Optimal TTM Tailoring for Population Cessation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimal TTM Tailoring for Population Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smoker Exclusion Criteria: pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: assessment only control group<br>Assessment at baseline, 12, and 24 months | |
| Active Comparator: Minimal Stage Tailoring<br>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<br>* Manual with 5 sections for each Stage of change delivered at baseline<br>* Other names: Stage-targeted self help manual;Behavioral: Stage Tailored Feedback Report<br>* Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.<br>* Other names: Stage Targeted Feedback Report;|
| Active Comparator: Moderate TTM Tailoring<br>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<br>* Manual with 5 sections for each Stage of change delivered at baseline<br>* Other names: Stage-targeted self help manual;Behavioral: Stage Tailored Feedback Report<br>* Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.<br>* Other names: Stage Targeted Feedback Report;Behavioral: Moderate TTM-Tailored Feedback Report<br>* Tailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months.<br>|
| Active Comparator: Full TTM tailoring<br>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<br>* Manual with 5 sections for each Stage of change delivered at baseline<br>* Other names: Stage-targeted self help manual;Behavioral: Stage Tailored Feedback Report<br>* Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.<br>* Other names: Stage Targeted Feedback Report;Behavioral: Moderate TTM-Tailored Feedback Report<br>* Tailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months.<br>Behavioral: Full TTM-Tailored Feedback Report<br>* 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.<br>|
| Active Comparator: Enhanced TTM+Addiction Tailoring<br>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<br>* Manual with 5 sections for each Stage of change delivered at baseline<br>* Other names: Stage-targeted self help manual;Behavioral: Stage Tailored Feedback Report<br>* Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.<br>* Other names: Stage Targeted Feedback Report;Behavioral: Moderate TTM-Tailored Feedback Report<br>* Tailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months.<br>Behavioral: Full TTM-Tailored Feedback Report<br>* 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.<br>Behavioral: Enhanced TTM+Addiction Tailored Feedback Report<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Population-based, Behavioral Intervention, Transtheoretical Model, Tailored Print Intervention