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Completed

NCT Number: NCT02585206

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Truth Initiative

Washington D.C., District of Columbia, 20001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalization

Behavioral

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.

Integration

Behavioral

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.

Dynamic Tailoring

Behavioral

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.

Message Intensity

Behavioral

Phase I Factor

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

Optimal-Adherence Text

Behavioral

Optimal-adherence text message intervention developed in Phase I

Other names: OA_TXT

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Phase II - 30day point prevalence abstinence

    Time frame: 3 months post randomization

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

  2. Phase II - 30day point prevalence abstinence

    Time frame: 15 months post randomization

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

Sponsors and collaborators

Lead sponsor

Truth Initiative

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 23, 2015
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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