An interventional study of Scheduled Gradual Reduction (SGR) and Text Messages in Smokeless Tobacco Cessation, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-16.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will receive the Scheduled Gradual Reduction (SGR) intervention, as well as SMS support text messages.
Behavioral: Scheduled Gradual Reduction (SGR) · Behavioral: Text Messages
Subjects will receive SMS support text messages
Behavioral: Text Messages
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.
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.
Proportion of Return Text Messages sent in Response to SGR Intervention
Assessed via text history
Time frame: 1 month
Proportion of Support Messages Read by Participants
Self-report
Time frame: 1 month
Ratings of Usefulness of the Intervention Received
Ratings will be assessed via patient questionnaire.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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