Effectiveness of Negotiating Self-determination to Reduce Cigarette Consumption
NCT02763527 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1566
Last updated 2020-11-04
Summary
Background: Smokers attended to outpatient clinics present an excellent 'teachable moment' for smoking cessation interventions. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of negotiating self-determination to reduce cigarette consumption among smokers attending outpatient clinics
Methods: A randomized controlled trial will be conducted in 10 out-patient clinics in Hong Kong. Subjects in the intervention group will receive a brief intervention on smoking reduction plus a smoking reduction leaflet. Additionally, subjects will be asked to think about a smoking reduction schedule for themselves after the negotiation with the counsellor. Subjects in the control group will receive a brief advice on quitting plus a leaflet on smoking cessation. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted. The primary outcome measure is biochemically validated abstinence at 6 months. Secondary outcomes are: (i) biochemically validated abstinence at 12 months, (ii) self-reported 7-day point prevalence of abstinence at 6 and 12 months, (iii) self-reported reduction of ≥ 50% in cigarette consumption at 6 and 12 months, and (iv) self-efficacy against tobacco at 6 and 12 months.
Conditions
- Smoking
Interventions
- BEHAVIORAL
-
Smoking reduction
A brief intervention on smoking reduction plus a smoking reduction leaflet
- BEHAVIORAL
-
Smoking Cessation
A brief advice on quitting plus a leaflet on smoking cessation
Sponsors & Collaborators
-
The University of Hong Kong
lead OTHER
Principal Investigators
-
William, Ho Cheung LI, PhD · The University of Hong Kong
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-06-30
- Primary Completion
- 2022-12-31
- Completion
- 2023-12-31
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