Smoking CessationNCT03401021
Factors Related to the Intention to Quit Among Male Smokers During Their Wives Pregnancy
An observational study of Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to use a cross-sectional study and semi-structured interview to explore the level of intention to quit smoking among male smokers whose partner got pregnant and further explore factors associated with their quit intention. 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?
- Questionnaires set
- How many people
- 466 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 Dec 2017to 31 Mar 2019
- Phase
- Observational
- 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
Study population: The study population is include males smokers who is/will planning to have a baby with their partners.
Who may be able to join
- (1) All participants should be males
- (2) All participants should be aged 18 or above;
- (3) All participants should be married;
- (4) All participants should be smoking at least one cigarette per day averagely during the past 3 months;
- (5) All participants should be able to communicate in Mandarin (including reading Chinese)
Who cannot join
- Smokers who meet the above criteria but are currently involved in other smoking cessation programs or the pilot study and/or mentally or physically unfit for communication will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With Quit Intention Among Male Smokers Whose Partner Got Pregnant: An Exploration Study
This study aims to use a cross-sectional study and semi-structured interview to explore the level of intention to quit smoking among male smokers whose partner got pregnant and further explore factors associated with their quit intention.
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 coronary heart disease, chronic obstructive lung disease, cancer, stroke, peptic ulcer, peripheral vascular disease, and so on. In addition, tobacco can also increase the incidence rate of cancer in lung, oral cavity, naso-, oro- and hypopharynx, nasal cavity et.al, as well as myeloid leukemia, among smokers.
For the male smokers at their reproductive ages, who is preparing to have a baby with their partners, 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, CHD, lung cancer and so on to adults. For the children, the passive smoking makes 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 smoking showed significantly lower scores in the habituation cluster and motor system cluster [16], 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 [4]. 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 intervention 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.
Cigarette can negatively influence the function of respiratory, urinary and other systems, as well as increase the risk of different types of cancer. Secondhand smoking is harmful to their family members. What's worse, the impact of the reproductive system will further damage their baby born in the future. As the overlooking of the impact of maternal smoking on the fetus, the smoking cessation research for the male smokers who plan to have a baby is absent. For Chinese people, the high prevalence and low quitting rate made this situation much worse. In addition, as the cancel of the one-child policy, lots of couples are planning to give birth to a baby in the future decades compared with the period the policy was valid. Considering the high prevalence of male smoking and upcoming high birth rate in China, more smokers, pregnant, and fetus are under the hazard of tobacco use.
Before applying interventions to help male smokers whose partner got pregnant to quit or reduce cigarette smoking, a study exploring their intention to quit smoking and relevant factors must be implemented.
- Conditions
- Smoking Cessation
- Being tested
- Questionnaires set
- Keywords
- intention to quit smoking, male smoker, smoking cessation, expectant fathers
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires setOther
Participants will be asked to respond to the demographic information sheet, Smoking characteristics sheet, the Fagerstrom Test of Nicotine Dependence, the Transtheoretical Model (TTM) variables, Smoking Self-efficacy Questionnaire (SEQ-12), Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR), and a smoking hazard questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Crrent Male smokers | Male smokers met the inclusion criteria below will be invited to fill in the questionnaires set, part of them will be invited to attend a semi-structured interview(optional).
1. be aged 18 or above,
2. have a history of smoking at least one cigarette per day before their partners became pregnant,
3. be involved with partners whose pregnancies could be confirmed,
4. able to read Chinese and communicate in the Mandarin dialect. Receives: Other: Questionnaires set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quit intention of smoking
The level of intention to quit of smoking among male smokers who planning to have a baby with their partners will be measured by b) The Transtheoretical Model (TTM) variables. The Stage of TTM will be assessed by asking the intention of quitting smoking in the past 6 months with the 6-items, which are Precontemplation, Contemplation, Preparation, Action, Maintenance, and Termination
Measured: Baseline
Secondary outcomes (4)
Self-efficacy level
Self-efficacy of participants against tobacco will be assessed by using by the SEQ-12. The SEQ-12 is categorized into two subscales, namely internal stimuli (6 items) and external stimuli (6 items), with total possible scores ranging from 6 to 30 for both internal stimuli and external stimuli. Higher scores of the SEQ-12 on both subscales indicate greater self-efficacy to refrain from smoking.
Measured: Baseline
Self-awareness of the hazard of smoking
The self-awareness of the hazard of smoking among the participants will be measured by a self-designed smoking hazard questionnaire list. The smoking hazard questionnaire lists 14 hazard of smoking and SHS to the pregnant, fetus, health, income, social activity, and so on. Participants responded to each items using a -10 to 10 rating scale ranging from -10 (most negative influence) to 10 (most positive influence).
Measured: Baseline
Family support level
The family support for smoking cessation will be assessed by using the Family APGAR. The Family APGAR is a 5-item measure of perceived family support [71]. Participants responded to each item using a 5-point rating scale ranging from 0 (never) to 4 (always). The standard scoring for the FAPGAR interprets high scores (7-10) as indicating a satisfactory support from family and low scores (0-3) indicating severe dysfunctionality support from the family members.
