Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility, acceptability and preliminary efficacy of a Scheduled Gradual Reduction (SGR) intervention via Short Message Service (SMS) text messaging plus SMS Support Messages in decreasing smokeless tobacco use in a rural population.

Detailed Description
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Participants will be randomized to either the Scheduled Gradual Reduction (SGR) group or the control group. All participants in both groups will complete surveys at the baseline, end of program, and 6 month time points. All participants in both groups will also receive supportive counseling text messages at various times during the day over a period of 4 weeks. Participants assigned to the SGR intervention group will receive their intervention, in addition to the supportive counseling messages received by the control group, via text message over a period of four weeks. Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use.

Official Title
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Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention: The Text to Forgo Smokeless Tobacco

Conditions
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Smokeless Tobacco Cessation

Intervention / Treatment
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* Behavioral: Scheduled Gradual Reduction (SGR)
* Behavioral: Text Messages


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years of age Have used smokeless tobacco for the last year, currently (past 30 days) uses smokeless tobacco daily, and use of at least one or more tins/cans per week Have an address in a rural census tract defined by a RUCA code of 4-10. Interested in participating in a cessation program Have access to a cell phone with unlimited texting ability and have knowledge of text messaging Exclusion Criteria: Non-English speaking Have smoked cigarettes or used any other tobacco product in the past 30 days (i.e., dual user) Currently participating in a smokeless tobacco cessation study Family member participating in a smokeless tobacco cessation study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scheduled Gradual Reduction (SGR)<br>Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages. | Behavioral: Scheduled Gradual Reduction (SGR)<br>* Participants in this group will group will receive the Scheduled Gradual Reduction (SGR) smokeless tobacco cessation reduction intervention via text message over a period of four weeks. Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use. In addition, this group will also receive the support messages that are sent to the control group.<br>Behavioral: Text Messages<br>* Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.<br>|
| Active Comparator: Control Group<br>Subjects will receive SMS support text messages | Behavioral: Text Messages<br>* Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Return Text Messages sent in Response to SGR Intervention | Assessed via text history | 1 month | 
| Proportion of Support Messages Read by Participants | Self-report | 1 month | 
| Ratings of Usefulness of the Intervention Received | Ratings will be assessed via patient questionnaire. | 1 month | 
| Quit Rate at 1 month | Quit rate will be assessed by participant self report via questionnaires. Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco. | 1 month | 
| Quit Rate at 6 Months | Quit rate will be assessed by participant self report via questionnaires. Participants will also be asked to provide a saliva sample to check for nicotine if they report that they have quit using smokeless tobacco. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smokeless tobacco, text message, tobacco cessation, tobacco