Clinical trial NCT05474651: Influencing Factors and Trigger Mechanism of Relapse in Expectant Fathers Who Quit Smoking
Official title: Influencing Factors and Trigger Mechanism of Relapse in Expectant Fathers Who Quit Smoking: An Exploratory Sequential Mixed Methods Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Smoking Cessation
Keywords: Expectant fathers
Smoking relapse
Mix-method study
Paternal Behavior
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 294
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* (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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Smoking relapse rate
timeFrame: Baseline
Secondary outcomes:
measure: Quality of relationship
timeFrame: Baseline
measure: Withdrawal symptoms
timeFrame: Baseline
measure: Self-efficacy level
timeFrame: Baseline
measure: Dependence of nicotine
timeFrame: Baseline
measure: Self-awareness of the hazard of smoking
timeFrame: Baseline
measure: Smoking rationalization
timeFrame: Baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: XIAW
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Wei Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References: