Smoking reduction intervention for smokers not willing to quit smoking: a randomised controlled trial

ISRCTN	ISRCTN05172176
DOI	https://doi.org/10.1186/ISRCTN05172176
Secondary identifying numbers	HHSRF 01030611

Submission date: 08/07/2008
Registration date: 25/07/2008
Last edited: 11/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Lam Tai-hing
Scientific

University of Hong Kong
5/F, William MW Mong Block
Li Ka Shing Faculty of Medicine Building
21 Sassoon Road
Pokfulam
Hong Kong
-
China

Phone	+852 2819 9287
Email	hrmrlth@hkucc.hku.hk

Study information

Study design	Single-centre, randomised, single-blind, placebo-controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Smoking reduction intervention for smokers not willing to quit smoking: a randomised controlled trial
Study acronym	Smoking Reduction (SR) Project
Study objectives	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
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	Smokers who have no intention to quit in the near future
Intervention	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
Intervention type	Other
Primary outcome measure	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
Secondary outcome measures	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
Overall study start date	25/10/2004
Completion date	30/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	3,826
Total final enrolment	1154
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	25/10/2004
Date of final enrolment	30/07/2006

Locations

Countries of recruitment

China

Study participating centre

University of Hong Kong

Hong Kong
-
China

Sponsor information

Food and Health Bureau (China)
Government

Government of the Hong Kong Special Administrative Region
Secretary for Food and Health
19/F, Murray Building
Garden Road
Hong Kong
-
China

Phone	+852 21892748
Email	enquiry@fhb.gov.hk
Website	http://www.fhb.gov.hk/en
"ROR"	https://ror.org/03qh32912

Funders

Funder type

Government

Health and Health Services Research Fund, Food and Health Bureau, Government of Hong Kong Special Administrative Region (China) (grant ref: No. 01030611)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2011	11/06/2019	Yes	No

Editorial Notes

11/06/2019: Publication reference and total final enrolment added.