NCT02701686

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

1.9 years

First QC Date

February 26, 2016

Last Update Submit

April 26, 2017

Conditions

Keywords

smoking cessation

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)

EXPERIMENTAL

Subjects 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.

Behavioral: quit immediately (QI)

cut down to quit (CDTQ)

EXPERIMENTAL

Subjects 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.

Behavioral: cut down to quit (CDTQ)

Interventions

advise to quit immediately using the AWARD model

quit immediately (QI)

advise to reduce cigarette consumption and quit eventally using the AWARD model

cut down to quit (CDTQ)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • William, Ho Cheung Li, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

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

Locations