A TTM-based Smoking Cessation Intervention in Helping Expectant Fathers to Quit Smoking and Maintain Abstinence

Not Applicable

Not yet recruiting

• Conditions: Smoking Cessation; Behavioral Intervention

• Registration Number: NCT06663475
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-28
• Study First Posted: 2024-10-29
• Study Start: 2024-11-04
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 1346

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biochemically validated smoking abstinence	12 month follow-up after randomization	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.

Secondary Outcome Measures

Name	Time	Method
Self-reported 7-day point prevalence quit rate	6, 12-month follow-up	Subjects report that they had not smoked within the recent 7 days.
Smoking Reduction	end of intervention; 3,6,12 month after randomization	Reduction in daily cigarette consumption by at least 50% compared with baseline.
Quit Attempt	end of intervention; 3,6,12 month after randomization	Self-reported abstinence for at least 24 hours
The change in transtheoretical model stages	end of intervention; 3,6,12 month after randomization	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).
the Fagerstrom tolerance questionnaire	end of intervention; 3,6,12 month after randomization	Nicotine Dependence will be measured by the Fagerstrom tolerance questionnaire.
Use of smoking cessation services	end of intervention; 3,6,12 month after randomization	Smoking cessation services include nicotine replacement treatment, counseling for smoking cessation, telephone counselling and other services.
Biochemically validated smoking abstinence	6 month follow-up	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.