Smoking CessationNCT05474651
Influencing Factors and Trigger Mechanism of Relapse in Expectant Fathers Who Quit Smoking
An observational study of Smoking Cessation, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to describe the relapse rate and characteristics of expectant fathers who quit smoking during their wives' pregnancy, to explore the influencing factors and triggering mechanisms,and describe their experience. 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
- 294 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2022to 30 Apr 2024
- 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 investigators will be admitted to the maternity ward of the partner hospital. Convenience sampling will be conducted, and expectant fathers who meet the criteria will be invited to participate in the study.
Who may be able to join
- (1) All participants should be aged 18 or above;
- (2) The newborn of the participant is alive, and the number of days of birth is ≤28 days;
- (3) All participants should have actively quit smoking during his wife's pregnancy, and maintained it for at least 24 hours;
- (4) All participants should be smoking at least 1 cigarette per day on average for at least 1 month in the past 1 year;
- (5) All participants should be able to communicate in Mandarin (including reading Chinese).
Who cannot join
- All participants 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: Influencing Factors and Trigger Mechanism of Relapse in Expectant Fathers Who Quit Smoking: An Exploratory Sequential Mixed Methods Study.
The purpose of this study is to describe the relapse rate and characteristics of expectant fathers who quit smoking during their wives' pregnancy, to explore the influencing factors and triggering mechanisms,and describe their experience.
Read the detailed description
Participants will be invited to recall their smoking status and experience during their wife's pregnancy (all participants and required to complete the questionnaire, and some of them will be invited to participate in semi-structured interviews).
In the quantitative study,participants need to finish the questionnaire,which includes the demographic information sheet, characteristics of smoking sheet, history of smoking cessation sheet, smoking hazard questionnaire, motivation to quit smoking sheet, ability to quit smoking sheet, alcohol consumption, exercise.
In the qualitative study,participants need to participate in semi-structured interview.The interview begins with "Have you tried smoking cessation before? Why? What is the result", and explores in-depth analysis based on the participants' answers.
- Conditions
- Smoking Cessation
- Being tested
- Questionnaires set
- Keywords
- Expectant fathers, Smoking relapse, Mix-method study, Paternal Behavior
- 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, characteristics of smoking sheet, the Fagerstrom Test of Nicotine Dependence,Smoking Self-efficacy Questionnaire, Cigarette Withdrawal Scale, smoking hazard questionnaire, motivation to quit smoking sheet, ability to quit smoking sheet, alcohol consumption, International Physical Activity Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires assessed expectant fathers who quit smoking | Participants who 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. Males ≥18 years old;
2. The wife has given birth, the newborn is live, and the number of days of birth is less than or equal to 28 days;
3. Self-reported smoking at least 1 cigarette per day on average for at least 1 month in the past 1 year;
4. Self-reported that they had quit smoking during their wife's pregnancy on purpose, and maintained it for at least 24 hours; Receives: Other: Questionnaires set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking relapse rate
A true or false sheet in the questionnaire.
Measured: Baseline
Secondary outcomes (6)
Quality of relationship
The quality of relationship will be assessed by using the Relationship Satisfaction scale.It includes five items and a six-point response format was used, ranging from 'strongly disagree' to 'strongly agree'.
Measured: Baseline
Withdrawal symptoms
The Cigarette Withdrawal Scale(CWS) is composed of 21 items, including four measuring depression-anxiety, four measuring craving, four measuring irritability-impatience, three measuring concentration difficulties, three measuring appetite-weight gain, and three measuring insomnia. The items were scored using a 5-point Likert-type scale (agree/disagree).
Measured: Baseline
Self-efficacy level
Self-efficacy of participants against tobacco will be assessed by using by the Smoking Self-Efficacy Questionnaire(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 selfefficacy to refrain from smoking.
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
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 20-items questionnaire is developed according to the literature review content, focusing on the impact of smoking hazard on maternal and neonate health.Participants were asked to answer whether the knowledge about tobacco harm contained in the entry is correct: yes, no, or don't know (about 20% interference items).The higher the total score,the better the mastery of self-awareness of the hazard of smoking.
