Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01516632
First received: March 15, 2011
Last updated: April 28, 2016
Last verified: April 2016
Results First Received: March 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Smoking Cessation
Intervention: Behavioral: SMS USA

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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)

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Smoking Cessation Text Messaging     Attention-Matched Control Group  
STARTED     101     63  
COMPLETED     77     48  
NOT COMPLETED     24     15  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).
The 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.
Total Total of all reporting groups

Baseline Measures
    Smoking Cessation Text Messaging     The Control Group     Total  
Number of Participants  
[units: participants]
  101     63     164  
Age  
[units: years]
Mean (Standard Deviation)
  21.6  (2.1)     21.6  (2.1)     21.6  (2.1)  
Gender  
[units: participants]
     
Female     44     28     72  
Male     57     35     92  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     22     8     30  
Not Hispanic or Latino     79     55     134  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     2     3  
Asian     2     2     4  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     13     9     22  
White     65     41     106  
More than one race     16     8     24  
Unknown or Not Reported     4     0     4  
Average number of cigarettes smoke per day  
[units: number of cigarettes per day]
Mean (Standard Deviation)
  12.4  (6.3)     11.9  (5.7)     12.2  (6.1)  
Nicotine dependent  
[units: participants]
     
Yes     90     59     149  
No     11     4     15  
Importance of Quitting [1]
[units: units on a scale]
Mean (Standard Deviation)
  8.7  (1.5)     8.9  (1.3)     8.8  (1.4)  
Confidence of one's ability to quit [2]
[units: units on a scale]
Mean (Standard Deviation)
  6.7  (2.2)     6.5  (2.6)     6.6  (2.4)  
Income [3]
[units: participants]
     
<$35,000     85     57     142  
>$35,000     16     6     22  
Married/living with someone  
[units: participants]
     
Yes     29     17     46  
No     72     46     118  
Current Employment Status  
[units: 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  
[units: participants]
     
Yes     43     25     68  
No     58     38     96  
Tenure with current cell phone number (months) [4]
[units: Months]
Mean (Standard Deviation)
  44.8  (28.2)     46.4  (31.6)     45.4  (29.5)  
Number of text messages sent on an average day  
[units: units on a scale]
Median (Inter-Quartile Range)
  50  
  (20 to 100)  
  45  
  (20 to 100)  
  50  
  (20 to 100)  
Number of text messages received on an average day  
[units: text messages per day]
Median (Inter-Quartile Range)
  60  
  (20 to 100)  
  50  
  (18 to 100)  
  50  
  (20 to 100)  
Planning on using an evidence-based quitting aid [5]
[units: participants]
     
Yes     26     11     37  
No     75     52     127  
Resistance self-efficacy [6]
[units: units on a scale]
Mean (Standard Deviation)
  10.6  (4.0)     10.5  (4.0)     10.55  (4.0)  
Social support from "special person" [7]
[units: units on a scale]
Mean (Standard Deviation)
  15.1  (5.4)     16.3  (3.9)     15.6  (4.9)  
Social support from friends [7]
[units: units on a scale]
Mean (Standard Deviation)
  16.1  (4.0)     16.6  (3.1)     16.3  (3.7)  
Social support from family [7]
[units: units on a scale]
Mean (Standard Deviation)
  15.3  (4.3)     15.9  (3.6)     15.5  (4.1)  
Depressive Symptomatology [8]
[units: units on a scale]
Mean (Standard Deviation)
  7.8  (6.2)     9.3  (6.4)     8.3  (6.3)  
[1] 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.
[2] 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.
[3] Low Income is <$35,000
[4] The length of time they have had the current cellular phone number
[5] Planning on using an evidence-based quitting aid for the current attempt
[6]

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.

[7]

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

[8]

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

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




  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations   [ Time Frame: 3-months post-quit ]

2.  Secondary:   Point Prevalence   [ Time Frame: 4-weeks post-quit ]

3.  Secondary:   Continuous Abstinence at 4-weeks Post-quit   [ Time Frame: 4 weeks post-quit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michele Ybarra
Organization: Center for Innovative Public Health Reserch
phone: (877) 302-6858 ext 1-801#
e-mail: michele@innovativepublichealth.org


Publications of Results:
Other Publications:

Responsible Party: Center for Innovative Public Health Research
ClinicalTrials.gov Identifier: NCT01516632     History of Changes
Other Study ID Numbers: R21CA135669 ( US NIH Grant/Contract Award Number )
5R21CA135669 ( US NIH Grant/Contract Award Number )
Study First Received: March 15, 2011
Results First Received: March 29, 2016
Last Updated: April 28, 2016
Health Authority: United States: Institutional Review Board