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

November 4, 2024 updated by: Wei XIA, PhD, Sun Yat-sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1346

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: general health education videos
general health education videos about hazards of secondhand smoke exposure for expectant fathers in obstetric clinic
Behavioral: usual care treatment
general health education videos about hazards of smoking for expectant fathers in obstetric clinic
Experimental: TTM-based health education about smoking cessation tailored for expectant fathers
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 month follow-up after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6, 12-month follow-up
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.
end of intervention; 3,6,12 month after randomization
Quit Attempt
Time Frame: end of intervention; 3,6,12 month after randomization
Self-reported abstinence for at least 24 hours
end of intervention; 3,6,12 month after randomization
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).
end of intervention; 3,6,12 month after randomization
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.
end of intervention; 3,6,12 month after randomization
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.
end of intervention; 3,6,12 month after randomization
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.
6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 4, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • L2023SYSU-HL-027
  • 72104259 (Other Grant/Funding Number: the National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be shared one year after the results of the study'are published. The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.

IPD Sharing Time Frame

One year after the results of the study are published

IPD Sharing Access Criteria

The researchers can access the data by contacting the PI at xiaw23@mail.sysu.edu.cn with the research purpose described.

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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