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Smoking CessationNCT03574077

Semi-personalized IM Smoking Cessation Interventions

A study testing Instant Messaging (IM), AWARD advice and NRT sampling in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
Instant Messaging (IM), AWARD advice and NRT sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
1 siteHong Kong
Study dates
27 Dec 2017to 31 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • School of Nursing, The University of Hong Kong

    Hong Kong, 000000

Other trials in Hong Kong

About this study

Official title: Semi-personalized Smoking Cessation Interventions for Adult Smokers Recruited at Smoking Hotspots: a Pilot Randomized Controlled Trial

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.

Being tested
Instant Messaging (IM), AWARD advice, NRT sampling, Active referral, SMS messaging
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Instant Messaging (IM)Behavioural

    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.

  • AWARD adviceBehavioural

    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.

  • NRT samplingBehavioural

    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.

  • Active referralBehavioural

    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.

  • SMS messagingBehavioural

    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.

Study groups in NCT03574077
Study groupRoleWhat they receive
Instant messagingExperimentalAWARD advice + NRT sampling + Active referral + Instant Messaging (IM)
Receives: Behavioral: Instant Messaging (IM); Behavioral: AWARD advice; Behavioral: NRT sampling; Behavioral: Active referral
SMS messagingActive comparatorAWARD advice + NRT sampling + Active referral + SMS messaging
Receives: Behavioral: AWARD advice; Behavioral: NRT sampling; Behavioral: Active referral; Behavioral: SMS messaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically validated abstinence

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

    Measured: 3-month follow-up

  2. Biochemically validated abstinence

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

    Measured: 6-month follow-up

Secondary outcomes (7)

  1. Self-reported 7-day point prevalence abstinence

    Self-reported no cigarette smoking (even a single puff) in the past 7 days

    Measured: 3-month and 6-month follow-up

  2. Level of nicotine dependence

    The Heaviness of Smoking Index, a validated scale, will be used to measure the level of nicotine dependence. This scale consists of 2 questions: (1) how soon after waking up does a participant smoke the first cigarette with responses "within 5 minutes", "6-30 minutes", "31-60 minutes" and "after 60 minutes"; (2) how many cigarettes does a participant smoke in a day with responses "1-10", "11-20" "21-30" and ">30".

    Measured: 3-month and 6-month follow-up

  3. Readiness to quit smoking

    Readiness to quit smoking will be measured by a question asking the planned quit day based on the Transtheoretical Model with the following responses: within 7days, with 30 days, within 60 days, not yet decided.

    Measured: 3-month and 6-month follow-up

  4. Quit attempts

    Self-reported quit attempts after enrollment in the study

    Measured: 3-month and 6-month follow-up

  5. Smoking reduction

    Reduction in the number of cigarettes smoked daily by at least 50% of the baseline amount

    Measured: 3-month and 6-month follow-up

  6. NRT use

    The amount of nicotine replacement therapy (NRT) used including the sampling received at baseline, NRT received from SC services, NRT bought by participants

    Measured: 3-month and 6-month follow-up

  7. SC services used

    Smoking cessation service used after enrollment in the study

    Measured: 3-month and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2018
  2. Study start27 Dec 2017
  3. Primary completion31 Oct 2018
  4. Study completion31 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03574077
Sponsor's protocol ID
UW15-232
Status last verified
Jan 2019
First submitted
9 Nov 2017
Last updated
9 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33927586

Questions about this trial

What is this clinical trial studying?

A study testing Instant Messaging (IM), AWARD advice and NRT sampling in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically validated abstinence (time frame: 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03574077, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.

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