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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Waterloo
Sponsor:
Information provided by (Responsible Party):
University of Waterloo
ClinicalTrials.gov Identifier:
NCT01983150
First received: November 6, 2013
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

The primary aim of this study will be to determine the effectiveness of a smartphone delivered app for young adult smokers on quitting smoking.


Condition Intervention
Cigarette Smoking
Behavioral: Crush the Crave Smartphone Smoking Cessation Application
Behavioral: Self-Help Guide "On the Road to Quitting"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Smartphone Intervention on Quitting Smoking in a Young Adult Population of Smokers: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • 30 day point prevalence of abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 7-day abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • Number of quit attempts [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    How many times did you stop using tobacco for 24 hours or longer over the past six months?

  • Consumption of cigarettes [ Time Frame: Baseline and at 6 months ] [ Designated as safety issue: No ]
    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.

  • Satisfaction and App Utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Satisfaction with program, app utilization metrics, and use of smoking cessation services (NRT, health professional consults,medications and quitline counseling)

  • Psychosocial measures [ Time Frame: Baseline and at 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1354
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crush the Crave Smartphone Smoking Cessation 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.
Behavioral: Crush the Crave Smartphone Smoking Cessation 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.
Other Names:
  • Android
  • iPhone
  • Mobile phone
  • Behavior change
  • Quit smoking
  • Social media
  • Facebook
Active Comparator: Self-Help Guide "On the Road to Quitting"
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.
Behavioral: Self-Help Guide "On the Road to Quitting"
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983150

Contacts
Contact: Stephanie Filsinger, MSc 519-888-4567 ext x32278 slfilsin@uwaterloo.ca

Locations
Canada, Ontario
University of Waterloo Recruiting
Waterloo, Ontario, Canada, N2L3G1
Contact: Neill B Baskerville, PhD    519-888-4567 ext 35236    nbbaskerville@uwaterloo.ca   
Contact: David Hammond, PhD    519-888-4567 ext x36462    dhammond@uwaterloo.ca   
Principal Investigator: Neill B Baskerville, PhD         
Sub-Investigator: David Hammond, PhD         
Sponsors and Collaborators
University of Waterloo
Investigators
Principal Investigator: Neill B Baskerville, PhD University of Waterloo
  More Information

No publications provided

Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT01983150     History of Changes
Other Study ID Numbers: 19275
Study First Received: November 6, 2013
Last Updated: May 26, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Waterloo:
Population Health
Smoking cessation
Young adults
Cancer prevention
Tobacco control strategies
Behaviour modification
Social Media
Smartphone technology

ClinicalTrials.gov processed this record on August 28, 2014