Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention

Not Applicable

Completed

• Conditions: Smokeless Tobacco Cessation
• Interventions: Behavioral: Scheduled Gradual Reduction (SGR); Behavioral: Text Messages

• Registration Number: NCT02613689
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2015-11-12
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-24
• Study Start: 2016-02
• Primary Completion: 2018-11
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scheduled Gradual Reduction (SGR)	Text Messages	Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.
Scheduled Gradual Reduction (SGR)	Scheduled Gradual Reduction (SGR)	Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.
Control Group	Text Messages	Subjects will receive SMS support text messages

Primary Outcome Measures

Name	Time	Method
Proportion of Return Text Messages sent in Response to SGR Intervention	1 month	Assessed via text history
Proportion of Support Messages Read by Participants	1 month	Self-report
Ratings of Usefulness of the Intervention Received	1 month	Ratings will be assessed via patient questionnaire.
Quit Rate at 1 month	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.
Quit Rate at 6 Months	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.

Trial Locations

Locations (1)

Duke University School of Nursing; 🇺🇸 Durham, North Carolina, United States