Optimal TTM Tailoring for Population Cessation (STAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01544010
First received: February 28, 2012
Last updated: May 26, 2015
Last verified: May 2015

February 28, 2012
May 26, 2015
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
Complete list of historical versions of study NCT01544010 on ClinicalTrials.gov Archive Site
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Optimal TTM Tailoring for Population Cessation
Optimal TTM Tailoring for Population Cessation
This study explored 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 sought 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 sought 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: assessment-only 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
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Smoking Cessation
  • Behavioral: Stage-Tailored Manual
    Manual with 5 sections for each Stage of change delivered at baseline
    Other Names:
    • Stage-based Manual
    • Stage-targeted self help manual
  • 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.
  • No Intervention: assessment only control group
    Assessment at baseline, 12, and 24 months
  • 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.
    Interventions:
    • Behavioral: Stage-Tailored Manual
    • Behavioral: Stage Tailored Feedback Report
  • 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.
    Interventions:
    • Behavioral: Stage-Tailored Manual
    • Behavioral: Stage Tailored Feedback Report
    • Behavioral: Moderate TTM-Tailored Feedback Report
  • 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.
    Interventions:
    • Behavioral: Stage-Tailored Manual
    • Behavioral: Stage Tailored Feedback Report
    • Behavioral: Moderate TTM-Tailored Feedback Report
    • Behavioral: Full TTM-Tailored Feedback Report
  • 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.
    Interventions:
    • 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
Redding CA, Prochaska JO, Rossi JS, Kobayashi H, Yin HQ, Paiva AL, Velicer WF, Blaney C, Diamond E, Cottrill S. (2014). Levels of Transtheoretical Model Tailoring for Cessation: Randomized Trial Outcomes. Annals of Behavioral Medicine, 47, S238.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3006
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • smoker

Exclusion Criteria:

  • pregnancy
Both
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01544010
DA023191-01A1
Yes
Not Provided
Not Provided
University of Rhode Island
University of Rhode Island
Not Provided
Principal Investigator: Colleen A Redding, Ph.D. University of Rhode Island
University of Rhode Island
May 2015

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