trial study to evaluate the effectiveness of a video-led intervention in helping male smokers whose partner got pregnant in Mainland China to quit smoking.
Detailed description
With a globally growing number of smokers, up to about half of men and one tenth of women are becoming smokers and relatively few stopping, especially in Mainland China.
It has been proved that tobacco is responsible for even more deaths and diseases. Smokers have two to three times mortality in middle age among otherwise similar persons who had never smoked. According to the literature review, smoking has been confirmed to be an important risk factor to most chronic diseases and cancer.
For the male smokers at their reproductive ages, who is preparing to have a baby, smoking may negatively influence their reproductive capacity. Sufficient studies found that the quantity and duration of smoking, especially the current smoking is positively associated with the risk of erectile dysfunction. Smoking may increase the risk of a higher risk of developing oligospermia, asthenozoospermia and teratozoospermia for man in the reproductive years, which may lead to the inefficiency of fertilization and even give birth to abnormal fetus. Besides, secondhand Smoking (SHS) exposure also have further and longer negative effects on their female partner and their baby born in the future. The non-smoking population is much more sensitive to the nicotine in the passive smoking than smokers. The SHS may increase the risk of respiratory infections, ear problem, immediate adverse effects on cardiovascular system, lung cancer and so on to adults. For the children, the passive smoking make children have a higher chance to get severe asthma, slow lung growth. Hence, children and women live with smokers may have a higher risk of premature death and disease. Besides, newborns whose mothers were exposed to secondhand smoke showed significantly lower scores in the habituation cluster and motor system cluster, as well as the delay of neurobehavioral development regardless of socio-demographic, obstetric and pediatric factors. Conclusively, smoking has direct and indirect negative effect to male smokers in reproductive ages themselves and their family members.
Based on the official statistic figures in 2010, about one third of people in China were current smokers, and the number of young smokers is increasing. While most current smokers (83.9%) report having no intention to quit smoking (WHO, 2011). On average, between 60% and 70% of Chinese men continue to smoke into middle age, which is different with the western countries. Hence, finding out a solution to decrease the married reproductive male smoking rate is extremely crucial.
Overall awareness of the health hazards of tobacco has improved in the last 15 years in China, but is still relatively poor. Even there were several patterns of propaganda and education applied in China, the efficiency is not very satisfactory. Hence, an effective education interventions that delivery the health hazards of tobacco to male smokers and secondhand smoking to their wives and baby born in the future should be developed and implemented for reproductive male smokers in China.
Different patterns of interventions, such as counselling, advertising, leaflets and so on have been implemented, however the effect is not so well as we expected. Thus, a more efficient intervention should be developed. As the high usage rate of smart phone, interventions implemented by cellphone can be considered as a new approach. Watching video has been proven to be significantly associated with prevalence abstinence. Video, combining with the advantage of text, image, and tones, will take visual, auditory and reading stimulation to the brain, consequently, enhance the delivery and memory of information for people. Hence video is an efficient intervention medium for smoking cessation.
Given that, a video-led intervention will be applied to help male smokers whose partner got pregnant in Mainland China to quit or reduce the cigarette smoking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Combination Product: Video+brief smoking cessation+pamphletVideo+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. The videos which presented the health effects of smoking, especially emphasizing the importance of smoking cessation on the fetal and pregnancy, will be sent in sequence through the smart phone to the participants in the experimental group. |
| Conditional control group | Active comparator | Combination Product: Text-message+brief smoking cessation+pamphletText-message+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. Text-message contains the same content with videos and will be sent in the same frequency with the videos through the smart phone to the participants in the Conditional control group. |
| Placebo control group | Placebo comparator | Other: brief smoking cessation+pamphletParticipants in the control group will be given a one-sentence smoking cessation advice during the baseline assessment. A leaflet showed the information related to the smoking cessation will be allocated to them at the same time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male resident aged 18 or above;
- smoking at least one cigarette per day averagely during the past 1 months and validated by exhaled CO test (≥ 4ppm);
- have a pregnant partner whose embryo had been confirmed to not have any significant deformity;
- able to communicate in Mandarin (including reading Chinese);
- have a smart phone for intervention and follow-up
Key exclusion criteria (2 listed)
- smokers who meet the above criteria but are currently involved in other smoking cessation programs or the pilot study;
- mentally or physically unfit for communication;
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 |
|---|---|---|
| Video+brief smoking cessation+pamphletThe videos presented the health effects of smoking, especially emphasizing the importance of smoking cessation on pregnant women, fetuses, and newborns. | Combination product | Experimental group |
| Text-message+brief smoking cessation+pamphletThe text -message contains the same content with the videos | Combination product | Conditional control group |
| brief smoking cessation+pamphletThe pamphlet showed the general information related to the smoking cessation, the brief smoking cessation only contains a sentence like "You'd better quit smoking." | Other | Placebo control group |
Primary outcome
Biochemically validated smoking abstinence at the 6-month follow-up
Time frame: 6-month follow-up
The biochemically validated smoking abstinence was confirmed by an exhaled carbon monoxide level < 4 parts per million (p.p.m.)
2 secondary outcomes
Self-reported 7-day point prevalence quit rate
Time frame: 6-month follow-up
The level of readiness to quit
Time frame: 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 32991589Xia W, Li HCW, Cai W, Song P, Zhou X, Lam KWK, Ho LLK, Cheung AT, Luo Y, Zeng C, Ho KY. Effectiveness of a video-based smoking cessation intervention focusing on maternal and child health in promoting quitting among expectant fathers in China: A randomized controlled trial. PLoS Med. 2020 Sep 29;17(9):e1003355. doi: 10.1371/journal.pmed.1003355. eCollection 2020 Sep.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
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.
William Ho Cheung LI, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video+brief smoking cessation+pamphlet, Text-message+brief smoking cessation+pamphlet and brief smoking cessation+pamphlet in people with Smoking Cessation, run by The University of Hong Kong at 1 site in 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biochemically validated smoking abstinence at the 6-month follow-up (time frame: 6-month follow-up). 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 NCT03236025, 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 13 Jan 2020.