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

NCT06663475 | Not Yet Recruiting DMC

• 2 other identifiers: L2023SYSU-HL-02772104259
• Study Type: interventional
• Target: 1,346
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Smoking Cessation; Behavioral Intervention

Outcome Measures

Primary Outcomes (1)

• Biochemically validated smoking abstinence

  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.

  12 month follow-up after randomization

Secondary Outcomes (7)

• 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

Study Arms (2)

general health education videos

ACTIVE COMPARATOR

general health education videos about hazards of secondhand smoke exposure for expectant fathers in obstetric clinic

Behavioral: usual care treatment

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

EXPERIMENTAL

health education videos based on transtheoretical model (TTM) to motivate quit attempt and maintain abstinence among smoking expectant fathers

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

Interventions

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.

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

usual care treatment BEHAVIORAL

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

general health education videos

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Wei XIA, PhD

CONTACT

86 18823359471; xiaw23@mail.sysu.edu.cn

Lishan Li

CONTACT

86 18990190178; LilyShine003@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: One year after the results of the study are published
• Access Criteria: The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.