Smoking CessationNCT05732220
Mobile EMA-based Peer Counselling for Youth Smokers
A study testing EMA assessment, EMA-based cessation counselling and Usual peer counselling in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This pilot trial aims to examine the feasibility, acceptability, and preliminary effectiveness of EMA-based peer counseling for youth smokers. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- EMA assessment, EMA-based cessation counselling and Usual peer counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 May 2023to 31 Oct 2024
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 15 to 25 years
- Have smoked in the past 30 days
- Own a smartphone with an mobile instant messaging app installed
- Can communicate in Chinese
Who cannot join
- Youth smokers who are participating in other smoking cessation studies or program other than the HKU Youth Quitline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Ecological Momentary Assessment-based Peer Counselling for Youth Smokers: a Pilot Randomised Controlled Trial
This pilot trial aims to examine the feasibility, acceptability, and preliminary effectiveness of EMA-based peer counseling for youth smokers.
Read the detailed description
Most smokers begin smoking during adolescence and early adulthood, a crucial period to prevent initiation and continuation of smoking. However, many proven smoking cessation interventions for adult smokers were not found effective in youth smokers, which may be partly explained by the vast differences in the pattern of tobacco use and determinants of quitting between adult and youth smokers. This calls for more research on novel intervention models to help young smokers quit.
The HKU Youth Quitline provides free smoking cessation support for smokers aged below 25 years since August 2005 in Hong Kong. The service provides multisession peer-led telephone counselling with an individualised quit plan devised for each young smoker according to their responses. Since the counselling model depends on the information retrospectively recalled by the smokers, it may be prone to recall and social desirability biases and fail to capture the variability of youth smoking patterns and momentary changes in personal (e.g., mood) and situational (e.g., peer smoking) antecedents of smoking episodes.
Recent advances in mobile technologies have enabled the use of more advanced and robust data collection approaches like ecological momentary assessment (EMA), which may benefit the counselling model by providing more ecologically valid data than traditional surveys. Previous studies have demonstrated the feasibility of using EMA to collect data on psychosocial processes and smoking behaviours in adolescent smokers. Therefore, we propose to develop and test a mobile EMA-based counselling intervention for youth smokers by conducting a pilot RCT.
- Conditions
- Smoking Cessation
- Being tested
- EMA assessment, EMA-based cessation counselling, Usual peer counselling
- Keywords
- counselling, ecological momentary assessment, young smoker, mobile health, adolescsent, quitline, Chinese
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMA assessmentBehavioural
Subjects will be asked to complete 3 waves of ecological momentary assessment (EMA) about smoking cues and smoking consumption via mobile phone at the first, second and third month after baseline (total 6 weeks)
EMA-based cessation counsellingBehavioural
Subjects will receive tailored peer counselling based on the participants' EMA responses at 1-month and 3-month telephone follow-ups.
Usual peer counsellingBehavioural
Subjects will receive peer counselling through telephone during follow-ups (usual care), in which the counsellor will apply the 5As model and motivational interviewing techniques.
| Study group | Role | What they receive |
|---|---|---|
| EMA+ group | Experimental | EMA assessment + EMA-based cessation counselling Receives: Behavioral: EMA assessment; Behavioral: EMA-based cessation counselling |
| EMA group | Active comparator | EMA assessment only + Usual peer counselling Receives: Behavioral: EMA assessment; Behavioral: Usual peer counselling |
| Control | Active comparator | Usual peer counselling Receives: Behavioral: Usual peer counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically-validated tobacco abstinence
Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL)
Measured: 6 months after randomisation
Secondary outcomes (6)
Self-reported 7-day point-prevalence tobacco abstinence
Being completely smoke-free in the past 7 days
Measured: 3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence
Being completely smoke-free in the past 7 days
Measured: 6 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence
Being completely smoke-free in the past 30 days
Measured: 3 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence
Being completely smoke-free in the past 30 days
Measured: 6 months after randomisation
Smoking reduction by at least 50%
Smoking reduction by at least half of the baseline daily number of cigarettes
Measured: 3 months after randomisation
Smoking reduction by at least 50%
Smoking reduction by at least half of the baseline daily number of cigarettes
Measured: 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start18 May 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzu Tsun Luk, The University of Hong Kong
- Investigators
- Tzu Tsun Luk, PhD, RN, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732220
- Sponsor's protocol ID
- 202111159206
- Status last verified
- Nov 2023
- First submitted
- 5 Feb 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan SS, Wong DC, Fong DY, Leung AY, Lam DO, Mak YW, Lam TH. The establishment and promotion of the first Youth Quitline in Hong Kong: challenges and opportunities. Eval Health Prof. 2008 Sep;31(3):258-71. doi: 10.1177/0163278708320156. Epub 2008 Jun 19.
PubMed 18566161Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
PubMed 18509902Van Zundert RM, Ferguson SG, Shiffman S, Engels R. Dynamic effects of craving and negative affect on adolescent smoking relapse. Health Psychol. 2012 Mar;31(2):226-34. doi: 10.1037/a0025204. Epub 2011 Sep 26.
PubMed 21942749McClure EA, Tomko RL, Carpenter MJ, Treiber FA, Gray KM. Acceptability and compliance with a remote monitoring system to track smoking and abstinence among young smokers. Am J Drug Alcohol Abuse. 2018;44(5):561-570. doi: 10.1080/00952990.2018.1467431. Epub 2018 May 8.
