Optimal TTM Tailoring for Population Cessation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3006 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Population Cessation Services

NCT01566994

Cancer

COMPLETED NA

Incentives for Participation Versus Outcomes

NCT01826331

Smoking

WITHDRAWN NA

Working Inside for Smoking Elimination

NCT01122589

Cigarette Smoking Tobacco Smoking

UNKNOWN NA

Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit

NCT02905656

Smoking Cessation

COMPLETED NA

Motivation and Skills for Detained Teen Smokers

NCT01387516

Motivational Intervention Nicotine Anonymous Cognitive Behavior Therapy +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

assessment only control group

Assessment at baseline, 12, and 24 months

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Stage-Tailored Manual

Intervention Type BEHAVIORAL

Manual with 5 sections for each Stage of change delivered at baseline

Stage Tailored Feedback Report

Intervention Type BEHAVIORAL

Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.

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.

Group Type ACTIVE_COMPARATOR

Stage-Tailored Manual

Intervention Type BEHAVIORAL

Manual with 5 sections for each Stage of change delivered at baseline

Stage Tailored Feedback Report

Intervention Type BEHAVIORAL

Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.

Moderate TTM-Tailored Feedback Report

Intervention Type BEHAVIORAL

Tailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months.

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.

Group Type ACTIVE_COMPARATOR

Stage-Tailored Manual

Intervention Type BEHAVIORAL

Manual with 5 sections for each Stage of change delivered at baseline

Stage Tailored Feedback Report

Intervention Type BEHAVIORAL

Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.

Moderate TTM-Tailored Feedback Report

Intervention Type BEHAVIORAL

Tailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months.

Full TTM-Tailored Feedback Report

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Stage-Tailored Manual

Intervention Type BEHAVIORAL

Manual with 5 sections for each Stage of change delivered at baseline

Stage Tailored Feedback Report

Intervention Type BEHAVIORAL

Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.

Moderate TTM-Tailored Feedback Report

Intervention Type BEHAVIORAL

Tailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months.

Full TTM-Tailored Feedback Report

Intervention Type BEHAVIORAL

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.

Enhanced TTM+Addiction Tailored Feedback Report

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stage-Tailored Manual

Manual with 5 sections for each Stage of change delivered at baseline

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL