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

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

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

Study Overview

• Status: Completed
• Conditions: Smoking, Tobacco
• Intervention / Treatment: Drug: Nicotine patch

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; 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; 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.; Other Names: Nicotinelle
NO_INTERVENTION: Control; 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?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Ching Ching Chan, FHKAM, Chinese University of Hong Kong

Publications and helpful links

General Publications

• Dai S, Chan MHM, Kam RKT, Li AM, Au CT, Chan KC. Monthly Motivational Interview Counseling and Nicotine Replacement Therapy for Smoking Parents of Pediatric Patients: A Randomized Controlled Trial. Front Pediatr. 2022 Apr 13;10:798351. doi: 10.3389/fped.2022.798351. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): July 31, 2019
• Study Completion (ACTUAL): July 31, 2019

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (ACTUAL): March 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Children; Randomised controlled trial; Motivational interview; Paediatrics; Nicotine replacement therapy; Smoking reduction; Environmental tobacco smoke exposure
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 01150077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No