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Clinical Trials/NCT03879889
NCT03879889
Completed
Phase 4

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

Chinese University of Hong Kong1 site in 1 country210 target enrollmentFebruary 1, 2017

Overview

Phase
Phase 4
Intervention
Nicotine patch
Conditions
Smoking, Tobacco
Sponsor
Chinese University of Hong Kong
Enrollment
210
Locations
1
Primary Endpoint
Validated successful smoking reduction rate
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
July 31, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kate Ching Ching Chan

Clinical Professional Consultant

Chinese University of Hong Kong

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: Nicotine patch

Outcomes

Primary Outcomes

Validated successful smoking reduction rate

Time Frame: Week-24

Urinary cotinine validated parental successful smoking reduction rate at week-24

Self-reported parental successful smoking reduction rate at week-24

Time Frame: Week-24

Self-reported reduction of daily cigarette consumption by 50% or more compared with baseline

Secondary Outcomes

  • Urinary cotinine validated parental smoking cessation rate at week-24(Week-24)
  • Change in children's urinary cotinine level from baseline to week-24(Week-24)
  • Parental self-reported smoking reduction rate of cigarette consumption(Week-24)
  • Parental self-reported smoking cessation rate of cigarette consumption(Week-24)

Study Sites (1)

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