Smokeless Tobacco CessationNCT02613689
Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention
A study testing Scheduled Gradual Reduction (SGR) and Text Messages in people with Smokeless Tobacco Cessation, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smokeless Tobacco Cessation
- What is being tested?
- Scheduled Gradual Reduction (SGR) and Text Messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Nursing
Durham, North Carolina, 27710
About this study
Official title: 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.
Read the 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.
- Conditions
- Smokeless Tobacco Cessation
- Being tested
- Scheduled Gradual Reduction (SGR), Text Messages
- Keywords
- smokeless tobacco, text message, tobacco cessation, tobacco
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled Gradual Reduction (SGR)Behavioural
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 MessagesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Scheduled Gradual Reduction (SGR) | Experimental | Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages. Receives: Behavioral: Scheduled Gradual Reduction (SGR); Behavioral: Text Messages |
| Control Group | Active comparator | Subjects will receive SMS support text messages Receives: Behavioral: Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Return Text Messages sent in Response to SGR Intervention
Assessed via text history
Measured: 1 month
Proportion of Support Messages Read by Participants
Self-report
Measured: 1 month
Ratings of Usefulness of the Intervention Received
Ratings will be assessed via patient questionnaire.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionNov 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smokeless Tobacco CessationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Devon Noonan, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613689
- Sponsor's protocol ID
- Pro00063791
- Other IDs
- 1R15CA198841-01
- Status last verified
- Jan 2019
- First submitted
- 12 Nov 2015
- Last updated
- 16 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Tobacco Use Disparities Through an Innovative Mobile Phone Intervention: The Text to Forgo Smokeless Tobacco
- ClinicalTrials.gov ID
- NCT02613689
- Acronym / sponsor ID
- Pro00063791
- Conditions
- Smokeless Tobacco Cessation
- Keywords
- smokeless tobacco, text message, tobacco cessation, tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scheduled Gradual Reduction (SGR) | Experimental | Behavioral: Scheduled Gradual Reduction (SGR), Behavioral: Text MessagesSubjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages. |
| Control Group | Active comparator | Behavioral: Text MessagesSubjects will receive SMS support text messages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Scheduled Gradual Reduction (SGR) |
| Text MessagesParticipants 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. | Behavioural | Control Group, Scheduled Gradual Reduction (SGR) |
Primary outcome
Proportion of Return Text Messages sent in Response to SGR Intervention
Time frame: 1 month
Assessed via text history
Proportion of Support Messages Read by Participants
Time frame: 1 month
Self-report
Ratings of Usefulness of the Intervention Received
Time frame: 1 month
Ratings will be assessed via patient questionnaire.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Devon Noonan, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduled Gradual Reduction (SGR) and Text Messages in people with Smokeless Tobacco Cessation, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Return Text Messages sent in Response to SGR Intervention (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.