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NCT Number: NCT06663475

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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.

usual care treatment

Behavioral

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

Primary outcomes

  1. 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

  1. Self-reported 7-day point prevalence quit rate

    Time frame: 6, 12-month follow-up

    Subjects report that they had not smoked within the recent 7 days.

  2. Smoking Reduction

    Time frame: end of intervention; 3,6,12 month after randomization

    Reduction in daily cigarette consumption by at least 50% compared with baseline.

  3. Quit Attempt

    Time frame: end of intervention; 3,6,12 month after randomization

    Self-reported abstinence for at least 24 hours

  4. The change in transtheoretical model stages

    Time frame: 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).

  5. the Fagerstrom tolerance questionnaire

    Time frame: end of intervention; 3,6,12 month after randomization

    Nicotine Dependence will be measured by the Fagerstrom tolerance questionnaire.

  6. Use of smoking cessation services

    Time frame: 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.

  7. Biochemically validated smoking abstinence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lishan Li

CONTACT

[email protected]

86 18990190178

Wei XIA, PhD

CONTACT

[email protected]

86 18823359471

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 29, 2024
Registry last updated
Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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