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

NCT03879889 | Completed Phase 4

• 1 other identifier: 01150077
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking, Tobacco

Keywords

Smoking reduction; Randomised controlled trial; Motivational interview; Nicotine replacement therapy; Environmental tobacco smoke exposure; Paediatrics; Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Urinary cotinine validated parental smoking cessation rate at 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

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

  Week-24

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

Also known as: Nicotinelle

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 35498786 DERIVED

MeSH Terms

Conditions

Tobacco Smoking; Smoking Reduction

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ching Ching Chan, FHKAM

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research study personnel who will conduct the data collection on outcome measures will be blinded to the group assignment. The researchers who will conduct the data analysis will also be blinded the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professional Consultant

Model Details: 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 Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: February 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)