NCT03401021

Brief Summary

This study aims to use a cross-sectional study and semi-structured interview to explore the level of intention to quit smoking among male smokers whose partner got pregnant and further explore factors associated with their quit intention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
466

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

January 8, 2018

Last Update Submit

May 2, 2019

Conditions

Smoking Cessation

Keywords

intention to quit smokingmale smokersmoking cessationexpectant fathers

Outcome Measures

Primary Outcomes (1)

  • Quit intention of smoking

    The level of intention to quit of smoking among male smokers who planning to have a baby with their partners will be measured by b) The Transtheoretical Model (TTM) variables. The Stage of TTM will be assessed by asking the intention of quitting smoking in the past 6 months with the 6-items, which are Precontemplation, Contemplation, Preparation, Action, Maintenance, and Termination

    Baseline

Secondary Outcomes (4)

  • Self-efficacy level

    Baseline

  • Self-awareness of the hazard of smoking

    Baseline

  • Family support level

    Baseline

  • Dependence of nicotine

    Baseline

Study Arms (1)

Crrent Male smokers

Male smokers 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. be aged 18 or above, 2. have a history of smoking at least one cigarette per day before their partners became pregnant, 3. be involved with partners whose pregnancies could be confirmed, 4. able to read Chinese and communicate in the Mandarin dialect.

Other: Questionnaires set

Interventions

Questionnaires setOTHER

Participants will be asked to respond to the demographic information sheet, Smoking characteristics sheet, the Fagerstrom Test of Nicotine Dependence, the Transtheoretical Model (TTM) variables, Smoking Self-efficacy Questionnaire (SEQ-12), Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR), and a smoking hazard questionnaire.

Crrent Male smokers

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsthe 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 VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population is include males smokers who is/will planning to have a baby with their partners.

You may qualify if:

  • (1) All participants should be males
  • (2) All participants should be aged 18 or above;
  • (3) All participants should be married;
  • (4) All participants should be smoking at least one cigarette per day averagely during the past 3 months;
  • (5) All participants should be able to communicate in Mandarin (including reading Chinese)

You may not qualify if:

  • Smokers 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Xia W, Li HCW, Song P, Ho KY, Luo Y, Liang T, Ho LLK, Cheung AT, Cai W. Perceptions, behaviours and attitudes towards smoking held by the male partners of Chinese pregnant women: a qualitative study. BMC Public Health. 2021 Oct 20;21(1):1901. doi: 10.1186/s12889-021-11966-4.

    PMID: 34670560DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Ho Cheung William Li, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 17, 2018

Study Start

December 6, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2019

Last Updated

May 6, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)