A Randomized Controlled Trial to Test the Effect of a Smartphone Quit Smoking Intervention on Young Adult Smokers

Cigarette Smoking Clinical Trial

Official title:

Effect of a Smartphone Intervention on Quitting Smoking in a Young Adult Population of Smokers: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983150
• Other study ID #: 19275
• Status: Completed
• Phase: N/A
• First received: November 6, 2013
• Last updated: December 1, 2015
• Start date: January 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1601
• Est. completion date: November 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 29 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Crush the Crave Application
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 Help
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.

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No
Secondary	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	6 months	No
Secondary	Number of quit attempts	How many times did you stop using tobacco for 24 hours or longer over the past six months?	6 months	No
Secondary	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.	Baseline and at 6 months	No
Secondary	Satisfaction and App Utilization	Satisfaction with program, app utilization metrics, and use of smoking cessation services (NRT, health professional consults,medications and quitline counseling)	6 months	No
Secondary	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.	Baseline and at 6 months	No