Smoking CessationNCT06663475
A TTM-based Smoking Cessation Intervention in Helping Expectant Fathers to Quit Smoking and Maintain Abstinence
A study testing TTM-based health education videos about smoking cessation for expectant fathers in people with Smoking Cessation and Behavioral Intervention, run by Sun Yat-sen University.
Trial summary
This study aims to evaluate the effectiveness of the video-based health education in smoking cessation among expectant fathers by using two-arm randomized clinical trial to motivate this subgroup attempt to quit, quit smoking and maintain abstinence in the long term. 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, Behavioral Intervention
- What is being tested?
- TTM-based health education videos about smoking cessation for expectant fathers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,346 participants
- Where
- No sites listed yet
- Study dates
- 4 Nov 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 adult
- has a pregnant partner
- at least smoke 1 cigarette per day on average in the last month
- be able to read or communicate in Chinese
Who cannot join
- be or was participated in other smoking cessation program in the past year
- mentally or physically unable to communicate with
- can't play videos by electronic devices
- the pregnant partner is a smoker
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of a Transtheoretical Model Based Health Education Intervention in Smoking Cessation Among Expectant Fathers: a Randomized Control Trial
This study aims to evaluate the effectiveness of the video-based health education in smoking cessation among expectant fathers by using two-arm randomized clinical trial to motivate this subgroup attempt to quit, quit smoking and maintain abstinence in the long term.
- Conditions
- Smoking Cessation, Behavioral Intervention
- Being tested
- TTM-based health education videos about smoking cessation for expectant fathers, usual care treatment
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTM-based health education videos about smoking cessation for expectant fathersBehavioural
Tailored for expectant fathers, this smoking cessation health education information will be developed based on transtheoretical model to motivate a quit attempt and maintain abstinence by using videos.
usual care treatmentBehavioural
general health education videos about hazards of smoking for expectant fathers in obstetric clinic
| Study group | Role | What they receive |
|---|---|---|
| general health education videos | Active comparator | general health education videos about hazards of secondhand smoke exposure for expectant fathers in obstetric clinic Receives: Behavioral: usual care treatment |
| TTM-based health education about smoking cessation tailored for expectant fathers | Experimental | health education videos based on transtheoretical model (TTM) to motivate quit attempt and maintain abstinence among smoking expectant fathers Receives: Behavioral: TTM-based health education videos about smoking cessation for expectant fathers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated smoking abstinence
Self-reported smoking abstinence will be biochemically validated by an exhaled carbon monoxide level < 4 parts per million (p.p.m) and negative for salivary cotinine test.
Measured: 12 month follow-up after randomization
Secondary outcomes (7)
Self-reported 7-day point prevalence quit rate
Subjects report that they had not smoked within the recent 7 days.
Measured: 6, 12-month follow-up
Smoking Reduction
Reduction in daily cigarette consumption by at least 50% compared with baseline.
Measured: end of intervention; 3,6,12 month after randomization
Quit Attempt
Self-reported abstinence for at least 24 hours
Measured: end of intervention; 3,6,12 month after randomization
The change in transtheoretical model stages
There are five stages according to the transtheoretical model, which are pre-contemplation (attempt to quit more than 30 days later), contemplation (attempt to quit within 30 days but more than 7 days), preparation (attempt to quit within 7 days), action stage (quitting) and maintain stage (maintain abstinence more than 6 months).
Measured: end of intervention; 3,6,12 month after randomization
the Fagerstrom tolerance questionnaire
Nicotine Dependence will be measured by the Fagerstrom tolerance questionnaire.
Measured: end of intervention; 3,6,12 month after randomization
Use of smoking cessation services
Smoking cessation services include nicotine replacement treatment, counseling for smoking cessation, telephone counselling and other services.
Measured: end of intervention; 3,6,12 month after randomization
Biochemically validated smoking abstinence
self-reported smoking abstinence will be biochemically validated by an exhaled carbon monoxide level < 4 parts per million (p.p.m) and negative for salivary cotinine test.
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 posted29 Oct 2024
- Study start4 Nov 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,346 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663475
- Sponsor's protocol ID
- L2023SYSU-HL-027
- Other IDs
- 72104259
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared one year after the results of the study'are published. The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Transtheoretical Model Based Health Education Intervention in Smoking Cessation Among Expectant Fathers: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06663475
- Acronym / sponsor ID
- L2023SYSU-HL-027
- Conditions
- Smoking Cessation, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,346 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Oct 2024 (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 evaluate the effectiveness of the video-based health education in smoking cessation among expectant fathers by using two-arm randomized clinical trial to motivate this subgroup attempt to quit, quit smoking and maintain abstinence in the long term.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general health education videos | Active comparator | Behavioral: usual care treatmentgeneral health education videos about hazards of secondhand smoke exposure for expectant fathers in obstetric clinic |
| TTM-based health education about smoking cessation tailored for expectant fathers | Experimental | Behavioral: TTM-based health education videos about smoking cessation for expectant fathershealth education videos based on transtheoretical model (TTM) to motivate quit attempt and maintain abstinence among smoking expectant fathers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male adult
- has a pregnant partner
- at least smoke 1 cigarette per day on average in the last month
- be able to read or communicate in Chinese
Key exclusion criteria (4 listed)
- be or was participated in other smoking cessation program in the past year
- mentally or physically unable to communicate with
- can't play videos by electronic devices
- the pregnant partner is a smoker
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 |
|---|---|---|
| TTM-based health education videos about smoking cessation for expectant fathersTailored for expectant fathers, this smoking cessation health education information will be developed based on transtheoretical model to motivate a quit attempt and maintain abstinence by using videos. | Behavioural | TTM-based health education about smoking cessation tailored for expectant fathers |
| usual care treatmentgeneral health education videos about hazards of smoking for expectant fathers in obstetric clinic | Behavioural | general health education videos |
Primary outcome
Biochemically validated smoking abstinence
Time frame: 12 month follow-up after randomization
Self-reported smoking abstinence will be biochemically validated by an exhaled carbon monoxide level < 4 parts per million (p.p.m) and negative for salivary cotinine test.
7 secondary outcomes
Self-reported 7-day point prevalence quit rate
Time frame: 6, 12-month follow-up
Smoking Reduction
Time frame: end of intervention; 3,6,12 month after randomization
Quit Attempt
Time frame: end of intervention; 3,6,12 month after randomization
The change in transtheoretical model stages
Time frame: end of intervention; 3,6,12 month after randomization
the Fagerstrom tolerance questionnaire
Time frame: end of intervention; 3,6,12 month after randomization
Use of smoking cessation services
Time frame: end of intervention; 3,6,12 month after randomization
Biochemically validated smoking abstinence
Time frame: 6 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: Yes. The data will be shared one year after the results of the study'are published. The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing TTM-based health education videos about smoking cessation for expectant fathers in people with Smoking Cessation and Behavioral Intervention, run by Sun Yat-sen University.
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: opening soon, as of the sponsor's last update on 6 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei XIA, PhD (86 18823359471, xiaw23@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically validated smoking abstinence (time frame: 12 month follow-up after randomization). 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 6 Nov 2024.