Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention

NCT ID: NCT02613689

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-12-31

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.

Conditions

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Smokeless Tobacco Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Scheduled Gradual Reduction (SGR)

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

Group Type EXPERIMENTAL

Scheduled Gradual Reduction (SGR)

Intervention Type BEHAVIORAL

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.

Text Messages

Intervention Type BEHAVIORAL

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.

Control Group

Subjects will receive SMS support text messages

Group Type ACTIVE_COMPARATOR

Text Messages

Intervention Type BEHAVIORAL

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.

Interventions

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Scheduled Gradual Reduction (SGR)

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.

Intervention Type BEHAVIORAL

Text Messages

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Devon Noonan, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University School of Nursing

Locations

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Duke University School of Nursing

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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1R15CA198841-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00063791

Identifier Type: -

Identifier Source: org_study_id

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