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Smoking CessationNCT03718169

Smartphone Application-based Smoking Cessation Programme Among Female Smokers

An observational study of Smoking Cessation, run by The University of Hong Kong at 1 site in China.

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

This project aims to develop a smartphone application to deliver a gender-specific programme for female smokers in Hong Kong. Through the smartphone application, we expect that our gender-specific smoking cessation programme can reach more female smokers in Hong Kong. Read more about this study

Who is it for?
Ages 15 years and older, women only
Conditions the study is for
Smoking Cessation
What is being tested?
questionnaires
How many people
200 participants
Where
1 siteChina
Study dates
3 Jun 2019to 31 Oct 2020
Phase
Observational
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 15 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Hong Kong female smokers.

Who may be able to join

  • Hong Kong female resident aged 18 or above
  • Able to communicate in Chinese (Cantonese)
  • Current Smokers

Who cannot join

  • Have difficulty to communicate via telephone
  • Having queries irrelevant to tobacco control

Trial locations and contacts

1 site in 1 country.

China1 site
  • The University of Hong Kong

    Hong Kong

Other trials in China

About this study

Official title: Using a Smartphone Application to Deliver a Gender-specific Smoking Cessation Programme Among Female Smokers in Hong Kong

This project aims to develop a smartphone application to deliver a gender-specific programme for female smokers in Hong Kong. Through the smartphone application, we expect that our gender-specific smoking cessation programme can reach more female smokers in Hong Kong. The objectives is to promote smoking cessation among female smokers in Hong Kong.

Read the detailed description

This is a one-year project, and it will be divided into 2 Phases. Phase I will focus on translating our gender-specific smoking cessation programme into a smartphone application. In Phase II, the investigators will promote the smartphone application to female smokers in the community.

Phase I: Translating our gender-specific smoking cessation programme into a smartphone application To translate our gender-specific smoking cessation programme into a smartphone application, an expert panel will be formed. The panel members include a chair professor, an associate professor, an assistant professor, a research assistant professor and a postdoctoral fellow, with all of whom have considerable experience in conducting studies on smoking cessation and tobacco control. The content of the smartphone application will be designed according to the gender-specific smoking cessation programme delivered by our women Quitline. In particular, the smartphone application aims to help female smokers abstain from cigarettes by their readiness to quit. For female smokers who are in the pre-contemplation or contemplation stage, the smartphone application will motivate them to quit by instructing them to list out the reasons for quitting, and providing them information about the damaging effects of smoking on health, especially those are specific to women. Regarding female smokers in the preparation stage, the smartphone application will assist them to individualize their own quit plan by computerized instructions, and provide generic tips how they can achieve abstinence step-by-step. Concerning female smokers in the action stage, skills for overcoming cigarette craving and withdrawal symptoms will be presented. In addition, hazardous effects of smoking will pop-up in their smartphones to remind them of smoking cessation throughout their quitting process. To address the needs and concerns of female smokers, gender-specific elements have been integrated into the smartphone application. In particular, the smartphone application will correct their misconceptions that smoking can be a method to control body weight and manage stress. At the same time, the smartphone application will display information about proper weight-loss strategies and relaxation techniques. Female smokers who need more intensive counseling can also contact our Quitline via the smartphone application.

Phase II: Promoting the smartphone application for female smokers in the community In order to promote the smartphone application for female smokers, the investigators plan to recruit 30 students from the University of Hong Kong to join this project. All recruited students will be invited to participate in a 1-day training workshop organized by our team. During the training workshop, the students will be educated on smoking hazards, the basic principles of smoking cessation and tobacco control policies.

Female smokers will be recruited in smoking hotspots where rubbish bins with a collector of cigarette butts are nearby. The trained university students will approach female smokers at the smoking hotspots, and deliver a small souvenir to them. The souvenir is a pack of tissue paper, with its packaging containing smoking cessation messages and the QR code of the smartphone application. If the smokers accept the souvenir, the students will then introduce this project. For female smokers who are interested to join, the students will assist them to download the smartphone application, briefly go through its content, and encourage them to use it. To remind the female smokers to continuously use the smartphone application for smoking cessation, warning messages about the hazardous effects of smoking will pop up weekly in their smartphones.

Being tested
questionnaires
Keywords
women
Medical subject headings
Smoking Cessation

What participants receive

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

  • questionnairesBehavioural

    Female smokers will be asked to complete a structured questionnaire at smoking hotspots. In addition, the smokers will respond to the same questionnaire at 6 months via telephone. The structured questionnaire will collect information related to their demographic characteristics and quitting behaviors, i.e. self-reported abstinence, smoking reduction and quit attempts.

Study groups in NCT03718169
Study groupRoleWhat they receive
Hong Kong female smokersHong Kong female smokers will be invited to fill in questionnaires about their current smoking situation and quit intention.
Receives: Behavioral: questionnaires

What is being measured

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

  1. 7-days point prevalence smoking abstinence at 6-month

    7-days point prevalence smoking abstinence is measured at 6-month. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self-reported smoking abstinence at 6-month.

    Measured: 6-month follow-up

Secondary outcomes (1)
  1. Bio-chemical validated smoking abstinence at 6-month

    Bio-chemical validated smoking abstinence is measured at 6-month. The participants who claim to have quitted smoking for at least 7 days are invited for biochemical validation (measurement of saliva cotinine level and exhaled carbon monoxide level) at 6-month. The participants are need to get the results of CO≤ 4ppm, and continine level ≤30 ng/ml as passing results.

    Measured: 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 posted24 Oct 2018
  2. Study start3 Jun 2019
  3. Primary completion12 Jun 2020
  4. Study completion31 Oct 2020

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03718169
Sponsor's protocol ID
KE funding
Status last verified
Jun 2020
First submitted
26 Aug 2018
Last updated
4 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Smoking Cessation, run by The University of Hong Kong at 1 site in China.

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 3 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 4 Nov 2020. 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 China. 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?

7-days point prevalence smoking abstinence at 6-month (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Nov 2020.

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