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Pilot RCT Results of Stop My Smoking USA
Pilot RCT Results of Stop My Smoking USA
Original Investigation
Medicine, Lansing, MI 48824; 3Center for Innovative Public Health Research, Santa Ana, CA 92672; 4University of Texas Health
Science Center at Houston, Houston, TX 77030; 5University of California, San Diego, Department of Family & Preventive
Medicine, La Jolla, CA 92093
Corresponding Author: Michele L. Ybarra, M.P.H, Ph.D., Center for Innovative Public Health Research, 555 El Camino Real
#A347, Santa Ana, CA 9267, USA. Telephone: 877-302-6858; Fax: 877-360-7627; E-mail: Michele@innovativepublichealth.org
Received July 5, 2012; accepted December 8, 2012
Abstract
Introduction: To address the lack of smoking cessation programs available to young adults, Stop My Smoking (SMS) USA, a
text messaging–based smoking cessation program, was developed and pilot tested.
Methods: This was a two-arm randomized controlled trial with adaptive randomization (arms were balanced by sex and smok-
ing level [heavy vs. light]), conducted nationally in the United States. One hundred sixty-four 18- to 25-year-old daily smokers
who were seriously thinking about quitting in the next 30 days were randomized to either (a) the 6-week SMS USA intervention
(n = 101) or (b) an attention-matched control group aimed at improving sleep and physical activity (n = 63). The main outcome
measure was 3-month continuous abstinence, verified by a significant other. Participants but not researchers were blinded to
study arm allocation.
Results: Based upon intent-to-treat analyses, intervention participants (39%) were significantly more likely than control par-
ticipants (21%) to have quit at 4 weeks postquit (adjusted odds ratio [aOR] = 3.33, 95% confidence interval [CI]: 1.48, 7.45).
Findings were not sustained at 3 months postquit, although rates in the SMS USA group were favored (40% vs. 30%, respec-
tively; aOR = 1.59, 95% CI: 0.78, 3.21). Subsequent analyses suggested that among intervention participants, SMS USA might
be more influential for youth not currently enrolled in a higher education (p = .06).
Conclusions: Consistent with pilot studies, the sample was underpowered. Data suggest, however, that the SMS USA program
affects smoking cessation rates at 4 weeks postquit. More research is needed before conclusions can be made about long-term
impact. Identifying profiles of users for whom the program may be particularly beneficial also will be important.
doi:10.1093/ntr/nts339
Advance Access publication January 24, 2013
© The Author 2013. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco.
All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
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and colleagues (2005) in New Zealand, a recent trial conducted in Relapse messages that focused on helping them get back on
the United Kingdom among 5,800 adults reports that “txt2stop” track and to recommit to quitting. If participants were smoking
users are more than twice as likely to have quit (as confirmed at both days, they were pathed to an Encouragement arm that
by biochemical verification) at 6 months compared with control focused on norms for quitting and suggested that participants
participants who received one text message per week, reminding try quitting again at later time.
them that they were in the study (Free et al., 2011). Participants received four messages per day during the
Stop My Smoking (SMS) USA is a text messaging–based 2-week Pre-Quit stage, with the exception of Day 1 and Day 14
smoking cessation program tailored to the experiences of when they received five and six messages, respectively. In the
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Table 1. Example Text Messages for the Intervention and Control Groups
Note. aExamples are mirror messages sent to the intervention and control groups, taken from five text messages each on Days 1–3, nine
on Day 15, five on Day 15, and two on Day 31.
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Muntaner, Smith, Tien, & Ybarra, 2004). Responses were cap- $20 after completing the 4-week and 3-month postquit follow-
tured on the PHQ’s (Kroenke, Spitzer, & Williams, 2001) four- ups, respectively. A third of participants received an additional
point Likert scale. The scale demonstrated acceptable internal $10 if they responded within 48 hr, another third of partici-
validity (Cronbach’s alpha = .87). Concurrent risky drinking is pants received $10 if they completed the online survey within
associated with reduced likelihood of smoking cessation (Sher, 48 hr of receiving a second reminder text, and a different third
Gotham, Erickson, & Wood, 1996). Participants who reported received $10 if they completed a minisurvey via text messaging
at least two of the four CAGE (Dhalla & Kopec, 2007) risky at 3 months. Participants could opt-out of the study at any time
drinking-related behaviors were coded as risky drinkers. by texting “end” to the program or by contacting project staff.
