Overview

This trial is active, not recruiting.

Condition smoking cessation
Treatments nicotine replacement therapy, minimal cessation advice, health warning leaflet
Sponsor The University of Hong Kong
Start date September 2016
End date January 2017
Trial size 32 participants
Trial identifier NCT02935231, PMCANp_2016

Summary

Background: Many smokers cannot quit due to nicotine withdrawal symptoms, which peak at the first week of abstinence. Proactive recruitment of smokers is needed as most smokers do not seek smoking cessation (SC) services. A smoking hotspot (SH) is defined as a public outdoor place where smokers stop/linger and smoke. We aim to include a reasonably "representative" or unbiased sample of SH at different locations from all 3 regions of Hong Kong. We will randomly select 6 eligible SH (2 in each regions) from the 15 hotspots in our previous community trial.

Methods: Two trained SC ambassadors (student helpers) and one supervisor (experienced research assistant) will be deployed for each session of intervention at a SH. Potential subjects will be approached using the "a-foot-into-the-door" method in which SC ambassador will ask if smoker would like to reduce/quit smoking and receive SC intervention or advices. Smokers will be assessed for eligibility and informed written consent will be sought. Subjects will complete a brief self-administered questionnaire (baseline) using tablet PC (please refer to Measurement). To reduce later hang-ups of telephone interventions or surveys, SC ambassador will save contact number of the trial into subjects' mobile phones.

Discussion: The findings will provide much needed and original evidence to support a main RCT on these new, proactive, simple and low-cost interventions for improving current SC services and policy for smokers who do not actively seek help from SC services in Hong Kong and elsewhere.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
This experimental group receivea health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potentian side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.
nicotine replacement therapy NRT
1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.
health warning leaflet
An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.
(Experimental)
This experimental group receive brief smoking cessation advice using AWARD model with a health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potentian side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days.
nicotine replacement therapy NRT
1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.
minimal cessation advice MCA
Brief smoking cessation advice using AWARD model. AWARD: (1) Ask smoking habit; (2) Warn about smoking risk; (3) Advice to quit as soon as possible; (4) Refer to smoking cessation service; and (5) Do-it-again: if relapse/fail.
health warning leaflet
An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.
(Experimental)
This experimental group receive brief smoking cessation advice using AWARD model with a health warning leaflet.
minimal cessation advice MCA
Brief smoking cessation advice using AWARD model. AWARD: (1) Ask smoking habit; (2) Warn about smoking risk; (3) Advice to quit as soon as possible; (4) Refer to smoking cessation service; and (5) Do-it-again: if relapse/fail.
health warning leaflet
An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.
(Active Comparator)
This control group receive a health warning leaflet.
health warning leaflet
An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.

Primary Outcomes

Measure
Exhaled CO validated abstinence
time frame: 3 month

Secondary Outcomes

Measure
Self-reported past 7-day point prevalence abstinence
time frame: 3 month
Nicotine Replacement Therapy use
time frame: 3 month
Smoking cessation service use
time frame: 3 month

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult smokers aged 18+ who smoke cigarettes daily. - Exhaled carbon monoxide (CO) level of 4ppm or above. - Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua) Exclusion Criteria: - Smokers who have contraindication for NRT use: severe angina, arrhythmia, myocardia infraction, pregnancy (or intended to become pregnant <6 months) or breastfeeding. - Smokers who have psychiatric/psychological diseases or regular psychotropic medications - Smokers who are using SC medication, NRT, other SC services or projects.

Additional Information

Official title Proactive Minimal Cessation Advice Plus Nicotine Replacement Therapy (PMCAN) for Smoking Cessation in Smokers at Smoking Hotspots: a Pilot Randomized Controlled Trial
Principal investigator Man Ping WANG
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by The University of Hong Kong.