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

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: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Message Intensity; Behavioral: Dynamic Tailoring; Behavioral: Integration; Behavioral: Personalization; Behavioral: Optimal-Adherence Text

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: Interventional
• Enrollment (Actual): 1485
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

18

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Phase I - Composite adherence metric	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	Self-reported 30-day point prevalence abstinence at 9 months post randomization	9 months post randomization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Truth Initiative

Publications and helpful links

General Publications

• Graham AL, Jacobs MA, Cohn AM, Cha S, Abroms LC, Papandonatos GD, Whittaker R. Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. BMJ Open. 2016 Mar 30;6(3):e010687. doi: 10.1136/bmjopen-2015-010687.
• Graham AL, Papandonatos GD, Cha S, Amato MS, Jacobs MA, Cohn AM, Abroms LC, Whittaker R. Effectiveness of an optimized text message and Internet intervention for smoking cessation: A randomized controlled trial. Addiction. 2022 Apr;117(4):1035-1046. doi: 10.1111/add.15677. Epub 2021 Sep 28.
• Graham AL, Papandonatos GD, Jacobs MA, Amato MS, Cha S, Cohn AM, Abroms LC, Whittaker R. Optimizing Text Messages to Promote Engagement With Internet Smoking Cessation Treatment: Results From a Factorial Screening Experiment. J Med Internet Res. 2020 Apr 2;22(4):e17734. doi: 10.2196/17734. Erratum In: J Med Internet Res. 2020 Jul 28;22(7):e21027.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Tobacco Use; Internet; Mobile Phone; Text Messaging
• Other Study ID 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