Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention

Duke University

Status: Completed

Conditions: Smokeless Tobacco Cessation

Treatments: Behavioral: Scheduled Gradual Reduction (SGR); Behavioral: Text Messages

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02613689

1R15CA198841-01 (U.S. NIH Grant/Contract)

Pro00063791

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Scheduled Gradual Reduction (SGR)

Experimental group

Description:

Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.

Treatment:

Behavioral: Scheduled Gradual Reduction (SGR)

Behavioral: Text Messages

Control Group

Active Comparator group

Description:

Subjects will receive SMS support text messages

Treatment:

Behavioral: Text Messages