Trial Outcomes & Findings for Smoking Cessation Via Text Messaging: Feasibility Testing of Stop My Smoking USA (NCT NCT01516632)
NCT ID: NCT01516632
Last Updated: 2016-06-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
3-months post-quit
Results posted on
2016-06-06
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.
Of the 1,916 people who expressed interest, 585 (31%) were eligible for the study. Of these 585, contact was not made with 49% (n = 284). Fifteen percent (n=90) declined to participate. 211 eligible participants consented to participate and were randomized into the study. 47 terminated after randomization (i.e. did not complete enrollment process)
Participant milestones
| Measure |
Smoking Cessation Text Messaging
6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging-based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
|
Attention-Matched Control Group
Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one's sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
63
|
|
Overall Study
COMPLETED
|
77
|
48
|
|
Overall Study
NOT COMPLETED
|
24
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking Cessation Via Text Messaging: Feasibility Testing of Stop My Smoking USA
Baseline characteristics by cohort
| Measure |
Smoking Cessation Text Messaging
n=101 Participants
6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging-based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
|
The Control Group
n=63 Participants
Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one's sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.6 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
21.6 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
21.6 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Average number of cigarettes smoke per day
|
12.4 number of cigarettes per day
STANDARD_DEVIATION 6.3 • n=5 Participants
|
11.9 number of cigarettes per day
STANDARD_DEVIATION 5.7 • n=7 Participants
|
12.2 number of cigarettes per day
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Nicotine dependent
Yes
|
90 participants
n=5 Participants
|
59 participants
n=7 Participants
|
149 participants
n=5 Participants
|
|
Nicotine dependent
No
|
11 participants
n=5 Participants
|
4 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Importance of Quitting
|
8.7 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants
|
8.9 units on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
|
8.8 units on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Confidence of one's ability to quit
|
6.7 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
6.5 units on a scale
STANDARD_DEVIATION 2.6 • n=7 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Income
<$35,000
|
85 participants
n=5 Participants
|
57 participants
n=7 Participants
|
142 participants
n=5 Participants
|
|
Income
>$35,000
|
16 participants
n=5 Participants
|
6 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Married/living with someone
Yes
|
29 participants
n=5 Participants
|
17 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Married/living with someone
No
|
72 participants
n=5 Participants
|
46 participants
n=7 Participants
|
118 participants
n=5 Participants
|
|
Current Employment Status
Not Working
|
36 participants
n=5 Participants
|
35 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Current Employment Status
Working ≤ 30 hr
|
24 participants
n=5 Participants
|
12 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Current Employment Status
Working > 30 hr
|
41 participants
n=5 Participants
|
16 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Currently Enrolled in College, University, or Junior College
Yes
|
43 participants
n=5 Participants
|
25 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Currently Enrolled in College, University, or Junior College
No
|
58 participants
n=5 Participants
|
38 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Tenure with current cell phone number (months)
|
44.8 Months
STANDARD_DEVIATION 28.2 • n=5 Participants
|
46.4 Months
STANDARD_DEVIATION 31.6 • n=7 Participants
|
45.4 Months
STANDARD_DEVIATION 29.5 • n=5 Participants
|
|
Number of text messages sent on an average day
|
50 units on a scale
n=5 Participants
|
45 units on a scale
n=7 Participants
|
50 units on a scale
n=5 Participants
|
|
Number of text messages received on an average day
|
60 text messages per day
n=5 Participants
|
50 text messages per day
n=7 Participants
|
50 text messages per day
n=5 Participants
|
|
Planning on using an evidence-based quitting aid
Yes
|
26 participants
n=5 Participants
|
11 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Planning on using an evidence-based quitting aid
No
|
75 participants
n=5 Participants
|
52 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Resistance self-efficacy
|
10.6 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
10.5 units on a scale
STANDARD_DEVIATION 4.0 • n=7 Participants
|
10.55 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Social support from "special person"
|
15.1 units on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
16.3 units on a scale
STANDARD_DEVIATION 3.9 • n=7 Participants
|
15.6 units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Social support from friends
|
16.1 units on a scale
STANDARD_DEVIATION 4.0 • n=5 Participants
|
16.6 units on a scale
STANDARD_DEVIATION 3.1 • n=7 Participants
|
16.3 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Social support from family
|
15.3 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
15.9 units on a scale
STANDARD_DEVIATION 3.6 • n=7 Participants
|
15.5 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Depressive Symptomatology
|
7.8 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
9.3 units on a scale
STANDARD_DEVIATION 6.4 • n=7 Participants
|
8.3 units on a scale
STANDARD_DEVIATION 6.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3-months post-quitContinuous 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.
Outcome measures
| Measure |
Smoking Cesssation Via Text Messaging
n=101 Participants
The 6-week smoking cessation program
SMS (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.
|
Attention Matched Control
n=63 Participants
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.
SMS (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.
|
|---|---|---|
|
Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations
|
40 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 4-weeks post-quitA cigarette, even just a puff, within the last 7 days (yes/no).
Outcome measures
| Measure |
Smoking Cesssation Via Text Messaging
n=101 Participants
The 6-week smoking cessation program
SMS (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.
|
Attention Matched Control
n=63 Participants
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.
SMS (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.
|
|---|---|---|
|
Point Prevalence
|
44 participants
|
17 participants
|
SECONDARY outcome
Timeframe: 4 weeks post-quitSmoking five or fewer cigarettes since quit day at 4 weeks post-quit as verified by a significant other
Outcome measures
| Measure |
Smoking Cesssation Via Text Messaging
n=101 Participants
The 6-week smoking cessation program
SMS (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.
|
Attention Matched Control
n=63 Participants
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.
SMS (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.
|
|---|---|---|
|
Continuous Abstinence at 4-weeks Post-quit
|
34 participants
|
13 participants
|
Adverse Events
Smoking Cessation Text Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention-Matched Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michele Ybarra
Center for Innovative Public Health Reserch
Phone: (877) 302-6858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place