Optimal TTM Tailoring for Population Cessation (STAR)

May 26, 2015 updated by: University of Rhode Island
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3006

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Kingston, Rhode Island, United States, 02881
        • University of Rhode Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • smoker

Exclusion Criteria:

  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking cessation (quit) rate
Time Frame: 24 months
Self-report point prevalence abstinence
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rhode Island

Investigators

  • Principal Investigator: Colleen A Redding, Ph.D., University of Rhode Island

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (ESTIMATE)

March 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DA023191-01A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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