Measured: Baseline
Smoking rationalization
The smoking rationalization will be measured by a 26-item scale within six dimensions (smoking functional beliefs, risk generalization beliefs, social acceptability beliefs, safe smoking beliefs, self-exempting beliefs, and quitting is harmful beliefs). Each item used a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neither disagree nor agree, 4 = agree, 5 = strongly agree, higher scores represent higher levels of rationalization).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start23 Nov 2022
- Primary completion28 Feb 2024
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474651
- Sponsor's protocol ID
- wjn-relapse（father）-2022.07
- Status last verified
- Apr 2024
- First submitted
- 24 Jul 2022
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The non-identified individual participant data will be shared after the outcomes have been published.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Factors and Trigger Mechanism of Relapse in Expectant Fathers Who Quit Smoking: An Exploratory Sequential Mixed Methods Study.
- ClinicalTrials.gov ID
- NCT05474651
- Acronym / sponsor ID
- wjn-relapse（father）-2022.07
- Conditions
- Smoking Cessation
- Keywords
- Expectant fathers, Smoking relapse, Mix-method study, Paternal Behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 26 Jul 2022 (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.
The purpose of this study is to describe the relapse rate and characteristics of expectant fathers who quit smoking during their wives' pregnancy, to explore the influencing factors and triggering mechanisms,and describe their experience.
Detailed description
Participants will be invited to recall their smoking status and experience during their wife's pregnancy (all participants and required to complete the questionnaire, and some of them will be invited to participate in semi-structured interviews).
In the quantitative study,participants need to finish the questionnaire,which includes the demographic information sheet, characteristics of smoking sheet, history of smoking cessation sheet, smoking hazard questionnaire, motivation to quit smoking sheet, ability to quit smoking sheet, alcohol consumption, exercise.
In the qualitative study,participants need to participate in semi-structured interview.The interview begins with "Have you tried smoking cessation before? Why? What is the result", and explores in-depth analysis based on the participants' answers.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires assessed expectant fathers who quit smoking | – | Other: Questionnaires setParticipants who 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. Males ≥18 years old; 2. The wife has given birth, the newborn is live, and the number of days of birth is less than or equal to 28 days; 3. Self-reported smoking at least 1 cigarette per day on average for at least 1 month in the past 1 year; 4. Self-reported that they had quit smoking during their wife's pregnancy on purpose, and maintained it for at least 24 hours; |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will be admitted to the maternity ward of the partner hospital. Convenience sampling will be conducted, and expectant fathers who meet the criteria will be invited to participate in the study.
Key inclusion criteria (5 listed)
- (1) All participants should be aged 18 or above;
- (2) The newborn of the participant is alive, and the number of days of birth is ≤28 days;
- (3) All participants should have actively quit smoking during his wife's pregnancy, and maintained it for at least 24 hours;
- (4) All participants should be smoking at least 1 cigarette per day on average for at least 1 month in the past 1 year;
- (5) All participants should be able to communicate in Mandarin (including reading Chinese).
Key exclusion criteria (1 listed)
- All participants 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, characteristics of smoking sheet, the Fagerstrom Test of Nicotine Dependence,Smoking Self-efficacy Questionnaire, Cigarette Withdrawal Scale, smoking hazard questionnaire, motivation to quit smoking sheet, ability to quit smoking sheet, alcohol consumption, International Physical Activity Questionnaire. | Other | Questionnaires assessed expectant fathers who quit smoking |
Primary outcome
Smoking relapse rate
Time frame: Baseline
A true or false sheet in the questionnaire.
6 secondary outcomes
Quality of relationship
Time frame: Baseline
Withdrawal symptoms
Time frame: Baseline
Self-efficacy level
Time frame: Baseline
Dependence of nicotine
Time frame: Baseline
Self-awareness of the hazard of smoking
Time frame: Baseline
Smoking rationalization
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Individual participant dataSharing planned: Yes. The non-identified individual participant data will be shared after the outcomes have been published.
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.
Wei Xia, PhD principal investigator
Sun Yat-sen University
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 Sun Yat-sen University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 2 May 2024. 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 China. 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?
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?
Smoking relapse rate (time frame: Baseline). 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 2 May 2024.