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Clinical Trials/NCT02613689
NCT02613689
Completed
N/A

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

Duke University1 site in 1 country100 target enrollmentFebruary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Smokeless Tobacco Cessation
Sponsor
Duke University
Enrollment
100
Locations
1
Primary Endpoint
Ratings of Usefulness of the Intervention Received
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
December 31, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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-
  • 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

Outcomes

Primary Outcomes

Ratings of Usefulness of the Intervention Received

Time Frame: 1 month

Ratings will be assessed via patient questionnaire.

Quit Rate at 1 month

Time Frame: 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.

Proportion of Return Text Messages sent in Response to SGR Intervention

Time Frame: 1 month

Assessed via text history

Proportion of Support Messages Read by Participants

Time Frame: 1 month

Self-report

Quit Rate at 6 Months

Time Frame: 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.

Study Sites (1)

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