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
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal TTM Tailoring for Population Cessation

Resource links provided by NLM:


Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • 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
Study Completion Date: June 2012
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
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.
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
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:
  • 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.
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:
  • 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.
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:
  • 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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • smoker

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544010

Locations
United States, Rhode Island
University of Rhode Island
Kingston, Rhode Island, United States, 02881
Sponsors and Collaborators
University of Rhode Island
Investigators
Principal Investigator: Colleen A Redding, Ph.D. University of Rhode Island
  More Information

Publications:
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.

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: May 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rhode Island:
Transtheoretical Model
Tailored Print Intervention
Population-based
Behavioral Intervention

ClinicalTrials.gov processed this record on July 29, 2015