Clinical trial NCT02613689: Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention
Official title: Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention: The Text to Forgo Smokeless Tobacco
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smokeless Tobacco Cessation
Keywords: smokeless tobacco, text message, tobacco cessation, tobacco
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 4-10.
* 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

Primary outcomes:
measure: Proportion of Return Text Messages sent in Response to SGR Intervention
timeFrame: 1 month
measure: Proportion of Support Messages Read by Participants
timeFrame: 1 month
measure: Ratings of Usefulness of the Intervention Received
timeFrame: 1 month
measure: Quit Rate at 1 month
timeFrame: 1 month
measure: Quit Rate at 6 Months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University School of Nursing
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Devon Noonan, PhD
role: PRINCIPAL_INVESTIGATOR
References: