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Clinical Trials/NCT02585206
NCT02585206
Completed
N/A

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

Truth Initiative1 site in 1 country1,485 target enrollmentMarch 29, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
Truth Initiative
Enrollment
1485
Locations
1
Primary Endpoint
Phase I - Composite adherence metric
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 29, 2018
End Date
July 10, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amanda L. Graham, PhD

Director, Research Development

Truth Initiative

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

  • Not provided

Outcomes

Primary Outcomes

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.

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

  • Phase II - 30day point prevalence abstinence(15 months post randomization)

Study Sites (1)

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