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Four-week follow-up was conducted between April and similar across the two groups except for employment sta-
June; and 3-month follow-up between June and August, 2011. tus. Smoking behavior and psychosocial characteristics were
Eighty-seven percent of participants responded at 4 weeks similar.
postquit and 80% at 3 months postquit. Differential follow-up
between the intervention and control groups was not observed Smoking Cessation Outcomes
at either 4 weeks (86% vs. 87%, respectively; p = .83) or
3 months (80% vs. 80%, respectively; p = .91) follow-up. Five One-hundred and one participants randomized to the interven-
intervention participants actively withdrew from the program. tion and 63 randomized to the control group were included in
No control participants withdrew. the analyses. Based on ITT analysis, 40% of the participants in
the intervention arm had a verified quit status compared with
30% in the control arm at 3 months postquit. The observed dif-
Baseline Data
ference was not statistically significant (OR = 1.62, 95% CI:
A summary of baseline participant characteristics by study 0.82, 3.21). The intervention arm continued to be favored,
arm is shown in Table 2. Characteristics were statistically although not significantly, after adjusting for biological sex, the
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Table 2. Summary Statistics for the Baseline Characteristics by the Study Arm
Intervention
Control (n = 63) (n = 101)
Participants demographic and other characteristics at baseline % (n) % (n) p
Age (M, SD: Range: 18–25) 21.6 (2.1) 21.6 (2.1) .82
Female 44.4 (28) 43.6 (44) .91
Low income (<$35,000 vs. higher) 90.5 (57) 84.2 (85) .25
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Table 3. Intent to Treat–Based Multivariable Model of the Relative Odds of Verified Quit Status at 3 Months
Postquit Day (n = 164)
Notes. Bold text denotes statistically significant differences at α = .05; aOR = adjusted odds ratio, ORs adjusted for all other variables
shown above; CI = confidence interval.
these characteristics and arm assignment. On the other hand, they received too many messages (23% and 12%, respectively).
results suggested that enrollment in higher education settings About three in four in both groups (82% and 74%, respectively)
was an effect modifier within the context of other potentially agreed that they were likely to recommend the program to others.
influential characteristics (arm assignment × school status; Appraisal of the Text Buddy among intervention partici-
aOR = 4.7, 95% CI: 1.01, 22.3). The intervention appeared to pants is shown in Table 5. About half (51%) of intervention
be more influential for intervention participants not enrolled participants contacted their Text Buddy at least once. Usage
in higher education compared with control participants not was highly skewed and ranged between 1 and 51 messages
enrolled in higher education (see Table 3). (M = 6.5, SD = 11.0). Users and nonusers were similar by
participant sex, age, smoking intensity, and school status.
Smoking Behavior Among Those Who Continue Intervention participants who rated their Text Buddy as helpful
to Smoke were more likely to have quit at 3 months than participants who
rated their Text Buddy otherwise (77% vs. 32%, p = .001); sim-
Among the 104 participants who reported smoking since their ilar results were noted for those who rated their buddy as sup-
quit day, 30% of intervention and 20% of control participants portive (65% vs. 31%, p = .002). Average change from baseline
reported not smoking—even a puff—in the past 7 days at to 3-month follow-up in nonprogram–related social support
3-month follow-up (p = .52). Among the 93 participants who from friends, family, and a special person was similar between
reported smoking at least one cigarette in the past 28 days at those who found their Text Buddy helpful and supportive and
3-month follow-up, those in the intervention reported reducing those who did not however (e.g., Text Buddy was unsupportive:
their average daily intake by 6.7 cigarettes (SD = 8.3) and the M = 3.0, SD = 12.0; supportive: M = 1.7, SD = 11.6; p = .62).
control group by 5.9 cigarettes (SD = 4.5; p = .60). One in three intervention participants (34%) used the Text
Crave automated support at least once during the program.
Usage ranged from 1 to 15 messages (M = 3.5, SD = 3.3).
Program Acceptability
Users and nonusers were similar by participant sex, age, smok-
Indicators of program acceptability are shown in Table 4. Few ing intensity, and school status. There was some indication that
participants said that the program disrupted their daily sched- users were less likely to be minority race (22%) compared with
ule (10% of intervention and 6% of control participants) or that nonusers (40%, p = .07). Sixty-one percent rated Text Crave
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as somewhat or very helpful. Participants who found Text if anyone is out there…my quit day is coming up july 1. What
Crave helpful were more likely than those who did not quit at about you guys?”
3 months (55% vs. 28%, p = .001).
There were 355 hits on the Web site main page during the
3 months of field. The most popular subpage was the Board, Discussion
which received 198 page views. Only 11 user accounts were
created and seven posts posted, however. One particularly Findings from the pilot RCT of SMS USA suggest that the
poignant example was this unanswered post: “was just wonder- intervention affects self-reported quitting rates at 4 weeks, as
ing what people thought of the text messages so far? not sure verified by a significant other, in a sample that includes those
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Table 5. Appraisal of Intervention Components Among Intervention Participants Who Responded at 3 Months
traditionally not incorporated into smoking cessation research SMS USA appears to be effective in reaching people who
in the United States. Quitting rates are not significantly dif- might otherwise not access evidence-based smoking cessation
ferent for SMS USA participants and control participants at programs: more than two in three (71%) had never used an
3 months postquit. The study is not powered to detect sig- evidence-based quitting aid (i.e., pharmacotherapy, individual
nificant differences (as is consistent with pilot designs)—par- therapy, or group therapy) before enrolling in SMS USA. This
ticularly within subgroups. Future studies with larger sample may in part be because of the study’s unique outreach to young
sizes are needed before conclusions can be drawn. Current adults outside of higher education settings. Indeed, 57% of
data suggest intriguing areas for future inquiry however, participants are working and 59% are not currently enrolled
including that the program might be particularly helpful for in higher education courses. The sample also is racially and
young adults outside of higher education settings, a group of economically diverse: 35% are non-White and 43% report an
young smokers traditionally not included in smoking cessa- annual household income of less than $15,000. It also is major-
tion research. Other groups who may also benefit from the ity male (56%). Although the ability for technology-based
program to a greater degree might be non-White and male interventions to reach a wide range of people is often touted, it
participants. is rarely realized in research studies. Instead, smoking cessation
Findings also suggest that SMS USA is acceptable among study samples recruited online tend to be more female, White,
this understudied population. The extensive development activi- and educated compared with the general smoking population
ties (Ybarra, Prescott, & Holtrop, 2012) seem to have resulted (Cobb, Graham, Bock, Papandonatos, & Abrams, 2005; Feil,
in salient content that is neither disruptive nor too frequent. Noell, Lichtenstein, Boles, & McKay, 2003; Stoddard et al.,
Unlike previous studies that have offered the Text Buddy as 2005). Although we did not have specific recruitment goals,
an opt-in intervention component (Free et al., 2011; Rodgers we purposefully targeted a diversity of communities and moni-
et al., 2005; Whittaker et al., 2009), all participants are assigned tored the demographic characteristics of the sample to ensure
a buddy in SMS USA. Although only half of participants sent a a diverse sample. Given that lower income and racial minor-
message to their buddy and the component did not receive posi- ity groups are disproportionately represented in the smoking
tive ratings from the majority of participants, those who found population (Centers for Disease Control and Prevention, 1998,
their buddy to be supportive and helpful were significantly more 2010), it is encouraging that results suggest that SMS USA has
likely to quit. Text Crave was utilized by only one in three par- the potential to be especially beneficial to these groups.
ticipants but it received positive ratings by two in three users This is one of the few studies to test a text messaging–based
and was associated with increased likelihood of quitting. It may program against a blinded control group. Content was intention-
be that text messaging–based smoking cessation programs are ally designed not to include components necessary to affect ces-
more effective for smokers who are open to using these types of sation (e.g., preparation for quitting) and instead talked about the
components, and those who do not may find other types of ces- importance of quitting within the context of improving one’s fit-
sation programs (e.g., telephone quit lines) to be better aligned ness and sleep. Three in four control participants said that the
with their quitting needs. messages talked about what they were feeling and experiencing,
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suggesting that participants were successfully blinded with con- Declaration of Interests
tent that had perceived utility, yet provided insufficient transfer
of skills for cessation. The observed difference in cessation rates The authors have no competing interests to declare.
between the two study groups is the first evidence to support the
hypothesis that above and beyond the simple act of text messag-
ing, content does matter when trying to affect cessation. Text mes- Acknowledgments
saging is simply the delivery mode; it is not the intervention itself. We would like to thank the entire Study team from Center
As with other delivery mechanisms (e.g., in-person, online), the for Innovative Public Health (Internet Solutions for Kids),
Conclusions
Findings provide reason for optimism that text messaging– References
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