NCT03574077

Brief Summary

Text messaging can provide smokers with quitting methods, information on available smoking cessation (SC) services and social support. This kind of intervention was proven to be effective for smoking cessation. Instant messaging (IM), by sending text and pictures, could provide users with better instantaneous and inexpensive support in their time of need. However, IM intervention is understudied in smoking cessation or other health-related areas to our knowledge, its approaches and efficacy warrant further investigation. This study aims to assess the effect of the combined intervention (nicotine replacement therapy sampling, active referral, and brief advice plus a supportive semi-personalized instant messaging advice) on smoking cessation and to assess the effect of the above interventions on secondary outcomes, including quit intention and attempts, smoking reduction, level of nicotine dependence, use of nicotine replacement therapy (NRT) and SC services.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

November 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 27, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

November 9, 2017

Last Update Submit

January 8, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Biochemically validated abstinence

    Biochemically validated abstinence (exhaled carbon monoxide \<4 ppm and saliva cotinine \<= 10 ng/ml)

    3-month follow-up

  • Biochemically validated abstinence

    Biochemically validated abstinence (exhaled carbon monoxide \<4 ppm and saliva cotinine \<= 10 ng/ml)

    6-month follow-up

Secondary Outcomes (7)

  • Self-reported 7-day point prevalence abstinence

    3-month and 6-month follow-up

  • Level of nicotine dependence

    3-month and 6-month follow-up

  • Readiness to quit smoking

    3-month and 6-month follow-up

  • Quit attempts

    3-month and 6-month follow-up

  • Smoking reduction

    3-month and 6-month follow-up

  • +2 more secondary outcomes

Study Arms (2)

Instant messaging

EXPERIMENTAL

AWARD advice + NRT sampling + Active referral + Instant Messaging (IM)

Behavioral: Instant Messaging (IM)Behavioral: AWARD adviceBehavioral: NRT samplingBehavioral: Active referral

SMS messaging

ACTIVE COMPARATOR

AWARD advice + NRT sampling + Active referral + SMS messaging

Behavioral: AWARD adviceBehavioral: NRT samplingBehavioral: Active referralBehavioral: SMS messaging

Interventions

Tailored automatic, fix- scheduled regular messages will be sent and counselors will interact with smokers in the intervention group through WhatsApp since initial contact and until 2-month after baseline. The interaction will follow the principle of Motivational Interviewing, which will focus on enabling change through the enhancement of intrinsic motivation and the exploration and resolution of ambivalence. Counsellors will identify discrepancies between participants' thought and their action, support their autonomy, be empathetic towards the participant, avoid confrontation, and adjust to resistance. Any smokers who do not use IM or refuse to receive IM messages will be contacted via SMS messages or telephone calls. For smokers who do not respond to regular messages, 3 additional prompt messages will be sent in the 1st month to initiate a conversation.

Instant messaging
AWARD adviceBEHAVIORAL

AWARD will be delivered to smokers onsite and this includes: Ask about smoking history, Warn about the high risk, Advise to quit or reduce smoking as soon as possible, Refer smokers to smoking cessation services (with a SC service information card), and Do it again: to repeat the intervention; participants who fail to quit or relapse will be encouraged to quit again (and those who have quit smoking will be encouraged to prevent relapse) during telephone follow-ups. The whole process of AWARD can be delivered within 1 to 2 minutes.

Instant messagingSMS messaging
NRT samplingBEHAVIORAL

One-week free nicotine replacement therapy (NRT) sampling (gum or patch) will be disseminated to participants who are interested to try after completing the baseline questionnaire. An NRT use card containing reminders of NRT use and potential side effects will be given. Counselors and research staff will also check the side effects of NRT use during WhatsApp interaction and telephone follow-ups.

Instant messagingSMS messaging
Active referralBEHAVIORAL

SC ambassadors will introduce various SC services in Hong Kong (using the SC service information card) and motivate smokers to use the SC services. Written consents will be obtained from smokers who are ready to book the service onsite for transfer of their contact telephone numbers to their chosen service providers. Our research staff will transfer the information to the service providers within a week since the enrollment. For smokers in Group A, our research staff will also assist them to re-book the appointments upon their request at follow-up. SC ambassadors will encourage smokers in Group A who are not ready to book SC service to make an early appointment and assist them at follow-up.

Instant messagingSMS messaging
SMS messagingBEHAVIORAL

All smokers will receive fix-schedule general messages on SC through short message service (SMS) since their initial participation until 2-month after baseline. These messages include: (a) brief health warning, (b) benefit of quitting, (c) methods to quit and to cope with craving, and (d) SC services and their effectiveness. General SC messages will be sent twice per week in the 1st month and once per week in the 2nd month after joining this study.

SMS messaging

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years or above and smoked at least 1 cigarette daily;
  • Hong Kong residents able to read and speak Cantonese;
  • Exhaled carbon monoxide of 4 ppm or above, assessed by a Smokerlyzer;
  • Using a cell phone with instant messaging tool (e.g. WhatsApp, WeChat);
  • Able to use instant messaging tool (e.g. WhatsApp, WeChat) for communication;

You may not qualify if:

  • Have psychiatric/ psychological diseases or regular psychotropic medications; and
  • Using SC medication, NRT, other SC services or projects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The University of Hong Kong

Hong Kong, 000000, Hong Kong

Location

Related Publications (1)

  • Zhao SZ, Wu YS, Chau SL, Fong DYT, Lam TH, Wang MP. Mobile chat-based support plus nicotine replacement therapy sampling to promote smoking cessation for community smokers: A randomized controlled trial. Tob Induc Dis. 2021 Apr 27;19:32. doi: 10.18332/tid/133373. eCollection 2021.

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All outcome assessors will be blinded to the group allocation, this RCT will be single-blinded.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This pilot randomized controlled trial (RCT) has 2 arms: intervention group A (Group A), and control group (Group B). The participants will be randomly assigned to one of the 2 groups. The investigators will randomly select 12 smoking hotspots (SH) from different locations in Hong Kong Island, Kowloon and New Territories for recruitment (4 in each region). A total of 24 sessions of recruitment activities will be organized to recruit 282 participants. The onsite recruitment and counselling will be conducted by trained SC ambassadors. SC ambassadors will approach smokers using a "foot-in- the-door" technique. Smoking status will be validated using exhaled carbon monoxide (CO) and eligibility will be checked by a short questionnaire.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Man Ping WANG, Assistant Professor, School of Nursing, HKU

Study Record Dates

First Submitted

November 9, 2017

First Posted

June 29, 2018

Study Start

December 27, 2017

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations