Optimal TTM Tailoring for Population Cessation (STAR)
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ClinicalTrials.gov Identifier: NCT01544010 |
Recruitment Status
:
Completed
First Posted
: March 5, 2012
Last Update Posted
: May 27, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Cessation | Behavioral: Stage-Tailored Manual Behavioral: Stage Tailored Feedback Report Behavioral: Moderate TTM-Tailored Feedback Report Behavioral: Full TTM-Tailored Feedback Report Behavioral: Enhanced TTM+Addiction Tailored Feedback Report | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3006 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Optimal TTM Tailoring for Population Cessation |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
No Intervention: assessment only control group
Assessment at baseline, 12, and 24 months
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Active Comparator: Minimal Stage Tailoring
This group will receive a Stage-Tailored Manual at baseline. It will also get Stage Tailored Feedback Reports based on assessments at Baseline, 6, and 12 months. Outcomes will be assessed at 24 months.
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Behavioral: Stage-Tailored Manual
Manual with 5 sections for each Stage of change delivered at baseline
Other Names:
Behavioral: Stage Tailored Feedback Report
Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.
Other Name: Stage Targeted Feedback Report
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Active Comparator: Moderate TTM Tailoring
This group will receive a Stage-Tailored Manual at baseline. It will also get Moderate TTM-Tailored Feedback Reports, that is, integrated tailored feedback reports based on assessments of stage of change, decisional balance and temptations at Baseline, 6, and 12 months. Outcomes will be assessed at 24 months.
|
Behavioral: Stage-Tailored Manual
Manual with 5 sections for each Stage of change delivered at baseline
Other Names:
Behavioral: Stage Tailored Feedback Report
Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.
Other Name: Stage Targeted Feedback Report
Behavioral: Moderate TTM-Tailored Feedback Report
Tailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months.
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Active Comparator: Full TTM tailoring
This group will receive a Stage-Tailored Manual at baseline. It will also get Full TTM-Tailored Feedback Reports, that is, integrated tailored feedback reports based on assessments of stage of change, decisional balance (pros + cons), temptations and (ten) processes of change at Baseline, 6, and 12 months. Outcomes will be assessed at 24 months.
|
Behavioral: Stage-Tailored Manual
Manual with 5 sections for each Stage of change delivered at baseline
Other Names:
Behavioral: Stage Tailored Feedback Report
Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.
Other Name: Stage Targeted Feedback Report
Behavioral: Moderate TTM-Tailored Feedback Report
Tailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months.
Behavioral: Full TTM-Tailored Feedback Report
Tailored print feedback report based on assessment of Stages, Pros, Cons, Temptations, 10 Processes of Change were delivered at baseline, 6 months and 12 months.
|
Active Comparator: Enhanced TTM+Addiction Tailoring
This group will receive a Stage-Tailored Manual at baseline. It will also get Enhanced TTM+Addiction Tailored Feedback Reports, that is, integrated tailored feedback reports based on assessments of addiction levels (# cigarettes/day) stage of change, decisional balance (pros + cons), temptations and (ten) processes of change at Baseline, 6, and 12 months. Outcomes will be assessed at 24 months.
|
Behavioral: Stage-Tailored Manual
Manual with 5 sections for each Stage of change delivered at baseline
Other Names:
Behavioral: Stage Tailored Feedback Report
Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.
Other Name: Stage Targeted Feedback Report
Behavioral: Moderate TTM-Tailored Feedback Report
Tailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months.
Behavioral: Full TTM-Tailored Feedback Report
Tailored print feedback report based on assessment of Stages, Pros, Cons, Temptations, 10 Processes of Change were delivered at baseline, 6 months and 12 months.
Behavioral: Enhanced TTM+Addiction Tailored Feedback Report
Tailored print feedback report based on assessment of Addiction level (# cigarettes/day),Stages, Pros, Cons, Temptations, 10 Processes of Change were delivered at baseline, 6 months and 12 months.
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- Smoking cessation (quit) rate [ Time Frame: 24 months ]Self-report point prevalence abstinence

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- smoker
Exclusion Criteria:
- pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544010
United States, Rhode Island | |
University of Rhode Island | |
Kingston, Rhode Island, United States, 02881 |
Principal Investigator: | Colleen A Redding, Ph.D. | University of Rhode Island |
Publications:
Responsible Party: | University of Rhode Island |
ClinicalTrials.gov Identifier: | NCT01544010 History of Changes |
Other Study ID Numbers: |
DA023191-01A1 |
First Posted: | March 5, 2012 Key Record Dates |
Last Update Posted: | May 27, 2015 |
Last Verified: | May 2015 |
Keywords provided by University of Rhode Island:
Transtheoretical Model Tailored Print Intervention Population-based Behavioral Intervention |