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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06663475
Enrollment
1346
Registered
2024-10-29
Start date
2024-11-04
Completion date
2026-12-31
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation, Behavioral Intervention

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.

Interventions

BEHAVIORALTTM-based health education videos about smoking cessation for expectant fathers

Tailored for expectant fathers, this smoking cessation health education information will be developed based on transtheoretical model to motivate a quit attempt and maintain abstinence by using videos.

general health education videos about hazards of smoking for expectant fathers in obstetric clinic

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Biochemically validated smoking abstinence12 month follow-up after randomizationSelf-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

MeasureTime frameDescription
Smoking Reductionend of intervention; 3,6,12 month after randomizationReduction in daily cigarette consumption by at least 50% compared with baseline.
Quit Attemptend of intervention; 3,6,12 month after randomizationSelf-reported abstinence for at least 24 hours
The change in transtheoretical model stagesend of intervention; 3,6,12 month after randomizationThere 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).
Self-reported 7-day point prevalence quit rate6, 12-month follow-upSubjects report that they had not smoked within the recent 7 days.
Use of smoking cessation servicesend of intervention; 3,6,12 month after randomizationSmoking cessation services include nicotine replacement treatment, counseling for smoking cessation, telephone counselling and other services.
Biochemically validated smoking abstinence6 month follow-upself-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.
the Fagerstrom tolerance questionnaireend of intervention; 3,6,12 month after randomizationNicotine Dependence will be measured by the Fagerstrom tolerance questionnaire.

Contacts

Primary ContactWei XIA, PhD
xiaw23@mail.sysu.edu.cn86 18823359471
Backup ContactLishan Li
LilyShine003@gmail.com86 18990190178

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026