NCT03983330

Brief Summary

To conduct a pilot study to determine the feasibility, potential efficacy and effect size of a personalized general health promotion approach using Information Communication Technology (WhatsApp or WeChat) to deliver a brief Motivational interviewing (MI) in promoting smoking cessation among smokers having follow-up in a Special Out-Patient Clinic (SOPC). In addition, this pilot study aims to assess the potential facilitators and barriers of future implementation of using such approach for smokers with chronic diseases. Based on the findings of the pilot study, a large RCT will be conducted to evaluate the effectiveness and costs of a personalized general health promotion approach in promoting smoking cessation for smokers with chronic diseases in Hong Kong in the future.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

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

May 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

May 26, 2019

Last Update Submit

November 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Biochemically validated smoking abstinence at 12 months

    The biochemically validated 7-day point prevalence of abstinence will be confirmed by saliva cotinine level \< 115 ng/ml in parallel test and a carbon monoxide level in expired air \< 9 parts per million (p.p.m.).

    12-month follow-up

Secondary Outcomes (3)

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

    6- and 12-month follow-up

  • Self-reported reduction of ≥ 50% in cigarette consumption at 6 and 12 months

    6- and 12-month follow-up

  • Any behavioural change reported by the subjects at 1, 3, 6 and 12 months

    1-, 3-, 6- and 12-month follow-ups

Study Arms (2)

Intervention group

EXPERIMENTAL

The trained RA will deliver brief MI to each subject individually via WeChat or WhatsApp in the smart phones throughout the study period. The brief MI messages will be delivered more intensively as preferred by the subject (usually not less than once per 2-3 days and no more than 2 times per day) for the first 6 months. The frequency of delivering message through WeChat or WhatsApp will be interactive, depended on subjects' actions and responses. Start from 6 months, minimal messages by merely following the subjects' progress and responding to their questions to maintain contact will be provided to subjects till one-year follow-up. The readiness of quitting smoking will be assessed at 3-month follow-up. For those who are willing to take further actions to promote their health, i.e. with an intention to quit smoking, health advice on smoking will be given with more emphasis on the health benefits of quitting. The whole intervention will be given through WeChat/WhatsApp.

Behavioral: Brief Motivational Interviewing (i-BMI)

Control group

OTHER

Subjects in the control group will not receive brief MI and follow-up booster intervention. Subjects will be informed that they will receive follow-up telephone call at 1, 3, 6 and 12 months

Behavioral: Control

Interventions

The trained RA will ask the subjects about the priority of engaging in any desirable health-related lifestyle practice as identified in the completed baseline questionnaires and to state a targeted goal that they perceive as the easiest to achieve. Each subject will then receive an individual face-to-face brief MI (about 5 mins) with generic health advice on selected health-related lifestyle practice. They will then be informed to receive an individual brief MI intervention to assist behavioural changes or achieve goals as desired or chosen by them via WeChat or WhatsApp in smart phones throughout the study period. They will be given a self-help smoking cessation booklet with Hotline number. The RA will then deliver brief MI to each subject individually via WeChat or WhatsApp in smart phones throughout the study period. Readiness of quitting smoking will be assessed at 3-month follow-up. Upon request by subjects, we shall provide them with more comprehensive information on quitting.

Intervention group
ControlBEHAVIORAL

Similar to the intervention group, the trained RA will first ask the subjects about the priority of engaging in any desirable health-related lifestyle practice and to state a targeted goal in which they perceive as the easiest to achieve after completing the baseline questionnaires. In addition, the subjects will be given a self-help smoking cessation booklet with Hotline (Tel.: 1833183). However, subjects in the control group will not receive brief MI and follow-up booster intervention. Subjects will be informed that they will receive follow-up telephone call at 1, 3, 6 and 12 months.

Control group

Eligibility Criteria

Age18 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
  • no intention to quit smoking (pre-contemplation stage), but are willing to take action to promote health
  • have a smart phone and able to use instant messaging tool (e.g. WhatsApp, WeChat) for communication, and
  • willing to receive health promotion advices via WhatsApp/WeChat in the smart phone throughout the study

You may not qualify if:

  • unable to give informed consent or participate in our intervention due to impaired mental status, cognitive impairment, or communication barrier, and
  • participation in other smoking cessation programmes or services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

  • Li WHC, Ho LLK, Cheung AT, Wong MP, Cheung DYT, Xia W, Lam TH. A general health promotion approach to helping smokers with non-communicable diseases quit smoking: A pilot randomized controlled trial. Front Public Health. 2022 Oct 18;10:957547. doi: 10.3389/fpubh.2022.957547. eCollection 2022.

  • Li WHC, Ho KY, Lam KKW, Wang MP, Cheung DYT, Ho LLK, Xia W, Lam TH. A study protocol for a randomised controlled trial evaluating the use of information communication technology (WhatsApp/WeChat) to deliver brief motivational interviewing (i-BMI) in promoting smoking cessation among smokers with chronic diseases. BMC Public Health. 2019 Aug 9;19(1):1083. doi: 10.1186/s12889-019-7417-6.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Ho Cheung William Li, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Cheung William Li, PhD

CONTACT

Vanessa Yeung

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

May 26, 2019

First Posted

June 12, 2019

Study Start

June 1, 2019

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations