The Effectiveness of a Transtheoretical Model Based Health Education Intervention in Smoking Cessation Among Expectant Fathers: a Randomized Control Trial

Sun Yat-sen University0 sites1,346 target enrollmentNovember 4, 2024

ConditionsSmoking Cessation Behavioral Intervention

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Smoking Cessation
Sponsor: Sun Yat-sen University
Enrollment: 1346
Primary Endpoint: Biochemically validated smoking abstinence
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 4, 2024

End Date

December 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Wei XIA, PhD

Principle Investigator

Sun Yat-sen University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Biochemically validated smoking abstinence

Time Frame: 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 Outcomes

Self-reported 7-day point prevalence quit rate(6, 12-month follow-up)
Smoking Reduction(end of intervention; 3,6,12 month after randomization)
Quit Attempt(end of intervention; 3,6,12 month after randomization)
The change in transtheoretical model stages(end of intervention; 3,6,12 month after randomization)
the Fagerstrom tolerance questionnaire(end of intervention; 3,6,12 month after randomization)
Use of smoking cessation services(end of intervention; 3,6,12 month after randomization)
Biochemically validated smoking abstinence(6 month follow-up)