Influencing Factors and Trigger Mechanism of Relapse in Expectant Fathers Who Quit Smoking

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Questionnaires set

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 Type: Observational
• Enrollment (Estimated): 294

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • XIAW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).; Males ≥18 years old;; The wife has given birth, the newborn is live, and the number of days of birth is less than or equal to 28 days;; Self-reported smoking at least 1 cigarette per day on average for at least 1 month in the past 1 year;; Self-reported that they had quit smoking during their wife's pregnancy on purpose, and maintained it for at least 24 hours;

Other: Questionnaires set; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking relapse rate	A true or false sheet in the questionnaire.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	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).	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.	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.	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.	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).	Baseline

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Wei Xia, PhD, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Actual): February 28, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: July 24, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Expectant fathers; Smoking relapse; Mix-method study; Paternal Behavior
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: wjn-relapse（father）-2022.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The non-identified individual participant data will be shared after the outcomes have been published.
• IPD Sharing Time Frame: After the publication of the study
• IPD Sharing Access Criteria: Researchers should contact the PI for approval of the study protocol.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No