Smoking, Tobacco
Conditions
Keywords
Smoking reduction, Randomised controlled trial, Motivational interview, Nicotine replacement therapy, Environmental tobacco smoke exposure, Paediatrics, Children
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.
Interventions
DRUGNicotine 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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Urinary cotinine validated parental smoking cessation rate at week-24 | Week-24 | Urinary cotinine validated parental smoking cessation rate at 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 |
| 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 |
Countries
Hong Kong
Outcome results
None listed