- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01516632
Smoking Cessation Via Text Messaging: Feasibility Testing of Stop My Smoking USA (SMS USA)
Smoking Cessation Via Text Messaging: Feasibility Testing of SMS USA
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Santa Ana, California, United States, 92705
- Internet Solutions for Kids, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 28 cigarettes or more per week (at least 4/day) and on at least 6 days/week.
- Owning a text-capable cell phone and cognizant of how to send and receive text messages
- Currently enrolled or intending to enroll in an unlimited text messaging plan
- Enrolled with a cell phone carrier that was compatible with the program software
- Agree to verification of smoking cessation status by a significant other
- Able to read and write in English
- Informed consent
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SMS USA
The 6-week smoking cessation intervention
|
Intervention participants receive text messages daily pre-and post-quit.
Everyone receives messages 14 days prior to the Quit day, and through the day after Quit.
Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively.
Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again.
Other Names:
|
|
No Intervention: Attention matched control
Messages aimed at improving one's sleep and increasing one's fitness, along with general messages about the most well known health dangers of smoking.
Messages sent on the same schedule as the intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations
Time Frame: 3-months post-quit
|
Continuous abstinence is defined as 5 or fewer cigarettes smoked since one's quit date. The question was asked based upon West et al., 2005: "Have you smoked at all, even just a puff, since [insert quit date]?" If yes, the respondent will be probed for how many cigarettes were smoked. Responses will be categorized into one of three options: A) No, not a puff; B) 1-5 cigarettes; C) More than 5 cigarettes. Self-reported cessation is confirmed by a significant other. |
3-months post-quit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Point Prevalence
Time Frame: 4-weeks post-quit
|
A cigarette, even just a puff, within the last 7 days (yes/no).
|
4-weeks post-quit
|
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Continuous Abstinence at 4-weeks Post-quit
Time Frame: 4 weeks post-quit
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Smoking five or fewer cigarettes since quit day at 4 weeks post-quit as verified by a significant other
|
4 weeks post-quit
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Ybarra ML, Holtrop JS, Prescott TL, Strong D. Process evaluation of a mHealth program: lessons learned from Stop My Smoking USA, a text messaging-based smoking cessation program for young adults. Patient Educ Couns. 2014 Nov;97(2):239-43. doi: 10.1016/j.pec.2014.07.009. Epub 2014 Jul 17.
- Ybarra ML, Prescott TL, Holtrop JS. Steps in tailoring a text messaging-based smoking cessation program for young adults. J Health Commun. 2014 Dec;19(12):1393-407. doi: 10.1080/10810730.2014.901441. Epub 2014 Apr 25.
- Filion AJ, Darlington G, Chaput JP, Ybarra M, Haines J. Examining the influence of a text message-based sleep and physical activity intervention among young adult smokers in the United States. BMC Public Health. 2015 Jul 16;15:671. doi: 10.1186/s12889-015-2045-2.
- Ybarra ML, Holtrop JS, Prescott TL, Rahbar MH, Strong D. Pilot RCT results of stop my smoking USA: a text messaging-based smoking cessation program for young adults. Nicotine Tob Res. 2013 Aug;15(8):1388-99. doi: 10.1093/ntr/nts339. Epub 2013 Jan 24.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R21CA135669 (U.S. NIH Grant/Contract)
- 5R21CA135669 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Informed Consent Form
Information comments: All study materials (e.g., consent form, assessments) can be downloaded from the project website
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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