NCT03921606

Brief Summary

This study aims to evaluate the effectiveness of a general health promotion (GHP) approach using information communication technology (ICT) to deliver a brief motivational interviewing (MI) to motivate smokers with chronic diseases to quit smoking. Subjects in the intervention group will receive a GHP approach using ICT (e.g., WhatsApp/WeChat) to deliver brief MI. Subjects in the control group will receive an individual face-to-face generic health advice plus a self-help booklet on smoking cessation at the time of recruitment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 4, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.9 years

First QC Date

March 4, 2019

Last Update Submit

November 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Biochemically validated smoking abstinence at 6 months

    The biochemically validated smoking abstinence will be confirmed by a saliva cotinine level of less than 115 ng/ml in parallel test and a carbon monoxide level in expired air of less than 9 parts per million (ppm)

    6-month follow-up

Secondary Outcomes (3)

  • biochemically validated smoking abstinence at 12 months

    12-month follow-up

  • Self-reported 7-day point prevalence of smoking abstinence at 6 and 12 months

    6- and 12-month follow-up

  • Any behavioural change reported by the subjects at 3, 6 and 12 months

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

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive a brief MI via WhatsApp/WeChat on a smartphone during the study period. The brief MI messages will be delivered more intensively as preferred by the subject (usually not less than once every 2 to 3 days and no more than 2 times per day) for the first 6 months. The frequency of delivering the messages via WhatsApp/WeChat will be interactive, depending on the subjects' actions and responses, and may take several sessions of chats within several days or weeks. However, the total time spent by the interventionist will not be more than that for a traditional MI with several long sessions. After 6 months, minimal messages will be provided to the subjects by merely following their progress of behavioural changes and responding to their questions to maintain contact until the 1-year follow-up. The total time spent will be recorded and analysed.

Behavioral: Motivational Interviewing (i-BMI)

Control group

OTHER

The control group will receive individual face-to-face generic health advice (about 5 minutes) on a health-related lifestyle practice such as eating more vegetables and fruits, eating less high salt, fat or sugar foods, consuming less sugary drinks, engaging in more exercise of any kind or intensity, reducing alcohol consumption or reducing weight (if overweight or obese) in SOPCs. A self-help booklet on smoking cessation published by the Hong Kong Council on Smoking and Health with Hotline will be also provided in the SOPCs. The subjects in this group will receive the same schedule of follow-ups as in the intervention group, but they will not receive any follow-up booster intervention.

Behavioral: Individual face-to-face generic health advice

Interventions

A brief MI via WhatsApp/WeChat

Experimental group

Individual face-to-face generic health advice (about 5 minutes) on a health-related lifestyle practice such as eating more vegetables and fruits, eating less high salt, fat or sugar foods, consuming less sugary drinks, engaging in more exercise of any kind or intensity, reducing alcohol consumption or reducing weight (if overweight or obese). A self-help booklet on smoking cessation published by the Hong Kong Council on Smoking and Health with Hotline will be also provided in the SOPCs.

Control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years or above,
  • able to speak Cantonese and read Chinese
  • do not intend to quit smoking (pre-contemplation stage), but are willing to promote their health
  • use a smartphone and can use an instant messaging tool (e.g., WhatsApp/WeChat)
  • willing to receive health promotion advice and interact with our interventionist via WhatsApp/WeChat on a smartphone throughout the study period

You may not qualify if:

  • inability to give informed consent or participate in our intervention due to impaired mental status, cognitive impairment or communication barriers
  • participate in another smoking cessation programme or service

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ho Cheung William Li, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Cheung William Li, PhD

CONTACT

Long Kwan Ho, MPhil

CONTACT

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

March 4, 2019

First Posted

April 19, 2019

Study Start

April 10, 2019

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations