Trials / Completed
CompletedNCT02585206
Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,485 (actual)
- Sponsor
- Truth Initiative · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| BEHAVIORAL | Optimal-Adherence Text | Optimal-adherence text message intervention developed in Phase I |
Timeline
- Start date
- 2018-03-29
- Primary completion
- 2019-12-19
- Completion
- 2020-07-10
- First posted
- 2015-10-23
- Last updated
- 2021-02-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02585206. Inclusion in this directory is not an endorsement.