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Optimal TTM Tailoring for Population Cessation (STAR)

U

University of Rhode Island

Status

Completed

Conditions

Smoking Cessation

Treatments

Behavioral: Enhanced TTM+Addiction Tailored Feedback Report
Behavioral: Moderate TTM-Tailored Feedback Report
Behavioral: Stage-Tailored Manual
Behavioral: Stage Tailored Feedback Report
Behavioral: Full TTM-Tailored Feedback Report

Study type

Interventional

Funder types

Other

Identifiers

NCT01544010
DA023191-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment

3,006 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • smoker

Exclusion criteria

  • pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

3,006 participants in 5 patient groups

assessment only control group
No Intervention group
Description:
Assessment at baseline, 12, and 24 months
Minimal Stage Tailoring
Active Comparator group
Description:
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.
Treatment:
Behavioral: Stage Tailored Feedback Report
Behavioral: Stage-Tailored Manual
Moderate TTM Tailoring
Active Comparator group
Description:
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.
Treatment:
Behavioral: Stage Tailored Feedback Report
Behavioral: Stage-Tailored Manual
Behavioral: Moderate TTM-Tailored Feedback Report
Full TTM tailoring
Active Comparator group
Description:
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.
Treatment:
Behavioral: Stage Tailored Feedback Report
Behavioral: Stage-Tailored Manual
Behavioral: Moderate TTM-Tailored Feedback Report
Behavioral: Full TTM-Tailored Feedback Report
Enhanced TTM+Addiction Tailoring
Active Comparator group
Description:
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.
Treatment:
Behavioral: Stage Tailored Feedback Report
Behavioral: Stage-Tailored Manual
Behavioral: Enhanced TTM+Addiction Tailored Feedback Report
Behavioral: Moderate TTM-Tailored Feedback Report
Behavioral: Full TTM-Tailored Feedback Report

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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