"Quit Smoking on Your Own" Brief Online Study (TC-PAU-1)

September 27, 2016 updated by: Ricardo F. Muñoz, Ph.D., i4Health

Most individuals who smoke want to quit smoking. Most individuals who want to quit, quit on their own. The purpose of this study is to determine whether very brief suggestions provided online are comparatively more effective than others in increasing motivation to quit immediately after the suggestions are implemented and actual quit rates one month later.

There are no costs associated with participating in this study and participants will not be compensated for their participation.

To join the study paste the following link into your browser:

https://www.i4health-pau.org/quit-smoking-on-your-own

The entire study takes place online on an automated website.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will be recruited online using search engine ads (e.g., Google), online association list serves, community websites designed to reach individuals interested in participating in research studies, and social media sites related to smoking cessation efforts.

The entire study will be administered online. Participants may complete it at a time and place of their convenience.

To join the study paste the following link into your browser:

https://www.i4health-pau.org/quit-smoking-on-your-own

The website will automatically obtain consent, ask 16 brief questions as a pre-test, randomize to 4 very brief interventions, ask 4 post-test questions, and at 1-month follow-up, send an email with a link to a 6-question survey. The initial online session is expected to take between 3 and 8 minutes and the 1-month follow-up survey less than 2 minutes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
345

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto University i4Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (18 years of age or older)
  • Smoker who wants to quit
  • Access to the Internet

Exclusion Criteria:

  • Less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Condition #1
Condition #1 will consist of Brief Intervention #1, a brief online suggestion that takes less than 1 minute to complete.
Behavioral: Brief Intervention #1
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete.
Experimental: Condition #2
Condition #2 will consist of Brief Intervention #1 and Brief Intervention #2 that together take less than a minute to complete.
Behavioral: Brief Intervention #1
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete.
Behavioral: Brief Intervention #2
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete.
Experimental: Condition #3
Condition #3 will consist of Brief Intervention #1 and Brief Intervention #3, which, together, will take less than 8 minutes to complete.
Behavioral: Brief Intervention #1
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete.
Behavioral: Brief Intervention #3
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 7 minutes to complete.
Experimental: Condition #4
Condition #4 will consist of Brief Intervention #1, Brief Intervention #2, and Brief Intervention #3, which, together, will take less than 8 minutes to complete.
Behavioral: Brief Intervention #1
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete.
Behavioral: Brief Intervention #2
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete.
Behavioral: Brief Intervention #3
Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 7 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants who report quitting smoking
Time Frame: 1 month
Percentage of respondents who respond "no" to the question: "Have you smoked 1 or more cigarettes in the last 7 days?"
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Motivation to quit smoking
Time Frame: 10 minutes
Pre-post measure of motivation before and after the brief suggestions being tested are administered online. Specifically, response on a 0 to 10 scale (from "not at all" to "extremely") to the question "How motivated are you to stop smoking in the next 4 weeks?"
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
i4Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ricardo F Muñoz, Ph.D., Palo Alto University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TC-PAU-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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