NCT02613689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

November 12, 2015

Last Update Submit

January 15, 2019

Conditions

Smokeless Tobacco Cessation

Keywords

smokeless tobacco, text message, tobacco cessation, tobacco

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

Scheduled Gradual Reduction (SGR)

EXPERIMENTAL

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

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

Control Group

ACTIVE COMPARATOR

Subjects will receive SMS support text messages

Behavioral: Text Messages

Interventions

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.

Scheduled Gradual Reduction (SGR)
Text MessagesBEHAVIORAL

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 GroupScheduled Gradual Reduction (SGR)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University School of Nursing

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Tobacco Use CessationTobacco Use

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Devon Noonan, PhD

    Duke University School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 24, 2015

Study Start

February 1, 2016

Primary Completion

November 1, 2018

Study Completion

December 31, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

US(1)