Optimal TTM Tailoring for Population Cessation (STAR)
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Purpose
This study will explore optimal tailoring strategies for population tobacco cessation in 4 treatment groups and a control group over 24 months. Transtheoretical model (TTM) tailored feedback on all 14 variables has been found to be a robust population cessation strategy across studies. This proposal seeks to find a subset of these variables that is optimal for tailoring, both minimizing response burden while maximizing effectiveness. Addiction variables have been demonstrated to predict smoking outcomes across studies as well, so we will integrate tailored feedback using TTM and addiction variables into an enhanced tailoring group. Optimally tailored feedback that both helps unmotivated smokers reduce their addiction and helps motivated smokers quit could lead to a breakthrough in population cessation.
| Condition | Intervention |
|---|---|
|
Smoking Cessation |
Behavioral: Minimal Tailoring (stage only) Behavioral: Moderate tailoring (Stage, Pros, Cons, Efficacy) Behavioral: Full TTM tailoring (all TTM constructs) Behavioral: Enhanced TTM tailoring (Full TTM + Addiction) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Optimal TTM Tailoring for Population Cessation |
- Smoking cessation (quit) rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]Self-report point prevalence abstinence
| Enrollment: | 3006 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: assessment only control group
Assessment at baseline, 12, and 24 months
|
|
|
Experimental: Minimal tailoring (stage only);
This group will receive stage-targeted feedback at Baseline, 6, and 12 months, in addition to a stage-targeted manual at baseline. Outcomes will be assessed at 24 months.
|
Behavioral: Minimal Tailoring (stage only)
Tailored print feedback report based on Stage of change only. Three feedback reports were delivered at baseline, 6 months and 12 months and one stage-targeted manual was delivered at baseline.
|
|
Experimental: Moderate tailoring (stage, pros+cons, efficacy);
This group will receive stage-targeted and tailored feedback based on decisional balance and temptations at Baseline, 6, and 12 months, in addition to a stage-targeted manual at baseline. Outcomes will be assessed at 24 months.
|
Behavioral: Moderate tailoring (Stage, Pros, Cons, Efficacy)
Tailored print feedback report based on Stages, Pros, Cons, and Temptations. Three feedback reports were delivered at baseline, 6 months and 12 months and one stage-targeted manual was delivered at baseline.
|
|
Experimental: Full TTM tailoring (all TTM constructs)
This group will receive stage-targeted and tailored feedback based on decisional balance (pros + cons), temptations and (ten) processes of change at Baseline, 6, and 12 months, in addition to a stage-targeted manual at baseline. Outcomes will be assessed at 24 months.
|
Behavioral: Full TTM tailoring (all TTM constructs)
Tailored print feedback report based on Stages, Pros, Cons, Temptations, 10 Processes of Change. Three feedback reports were delivered at baseline, 6 months and 12 months and one stage-targeted manual was delivered at baseline.
|
|
Experimental: Enhanced TTM tailoring + addiction variables
This group will receive stage-targeted and tailored feedback materials based on addiction level (# cigarettes/day), decisional balance (pros + cons), efficacy and (ten) processes of change at Baseline, 6, and 12 months, in addition to a stage-targeted manual at baseline. Outcomes will be assessed at 24 months.
|
Behavioral: Enhanced TTM tailoring (Full TTM + Addiction)
Tailored print feedback report based on Addiction Level(# cigarettes/day),Stages, Pros, Cons, Temptations, 10 Processes of Change. Three feedback reports were delivered at baseline, 6 months and 12 months and one stage-targeted manual was delivered at baseline.
|
Detailed Description:
Smoking remains one of the biggest causes of premature morbidity and mortality. Nicotine addiction continues to challenge researchers to optimize their best interventions, and these challenges increase with efforts to integrate smoking cessation into multiple behavior change research and dissemination. Tailored intervention strategies have demonstrated effectiveness, yet much research remains to be done exploring optimal tailoring strategies. Transtheoretical model (TTM) tailored feedback on all 14 variables has been demonstrated to be a robust population cessation strategy across studies, producing 22-25% quit rates at 18-24 month final timepoints. This proposal seeks to find a subset of these variables that is optimal for tailoring, both minimizing response burden while maximizing effectiveness. Addiction variables have been demonstrated to predict smoking outcomes across studies as well, so we will integrate tailored feedback using TTM and addiction variables into an enhanced tailoring group. Enhanced addiction tailored feedback that both helps unmotivated smokers reduce their addiction and helps motivated smokers quit could lead to a breakthrough in population cessation. This proposal tests four types of TTM-tailoring for smoking cessation in an additive design: no treatment control group; Minimal tailoring (stage only); Moderate tailoring (stage, pros, cons, efficacy); Full TTM tailoring (all 14 TTM variables); and Enhanced TTM tailoring plus addiction variables. Smokers will be randomized to one of five treatment groups and evaluated at baseline, 6 months, 12 months, and 24 months. Treatment groups will receive tailored feedback at baseline, 6 months, and 12 months. Analyses will compare treatment groups on quit rates at the final timepoint to see how effectively each treatment helps smokers to quit. A series of mediation and moderation analyses will examine how each treatment works. This study has the potential to find an optimal tailoring strategy for population cessation that could accelerate future multiple behavior change research and dissemination efforts.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- smoker
Exclusion Criteria:
- pregnancy
Contacts and Locations| United States, Rhode Island | |
| University of Rhode Island | |
| Kingston, Rhode Island, United States, 02881 | |
| Principal Investigator: | Colleen A Redding, Ph.D. | Univeristy of Rhode Island |
More Information
No publications provided
| Responsible Party: | University of Rhode Island |
| ClinicalTrials.gov Identifier: | NCT01544010 History of Changes |
| Other Study ID Numbers: | DA023191-01A1 |
| Study First Received: | February 28, 2012 |
| Last Updated: | February 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Rhode Island:
|
Transtheoretical Model Tailored Print Intervention Population-based Behavioral Intervention |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 23, 2013