NCT01670864

Brief Summary

Background According to the report of Census \& Statistics Department, there are still 659,300 daily smokers (11.1%) in Hong Kong and smoking kills over 7,000 people per year. The Quit and Win programme provided another opportunity to reach large group of smokers, and it aims to widespread quit attempts among smokers via incentives in order to boost up the number of quitters. Although such competitions appear to reach large cohorts of smokers, there is still insufficient evidence of its effectiveness in helping smokers to achieve complete cessation. Aim This project aims to promote and evaluate community-based smoking cessation services through the Quit to Win Contest organised in the 18 districts of Hong Kong. The specific objectives of the study are (1) to build capacity in the community on smoking cessation through a training programme; (2) to empower the participated NGOs (a) to raise the awareness of smoking cessation in the community level; (b) to reach as many smokers as possible; (c) to arouse the interest of smokers to quit, through organizing the Quit to Win Contest; (3) to test the effectiveness of community-based on-site face-to-face counselling and Short Message Service (SMS) message vs. self-help booklet to assist current smokers to quit smoking; and (4) to build-up a community-based participatory research (CBPR) model in smoking cessation intervention at a district level in Hong Kong. Methods A community-based participatory (CBP) approach, which is an effective way to engage public health researchers and community members (NGOs, other major stakeholders, and participants), will be used. Two domains of outcome will be assessed: (1) Effectiveness of smoking cessation interventions, (2) process evaluation of the recruitment activities including number of eligible participants and amount of publicity. Procedure At the recruitment sites, after screening for eligibility of participants for the Quit to Win Contest, smoking counselor will measure eligible participant's level of carbon monoxide (CO) on expired air, and provide the self-help smoking cessation materials developed by the Hong Kong Council on Smoking and Health (COSH). Then the counselor will explain and invite the participants to join the cluster randomized controlled trial on smoking cessation intervention. Participants will be allocated to one of the groups of the smoking cessation intervention. 3- and 6-month follow-ups will be conducted Hypothesis We hypothesize that the on-site brief smoking cessation advice will lead to significant increases in rates of smoking cessation in the intervention group than the control group (with the self-help materials only). Another hypothesis to be tested is that the intervention of sending SMS messages of smoking cessation advice is effective to increase the quit rate comparing to the control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

2 months

First QC Date

August 17, 2012

Last Update Submit

July 22, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • The self-reported 7-day point prevalence (pp) quit rate of smoking at 3 months

    Whether the participant has quitted smoking in the past seven days at the time point of 3 months

    Three months

Secondary Outcomes (2)

  • Biochemical validated and self-reported smoking habit at 3 and 6 months

    3 and 6 months after recruitment

  • Service output of the community-based smoking cessation intervention

    Whole project

Study Arms (3)

Counseling group

EXPERIMENTAL

Study participants in the counseling group will receive a brief on-site face-to-face smoking cessation counseling from our trained smoking cessation counselor on the study site after signing the consent form. They will receive advice on quitting smoking and specific warning about the hazardous effects of smoking on health. A special designed health education card, based on the health education model, will be also provided to the participants. Additional telephone follow-up counseling (reminder) at 1-week \& 1-month will be made to the participants in this group.

Behavioral: Counseling group

SMS intervention group

EXPERIMENTAL

Study participants in the SMS group will receive SMS text messages on smoking cessation advice and warning on the hazardous effects of smoking on health. The participants will receive a total of 16 tailored SMS messages after recruitment.

Behavioral: SMS intervention group

Control group

NO INTERVENTION

Study participants in the control group will not receive any quitting assistance other than the self-help materials from the recruitment sites.

Interventions

The content for the brief counseling group adopts a AWARD approach including asking the smoking habit, warning about the health risks associated with smoking, advising the smokers to quit, referring to specialized service, and repeating the above messages. A special designed health education card, based on the health education model, will be also provided to the participants. Additional telephone follow-up counseling (reminder) at 1-week \& 1-month will be made to the participants in this group.

Counseling group

The text messages are divided into two groups which target to smokers who are ready to quit and those who are not ready to quit. For smokers who are ready to quit, messages would be focused on practical advice and emotional support. For smokers who are not ready to quit, messages would be focused on motivating the smokers to have quit attempt.

SMS intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hong Kong residents aged 18 or above
  • Smoke at least 1 cigarette per day in the past 3 months
  • Able to communicate in Cantonese and read Chinese
  • Have a local network mobile phone
  • Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO smokerlyzer

You may not qualify if:

  • Smokers who have difficulties (either physical or cognitive condition) to communicate
  • Currently following other forms of smoking cessation programme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong SAR, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 17, 2012

First Posted

August 22, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations