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
  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

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
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
Criteria

Inclusion Criteria:

  • smoker

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
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. 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 April 17, 2014