Clinical trial NCT02585206: Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment
Official title: Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Mobile Phone
Text Messaging
Internet
Tobacco Use
Lead sponsor: Truth Initiative
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 1485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Phase I: full factorial design of four factors each with 2 levels (16 arms); Phase II: 2-arm randomized trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Phase I - Composite adherence metric
timeFrame: 3 months
measure: Phase II - 30-day point prevalence abstinence
timeFrame: 9 months post randomization
Secondary outcomes:
measure: Phase II - 30day point prevalence abstinence
timeFrame: 3 months post randomization
measure: Phase II - 30day point prevalence abstinence
timeFrame: 15 months post randomization
Other outcomes:
Locations:
city: Washington
country: United States
facility: Truth Initiative
state: District of Columbia
Study officials:
affiliation: Truth Initiative
name: Amanda L Graham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Graham AL, Jacobs MA, Cohn AM, Cha S, Abroms LC, Papandonatos GD, Whittaker R. Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol. BMJ Open. 2016 Mar 30;6(3):e010687. doi: 10.1136/bmjopen-2015-010687.
citation: Graham AL, Papandonatos GD, Cha S, Amato MS, Jacobs MA, Cohn AM, Abroms LC, Whittaker R. Effectiveness of an optimized text message and Internet intervention for smoking cessation: A randomized controlled trial. Addiction. 2022 Apr;117(4):1035-1046. doi: 10.1111/add.15677. Epub 2021 Sep 28.
citation: Graham AL, Papandonatos GD, Jacobs MA, Amato MS, Cha S, Cohn AM, Abroms LC, Whittaker R. Optimizing Text Messages to Promote Engagement With Internet Smoking Cessation Treatment: Results From a Factorial Screening Experiment. J Med Internet Res. 2020 Apr 2;22(4):e17734. doi: 10.2196/17734.