Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong

Study Overview
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Brief Summary
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A randomized controlled trial to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong.

Detailed Description
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This is a single blinded randomized controlled trial aiming to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong. This trial consists of a 24-week intervention period. Eligible families will be randomly assigned to either intervention group or control group. Smoking parent(s) in intervention group will be given face-to-face counselling on smoking reduction and adherence to nicotine replacement therapy (NRT) with motivational interviews, provision of NRT and monthly phone follow-up for counselling and support. Smoking parent(s) in control group will be given standard advice and information on smoking cessation.

Official Title
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Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong: a Randomised Controlled Trial

Conditions
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Smoking, Tobacco

Intervention / Treatment
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* Drug: Nicotine patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ethnic Chinese family with children aged younger than 18 years of age. Children who are admitted to the paediatric inpatient units or attend the paediatric specialist clinic at the Prince of Wales Hospital. Children with at least one custodial smoking parent who is living with them. Written informed consent obtained from parents. Exclusion Criteria: Families not residing in Hong Kong. Children in foster care. Children with unclear custody. Smoking paediatric patients. Presence of smoking household members apart from the parents. Smoking parent who is contraindicated to use nicotine replacement therapy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A single blinded randomized controlled trial aiming to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong. This trial consists of a 24-week intervention period. Eligible families will be randomly assigned to either intervention group or control group. Smoking parent(s) in intervention group will be given face-to-face counselling on smoking reduction and adherence to nicotine replacement therapy (NRT) with motivational interviews, provision of NRT and monthly phone follow-up for counselling and support. Smoking parent(s) in control group will be given standard advice and information on smoking cessation.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention arm will include face-to-face counseling on smoking reduction and adherence to nicotine replacement therapy (NRT) with motivational interviews, provision of free NRT, referral to quit smoking hotline, monthly phone follow-up and two follow-up visits. | Drug: Nicotine patch<br>* Four weeks of nicotine patch will be provided at the first contact, which will be prescribed using the guidelines based on the subject's daily cigarette consumption. At week-4 visit, four more weeks of NRT will be provided.<br>* Other names: Nicotinelle;|
| No Intervention: Control<br>Smoking parents will be given standard advice on smoking cessation. They will be given an information leaflet showing standard information on the currently available smoking cessation service as well as a smoking cessation hotline. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated successful smoking reduction rate | Urinary cotinine validated parental successful smoking reduction rate at week-24 | Week-24 | 
| Self-reported parental successful smoking reduction rate at week-24 | Self-reported reduction of daily cigarette consumption by 50% or more compared with baseline | Week-24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary cotinine validated parental smoking cessation rate at week-24 | Urinary cotinine validated parental smoking cessation rate at week-24 | Week-24 | 
| Parental self-reported smoking reduction rate of cigarette consumption | Parental self-reported smoking reduction rate of cigarette consumption | Week-24 | 
| Parental self-reported smoking cessation rate of cigarette consumption | Parental self-reported 7-day point-prevalence tobacco abstinence | Week-24 | 
| Change in children's urinary cotinine level from baseline to week-24 | Change in children's urinary cotinine level from baseline to week-24 | Week-24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking reduction, Randomised controlled trial, Motivational interview, Nicotine replacement therapy, Environmental tobacco smoke exposure, Paediatrics, Children