Smoking CessationSTARNCT01544010
Optimal TTM Tailoring for Population Cessation
A study testing Stage-Tailored Manual, Stage Tailored Feedback Report and Moderate TTM-Tailored Feedback Report in people with Smoking Cessation, run by University of Rhode Island at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Stage-Tailored Manual, Stage Tailored Feedback Report and Moderate TTM-Tailored Feedback Report
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,006 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- smoker
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rhode Island
Kingston, Rhode Island, 02881
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Stage-Tailored Manual, Stage Tailored Feedback Report, Moderate TTM-Tailored Feedback Report, Full TTM-Tailored Feedback Report, Enhanced TTM+Addiction Tailored Feedback Report
- Keywords
- Transtheoretical Model, Tailored Print Intervention, Population-based, Behavioral Intervention
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stage-Tailored ManualBehavioural
Also called Stage-based Manual, Stage-targeted self help manual
Manual with 5 sections for each Stage of change delivered at baseline
Stage Tailored Feedback ReportBehavioural
Also called Stage Targeted Feedback Report
Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.
Moderate TTM-Tailored Feedback ReportBehavioural
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 ReportBehavioural
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 ReportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Stage-Tailored Manual; Behavioral: 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. Receives: Behavioral: Stage-Tailored Manual; Behavioral: Stage Tailored Feedback Report; Behavioral: 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. Receives: Behavioral: Stage-Tailored Manual; Behavioral: Stage Tailored Feedback Report; Behavioral: Moderate TTM-Tailored Feedback Report; Behavioral: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking cessation (quit) rate
Self-report point prevalence abstinence
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startFeb 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colleen A Redding, Ph.D., Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544010
- Sponsor's protocol ID
- DA023191-01A1
- Acronym
- STAR
- Status last verified
- May 2015
- First submitted
- 28 Feb 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal TTM Tailoring for Population Cessation
- ClinicalTrials.gov ID
- NCT01544010
- Acronym / sponsor ID
- STAR / DA023191-01A1
- Conditions
- Smoking Cessation
- Keywords
- Transtheoretical Model, Tailored Print Intervention, Population-based, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,006 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| assessment only control group | No intervention | –Assessment at baseline, 12, and 24 months |
| Minimal Stage Tailoring | Active comparator | Behavioral: Stage-Tailored Manual, Behavioral: Stage Tailored Feedback ReportThis 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. |
| Moderate TTM Tailoring | Active comparator | Behavioral: Stage-Tailored Manual, Behavioral: Stage Tailored Feedback Report, Behavioral: Moderate TTM-Tailored Feedback ReportThis 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. |
| Full TTM tailoring | Active comparator | Behavioral: Stage-Tailored Manual, Behavioral: Stage Tailored Feedback Report, Behavioral: Moderate TTM-Tailored Feedback Report, Behavioral: Full TTM-Tailored Feedback ReportThis 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. |
| Enhanced TTM+Addiction Tailoring | Active comparator | 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 ReportThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- smoker
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stage-Tailored ManualAlso: Stage-based Manual, Stage-targeted self help manualManual with 5 sections for each Stage of change delivered at baseline | Behavioural | Enhanced TTM+Addiction Tailoring, Full TTM tailoring, Minimal Stage Tailoring, Moderate TTM Tailoring |
| Stage Tailored Feedback ReportAlso: Stage Targeted Feedback ReportTailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months. | Behavioural | Enhanced TTM+Addiction Tailoring, Full TTM tailoring, Minimal Stage Tailoring, Moderate TTM Tailoring |
| Moderate TTM-Tailored Feedback ReportTailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months. | Behavioural | Enhanced TTM+Addiction Tailoring, Full TTM tailoring, Moderate TTM Tailoring |
| Full TTM-Tailored Feedback ReportTailored print feedback report based on assessment of Stages, Pros, Cons, Temptations, 10 Processes of Change were delivered at baseline, 6 months and 12 months. | Behavioural | Enhanced TTM+Addiction Tailoring, Full TTM tailoring |
| Enhanced TTM+Addiction Tailored Feedback ReportTailored 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. | Behavioural | Enhanced TTM+Addiction Tailoring |
Primary outcome
Smoking cessation (quit) rate
Time frame: 24 months
Self-report point prevalence abstinence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- BackgroundRedding 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.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen A Redding, Ph.D. principal investigator
University of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stage-Tailored Manual, Stage Tailored Feedback Report and Moderate TTM-Tailored Feedback Report in people with Smoking Cessation, run by University of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking cessation (quit) rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.