Expired Study
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Washington, District of Columbia 20001


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

1R01DA038139


NCT ID:

NCT02585206


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Truth Initiative


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

18


Number of Groups:

0


Total Enrollment:

1485


Enrollment Type:

Actual


Overall Contact Information

Official Name:Amanda L Graham, PhD
Principal Investigator
Truth Initiative

Study Dates

Start Date:March 29, 2018
Completion Date:July 2020
Completion Type:Anticipated
Primary Completion Date:July 2020
Primary Completion Type:Anticipated
Verification Date:May 2019
Last Changed Date:May 8, 2019
First Received Date:October 22, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Phase I - Composite adherence metric
Time Frame:3 months
Safety Issues:False
Description: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 pe
Outcome Type:Primary Outcome
Measure:Phase II - 30-day point prevalence abstinence
Time Frame:9 months post randomization
Safety Issues:False
Description:Self-reported 30-day point prevalence abstinence at 9 months post randomization
Outcome Type:Secondary Outcome
Measure:Phase II - 30day point prevalence abstinence
Time Frame:3 months post randomization
Safety Issues:False
Description:Self-reported 30-day point prevalence abstinence at 3 months post randomization
Outcome Type:Secondary Outcome
Measure:Phase II - 30day point prevalence abstinence
Time Frame:15 months post randomization
Safety Issues:False
Description:Self-reported 30-day point prevalence abstinence at 15 months post randomization

Study Interventions

Intervention Type:Behavioral
Name:Personalization
Description: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.
Arm Name:Arm 9
Intervention Type:Behavioral
Name:Integration
Description: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 se
Arm Name:Arm 5
Intervention Type:Behavioral
Name:Dynamic Tailoring
Description: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.
Arm Name:Arm 3
Intervention Type:Behavioral
Name:Message Intensity
Description:Phase I Factor Varying levels of text message intensity over a 12-week period.
Arm Name:Arm 2
Intervention Type:Behavioral
Name:Optimal-Adherence Text
Description:Optimal-adherence text message intervention developed in Phase I
Arm Name:WEB+OA_TXT
Other Name:OA_TXT

Study Arms

Study Arm Type:Active Comparator
Arm Name:WEB+OA_TXT
Description:Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program PLUS optimal-adherence text message program from Phase I.
Study Arm Type:No Intervention
Arm Name:WEB
Description:Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program.
Study Arm Type:Active Comparator
Arm Name:Arm 16
Description:Personalization ON Integration ON Dynamic Tailoring ON Message Intensity ON
Study Arm Type:Active Comparator
Arm Name:Arm 15
Description:Personalization ON Integration ON Dynamic Tailoring ON Message Intensity OFF
Study Arm Type:Active Comparator
Arm Name:Arm 14
Description:Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity ON
Study Arm Type:Active Comparator
Arm Name:Arm 13
Description:Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity OFF
Study Arm Type:Active Comparator
Arm Name:Arm 12
Description:Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity ON
Study Arm Type:Active Comparator
Arm Name:Arm 11
Description:Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity OFF
Study Arm Type:Active Comparator
Arm Name:Arm 10
Description:Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity ON
Study Arm Type:Active Comparator
Arm Name:Arm 9
Description:Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity OFF
Study Arm Type:Active Comparator
Arm Name:Arm 8
Description:Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity ON
Study Arm Type:Active Comparator
Arm Name:Arm 7
Description:Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity OFF
Study Arm Type:Active Comparator
Arm Name:Arm 6
Description:Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity ON
Study Arm Type:Active Comparator
Arm Name:Arm 5
Description:Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity OFF
Study Arm Type:Active Comparator
Arm Name:Arm 4
Description:Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity ON
Study Arm Type:Active Comparator
Arm Name:Arm 3
Description:Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity OFF
Study Arm Type:Active Comparator
Arm Name:Arm 2
Description:Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity ON
Study Arm Type:No Intervention
Arm Name:Arm 1
Description:All 4 factors off - standard text message program Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity OFF

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Truth Initiative

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
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.
PMID:27029775

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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