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

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Intervention (experimental) and 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.

The registry classes the interventions as drug.

More on the Plan

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 control group will be given standard advice and information on smoking cessation.

Who Took Part

The registry lists 210 actual participants took part.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: families not residing in hong kong; children in foster care; children with unclear custody.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2017-02-01 with completion listed for 2019-07-31.

It ran at 1 site in Hong Kong.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Urinary cotinine validated parental smoking cessation rate at week-24, Parental self-reported smoking cessation rate of cigarette consumption and Change in children's urinary cotinine level from baseline to week-24.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 210 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.