Smoking Cessation
Conditions
Keywords
Mobile Phone, Text Messaging, Internet, Tobacco Use
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.
Interventions
BEHAVIORALPersonalization
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.
BEHAVIORALIntegration
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.
BEHAVIORALDynamic 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.
BEHAVIORALMessage Intensity
Phase I Factor Varying levels of text message intensity over a 12-week period.
BEHAVIORALOptimal-Adherence Text
Optimal-adherence text message intervention developed in Phase I
Sponsors
Truth Initiative
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Phase I: full factorial design of four factors each with 2 levels (16 arms); Phase II: 2-arm randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Phase II - 30day point prevalence abstinence | 3 months post randomization | Self-reported 30-day point prevalence abstinence at 3 months post randomization |
Countries
United States
Outcome results
None listed