Twitter-enabled Mobile Messaging for Smoking Relapse Prevention
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| First Received Date ICMJE | May 17, 2012 | ||||||||
| Last Updated Date | May 21, 2012 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
7-day point prevalence abstinence from smoking at 30 days after the quit date [ Time Frame: 30 days after quit date ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01602536 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
* 7-day point prevalence abstinence from smoking at 7 and 60 days after quit date [ Time Frame: 7 days and 60 days after quit date ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Twitter-enabled Mobile Messaging for Smoking Relapse Prevention | ||||||||
| Official Title ICMJE | Twitter-enabled Mobile Messaging for Smoking Relapse Prevention | ||||||||
| Brief Summary | In Phase I (first 12 months), consistent with Aim 1, we have developed a treatment protocol for smoking cessation and relapse prevention that uses virtual quit-smoking Twitter groups and Twitter-enabled interactive peer messaging. We are in the process of testing and refining this protocol using 40 participants in 2 quit-smoking Twitter groups. In Phase II (24 months), consistent with Aim 2, we will conduct a two-condition (test vs. control) randomized controlled trial of the treatment protocol created in Phase I. This research will provide crucial pilot data about the viability and methodology of a larger randomized controlled trial that would directly measure smoking behavior. |
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| Detailed Description | Smoking relapse rates remain high, innovative strategies are needed to lower them, and web-based social networking may help like Twitter. This developmental research examines whether providing virtual (web-based) social support to smokers, through Twitter-enabled interactive peer texting, can help smokers quit and avoid relapses. Twitter is a free social networking and micro-blogging service, one of the most advanced and novel technologies available today that can provide social support to smokers, and it is the only service that provides free texting to groups. It is global and has many features that are associated with treatment success including interactive, multi-way, live messaging and mobile accessibility, because the messages go instantly to mobile phones and to the web. It can provide an innovative way to reach smokers who might otherwise not seek treatment, and it can be extended to other health domains. In Phase II which will start July 1, 2012, we will conduct a two-condition randomized controlled trial (Aim 2). All participants (N=240) will receive 8 weeks of free nicotine patches, referral to the NCI's online Smokefree.gov Quit Guide, and instruction to set a quit date within 8 days of study start. In this Phase II trial, participants will also be randomly assigned at the individual level to one of two conditions: (1) a virtual quit-smoking Twitter group condition where the group members are instructed to use Twitter-enabled interactive peer messaging to help them quit and stay quit, or (2) a control group condition where the group members are not given this instruction or a Twitter group. There will be 6 Twitter groups and 6 control groups with 20 smokers randomly assigned to each group (i.e., N=120 test, N=120 control). The primary outcomes will be self-reported 7-day point prevalence abstinence at 7, 30 and 60 days after the quit date. Participants' tweets, their virtual and face-to-face social networks, and several other mediating and moderating variables will also be analyzed. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Smoking | ||||||||
| Intervention ICMJE | Behavioral: quit smoking twitter group social support intervention
All participants will receive 8 weeks of free nicotine patches, referral to the NCI's online Smokefree.gov Quit Guide, and instruction to set a quit date within 8 days of study start. Participants will also be randomly assigned at the individual level to one of two conditions: (1) a virtual quit-smoking Twitter group condition where the group members are instructed to use Twitter-enabled interactive peer messaging to help them quit and stay quit, or (2) a control group condition where the group members are not given this instruction or a Twitter group. |
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| Study Arm (s) | Experimental: quit smoking twitter group
We form 20-person virtual quit smoking groups and instruct the group members to tweet each other (send short messages) using Twitter.
Intervention: Behavioral: quit smoking twitter group social support intervention |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 280 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 59 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01602536 | ||||||||
| Other Study ID Numbers ICMJE | 1R34DA030538-01A1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Cornelia Pechmann, University of California, Irvine | ||||||||
| Study Sponsor ICMJE | University of California, Irvine | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||||||
| Verification Date | May 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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