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Quit and Win Contests to Improve Smoking Cessation Among College Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01096108
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : August 22, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE March 29, 2010
First Posted Date  ICMJE March 30, 2010
Last Update Posted Date August 22, 2014
Study Start Date  ICMJE April 2010
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
Efficacy of extended versus standard quit and win contests [ Time Frame: 6 Months ]
The aim is to evaluate the separate and combined efficacy of increased dose of treatment and adding counseling to enhance smoking abstinence among college students
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
Efficacy of extended versus standard quit and win contests [ Time Frame: 6 Months ]
The aim is to evaluate the separate and combined efficacy of increased dose of treatment to enhance smoking abstinence among college students
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2012)
Efficacy of motivational and problem solving counseling versus no counseling [ Time Frame: 6 Months ]
The aim is to 1) determine relative cost-effectiveness of extended incentives and motivational and problem-solving (MAPS) counseling. 2) Examine potential mediators and moderators of intervention effects.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2010)
Efficacy of motivational relapse prevention counseling versus contact counseling [ Time Frame: 9 Months ]
The aim is to evaluate the separate and combined efficacy of enhanced content to treatment to enhance smoking abstinence among college students. 1) Determine relative cost-effectiveness of extended incentives and MARS counseling. 2) Examine potential mediators and moderators of intervention effects.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quit and Win Contests to Improve Smoking Cessation Among College Students
Official Title  ICMJE Enhancing Quit and Win Contests to Improve Smoking Cessation Among College Students
Brief Summary

Standard Quit and Win contests, in which smokers typically quit for one month in return for the opportunity to win prizes, are simple and easy to implement and may be cost-effective in encouraging smokers to quit. By extending contest length and enhancing counseling content, Quit and Win contests may be more effective at encouraging smoking abstinence.

This study aims to evaluate the efficacy of extended and content-enhanced Quit and Win contests to enhance smoking abstinence at college campuses.

Detailed Description

Participants will be randomized to 1 of 4 treatment groups with varying counseling treatments and contest lengths. All participants receive a 2 week supply of nicotine replacement therapy (NRT) and weekly support emails. Follow-up assessment surveys occur at 1, 3, 4 and 6 months post enrollment.

Participants who have completed the follow-up assessment surveys and self-reported that they are tobacco-free will be asked to provide a urine sample in order to verify abstinence.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Tobacco Use Cessation
Intervention  ICMJE
  • Behavioral: Standard contest (1 month)
    Smoking abstinence, 1 prize award (month 1)
  • Behavioral: Motivational and Problem-Solving
    Counseling phone calls
  • Behavioral: Extended Contests
    Smoking abstinence, 3 contest prize awards (contests 1, 2 and 3)
Study Arms  ICMJE
  • Experimental: Standard Contest
    Smoking abstinence, 1 prize award (month 1)
    Intervention: Behavioral: Standard contest (1 month)
  • Experimental: Standard Contest plus MAPS
    Smoking abstinence, 1 prize award (month 1) plus motivational and problem-solving counseling (MAPS - Counseling phone calls); 20 weeks.
    Interventions:
    • Behavioral: Standard contest (1 month)
    • Behavioral: Motivational and Problem-Solving
  • Experimental: Extended Contests
    Smoking abstinence, 3 contest prize awards (contests 1, 2 and 3)
    Intervention: Behavioral: Extended Contests
  • Experimental: Extended Contests plus MAPS
    Extended quit and win contests (3 successive monthly contests) plus motivational and problem-solving counseling (MAPS). {Smoking abstinence, 3 contest prize awards (contests 1, 2 and 3) plus Counseling phone calls.
    Interventions:
    • Behavioral: Motivational and Problem-Solving
    • Behavioral: Extended Contests
Publications * Thomas JL, Bengtson JE, Wang Q, Luo X, Marigi E, Ghidei W, Ahluwalia JS. Abstinence rates among college cigarette smokers enrolled in a randomized clinical trial evaluating Quit and Win contests: The impact of concurrent hookah use. Prev Med. 2015 Jul;76:20-5. doi: 10.1016/j.ypmed.2015.03.010. Epub 2015 Mar 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2013)
1318
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2010)
1256
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Enrolled full or part-time at one of the participating campuses
  • Smoke at least 10 days per month
  • Intending to be in school for the entire academic year (i.e., next 2 semesters)
  • Willing to provide a baseline urine sample to verify smoking status
  • Able to read English
  • Access to working telephone for phone-based counseling and surveys
  • Access to a computer with internet access
  • Provide written informed consent

Exclusion Criteria:

  • Prior to concurrent enrollment in this study through a different college campus or in a different academic year
  • those who have used a cessation aid within the last 7 days
  • pregnant or planning to become pregnant in next 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01096108
Other Study ID Numbers  ICMJE 2008NTLS155
0901S57761 ( Other Identifier: IRB, University of Minnesota )
R01 HL093114-01 ( Other Grant/Funding Number: National Heart, Lung, and Blood Institute )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Janet L Thomas, Ph.D. Masonic Cancer Center, University of Minnesota
PRS Account University of Minnesota
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP