A Comparison of the Effectiveness of Two Approaches in Achieving Smoking Abstinence
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to test the effectiveness of negotiating self determination to reduce cigarette consumption. A single-blinded multi-centre randomized controlled is employed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2014
Typical duration for not_applicable
1 active site
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
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 26, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedApril 28, 2017
April 1, 2017
1.9 years
February 26, 2016
April 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
self-reported 7-day point prevalence of abstinence
6 months
self-reported 7-day point prevalence of abstinence
12 months
self-reported reduction of ≥ 50% in cigarette consumption
6 months
self-reported reduction of ≥ 50% in cigarette consumption
12 months
Secondary Outcomes (6)
biochemically validated abstinence (exhaled CO test & saliva cotinine test)
6 months
biochemically validated abstinence (exhaled CO test & saliva cotinine test)
12 months
self-efficacy in quitting
6 months
self-efficacy in quitting
12 months
number of quit attempts made
6 months
- +1 more secondary outcomes
Study Arms (2)
quit immediately (QI)
EXPERIMENTALSubjects in the QI group will receive a smoking cessation booklet plus a brief intervention using the AWARD model: (a) Ask about smoking history, (b) Warn about the high risk, (c) Advise to quit now, as quitting can greatly reduce risks, (d) Refer smokers to a smoking cessation clinic, and (e) Do it again: repeat the intervention during each telephone follow-up. The whole intervention will be limited to less than 1 min or slightly longer if necessary. For the subsequent telephone follow-ups at 1, 3, 6 and 12 months, the counsellor will congratulate to the subjects who successfully quit smoking, while deliver the same brief intervention as a booster for those who continue to smoke.
cut down to quit (CDTQ)
EXPERIMENTALSubjects in the CDTQ group will also receive the smoking cessation booklet plus a brief intervention using the AWARD model. Instead of asking them to quit immediately, they will be advised gradually cutting down on their cigarette consumption. Also, the subjects will be provided with an education card that contains reduction strategies and a suggested plan to reduce smoking. For the subsequent telephone follow-ups at 1, 3, 6 and 12 months, the nurse counsellor will repeat the warning message that one out of two smokers will be killed by smoking, and remind the subjects of their next reduction target. The counsellor will congratulate subjects who quit or reduce smoking on their success. When subjects fail to quit or reduce their cigarette consumption, the counsellor will reinforce the health hazards of continued smoking and the benefits of quitting, and encourage them to try again immediately or in the near future.
Interventions
advise to quit immediately using the AWARD model
advise to reduce cigarette consumption and quit eventally using the AWARD model
Eligibility Criteria
You may qualify if:
- aged 18 years or above,
- smoke at least two cigarettes per day,
You may not qualify if:
- those with unstable medical conditions as advised by the doctor in charge,
- poor cognitive state or mental illness,
- participation in other smoking cessation programmes or services.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sai Ying Pun Jockey Club General Out-patient Clinic in Hong Kong
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William, Ho Cheung Li, PhD
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 26, 2016
First Posted
March 8, 2016
Study Start
June 1, 2014
Primary Completion
May 1, 2016
Study Completion
November 1, 2016
Last Updated
April 28, 2017
Record last verified: 2017-04