Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 662 for:    SMS

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01516632
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Collaborators:
Michigan State University
The University of Texas Health Science Center, Houston
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Center for Innovative Public Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Smoking Cessation
Intervention Behavioral: SMS USA
Enrollment 164
Recruitment Details 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.
Pre-assignment Details 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)
Arm/Group Title Smoking Cessation Text Messaging Attention-Matched Control Group
Hide Arm/Group Description 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). 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.
Period Title: Overall Study
Started 101 63
Completed 77 48
Not Completed 24 15
Arm/Group Title Smoking Cessation Text Messaging The Control Group Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 101 63 164
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants 63 participants 164 participants
21.6  (2.1) 21.6  (2.1) 21.6  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 63 participants 164 participants
Female
44
  43.6%
28
  44.4%
72
  43.9%
Male
57
  56.4%
35
  55.6%
92
  56.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 63 participants 164 participants
Hispanic or Latino
22
  21.8%
8
  12.7%
30
  18.3%
Not Hispanic or Latino
79
  78.2%
55
  87.3%
134
  81.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 63 participants 164 participants
American Indian or Alaska Native
1
   1.0%
2
   3.2%
3
   1.8%
Asian
2
   2.0%
2
   3.2%
4
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.6%
1
   0.6%
Black or African American
13
  12.9%
9
  14.3%
22
  13.4%
White
65
  64.4%
41
  65.1%
106
  64.6%
More than one race
16
  15.8%
8
  12.7%
24
  14.6%
Unknown or Not Reported
4
   4.0%
0
   0.0%
4
   2.4%
Average number of cigarettes smoke per day  
Mean (Standard Deviation)
Unit of measure:  Number of cigarettes per day
Number Analyzed 101 participants 63 participants 164 participants
12.4  (6.3) 11.9  (5.7) 12.2  (6.1)
Nicotine dependent  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 63 participants 164 participants
Yes 90 59 149
No 11 4 15
Importance of Quitting   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 101 participants 63 participants 164 participants
8.7  (1.5) 8.9  (1.3) 8.8  (1.4)
[1]
Measure Description: The score ranged from 0-10 with higher scores reflecting more importance Miller, W. R., Zweben, A., DiClemente, C. C., & Rychtarik, R. G. (1992). Motivational Enhancement Therapy Manual: A clinical research guide for therapists treating individuals with alcohol abuse and dependence. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism.
Confidence of one's ability to quit   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 101 participants 63 participants 164 participants
6.7  (2.2) 6.5  (2.6) 6.6  (2.4)
[1]
Measure Description: The score ranged from 0-10 with higher scores reflecting more confidence Miller, W. R., Zweben, A., DiClemente, C. C., & Rychtarik, R. G. (1992). Motivational Enhancement Therapy Manual: A clinical research guide for therapists treating individuals with alcohol abuse and dependence. Rockville, MD: National Institute on Alcohol Abuse and Alcoholism.
Income   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 63 participants 164 participants
<$35,000 85 57 142
>$35,000 16 6 22
[1]
Measure Description: Low Income is <$35,000
Married/living with someone  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 63 participants 164 participants
Yes 29 17 46
No 72 46 118
Current Employment Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 63 participants 164 participants
Not Working 36 35 71
Working ≤ 30 hr 24 12 36
Working > 30 hr 41 16 57
Currently Enrolled in College, University, or Junior College  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 63 participants 164 participants
Yes 43 25 68
No 58 38 96
Tenure with current cell phone number (months)   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 101 participants 63 participants 164 participants
44.8  (28.2) 46.4  (31.6) 45.4  (29.5)
[1]
Measure Description: The length of time they have had the current cellular phone number
Number of text messages sent on an average day  
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 101 participants 63 participants 164 participants
50
(20 to 100)
45
(20 to 100)
50
(20 to 100)
Number of text messages received on an average day  
Median (Inter-Quartile Range)
Unit of measure:  Text messages per day
Number Analyzed 101 participants 63 participants 164 participants
60
(20 to 100)
50
(18 to 100)
50
(20 to 100)
Planning on using an evidence-based quitting aid   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants 63 participants 164 participants
Yes 26 11 37
No 75 52 127
[1]
Measure Description: Planning on using an evidence-based quitting aid for the current attempt
Resistance self-efficacy   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 101 participants 63 participants 164 participants
10.6  (4.0) 10.5  (4.0) 10.55  (4.0)
[1]
Measure Description:

The scale was a 4-item measure developed by Lawrance L, Rubinson L. Self-efficacy as a predictor of smoking behavior in young adolescents. Addict Behav. 1986;11(4):367-382.

