Optimal TTM Tailoring for Population Cessation (STAR)

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
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	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	3006 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Optimal TTM Tailoring for Population Cessation
Study Start Date :	February 2009
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	June 2012

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. Smoking cessation (quit) rate [ Time Frame: 24 months ]
   Self-report point prevalence abstinence

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• smoker

Exclusion Criteria:

• pregnancy

Contacts and Locations

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	March 5, 2012
Last Update Posted:	May 27, 2015
Last Verified:	May 2015

Keywords provided by University of Rhode Island:

Transtheoretical Model; Tailored Print Intervention; Population-based; Behavioral Intervention