- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01983150
A Randomized Controlled Trial to Test the Effect of a Smartphone Quit Smoking Intervention on Young Adult Smokers
December 1, 2015 updated by: University of Waterloo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1601
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Waterloo, Ontario, Canada, N2L3G1
- University of Waterloo
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 29 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- opposite of the above
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Crush the Crave Application
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.
|
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.
Other Names:
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Active Comparator: On the Road to Quitting - Self Help
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
7-day abstinence
Time Frame: 6 months
|
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
|
6 months
|
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Number of quit attempts
Time Frame: 6 months
|
How many times did you stop using tobacco for 24 hours or longer over the past six months?
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6 months
|
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Consumption of cigarettes
Time Frame: Baseline and at 6 months
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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.
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Baseline and at 6 months
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Satisfaction and App Utilization
Time Frame: 6 months
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Satisfaction with program, app utilization metrics, and use of smoking cessation services (NRT, health professional consults,medications and quitline counseling)
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6 months
|
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Psychosocial measures
Time Frame: Baseline and at 6 months
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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.
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Baseline and at 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neill B Baskerville, PhD, University of Waterloo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Baskerville 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.
- Baskerville 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.
- Baskerville 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
November 6, 2013
First Submitted That Met QC Criteria
November 12, 2013
First Posted (Estimate)
November 13, 2013
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
December 1, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19275
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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