Cigarette SmokingNCT01983150
A Randomized Controlled Trial to Test the Effect of a Smartphone Quit Smoking Intervention on Young Adult Smokers
A study testing Crush the Crave Application and On the Road to Quitting - Self Help in people with Cigarette Smoking, run by University of Waterloo at 1 site in Canada.
Trial summary
The primary aim of this study will be to determine the effectiveness of a smartphone delivered app for young adult smokers on quitting smoking. Read more about this study
- Who is it for?
- Ages 19 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Crush the Crave Application and On the Road to Quitting - Self Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,601 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Nov 2015
- 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 19 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 19 to 29 years
- Currently smoking cigarettes daily or occasionally
- Residing in Canada
- Considering quitting smoking in the next 30 days
- Have an Android or iPhone OS smartphone
- Able to provide informed consent
- English comprehension
- Not referred by a study participant
Who cannot join
- opposite of the above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Smartphone Intervention on Quitting Smoking in a Young Adult Population of Smokers: A Randomized Controlled Trial
The primary aim of this study will be to determine the effectiveness of a smartphone delivered app for young adult smokers on quitting smoking.
Read the detailed description
The principle study purpose of the randomized controlled trial is to determine the effectiveness of a smartphone delivered app for young adult smokers on smoking cessation at six months using a randomized controlled trial. Secondary aims of this study include examining: 1) proximal outcome measures of cessation behaviour; 2) satisfaction, extent of app use and use of NRT and other cessation services; 3) mediators of cessation outcomes between conditions; and 4) the incremental cost-effectiveness.
- Conditions
- Cigarette Smoking
- Being tested
- Crush the Crave Application, On the Road to Quitting - Self Help
- Keywords
- Population Health, Smoking cessation, Young adults, Cancer prevention, Tobacco control strategies, Behaviour modification, Social Media, Smartphone technology
- Medical subject headings
- Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crush the Crave ApplicationBehavioural
Also called Android, iPhone, Mobile phone, Behavior change
Crush the Crave (CTC) allows users to customize a quit plan by choosing a quit date and then deciding whether to quit now or cut down the number of cigarettes they smoke every week up to the quit date. CTC reminds users of money saved and health improvements. Based on contingency reinforcement, rewards are provided, which smokers can then choose to share with their social network via Facebook. Supportive text messages tailored to their specific quit plan and where they are in the quitting experience are provided. CTC allows tracking of daily smoking habits and cravings as well as craving triggers or psychosocial determinants by recording when, where and why smoking occurred. Online distractions to help smokers deal with cravings are provided.
On the Road to Quitting - Self HelpBehavioural
The control group will receive an evidence-based self-help guide known as "On the Road to Quitting" that has been developed by Health Canada for young adult smokers. Participants will be able to both view the self-help guide via the internet and will receive a printed version of the guide.
| Study group | Role | What they receive |
|---|---|---|
| Crush the Crave Application | Experimental | Crush the Crave (CTC) intervention group will receive a quit smoking smartphone intervention via the internet that is based on scientific findings related to tobacco use among young adults. It is a multi-component intervention informed by evidence on quitting smoking. The app was developed with the input of key experts in the field of smoking cessation, was assessed against Fiore's practice guidelines for treating tobacco use and dependence, and was tested with eight focus groups of male and female young adult smokers (n=57) on functionality, look and feel and usability, as well as being piloted by over 300 smokers. Receives: Behavioral: Crush the Crave Application |
| On the Road to Quitting - Self Help | Active comparator | The control group will receive an evidence-based self-help guide known as "On the Road to Quitting"(45) that has been developed by Health Canada for young adult smokers. Participants will be able to both view the self-help guide via the internet and will receive a printed version of the guide. Receives: Behavioral: On the Road to Quitting - Self Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day point prevalence of abstinence
30 day point prevalence of abstinence at 6 months,operationalized as not having smoked any cigarettes, even a puff, or used other tobacco in the last 30 days.
Measured: 6 months
Secondary outcomes (5)
7-day abstinence
7 day point prevalence of abstinence at 6 months,operationalized as not having smoked any cigarettes, even a puff, or used other tobacco in the last 30 days
Measured: 6 months
Number of quit attempts
How many times did you stop using tobacco for 24 hours or longer over the past six months?
Measured: 6 months
Consumption of cigarettes
Reduction in the consumption of cigarettes since baseline and behavioural intentions to quit smoking using questions from the Minimal Dataset and nicotine withdrawal using the Fagerstrom test for nicotine dependence.
Measured: Baseline and at 6 months
Satisfaction and App Utilization
Satisfaction with program, app utilization metrics, and use of smoking cessation services (NRT, health professional consults,medications and quitline counseling)
Measured: 6 months
Psychosocial measures
Beliefs, attitudes and social norms using the Smoking Attitudes Scale, stress using the 14-item Perceived Stress Scale, self-efficacy using Etter's 12 items, and perceived social support using the modified 7-item subjective support subscale of the Duke Social Support Index.
Measured: Baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,601 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neill B Baskerville, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983150
- Sponsor's protocol ID
- 19275
- Status last verified
- Dec 2015
- First submitted
- 6 Nov 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
PubMed 39868569Baskerville NB, Struik LL, Guindon GE, Norman CD, Whittaker R, Burns C, Hammond D, Dash D, Brown KS. Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Oct 23;6(10):e10893. doi: 10.2196/10893.
PubMed 30355563Baskerville NB, Struik LL, Dash D. Crush the Crave: Development and Formative Evaluation of a Smartphone App for Smoking Cessation. JMIR Mhealth Uhealth. 2018 Mar 2;6(3):e52. doi: 10.2196/mhealth.9011.
