Clinical trial NCT07014124: Smoking Cessation for Fathers of Sick Children
Official title: mHealth-based Motivational Counselling Integrate With a Sample of Nicotine Replacement Therapy for Fathers of Sick Children Who Smoke Cigarettes: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cigarette Smoking
mHealth Intervention
Keywords: tobacco exposure
sick children
quit smoking
Nicotine replacement therapy
mHealth support
smoking fathers
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion criteria for parents：

* Parents (mainly fathers) aged ≥18 years and smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
* Living with a child aged \<18 years who attended the clinic or were admitted to the pediatric ward
* Hong Kong residents able to read and communicate in Cantonese or Putonghua
* Owned a smartphone and can use an instant messaging app (e.g., WhatsApp, Facebook) Inclusion criteria for children
* Children aged \<18 years who attended the clinic or were admitted to the pediatric ward
* Lives with at least one or more parents who smoke at least one cigarette (including alternative tobacco products) daily in the past seven days
* Able to provide biochemical samples (e.g. saliva) for purpose of research

Exclusion criteria for parents

* Smokers having a history of psychiatric/psychological disease or currently on regular psychotropic medications
* Smokers using smoking cessation medications or other smoking cessation services or projects Exclusion criteria for children
* Children who already have serious health diseases (e.g.chronic disease, genetic disease)
* Children who are participating in other clinical trials that may affect the results of this study
* Children who live in certain environments, such as those living in highly contaminated areas or areas with other potential disease-causing factors

Primary outcomes:
measure: Biochemically validated abstinence
timeFrame: 3-months follow-ups
Secondary outcomes:
measure: Biochemically validated abstinence
timeFrame: 6-month follow-up
measure: Past 7-day point prevalence abstinence (PPA)
timeFrame: 3-month follow-up
measure: Past 7-day point prevalence abstinence (PPA)
timeFrame: 6-month follow-up
measure: Smoking reduction
timeFrame: 3-month follow-up
measure: Smoking reduction
timeFrame: 6-month follow-up
measure: Use of smoking cessation services
timeFrame: 3-month follow-up
measure: Use of smoking cessation services
timeFrame: 6-month follow-up
measure: Respiratory symptoms
timeFrame: 3-month follow-up
measure: Respiratory symptoms
timeFrame: 6-month follow-up
measure: Perceived family well-being
timeFrame: 3-month follow-up
measure: Perceived family well-being
timeFrame: 6-month follow-up
measure: Self-reported life quality
timeFrame: 3-month follow-up
measure: Self-reported life quality
timeFrame: 6-month follow-up
measure: Self-reported secondhand exposure
timeFrame: 3-month follow-up
measure: Self-reported secondhand exposure
timeFrame: 6-month follow-up
measure: Self-reported thirdhand exposure
timeFrame: 3-month follow-up
measure: Self-reported thirdhand exposure
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
state: Pokfulam
Study officials:
References: