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Completed

NCT Number: NCT03879889

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

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

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Key information

Conditions

Smoking, Tobacco Behavior Health Behavior Smoking Smoking Reduction Tobacco Smoking Tobacco Use

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prince of Wales Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine patch

Drug

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

Primary outcomes

  1. Validated successful smoking reduction rate

    Time frame: Week-24

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

  2. 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

  1. Urinary cotinine validated parental smoking cessation rate at week-24

    Time frame: Week-24

    Urinary cotinine validated parental smoking cessation rate at week-24

  2. Parental self-reported smoking reduction rate of cigarette consumption

    Time frame: Week-24

    Parental self-reported smoking reduction rate of cigarette consumption

  3. Parental self-reported smoking cessation rate of cigarette consumption

    Time frame: Week-24

    Parental self-reported 7-day point-prevalence tobacco abstinence

  4. Change in children's urinary cotinine level from baseline to week-24

    Time frame: Week-24

    Change in children's urinary cotinine level from baseline to week-24

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2019
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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