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

Sponsor
Truth Initiative (Other)
Overall Status
Completed
CT.gov ID
NCT02585206
Collaborator
(none)
1,485
1
18
27.4
54.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Personalization
  • Behavioral: Integration
  • Behavioral: Dynamic Tailoring
  • Behavioral: Message Intensity
  • Behavioral: Optimal-Adherence Text
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1485 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Phase I: full factorial design of four factors each with 2 levels (16 arms); Phase II: 2-arm randomized trialPhase I: full factorial design of four factors each with 2 levels (16 arms); Phase II: 2-arm randomized trial
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment
Actual Study Start Date :
Mar 29, 2018
Actual Primary Completion Date :
Dec 19, 2019
Actual Study Completion Date :
Jul 10, 2020

Arms and Interventions

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: 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: Message Intensity
Phase I Factor Varying levels of text message intensity over a 12-week period.

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: 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: Message Intensity
Phase I Factor Varying levels of text message intensity over a 12-week period.

Active Comparator: Arm 7

Personalization OFF Integration ON Dynamic Tailoring ON 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: 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 8

Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity ON

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: 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: Message Intensity
Phase I Factor Varying levels of text message intensity over a 12-week period.

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: 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.

Behavioral: Message Intensity
Phase I Factor Varying levels of text message intensity over a 12-week period.

Active Comparator: Arm 11

Personalization ON Integration OFF Dynamic Tailoring ON 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.

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 12

Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity ON

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.

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: Message Intensity
Phase I Factor Varying levels of text message intensity over a 12-week period.

Active Comparator: Arm 13

Personalization ON Integration ON 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.

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 14

Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity ON

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.

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: Message Intensity
Phase I Factor Varying levels of text message intensity over a 12-week period.

Active Comparator: Arm 15

Personalization ON Integration ON Dynamic Tailoring ON 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.

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: 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 16

Personalization ON Integration ON Dynamic Tailoring ON Message Intensity ON

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.

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: 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: Message Intensity
Phase I Factor Varying levels of text message intensity over a 12-week period.

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
  • Outcome Measures

    Primary Outcome Measures

    1. Phase I - Composite adherence metric [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.

    2. Phase II - 30-day point prevalence abstinence [9 months post randomization]

      Self-reported 30-day point prevalence abstinence at 9 months post randomization

    Secondary Outcome Measures

    1. Phase II - 30day point prevalence abstinence [3 months post randomization]

      Self-reported 30-day point prevalence abstinence at 3 months post randomization

    2. Phase II - 30day point prevalence abstinence [15 months post randomization]

      Self-reported 30-day point prevalence abstinence at 15 months post randomization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Truth Initiative Washington District of Columbia United States 20001

    Sponsors and Collaborators

    • Truth Initiative

    Investigators

    • Principal Investigator: Amanda L Graham, PhD, Truth Initiative

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Amanda L. Graham, PhD, Director, Research Development, Truth Initiative
    ClinicalTrials.gov Identifier:
    NCT02585206
    Other Study ID Numbers:
    • 1R01DA038139
    First Posted:
    Oct 23, 2015
    Last Update Posted:
    Feb 16, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amanda L. Graham, PhD, Director, Research Development, Truth Initiative

    Study Results

    No Results Posted as of Feb 16, 2021