Measured: Baseline
Dependence of nicotine
The level of nicotine dependence of the participants will be measured by the Fagerstrom Test of Nicotine Dependence (FTND) scale. The FTND is a standard instrument for assessing the intensity of physical addiction to nicotine.The test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerstrom score, the more intense is the patient's physical dependence on nicotine.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start6 Dec 2017
- Primary completion31 Mar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho Cheung William Li, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401021
- Sponsor's protocol ID
- UW17-509
- Status last verified
- May 2019
- First submitted
- 8 Jan 2018
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xia W, Li HCW, Song P, Ho KY, Luo Y, Liang T, Ho LLK, Cheung AT, Cai W. Perceptions, behaviours and attitudes towards smoking held by the male partners of Chinese pregnant women: a qualitative study. BMC Public Health. 2021 Oct 20;21(1):1901. doi: 10.1186/s12889-021-11966-4.
PubMed 34670560
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Quit Intention Among Male Smokers Whose Partner Got Pregnant: An Exploration Study
- ClinicalTrials.gov ID
- NCT03401021
- Acronym / sponsor ID
- UW17-509
- Conditions
- Smoking Cessation
- Keywords
- intention to quit smoking, male smoker, smoking cessation, expectant fathers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 17 Jan 2018 (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 cross-sectional study and semi-structured interview to explore the level of intention to quit smoking among male smokers whose partner got pregnant and further explore factors associated with their quit intention.
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 coronary heart disease, chronic obstructive lung disease, cancer, stroke, peptic ulcer, peripheral vascular disease, and so on. In addition, tobacco can also increase the incidence rate of cancer in lung, oral cavity, naso-, oro- and hypopharynx, nasal cavity et.al, as well as myeloid leukemia, among smokers.
For the male smokers at their reproductive ages, who is preparing to have a baby with their partners, 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, CHD, lung cancer and so on to adults. For the children, the passive smoking makes 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 smoking showed significantly lower scores in the habituation cluster and motor system cluster [16], 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 [4]. 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 intervention 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.
Cigarette can negatively influence the function of respiratory, urinary and other systems, as well as increase the risk of different types of cancer. Secondhand smoking is harmful to their family members. What's worse, the impact of the reproductive system will further damage their baby born in the future. As the overlooking of the impact of maternal smoking on the fetus, the smoking cessation research for the male smokers who plan to have a baby is absent. For Chinese people, the high prevalence and low quitting rate made this situation much worse. In addition, as the cancel of the one-child policy, lots of couples are planning to give birth to a baby in the future decades compared with the period the policy was valid. Considering the high prevalence of male smoking and upcoming high birth rate in China, more smokers, pregnant, and fetus are under the hazard of tobacco use.
Before applying interventions to help male smokers whose partner got pregnant to quit or reduce cigarette smoking, a study exploring their intention to quit smoking and relevant factors must be implemented.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crrent Male smokers | – | Other: Questionnaires setMale smokers met the inclusion criteria below will be invited to fill in the questionnaires set, part of them will be invited to attend a semi-structured interview(optional). 1. be aged 18 or above, 2. have a history of smoking at least one cigarette per day before their partners became pregnant, 3. be involved with partners whose pregnancies could be confirmed, 4. able to read Chinese and communicate in the Mandarin dialect. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is include males smokers who is/will planning to have a baby with their partners.
Key inclusion criteria (5 listed)
- (1) All participants should be males
- (2) All participants should be aged 18 or above;
- (3) All participants should be married;
- (4) All participants should be smoking at least one cigarette per day averagely during the past 3 months;
- (5) All participants should be able to communicate in Mandarin (including reading Chinese)
Key exclusion criteria (1 listed)
- Smokers who meet the above criteria but are currently involved in other smoking cessation programs or the pilot study and/or mentally or physically unfit for communication will be excluded.
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 |
|---|---|---|
| Questionnaires setParticipants will be asked to respond to the demographic information sheet, Smoking characteristics sheet, the Fagerstrom Test of Nicotine Dependence, the Transtheoretical Model (TTM) variables, Smoking Self-efficacy Questionnaire (SEQ-12), Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR), and a smoking hazard questionnaire. | Other | Crrent Male smokers |
Primary outcome
Quit intention of smoking
Time frame: Baseline
The level of intention to quit of smoking among male smokers who planning to have a baby with their partners will be measured by b) The Transtheoretical Model (TTM) variables. The Stage of TTM will be assessed by asking the intention of quitting smoking in the past 6 months with the 6-items, which are Precontemplation, Contemplation, Preparation, Action, Maintenance, and Termination
4 secondary outcomes
Self-efficacy level
Time frame: Baseline
Self-awareness of the hazard of smoking
Time frame: Baseline
Family support level
Time frame: Baseline
Dependence of nicotine
Time frame: Baseline
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 6 May 2019.
- Derived from this study: PubMed 34670560Xia W, Li HCW, Song P, Ho KY, Luo Y, Liang T, Ho LLK, Cheung AT, Cai W. Perceptions, behaviours and attitudes towards smoking held by the male partners of Chinese pregnant women: a qualitative study. BMC Public Health. 2021 Oct 20;21(1):1901. doi: 10.1186/s12889-021-11966-4.
- 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.
Ho Cheung William 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?
An observational study of 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 1 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 6 May 2019. 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. 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?
Quit intention of smoking (time frame: Baseline). 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 NCT03401021, 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 6 May 2019.