Optimal TTM Tailoring for Population Cessation (STAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Rhode Island.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01544010
First received: February 28, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted

February 28, 2012
February 28, 2012
February 2009
June 2012   (final data collection date for primary outcome measure)
Smoking cessation (quit) rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Self-report point prevalence abstinence
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Optimal TTM Tailoring for Population Cessation
Optimal TTM Tailoring for Population Cessation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Smoking Cessation
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Minimal Tailoring (stage only)
  • 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.
    Intervention: Behavioral: Moderate tailoring (Stage, Pros, Cons, Efficacy)
  • 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.
    Intervention: Behavioral: Full TTM tailoring (all TTM constructs)
  • 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.
    Intervention: Behavioral: Enhanced TTM tailoring (Full TTM + Addiction)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3006
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • smoker

Exclusion Criteria:

  • pregnancy
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01544010
DA023191-01A1
Yes
University of Rhode Island
University of Rhode Island
Not Provided
Principal Investigator: Colleen A Redding, Ph.D. Univeristy of Rhode Island
University of Rhode Island
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP