Smoking Cessation for Fathers of Sick Children

Not Applicable

Recruiting

• Conditions: Cigarette Smoking; mHealth Intervention

• Registration Number: NCT07014124
• Lead Sponsor: The University of Hong Kong

Brief Summary

The project aims to develop and examine the feasibility, acceptability, and preliminary effectiveness of a proactive intervention model combined brief advice, nicotine replacement therapy sampling and mHealth-based individual counselling in increasing smoking abstinence for fathers of sick children.

Detailed Description

Targeted participants are fathers of sick children who smoke daily in the past 7 days and live together with their children. The primary caregiver will be selected if both parents smoke. Participants will be recruited from pediatric wards/outpatient departments of Queen Mary Hospital (QMH), a major acute hospital in Hong Kong. The recruitment will be extended to other public hospitals if needed.

This study will be a two-arm, parallel pilot randomized trial with follow-ups at 1-, 3-, and 6-month since enrolment using standard methodology (CONSORT) to evaluate the effectiveness of the intervention. Surveys will be collected via telephone and children's saliva will be collected face-to-face at 3-months and 6-months after randomisation using Alere iScreen OFD saliva cotinine test device. Semi-structured individual telephone or face-to-face in-depth interviews will be conducted with the participants in the intervention group at 6 months follow-up to explore the participants' perception towards the intervention.

This study's clinical outcome will be biochemically validated abstinence at 3 months after randomisation. Secondary outcomes include validated abstinence at 6 months after randomisation, self-reported 7-day point prevalence abstinence (PPA), 24-hour quit attempts, and smoking reduction by at least 50% at 3 and 6 months. Incentives of HK$200 will be given to participants who report 7-day PPA at 1 month post randomisation. Additionally, incentives of HK$ 500 will be provided for the completion of each biochemical validation (a total $1000 for validation at 3- and 6-month). Such an amount can increase the response rate in our experience. Another incentive of $200 will be given to subjects completing qualitative interviews.

Study Timeline

• Study First Submitted: 2025-01-16
• Study Start: 2025-03-18
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-10
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-03-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biochemically validated abstinence	3-months follow-ups	Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device

Secondary Outcome Measures

Name	Time	Method
Respiratory symptoms	6-month follow-up	Respiratory symptoms will be measured by a self-reported question: Have you ever experienced respiratory symptoms in the past 7 days? If yes, please list.
Perceived family well-being	6-month follow-up	Perceived family well-being will be measured by the Family Apgar Scale. The total scale ranges from 0 to 10, with the higher score indicating a healthier family function.
Self-reported life quality	6-month follow-up	Quality of life will be measured by the WHOQoL scale. The total score ranges 0 to 100, with higher scores indicates better quality of life.
Self-reported secondhand exposure	6-month follow-up	Self-reported secondhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to secondhand smoke and when you are exposed to secondhand smoke.
Self-reported thirdhand exposure	6-month follow-up	Self-reported thirdhand exposure by children in the past 7 days (yes/no). If yes, we will ask where you are exposed to thirdhand smoke and when you are exposed to thirdhand smoke.
Biochemically validated abstinence	6-month follow-up	Face-to-face biochemical validation using Alere iScreen OFD saliva cotinine test device
Past 7-day point prevalence abstinence (PPA)	6-month follow-up	Past 7-day PPA will be measured by a self-reported question: Have you ever smoked in the past 7 days?
Smoking reduction	6-month follow-up	50% or above reduction in cigarette consumption compared with baseline
Use of smoking cessation services	6-month follow-up	Use of smoking cessation services will be measured by a self-reported question: Have you ever used smoking cessation services in the past 7 days?

Trial Locations

Locations (1)

School of Nursing, The University of Hong Kong; 🇭🇰 Hong Kong, Pokfulam, Hong Kong