Quit-smoking support for fathers of sick children
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
This project will try a proactive program of brief advice, free nicotine replacement sampling, and smartphone counselling to help fathers of sick children stop smoking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, Pokfulam) |
| Trial ID | NCT07014124 on ClinicalTrials.gov |
What this trial studies
This is a two-arm, parallel pilot randomized trial recruiting fathers who smoke from pediatric wards and outpatient clinics at Queen Mary Hospital in Hong Kong, with recruitment extended to other public hospitals if needed. Participants are randomized to receive brief cessation advice, nicotine replacement therapy (NRT) sampling, mHealth-based individual motivational counselling, and self-help materials versus usual care, with follow-ups at 1, 3, and 6 months. The primary clinical outcome is biochemically validated abstinence at 3 months, with additional outcomes at 6 months, self-reported point-prevalence abstinence, quit attempts, and smoking reduction; children's saliva cotinine will be collected at 3 and 6 months for validation. The trial also includes qualitative interviews with intervention participants at 6 months to explore acceptability and feasibility, and participants who report short-term abstinence receive modest cash incentives.
Who should consider this trial
Good fit: Ideal candidates are Hong Kong residents aged 18 or older who smoke at least one cigarette daily, live with a child under 18 who visited or was admitted to the pediatric service, and can read Cantonese or Putonghua and use a smartphone messaging app.
Not a fit: People already using smoking-cessation medications, with a history of psychiatric disease or on regular psychotropic medication, those not living with their children, or those without a smartphone or ability to attend face-to-face saliva collection are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could raise quit rates among fathers who smoke and reduce children's exposure to tobacco smoke.
How similar studies have performed: Combinations of NRT and counselling delivered by phone or digital tools have shown modest success in general smoking populations, but this proactive, father-focused, hospital-recruited model is relatively novel and has limited prior testing.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong, Pokfulam
- School of Nursing, The University of Hong Kong — Hong Kong, Pokfulam, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Shengzhi Zhao, PhD
- Email: lubabezz@connect.hku.hk
- Phone: +852 6561 4500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.