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Project Quit: Positive vs. Negative Offers of an Online Stop Smoking Program

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: NCT01923467
Recruitment Status : Completed
First Posted : August 15, 2013
Results First Posted : June 15, 2015
Last Update Posted : June 15, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Lawrence C. An, University of Michigan

Study Description
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Brief Summary:

This project is designed to test the effects of affirmation and positive/negative imagery on individuals' thoughts about quitting smoking and willingness to join a stop smoking program. Previous studies have noted that viewing negative images elicits a stronger emotional response, and many stop-smoking campaigns have used such images to push people to quit smoking. However, research also shows that people are generally resistant to health messages. Using affirmation can help to lessen that resistance.

In this study, we use a 2x3 design to study the individual effects of negative imagery and affirmation on smokers' intentions to quit smoking, acceptance of an offer to join a quit smoking program, and program participation and outcomes. We hope to find out whether there is an additive effect of the negative imagery and affirmation on the outcomes listed above. Our specific aims are:

Aim 1: Determine if affirmation increases the uptake of an offer of joining a stop smoking program.

Aim 2: Determine if image type (positive vs. neutral vs. negative) increases the uptake of the stop smoking program offer.

Aim 3: Determine whether there is an interaction between image type and affirmation in people's willingness to join a stop smoking program.


Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Project Quit stop smoking program Drug: Nicotine patches 21 mg Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 767 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Project Quit: Positive vs. Negative Offers of an Online Stop Smoking Program
Study Start Date : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Experimental: Project Quit plus NRT patches
All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.
 Behavioral: Project Quit stop smoking program
This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.

Drug: Nicotine patches 21 mg
Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt.
Other Name: Nicoderm CQ Step 1 (21 mg)


Outcome Measures
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Primary Outcome Measures :
  1. Acceptance of Offer to Join Stop Smoking Program [ Time Frame: 1 Day of Enrollment ]
    After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current smoker

Exclusion Criteria:

  • Current participation in another stop-smoking program
  • Current use of stop smoking medications
  • Pregnant or breastfeeding
  • Limited internet or email access
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923467


Locations
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United States, Michigan
Center for Health Communications Research, University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Lawrence C An, MD University of Michigan
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Lawrence C. An, Associate Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT01923467    
Other Study ID Numbers: P50CA101451 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2013    Key Record Dates
Results First Posted: June 15, 2015
Last Update Posted: June 15, 2015
Last Verified: December 2014
Keywords provided by Lawrence C. An, University of Michigan:
smoking
nicotine replacement
internet
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action