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ISRCTN
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ISRCTN05172176
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ClinicalTrials.gov identifier
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Public title
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Smoking reduction intervention for smokers not willing to quit smoking: a randomised controlled trial
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Scientific title
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Acronym
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Smoking Reduction (SR) Project
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Serial number at source
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HHSRF 01030611
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Study hypothesis
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1. The quit rate and the reduction rate are higher in the intervention groups than the control group
2. In the intervention groups, (a) the adherence rate to replacement therapy (NRT) and (b) the quit rate and the reduction rate are greater in those who have received additional adherence intervention than those who have not
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Lay summary
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Ethics approval
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Institutional Review Board of the University of Hong Kong/ Hospital Authority, Hong Kong West Cluster. Date of approval: 29/05/2003 (ref: UW 03-103 T/103)
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Study design
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Single-centre, randomised, single-blind, placebo-controlled study
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Countries of recruitment
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China
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Disease/condition/study domain
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Smokers who have no intention to quit in the near future
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Participants - inclusion criteria
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1. Both males and females, age 18 or above
2. Ethnic Chinese
3. Smokes at least 2 cigarettes per day
4. Have no intention to quit in the near future
5. Intends to reduce smoking in the next 7 days
6. Has no contraindication to NRT
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Participants - exclusion criteria
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1. Subjects who are psychologically or physically unable to communicate
2. Children and teenagers (age below 18)
3. Pregnant or intention to become pregnant within the next 6 months
4. Those on regular psychotropic medications and in the presence of any serious health problems that may make them unsuitable for using NRT, such as recent stroke, palpitation, or other life threatening conditions
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Anticipated start date
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25/10/2004
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Anticipated end date
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30/07/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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3,826
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Interventions
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Intervention group 1: Face-to-face stage-matched smoking cessation counselling delivered by trained counsellors at initial contact, 1 week and 1 month with NRT adherence intervention
Intervention group 2: Face-to-face stage-matched smoking cessation counselling delivered by trained counsellors at initial contact, 1 week and 1 month without NRT adherence intervention
Control: A placebo healthy diet education material and usual care provided by the hospital
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Primary outcome measure(s)
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1. Quit rate at 6 month follow-up
2. Reduction rate at 6 month follow-up
3. Adherence rate to NRT use at 4 weeks after the first use of NRT
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Secondary outcome measure(s)
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1. Validated quit rates at 6 months
2. Quit rate at 1 month without validation
3. Self-reported use of NRT continuously for at least 4 weeks or 8 weeks
4. Number of quitting attempts made by the subject. Duration of follow-up: 6 months after the baseline visit
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Sources of funding
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Health and Health Services Research Fund, Food and Health Bureau, Government of Hong Kong Special Administrative Region (China) (grant ref: No. 01030611)
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Trial website
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Publications
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Contact name
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Prof
Lam
Tai-hing
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Address
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University of Hong Kong
5/F, William MW Mong Block
Li Ka Shing Faculty of Medicine Building
21 Sassoon Road
Pokfulam
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City/town
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Hong Kong
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Zip/Postcode
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-
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Country
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China
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Tel
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+852 2819 9287
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Email
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hrmrlth@hkucc.hku.hk
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Sponsor
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Food and Health Bureau (China)
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Address
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Government of the Hong Kong Special Administrative Region
Secretary for Food and Health
19/F, Murray Building
Garden Road
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City/town
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Hong Kong
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Zip/Postcode
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-
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Country
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China
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Tel
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+852 21892748
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Fax
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+852 25413352
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Email
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enquiry@fhb.gov.hk
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Sponsor website:
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http://www.fhb.gov.hk/en
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Date applied
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08/07/2008
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Last edited
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25/07/2008
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Date ISRCTN assigned
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25/07/2008
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