The possible range of scores was from 4-20 with higher scores reflecting more self-efficacy.

Social support from "special person"   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 101 participants 63 participants 164 participants
15.1  (5.4) 16.3  (3.9) 15.6  (4.9)
[1]
Measure Description:

Measured using the Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, 1988)

The values range 4-20 with higher scores reflecting more social support

Social support from friends   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 101 participants 63 participants 164 participants
16.1  (4.0) 16.6  (3.1) 16.3  (3.7)
[1]
Measure Description:

Measured using the Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, 1988)

The values range 4-20 with higher scores reflecting more social support

Social support from family   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 101 participants 63 participants 164 participants
15.3  (4.3) 15.9  (3.6) 15.5  (4.1)
[1]
Measure Description:

Measured using the Multidimensional Scale of Perceived Social Support (Zimet, Dahlem, Zimet, & Farley, 1988)

The values range 4-20 with higher scores reflecting more social support

Depressive Symptomatology   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 101 participants 63 participants 164 participants
7.8  (6.2) 9.3  (6.4) 8.3  (6.3)
[1]
Measure Description:

Center for Epidemiologic Studies Depression Scale (Eaton, Muntaner, Smith, Tien, & Ybarra, 2004)

The scores range 0-27 with higher scores reflecting more depressive symptomatology

1.Primary Outcome
Title Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smoking Cesssation Via Text Messaging Attention Matched Control
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 101 63
Measure Type: Number
Unit of Measure: participants
40 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Smoking Cesssation Via Text Messaging, Attention Matched Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.62
Confidence Interval (2-Sided) 95%
.82 to 3.21
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Point Prevalence
Hide Description A cigarette, even just a puff, within the last 7 days (yes/no).
Time Frame 4-weeks post-quit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smoking Cessation Text Messaging Attention-Matched Control Group
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 101 63
Measure Type: Number
Unit of Measure: participants
44 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Smoking Cessation Text Messaging, Attention-Matched Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.55
Confidence Interval (2-Sided) 95%
1.22 to 5.30
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Continuous Abstinence at 4-weeks Post-quit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smoking Cessation Text Messaging Attention-Matched Control Group
Hide Arm/Group Description:
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).
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 Number of Participants Analyzed 101 63
Measure Type: Number
Unit of Measure: participants
34 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Smoking Cessation Text Messaging, Attention-Matched Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.33
Confidence Interval (2-Sided) 95%
1.48 to 7.45
Estimation Comments [Not Specified]
Time Frame Adverse event data were collected through the study period (i.e., from baseline to 4-week follow-up)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Smoking Cessation Text Messaging Attention-Matched Control Group
Hide Arm/Group Description 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). 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.
All-Cause Mortality
Smoking Cessation Text Messaging Attention-Matched Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Smoking Cessation Text Messaging Attention-Matched Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/63 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Smoking Cessation Text Messaging Attention-Matched Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)   0/63 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michele Ybarra
Organization: Center for Innovative Public Health Reserch
Phone: (877) 302-6858 ext 1-801#
EMail: michele@innovativepublichealth.org
Layout table for additonal information
Responsible Party: Center for Innovative Public Health Research
ClinicalTrials.gov Identifier: NCT01516632     History of Changes
Other Study ID Numbers: R21CA135669 ( U.S. NIH Grant/Contract )
5R21CA135669 ( U.S. NIH Grant/Contract )
First Submitted: March 15, 2011
First Posted: January 25, 2012
Results First Submitted: March 29, 2016
Results First Posted: June 6, 2016
Last Update Posted: June 6, 2016