Effectiveness of Negotiating Self-determination to Reduce Cigarette Consumption

NCT02763527 | Unknown DMC

• 1 other identifier: GRF
• Study Type: interventional
• Target: 1,566
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

smoking cessation

Outcome Measures

Primary Outcomes (1)

• biochemically validated abstinence using exhaled CO test

  6 months

Secondary Outcomes (9)

• biochemically validated abstinence using exhaled CO test

  12 months

• 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

Study Arms (2)

Smoking reduction

EXPERIMENTAL

Subjects will receive a brief intervention on smoking reduction with a warning message plus a smoking reduction leaflet. They will be asked to think about a tailored smoking reduction schedule for themselves after the negotiation with the trained counsellor. The trained counsellor will negotiate a schedule with subjects to reduce their smoking over an acceptable level. For the subsequent telephone follow up in the intervention group, information on reduction and cessation will be collected, followed by a "booster" intervention, which will repeat the health warning to positively encourage them to reinforce their efforts and the next reduction target. Four consecutive (1, 3, 6 and 12 months) follow-ups will be conducted over the telephone by trained interviewers.

Behavioral: Smoking reduction

Smoking Cessation

PLACEBO COMPARATOR

Subjects in the QI group will always be advised to quit immediately rather than to quit progressively. Subjects will receive a brief advice on quitting with a warning message similar to subjects in the QP group. In addition, subjects will receive a self-help quitting pamphlet published by the Hong Kong Council on Smoking and Health (COSH). Unlike the QP group, subjects in the QI group will not receive smoking reduction intervention and leaflet, and "booster" intervention during telephone follow-ups. However, they will undergo a similar schedule of telephone follow-up as those in the QP group.

Behavioral: Smoking Cessation

Interventions

Smoking reduction BEHAVIORAL

A brief intervention on smoking reduction plus a smoking reduction leaflet

Smoking reduction

Smoking Cessation BEHAVIORAL

A brief advice on quitting plus a leaflet on smoking cessation

Smoking Cessation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smokers
• who are Chinese
• aged 18 years or above
• who smoke at least two cigarettes per day
• with moderate to severe nicotine dependence, and
• have no intention to quit smoking ≤7 days, but are interested in reducing the number of cigarettes smoked per day .

You may not qualify if:

• smokers
• with unstable medical conditions as advised by the doctor in charge,
• with poor cognitive state or mental illness,
• who participate in other smoking cessation programmes or services,
• with mild nicotine dependence, or
• who claim that they can quit ≤7 days

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• William, Ho Cheung LI, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William, Ho Cheung LI, PhD

CONTACT

39176634; william3@hku.hk

Ka Yan, HO Ho, MPhil

CONTACT

39176328; devilbb@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 5, 2016
• Study Start: June 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 4, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share