CClinicalTrials.gg
CompletedNCT01516632SMS USAUpdated Jun 6, 2016Results posted

Smoking Cessation Via Text Messaging: Feasibility Testing of Stop My Smoking USA

An interventional study of SMS USA in Smoking Cessation, sponsored by Center for Innovative Public Health Research. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-06.

Sponsored by Center for Innovative Public Health Research · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Smoking Cessation

Keywords

  • Cellular Phone
  • Mobile Phone
  • Cognitive Behavior Therapy
  • Technology
  • Smoking cessation
  • young adults
03

In context

Lead sponsor

Center for Innovative Public Health Research is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

None

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    SMS USA

    The 6-week smoking cessation intervention

    Behavioral: SMS USA

  • 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.

Interventions

  • BehavioralSMS 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.

    Also known as: Stop My Smoking USA

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3-months post-quit

Secondary outcomes

  1. Point Prevalence

    A cigarette, even just a puff, within the last 7 days (yes/no).

    Time frame: 4-weeks post-quit

  2. 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

    Time frame: 4 weeks post-quit

07

Results

Posted Jun 6, 2016
Limitations and caveats
The main limitation of the study is its small sample size. Also, it is unclear how young adult smokers recruited on Craigslist compared with young adult smokers who would be recruited through other ways.

Participant flow

Participants were recruited nationally through online advertisements (e.g. Craigslist) between May 3, 2011 and August 4, 2011. Smokers expressed their interest by completing an online screener form, which was then e-mailed to the project coordinator.

Participant flow — Overall Study
MilestoneSmoking Cessation Text MessagingAttention-Matched Control Group
Started10163
Completed7748
Not completed2415

Outcome measures

PrimaryContinuous 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.

Time frame:
3-months post-quit
Reported as:
Number · participants
Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations
participantsSmoking Cesssation Via Text MessagingAttention Matched Control
Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations4019
Statistical analysis
  • Smoking Cesssation Via Text Messaging vs Attention Matched Control · Odds ratio (or): 1.62 · 95% CI .82 to 3.21
SecondaryPoint Prevalence

A cigarette, even just a puff, within the last 7 days (yes/no).

Time frame:
4-weeks post-quit
Reported as:
Number · participants
Point Prevalence
participantsSmoking Cessation Text MessagingAttention-Matched Control Group
Point Prevalence4417
Statistical analysis
  • Smoking Cessation Text Messaging vs Attention-Matched Control Group · Odds ratio (or): 2.55 · 95% CI 1.22 to 5.30
SecondaryContinuous 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

Time frame:
4 weeks post-quit
Reported as:
Number · participants
Continuous Abstinence at 4-weeks Post-quit
participantsSmoking Cessation Text MessagingAttention-Matched Control Group
Continuous Abstinence at 4-weeks Post-quit3413
Statistical analysis
  • Smoking Cessation Text Messaging vs Attention-Matched Control Group · Odds ratio (or): 3.33 · 95% CI 1.48 to 7.45

Adverse events

Collected over Adverse event data were collected through the study period (i.e., from baseline to 4-week follow-up). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Smoking Cessation Text Messaging—0/101 (0%)0/101 (0%)
Attention-Matched Control Group—0/63 (0%)0/63 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Smoking Cessation Text MessagingThe Control GroupTotal
Mean21.6 ± 2.121.6 ± 2.121.6 ± 2.1
Sex: Female, Male
Sex: Female, Male(Participants)Smoking Cessation Text MessagingThe Control GroupTotal
Female442872
Male573592
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Smoking Cessation Text MessagingThe Control GroupTotal
Hispanic or Latino22830
Not Hispanic or Latino7955134
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Smoking Cessation Text MessagingThe Control GroupTotal
American Indian or Alaska Native123
Asian224
Native Hawaiian or Other Pacific Islander011
Black or African American13922
White6541106
More than one race16824
Unknown or Not Reported404
Average number of cigarettes smoke per day
Average number of cigarettes smoke per day(number of cigarettes per day)Smoking Cessation Text MessagingThe Control GroupTotal
Mean12.4 ± 6.311.9 ± 5.712.2 ± 6.1
Nicotine dependent
Nicotine dependent(participants)Smoking Cessation Text MessagingThe Control GroupTotal
Yes9059149
No11415
Importance of Quitting
Importance of Quitting(units on a scale)Smoking Cessation Text MessagingThe Control GroupTotal
Mean8.7 ± 1.58.9 ± 1.38.8 ± 1.4
Confidence of one's ability to quit
Confidence of one's ability to quit(units on a scale)Smoking Cessation Text MessagingThe Control GroupTotal
Mean6.7 ± 2.26.5 ± 2.66.6 ± 2.4

13 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Internet Solutions for Kids, Inc.
    Santa Ana, California 92705, United States
09

References and documents

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 25103183 ↗
  • 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. PubMed 24766267 ↗
  • 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. PubMed 26178640 ↗
  • 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. PubMed 23348969 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01516632
Lead sponsor
Center for Innovative Public Health Research
Collaborators
Michigan State University, The University of Texas Health Science Center, Houston, National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 25, 2012
Start date
Jun 2009
Primary completion
Dec 2011
Completion
Dec 2011
Results posted
Jun 6, 2016
Last update
Jun 6, 2016

Study contacts

Michele Ybarra, MPH PhD
principal investigator · Center for Innovative Public Health Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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