A TTM-based Smoking Cessation Intervention in Helping Expectant Fathers to Quit Smoking and Maintain Abstinence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSun Yat-sen University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
TTM-based health education videos about smoking cessation for expectant fathers
BehavioralTailored 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 treatment
Behavioralgeneral health education videos about hazards of smoking for expectant fathers in obstetric clinic
Treatment groups
1,346 Participants
are divided into 2 treatment groupsGroup A: general health education videosActive comparator 1 intervention
Group B: TTM-based health education about smoking cessation tailored for expectant fathersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 month follow-up after randomizationSecondary outcomes
1
Self-reported 7-day point prevalence quit rate
Subjects report that they had not smoked within the recent 7 days.
Time frame
6, 12-month follow-up2
Smoking Reduction
Reduction in daily cigarette consumption by at least 50% compared with baseline.
Time frame
end of intervention; 3,6,12 month after randomization3
Quit Attempt
Self-reported abstinence for at least 24 hours
Time frame
end of intervention; 3,6,12 month after randomization4
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).
Time frame
end of intervention; 3,6,12 month after randomizationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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