Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment

February 12, 2021 updated by: Amanda L. Graham, PhD, Truth Initiative
This study is comprised of 2 phases to study the impact of a text message system on overall adherence to a web-based smoking cessation program. Phase I uses a full factorial design to identify the most optimal text message intervention to maximize adherence to the BecomeAnEX.org smoking cessation program. Phase II is a randomized controlled trial that compares regular BecomeAnEX users to those who will receive the optimized text message intervention (from Phase I) in conjunction with BecomeAnEX for impact on long-term abstinence.

Study Overview

Status

Status

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

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

This study is comprised of 2 active phases, all conducted with registered users on BecomeAnEX.org, a well-established smoking cessation website.

Phase I involves the initial development and optimization of the text message intervention. The investigators will examine the impact of 4 experimental text message intervention features on smokers' adherence to a web-based cessation intervention during the first 3 months of program enrollment. The investigators will utilize a full factorial design where participants will be randomized to 1 of 2 levels of each of the following features: 1) personalization (yes/no), 2) integration (yes/no), 3) dynamic tailoring (yes/no), and 4) message intensity (standard vs. decreasing). The primary outcome in Phase I will be a composite metric of utilization.

Phase II involves a 2-arm randomized trial that compares WEB alone to WEB plus the text message intervention from Phase I that yields optimal adherence (WEB+OA_TXT). The randomized trial will use a repeated measures design, with assessments at baseline, 3, 9, and 15 months. Follow-ups at 3, 9, and 15 months correspond to 0, 6, and 12 months post-treatment. The primary outcome is 30-day point prevalence abstinence (ppa) at 9-months. The investigators will assess and validate smoking status at all follow-ups. Other outcomes include motivation to quit, quit attempts, and continuous abstinence.

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.
1485

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
    • District of Columbia
      • Washington, District of Columbia, United States, 20001
        • Truth Initiative

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:

  • US residency
  • Current smoker
  • Access to and willingness to receive text messages on a mobile phone
  • Access to Internet
  • Access to and willingness to receive email communication from study personnel

Exclusion Criteria:

  • None

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

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.
No Intervention: Arm 1

All 4 factors off - standard text message program

Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity OFF
Active Comparator: Arm 2
Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity ON
Behavioral: Message Intensity

Phase I Factor

Varying levels of text message intensity over a 12-week period.
Active Comparator: Arm 3
Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity OFF
Behavioral: Dynamic Tailoring
Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.
Active Comparator: Arm 4
Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity ON
Behavioral: Message Intensity

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Behavioral: Dynamic Tailoring
Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.
Active Comparator: Arm 5
Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity OFF
Behavioral: Integration

Phase I Factor

Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention:

Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community

Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.
Active Comparator: Arm 6
Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity ON
Behavioral: Message Intensity

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Behavioral: Integration

Phase I Factor

Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention:

Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community

Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.
Active Comparator: Arm 7
Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity OFF
Behavioral: Dynamic Tailoring
Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.
Behavioral: Integration

Phase I Factor

Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention:

Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community

Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.
Active Comparator: Arm 8
Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity ON
Behavioral: Message Intensity

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Behavioral: Dynamic Tailoring
Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.
Behavioral: Integration

Phase I Factor

Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention:

Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community

Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.
Active Comparator: Arm 9
Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity OFF
Behavioral: Personalization

Phase I Factor

Personalized text messages using the participant's username and gender ("Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!"). Both data points will be pulled from BecomeAnEX registration data.
Active Comparator: Arm 10
Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity ON
Behavioral: Message Intensity

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Behavioral: Personalization

Phase I Factor

Personalized text messages using the participant's username and gender ("Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!"). Both data points will be pulled from BecomeAnEX registration data.
Active Comparator: Arm 11
Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity OFF
Behavioral: Dynamic Tailoring
Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.
Behavioral: Personalization

Phase I Factor

Personalized text messages using the participant's username and gender ("Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!"). Both data points will be pulled from BecomeAnEX registration data.
Active Comparator: Arm 12
Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity ON
Behavioral: Message Intensity

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Behavioral: Dynamic Tailoring
Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.
Behavioral: Personalization

Phase I Factor

Personalized text messages using the participant's username and gender ("Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!"). Both data points will be pulled from BecomeAnEX registration data.
Active Comparator: Arm 13
Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity OFF
Behavioral: Integration

Phase I Factor

Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention:

Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community

Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.

Behavioral: Personalization

Phase I Factor

Personalized text messages using the participant's username and gender ("Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!"). Both data points will be pulled from BecomeAnEX registration data.
Active Comparator: Arm 14
Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity ON
Behavioral: Message Intensity

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Behavioral: Integration

Phase I Factor

Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention:

Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community

Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.

Behavioral: Personalization

Phase I Factor

Personalized text messages using the participant's username and gender ("Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!"). Both data points will be pulled from BecomeAnEX registration data.
Active Comparator: Arm 15
Personalization ON Integration ON Dynamic Tailoring ON Message Intensity OFF
Behavioral: Dynamic Tailoring
Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.
Behavioral: Integration

Phase I Factor

Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention:

Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community

Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.

Behavioral: Personalization

Phase I Factor

Personalized text messages using the participant's username and gender ("Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!"). Both data points will be pulled from BecomeAnEX registration data.
Active Comparator: Arm 16
Personalization ON Integration ON Dynamic Tailoring ON Message Intensity ON
Behavioral: Message Intensity

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Behavioral: Dynamic Tailoring
Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.
Behavioral: Integration

Phase I Factor

Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention:

Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community

Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online.

Behavioral: Personalization

Phase I Factor

Personalized text messages using the participant's username and gender ("Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!"). Both data points will be pulled from BecomeAnEX registration data.
No Intervention: WEB

Phase II arm.

Full access to standard BecomeAnEX.org web-based smoking cessation program.
Active Comparator: WEB+OA_TXT

Phase II arm.

Full access to standard BecomeAnEX.org web-based smoking cessation program PLUS optimal-adherence text message program from Phase I.
Behavioral: Optimal-Adherence Text
Optimal-adherence text message intervention developed in Phase I
Other Names:
  • OA_TXT

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
Phase I - Composite adherence metric
Time Frame: 3 months
The investigators will create a composite metric of adherence for each Phase I participant using a weighted sum of their total number of number of visits, as well as of their page views, time on site, and use of the 6 interactive components of the site per visit during 3 months post-enrollment.
3 months
Phase II - 30-day point prevalence abstinence
Time Frame: 9 months post randomization
Self-reported 30-day point prevalence abstinence at 9 months post randomization
9 months post randomization

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
Phase II - 30day point prevalence abstinence
Time Frame: 3 months post randomization
Self-reported 30-day point prevalence abstinence at 3 months post randomization
3 months post randomization
Phase II - 30day point prevalence abstinence
Time Frame: 15 months post randomization
Self-reported 30-day point prevalence abstinence at 15 months post randomization
15 months post randomization

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.
Truth Initiative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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 29, 2018

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.
December 19, 2019

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.
July 10, 2020

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).
October 22, 2015

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.
October 22, 2015

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.
October 23, 2015

Study Record Updates

Last Update Posted (Actual)

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.
February 16, 2021

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.
February 12, 2021

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.
February 1, 2021

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.
  • 1R01DA038139 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Smoking Cessation

Clinical Trials on Message Intensity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings