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

NCT05474651 | Active Not Recruiting DMC

• 1 other identifier: wjn-relapse（father）-2022.07
• Study Type: observational
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Expectant fathers; Smoking relapse; Mix-method study; Paternal Behavior

Outcome Measures

Primary Outcomes (1)

• Smoking relapse rate

  A true or false sheet in the questionnaire.

  Baseline

Secondary Outcomes (6)

• Quality of relationship

  Baseline

• Withdrawal symptoms

  Baseline

• Self-efficacy level

  Baseline

• Dependence of nicotine

  Baseline

• Self-awareness of the hazard of smoking

  Baseline

Study Arms (1)

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;

Other: Questionnaires set

Interventions

Questionnaires set OTHER

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.

Questionnaires assessed expectant fathers who quit smoking

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The participant eligibility is based on both biological and self-representation of gender identity, smokers who is male biologically and also reported as a male will be eligible in this study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

XIAW

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Wei Xia, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A.P.

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 26, 2022
• Study Start: November 23, 2022
• Primary Completion: February 28, 2024
• Study Completion: April 30, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: After the publication of the study
• Access Criteria: Researchers should contact the PI for approval of the study protocol.

Locations

CN (1)