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Completed

NCT Number: NCT02613689

Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention

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.

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Key information

Conditions

Smokeless Tobacco Cessation Behavior Health Behavior Tobacco Use Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University School of Nursing

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scheduled Gradual Reduction (SGR)

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

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.

Primary outcomes

  1. Proportion of Return Text Messages sent in Response to SGR Intervention

    Time frame: 1 month

    Assessed via text history

  2. Proportion of Support Messages Read by Participants

    Time frame: 1 month

    Self-report

  3. Ratings of Usefulness of the Intervention Received

    Time frame: 1 month

    Ratings will be assessed via patient questionnaire.

  4. Quit Rate at 1 month

    Time frame: 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.

  5. Quit Rate at 6 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2015
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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