PubMed 29500157Baskerville NB, Struik LL, Hammond D, Guindon GE, Norman CD, Whittaker R, Burns CM, Grindrod KA, Brown KS. Effect of a mobile phone intervention on quitting smoking in a young adult population of smokers: randomized controlled trial study protocol. JMIR Res Protoc. 2015 Jan 19;4(1):e10. doi: 10.2196/resprot.3823.
PubMed 25599695
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Smartphone Intervention on Quitting Smoking in a Young Adult Population of Smokers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01983150
- Acronym / sponsor ID
- 19275
- Conditions
- Cigarette Smoking
- Keywords
- Population Health, Smoking cessation, Young adults, Cancer prevention, Tobacco control strategies, Behaviour modification, Social Media, Smartphone technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,601 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Nov 2013 (estimated)
- 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.
The primary aim of this study will be to determine the effectiveness of a smartphone delivered app for young adult smokers on quitting smoking.
Detailed description
The principle study purpose of the randomized controlled trial is to determine the effectiveness of a smartphone delivered app for young adult smokers on smoking cessation at six months using a randomized controlled trial. Secondary aims of this study include examining: 1) proximal outcome measures of cessation behaviour; 2) satisfaction, extent of app use and use of NRT and other cessation services; 3) mediators of cessation outcomes between conditions; and 4) the incremental cost-effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crush the Crave Application | Experimental | Behavioral: Crush the Crave ApplicationCrush the Crave (CTC) intervention group will receive a quit smoking smartphone intervention via the internet that is based on scientific findings related to tobacco use among young adults. It is a multi-component intervention informed by evidence on quitting smoking. The app was developed with the input of key experts in the field of smoking cessation, was assessed against Fiore's practice guidelines for treating tobacco use and dependence, and was tested with eight focus groups of male and female young adult smokers (n=57) on functionality, look and feel and usability, as well as being piloted by over 300 smokers. |
| On the Road to Quitting - Self Help | Active comparator | Behavioral: On the Road to Quitting - Self HelpThe control group will receive an evidence-based self-help guide known as "On the Road to Quitting"(45) that has been developed by Health Canada for young adult smokers. Participants will be able to both view the self-help guide via the internet and will receive a printed version of the guide. |
Who may qualify
- Ages
- 19 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 19 to 29 years
- Currently smoking cigarettes daily or occasionally
- Residing in Canada
- Considering quitting smoking in the next 30 days
- Have an Android or iPhone OS smartphone
Key exclusion criteria (1 listed)
- opposite of the above
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 |
|---|---|---|
| Crush the Crave ApplicationAlso: Android, iPhone, Mobile phone, Behavior changeCrush the Crave (CTC) allows users to customize a quit plan by choosing a quit date and then deciding whether to quit now or cut down the number of cigarettes they smoke every week up to the quit date. CTC reminds users of money saved and health improvements. Based on contingency reinforcement, rewards are provided, which smokers can then choose to share with their social network via Facebook. Supportive text messages tailored to their specific quit plan and where they are in the quitting experience are provided. CTC allows tracking of daily smoking habits and cravings as well as craving triggers or psychosocial determinants by recording when, where and why smoking occurred. Online distractions to help smokers deal with cravings are provided. | Behavioural | Crush the Crave Application |
| On the Road to Quitting - Self HelpThe control group will receive an evidence-based self-help guide known as "On the Road to Quitting" that has been developed by Health Canada for young adult smokers. Participants will be able to both view the self-help guide via the internet and will receive a printed version of the guide. | Behavioural | On the Road to Quitting - Self Help |
Primary outcome
30 day point prevalence of abstinence
Time frame: 6 months
30 day point prevalence of abstinence at 6 months,operationalized as not having smoked any cigarettes, even a puff, or used other tobacco in the last 30 days.
5 secondary outcomes
7-day abstinence
Time frame: 6 months
Number of quit attempts
Time frame: 6 months
Consumption of cigarettes
Time frame: Baseline and at 6 months
Satisfaction and App Utilization
Time frame: 6 months
Psychosocial measures
Time frame: Baseline and at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Derived from this study: PubMed 39868569Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.
- Derived from this study: PubMed 30355563Baskerville NB, Struik LL, Guindon GE, Norman CD, Whittaker R, Burns C, Hammond D, Dash D, Brown KS. Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Oct 23;6(10):e10893. doi: 10.2196/10893.
- Derived from this study: PubMed 29500157Baskerville NB, Struik LL, Dash D. Crush the Crave: Development and Formative Evaluation of a Smartphone App for Smoking Cessation. JMIR Mhealth Uhealth. 2018 Mar 2;6(3):e52. doi: 10.2196/mhealth.9011.
- Derived from this study: PubMed 25599695Baskerville NB, Struik LL, Hammond D, Guindon GE, Norman CD, Whittaker R, Burns CM, Grindrod KA, Brown KS. Effect of a mobile phone intervention on quitting smoking in a young adult population of smokers: randomized controlled trial study protocol. JMIR Res Protoc. 2015 Jan 19;4(1):e10. doi: 10.2196/resprot.3823.
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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.
Neill B Baskerville, PhD principal investigator
University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crush the Crave Application and On the Road to Quitting - Self Help in people with Cigarette Smoking, run by University of Waterloo at 1 site in Canada.
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 8 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: finished, as of the sponsor's last update on 2 Dec 2015. 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 Canada. 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?
30 day point prevalence of abstinence (time frame: 6 months). 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 NCT01983150, which also lists 4 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 2 Dec 2015.