NCT04890223

Brief Summary

This study aims to examine the efficacy of brief MI delivered by mobile instant messaging tools in promoting smoking cessation among unmotivated smokers with chronic diseases. Participants in the intervention group will receive a brief MI intervention while the control group will receive a placebo intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
728

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

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

First Submitted

Initial submission to the registry

May 12, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2023

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

1.7 years

First QC Date

May 12, 2021

Last Update Submit

August 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Biochemically validated smoking abstinence at 12 months

    The participants who self-reported not smoking within the past seven days will be invited to submit to a biochemical verification test of smoking abstinence, including an exhaled CO test and a salivary cotinine test. Smoking abstinence is defined as an exhaled CO level of less than 4 ppm and a saliva cotinine level lower than 15 ng/ml.

    12-month follow-up

Secondary Outcomes (6)

  • Biochemically validated smoking abstinence at 6 months

    6-month follow-up

  • Self-reported smoking abstinence

    3-, 6-, or 12-month follow-ups

  • Intention to quit

    3-, 6-, or 12-month follow-ups

  • Self-reported smoking reduction of at least 50%

    3-, 6-, or 12-month follow-ups

  • Quit attempts

    3-, 6-, or 12-month follow-ups

  • +1 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

The participants in the intervention group will be asked to identify an unfavourable behaviour that they wish to change when filling out the baseline questionnaire. The research nurse will conduct the individual face-to-face brief MI interviews for this purpose, which will last for approximately five to ten minutes. After the face-to-face brief MI interviews, the participants in the intervention group will receive brief MI messages individually by means of mobile instant messaging for six months from the baseline. After six months, the brief MI messages will cease to be delivered to the participants in the intervention group, with whom the research team will then maintain only minimal contact until the 12-month follow-up.

Behavioral: Brief MI intervention

Control group

PLACEBO COMPARATOR

Participants in the control group will be asked to identify an unfavourable behaviour that they want to change at the baseline but, rather than brief MI interviews delivered face-to-face, received generic health advice consultations on the selected unfavourable behaviour that lasted approximately five to ten minutes. Each participant will receive a self-help smoking cessation booklet titled Be Smart, Quit Smoking! published by the Hong Kong Council on Smoking and Health with information about the negative health consequences of smoking, reasons to quit, strategies for quitting, and smoking cessation services available in Hong Kong along with a public quitline number (specifically, 1833183). Those who express the intention to quit at follow-ups will receive usual smoking cessation support.

Behavioral: Placebo intervention

Interventions

Brief MI intervention

Intervention group

Generic health advice consultations and self-help smoking cessation booklets

Control group

Eligibility Criteria

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

You may qualify if:

  • Hong Kong Chinese over the age of 17
  • Had smoked at least one cigarette per day over the previous three months
  • Had been diagnosed with at least one chronic disease
  • Able to speak Cantonese and read Chinese
  • Willing to take action to improve their health but had no intention to quit smoking
  • Had a smartphone and were able to use mobile instant messaging tools
  • Willing to receive health promotion advice and communicate through mobile instant messaging

You may not qualify if:

  • Participating in other smoking cessation programs or services
  • With mental or cognitive impairment or communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Ho Cheung William Li, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 18, 2021

Study Start

June 1, 2021

Primary Completion

February 17, 2023

Study Completion

February 17, 2023

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations