Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Smokeless Tobacco Cessation
• Intervention / Treatment: Behavioral: Scheduled Gradual Reduction (SGR); Behavioral: Text Messages

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scheduled Gradual Reduction (SGR); Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.	Behavioral: 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.; 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.
Active Comparator: Control Group; Subjects will receive SMS support text messages	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Devon Noonan, PhD, Duke University School of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: smokeless tobacco, text message, tobacco cessation, tobacco
• Other Study ID Numbers: Pro00063791; 1R15CA198841-01 (U.S. NIH Grant/Contract)