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

Not Applicable

Completed

• Conditions: Smoking Cessation

• Registration Number: NCT02585206
• Lead Sponsor: Truth Initiative

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.

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 Timeline

• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-23
• Study Start: 2018-03-29
• Primary Completion: 2019-12-19
• Study Completion: 2020-07-10
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1485

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
Phase II - 30day point prevalence abstinence	15 months post randomization	Self-reported 30-day point prevalence abstinence at 15 months post randomization

Trial Locations

Locations (1)

Truth Initiative; 🇺🇸 Washington, District of Columbia, United States