PubMed 29737885Fanshawe TR, Halliwell W, Lindson N, Aveyard P, Livingstone-Banks J, Hartmann-Boyce J. Tobacco cessation interventions for young people. Cochrane Database Syst Rev. 2017 Nov 17;11(11):CD003289. doi: 10.1002/14651858.CD003289.pub6.
PubMed 29148565
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Ecological Momentary Assessment-based Peer Counselling for Youth Smokers: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05732220
- Acronym / sponsor ID
- 202111159206
- Conditions
- Smoking Cessation
- Keywords
- counselling, ecological momentary assessment, young smoker, mobile health, adolescsent, quitline, Chinese
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot trial aims to examine the feasibility, acceptability, and preliminary effectiveness of EMA-based peer counseling for youth smokers.
Detailed description
Most smokers begin smoking during adolescence and early adulthood, a crucial period to prevent initiation and continuation of smoking. However, many proven smoking cessation interventions for adult smokers were not found effective in youth smokers, which may be partly explained by the vast differences in the pattern of tobacco use and determinants of quitting between adult and youth smokers. This calls for more research on novel intervention models to help young smokers quit.
The HKU Youth Quitline provides free smoking cessation support for smokers aged below 25 years since August 2005 in Hong Kong. The service provides multisession peer-led telephone counselling with an individualised quit plan devised for each young smoker according to their responses. Since the counselling model depends on the information retrospectively recalled by the smokers, it may be prone to recall and social desirability biases and fail to capture the variability of youth smoking patterns and momentary changes in personal (e.g., mood) and situational (e.g., peer smoking) antecedents of smoking episodes.
Recent advances in mobile technologies have enabled the use of more advanced and robust data collection approaches like ecological momentary assessment (EMA), which may benefit the counselling model by providing more ecologically valid data than traditional surveys. Previous studies have demonstrated the feasibility of using EMA to collect data on psychosocial processes and smoking behaviours in adolescent smokers. Therefore, we propose to develop and test a mobile EMA-based counselling intervention for youth smokers by conducting a pilot RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMA+ group | Experimental | Behavioral: EMA assessment, Behavioral: EMA-based cessation counsellingEMA assessment + EMA-based cessation counselling |
| EMA group | Active comparator | Behavioral: EMA assessment, Behavioral: Usual peer counsellingEMA assessment only + Usual peer counselling |
| Control | Active comparator | Behavioral: Usual peer counsellingUsual peer counselling |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 15 to 25 years
- Have smoked in the past 30 days
- Own a smartphone with an mobile instant messaging app installed
- Can communicate in Chinese
Key exclusion criteria (1 listed)
- Youth smokers who are participating in other smoking cessation studies or program other than the HKU Youth Quitline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMA assessmentSubjects will be asked to complete 3 waves of ecological momentary assessment (EMA) about smoking cues and smoking consumption via mobile phone at the first, second and third month after baseline (total 6 weeks) | Behavioural | EMA group, EMA+ group |
| EMA-based cessation counsellingSubjects will receive tailored peer counselling based on the participants' EMA responses at 1-month and 3-month telephone follow-ups. | Behavioural | EMA+ group |
| Usual peer counsellingSubjects will receive peer counselling through telephone during follow-ups (usual care), in which the counsellor will apply the 5As model and motivational interviewing techniques. | Behavioural | Control, EMA group |
Primary outcome
Biochemically-validated tobacco abstinence
Time frame: 6 months after randomisation
Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL)
6 secondary outcomes
Self-reported 7-day point-prevalence tobacco abstinence
Time frame: 3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence
Time frame: 6 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence
Time frame: 3 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence
Time frame: 6 months after randomisation
Smoking reduction by at least 50%
Time frame: 3 months after randomisation
Smoking reduction by at least 50%
Time frame: 6 months after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 18566161Chan SS, Wong DC, Fong DY, Leung AY, Lam DO, Mak YW, Lam TH. The establishment and promotion of the first Youth Quitline in Hong Kong: challenges and opportunities. Eval Health Prof. 2008 Sep;31(3):258-71. doi: 10.1177/0163278708320156. Epub 2008 Jun 19.
- Background: PubMed 18509902Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.
- Background: PubMed 21942749Van Zundert RM, Ferguson SG, Shiffman S, Engels R. Dynamic effects of craving and negative affect on adolescent smoking relapse. Health Psychol. 2012 Mar;31(2):226-34. doi: 10.1037/a0025204. Epub 2011 Sep 26.
- Background: PubMed 29737885McClure EA, Tomko RL, Carpenter MJ, Treiber FA, Gray KM. Acceptability and compliance with a remote monitoring system to track smoking and abstinence among young smokers. Am J Drug Alcohol Abuse. 2018;44(5):561-570. doi: 10.1080/00952990.2018.1467431. Epub 2018 May 8.
- Background: PubMed 29148565Fanshawe TR, Halliwell W, Lindson N, Aveyard P, Livingstone-Banks J, Hartmann-Boyce J. Tobacco cessation interventions for young people. Cochrane Database Syst Rev. 2017 Nov 17;11(11):CD003289. doi: 10.1002/14651858.CD003289.pub6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu Tsun Luk, PhD, RN principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMA assessment, EMA-based cessation counselling and Usual peer counselling 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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?
Results are not available in the source record.
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 tobacco abstinence (time frame: 6 months after randomisation). 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 NCT05732220, which also lists 5 linked publications.
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 7 Nov 2023.