NCT03235713

Brief Summary

The study aims to (1) evaluate the effectiveness of the recent renewal of tobacco health warnings (HWs) on noticing and anti-smoking responses, and (2) assess the effect of exposure to point-of-sale (POS) tobacco displays and smoking hotspots on nicotine-craving intensity and smoking-related behaviors. The study will use time-based system-triggered ecological momentary assessments to collect real-time data about exposures to smoking-related cues and behaviors. With a smartphone app installed in the mobile phones of the participants, they will each day complete at least 3 pairs of EMA prompted randomly for only 2 days (a working and a nonworking day). Outcomes include exposure and responses to tobacco HWs, exposure to POS tobacco displays, exposure to smoking hotspots and smoking and quitting outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

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

July 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

July 27, 2017

Last Update Submit

April 16, 2019

Conditions

Keywords

Ecological momentary assessments

Outcome Measures

Primary Outcomes (4)

  • Exposure and responses to tobacco HWs

    The question set includes (1) whether he/she has noticed tobacco HWs in the past 2 hours (yes/no), (2) whether he/she has thought of the harms of smoking due to the HWs (yes/no), (3) whether he/she has thought of quitting due to the HWs (yes/no), and (4) whether he/she has forgone cigarettes due to PWs (yes/no). All items will be re-assessed in the later waves of EMA data collection.

    2 hours

  • Exposure to POS tobacco displays

    The question set includes (1) whether he/she has entered into any retail shops selling tobacco in the past hour (e.g. 7-11, OK) (yes/no), (2) if he/she has noticed tobacco POS displays in those retail shops in the past 2 hours (yes/no), and (3) in what extent he/she perceive the displays as attractive (5-point scale).

    2 hours

  • Exposure to smoking hotspots

    The question set includes (1) whether he/she has witnessed a group of smokers (at least 3 smokers) smoking at one specific outdoor area nearby a rubbish bin in the past 2 hours (yes/no), (2) if yes, whether he/she was within 3 meters of such "cluster" of smokers and (3) whether he/she has smoked at these places in the past hour (yes/no).

    2 hours

  • Smoking and quitting outcomes

    The question set includes (1) the craving intensity in the past half hour (no craving, mild, fair, heavy, very heavy), (2) whether he/she has bought tobacco in the past half hour (yes/no), (3) whether he/she has smoked in past half hour (yes/no) and (4) whether the above responses have been due to the exposure to POS tobacco displays and/or smoking hotspots.

    half an hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study targets to recruit 300 smokers, who will be from smoking cessation clinic (150), outside the retail shops selling tobacco (75), and smoking hotspots (75). All smoking cessation clinics under Tung Wah Group of Hospitals, Pok Oi Hospitals and Hospital Authority will be included. The recruited smokers in these clinics are ready to quit, which are more responsive to cue-induced cravings than other smokers. Smokers who are less ready to quit will be recruited from retail shops and smoking hotspots. These sites will be carefully selected for better recruitment.

You may qualify if:

  • daily smoker before enrolment in the clinics,
  • aged 18 years or older,
  • had a mobile phone,
  • his/her mobile phone can access the Internet,
  • he/she has no plan to travel overseas in the coming week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, 00, Hong Kong

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Derek Derek

    Tung Wah Group of Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 1, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations