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

Phase 4

Completed

• Conditions: Smoking, Tobacco
• Interventions: Drug: Nicotine patch

• Registration Number: NCT03879889
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-19
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Nicotine patch	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong