NCT01544010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,006

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

3.3 years

First QC Date

February 28, 2012

Last Update Submit

May 26, 2015

Conditions

Keywords

Transtheoretical ModelTailored Print InterventionPopulation-basedBehavioral Intervention

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation (quit) rate

    Self-report point prevalence abstinence

    24 months

Study Arms (5)

assessment only control group

NO INTERVENTION

Assessment at baseline, 12, and 24 months

Minimal Stage Tailoring

ACTIVE COMPARATOR

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 ManualBehavioral: Stage Tailored Feedback Report

Moderate TTM Tailoring

ACTIVE COMPARATOR

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 ManualBehavioral: Stage Tailored Feedback ReportBehavioral: Moderate TTM-Tailored Feedback Report

Full TTM tailoring

ACTIVE COMPARATOR

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 ManualBehavioral: Stage Tailored Feedback ReportBehavioral: Moderate TTM-Tailored Feedback ReportBehavioral: Full TTM-Tailored Feedback Report

Enhanced TTM+Addiction Tailoring

ACTIVE COMPARATOR

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 ManualBehavioral: Stage Tailored Feedback ReportBehavioral: Moderate TTM-Tailored Feedback ReportBehavioral: Full TTM-Tailored Feedback ReportBehavioral: Enhanced TTM+Addiction Tailored Feedback Report

Interventions

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

Also known as: Stage-based Manual, Stage-targeted self help manual
Enhanced TTM+Addiction TailoringFull TTM tailoringMinimal Stage TailoringModerate TTM Tailoring

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

Also known as: Stage Targeted Feedback Report
Enhanced TTM+Addiction TailoringFull TTM tailoringMinimal Stage TailoringModerate TTM Tailoring

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

Enhanced TTM+Addiction TailoringFull TTM tailoringModerate TTM Tailoring

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 TailoringFull TTM tailoring

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.

Enhanced TTM+Addiction Tailoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • smoker

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Colleen A Redding, Ph.D.

    University of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 5, 2012

Study Start

February 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations