Smoking CessationSMS USANCT01516632
Smoking Cessation Via Text Messaging: Feasibility Testing of Stop My Smoking USA
A study testing SMS USA in people with Smoking Cessation, run by Center for Innovative Public Health Research at 1 site in United States.
Trial summary
The investigators developed a text messaging-based smoking cessation program called SMS (Stop My Smoking) USA. It was tailored for the unique needs and smoking habits of young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- SMS USA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Internet Solutions for Kids, Inc.
Santa Ana, California, 92705
About this study
Official title: Smoking Cessation Via Text Messaging: Feasibility Testing of SMS USA
The investigators developed a text messaging-based smoking cessation program called SMS (Stop My Smoking) USA. It was tailored for the unique needs and smoking habits of young adults. The investigators hypothesized that those in the SMS USA intervention would be significantly more likely to be quit at 6-months compared to the attention-matched control group.
Read the detailed description
About one in four young adults are current smokers. Although over half report the desire to quit or cut down, quit rates in this age group have remained stagnant in the last ten years. Text messaging may represent a compelling intervention delivery method for smoking cessation for young adults because it is a medium they have widely adopted. Cell phone interventions also are unique because of their 'always on' capability - interventions are never far from the young adult's reach and they are received automatically instead of requiring the participant to initiate contact in order to receive the information. Dr. Ybarra, along with Drs. Holtrop and Graham, have developed SMS Turkey, an innovative behavioral intervention that uses text messaging to deliver CBT-based smoking cessation information to participants daily. Successful use of text messaging to deliver smoking cessation programs has been reported by Rodgers and colleagues in New Zealand and a replication study they are leading in the United Kingdom. These data provide optimism for the feasibility of text messaging-based smoking cessation programs in the United States. Using qualitative methods to inform design and content, and quantitative methods to assess the feasibility of the program, we propose to design and test SMS (Stop My Smoking) USA, a cell-phone based smoking cessation program for young adults ages 18-25. This innovative smoking cessation program uses technology widely adopted by young adults, an under-targeted population, to deliver a proactive, cognitive behavioral therapy (CBT)-based intervention. Our multidisciplinary team of researchers brings together expertise in Internet health and the design of tailored smoking cessation interventions.
- Conditions
- Smoking Cessation
- Being tested
- SMS USA
- Keywords
- Cellular Phone, Mobile Phone, Cognitive Behavior Therapy, Technology, Smoking cessation, young adults
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS USABehavioural
Also called Stop My Smoking USA
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.
| Study group | Role | What they receive |
|---|---|---|
| SMS USA | Experimental | The 6-week smoking cessation intervention Receives: Behavioral: SMS USA |
| Attention matched control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations
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.
Measured: 3-months post-quit
Secondary outcomes (2)
Point Prevalence
A cigarette, even just a puff, within the last 7 days (yes/no).
Measured: 4-weeks post-quit
Continuous Abstinence at 4-weeks Post-quit
Smoking five or fewer cigarettes since quit day at 4 weeks post-quit as verified by a significant other
Measured: 4 weeks post-quit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJun 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Innovative Public Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University, The University of Texas Health Science Center, Houston, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michele Ybarra, MPH PhD, Principal investigator, Center for Innovative Public Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516632
- Sponsor's protocol ID
- R21CA135669
- Other IDs
- 5R21CA135669
- Acronym
- SMS USA
- Status last verified
- Apr 2016
- First submitted
- 15 Mar 2011
- Last updated
- 6 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 25103183Ybarra 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.
PubMed 24766267Filion 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.
PubMed 26178640Ybarra 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.
PubMed 23348969
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation Via Text Messaging: Feasibility Testing of SMS USA
- ClinicalTrials.gov ID
- NCT01516632
- Acronym / sponsor ID
- SMS USA / R21CA135669
- Conditions
- Smoking Cessation
- Keywords
- Cellular Phone, Mobile Phone, Cognitive Behavior Therapy, Technology, Smoking cessation, young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Center for Innovative Public Health ResearchUniversity, hospital or other
- Collaborators
- Michigan State University, The University of Texas Health Science Center, Houston, National Cancer Institute (NCI)
- Study start
- Jun 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Posted 6 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators developed a text messaging-based smoking cessation program called SMS (Stop My Smoking) USA. It was tailored for the unique needs and smoking habits of young adults. The investigators hypothesized that those in the SMS USA intervention would be significantly more likely to be quit at 6-months compared to the attention-matched control group.
Detailed description
About one in four young adults are current smokers. Although over half report the desire to quit or cut down, quit rates in this age group have remained stagnant in the last ten years. Text messaging may represent a compelling intervention delivery method for smoking cessation for young adults because it is a medium they have widely adopted. Cell phone interventions also are unique because of their 'always on' capability - interventions are never far from the young adult's reach and they are received automatically instead of requiring the participant to initiate contact in order to receive the information. Dr. Ybarra, along with Drs. Holtrop and Graham, have developed SMS Turkey, an innovative behavioral intervention that uses text messaging to deliver CBT-based smoking cessation information to participants daily. Successful use of text messaging to deliver smoking cessation programs has been reported by Rodgers and colleagues in New Zealand and a replication study they are leading in the United Kingdom. These data provide optimism for the feasibility of text messaging-based smoking cessation programs in the United States. Using qualitative methods to inform design and content, and quantitative methods to assess the feasibility of the program, we propose to design and test SMS (Stop My Smoking) USA, a cell-phone based smoking cessation program for young adults ages 18-25. This innovative smoking cessation program uses technology widely adopted by young adults, an under-targeted population, to deliver a proactive, cognitive behavioral therapy (CBT)-based intervention. Our multidisciplinary team of researchers brings together expertise in Internet health and the design of tailored smoking cessation interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS USA | Experimental | Behavioral: SMS USAThe 6-week smoking cessation intervention |
| Attention matched control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS USAAlso: Stop My Smoking USAIntervention 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. | Behavioural | SMS USA |
Primary outcome
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.
2 secondary outcomes
Point Prevalence
Time frame: 4-weeks post-quit
Continuous Abstinence at 4-weeks Post-quit
Time frame: 4 weeks post-quit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25103183Ybarra 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.
- Background: PubMed 24766267Ybarra 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.
- Background: PubMed 26178640Filion 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.
- Results publication: PubMed 23348969Ybarra 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.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Ybarra, MPH PhD principal investigator
Center for Innovative Public Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS USA in people with Smoking Cessation, run by Center for Innovative Public Health Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations (time frame: 3-months post-quit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01516632, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.