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

April 28, 2016 updated by: Center for Innovative Public Health Research

Smoking Cessation Via Text Messaging: Feasibility Testing of SMS USA

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SMS USA
The 6-week smoking cessation intervention
Behavioral: SMS 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.
Other Names:
  • Stop My Smoking 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations
Time Frame: 3-months post-quit

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.
3-months post-quit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Point Prevalence
Time Frame: 4-weeks post-quit
A cigarette, even just a puff, within the last 7 days (yes/no).
4-weeks post-quit
Continuous Abstinence at 4-weeks Post-quit
Time Frame: 4 weeks post-quit
Smoking five or fewer cigarettes since quit day at 4 weeks post-quit as verified by a significant other
4 weeks post-quit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center for Innovative Public Health Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
The University of Texas Health Science Center, Houston
Michigan State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R21CA135669 (U.S. NIH Grant/Contract)
  • 5R21CA135669 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Informed Consent Form
    Information comments: All study materials (e.g., consent form, assessments) can be downloaded from the project website

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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