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

NCT ID: NCT02585206

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-29

Study Completion Date

2020-07-10

Brief Summary

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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

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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

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Phase I: full factorial design of four factors each with 2 levels (16 arms); Phase II: 2-arm randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

All 4 factors off - standard text message program

Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity OFF

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2

Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity ON

Group Type ACTIVE_COMPARATOR

Message Intensity

Intervention Type BEHAVIORAL

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Arm 3

Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity OFF

Group Type ACTIVE_COMPARATOR

Dynamic Tailoring

Intervention Type BEHAVIORAL

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 4

Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity ON

Group Type ACTIVE_COMPARATOR

Dynamic Tailoring

Intervention Type BEHAVIORAL

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.

Message Intensity

Intervention Type BEHAVIORAL

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Arm 5

Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity OFF

Group Type ACTIVE_COMPARATOR

Integration

Intervention Type BEHAVIORAL

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.

Arm 6

Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity ON

Group Type ACTIVE_COMPARATOR

Integration

Intervention Type BEHAVIORAL

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.

Message Intensity

Intervention Type BEHAVIORAL

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Arm 7

Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity OFF

Group Type ACTIVE_COMPARATOR

Integration

Intervention Type BEHAVIORAL

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.

Dynamic Tailoring

Intervention Type BEHAVIORAL

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 8

Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity ON

Group Type ACTIVE_COMPARATOR

Integration

Intervention Type BEHAVIORAL

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.

Dynamic Tailoring

Intervention Type BEHAVIORAL

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.

Message Intensity

Intervention Type BEHAVIORAL

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Arm 9

Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity OFF

Group Type ACTIVE_COMPARATOR

Personalization

Intervention Type BEHAVIORAL

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 10

Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity ON

Group Type ACTIVE_COMPARATOR

Personalization

Intervention Type BEHAVIORAL

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.

Message Intensity

Intervention Type BEHAVIORAL

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Arm 11

Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity OFF

Group Type ACTIVE_COMPARATOR

Personalization

Intervention Type BEHAVIORAL

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.

Dynamic Tailoring

Intervention Type BEHAVIORAL

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 12

Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity ON

Group Type ACTIVE_COMPARATOR

Personalization

Intervention Type BEHAVIORAL

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.

Dynamic Tailoring

Intervention Type BEHAVIORAL

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.

Message Intensity

Intervention Type BEHAVIORAL

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Arm 13

Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity OFF

Group Type ACTIVE_COMPARATOR

Personalization

Intervention Type BEHAVIORAL

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.

Integration

Intervention Type BEHAVIORAL

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.

Arm 14

Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity ON

Group Type ACTIVE_COMPARATOR

Personalization

Intervention Type BEHAVIORAL

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.

Integration

Intervention Type BEHAVIORAL

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.

Message Intensity

Intervention Type BEHAVIORAL

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Arm 15

Personalization ON Integration ON Dynamic Tailoring ON Message Intensity OFF

Group Type ACTIVE_COMPARATOR

Personalization

Intervention Type BEHAVIORAL

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.

Integration

Intervention Type BEHAVIORAL

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.

Dynamic Tailoring

Intervention Type BEHAVIORAL

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 16

Personalization ON Integration ON Dynamic Tailoring ON Message Intensity ON

Group Type ACTIVE_COMPARATOR

Personalization

Intervention Type BEHAVIORAL

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.

Integration

Intervention Type BEHAVIORAL

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.

Dynamic Tailoring

Intervention Type BEHAVIORAL

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.

Message Intensity

Intervention Type BEHAVIORAL

Phase I Factor

Varying levels of text message intensity over a 12-week period.

WEB

Phase II arm.

Full access to standard BecomeAnEX.org web-based smoking cessation program.

Group Type NO_INTERVENTION

No interventions assigned to this group

WEB+OA_TXT

Phase II arm.

Full access to standard BecomeAnEX.org web-based smoking cessation program PLUS optimal-adherence text message program from Phase I.

Group Type ACTIVE_COMPARATOR

Optimal-Adherence Text

Intervention Type BEHAVIORAL

Optimal-adherence text message intervention developed in Phase I

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Message Intensity

Phase I Factor

Varying levels of text message intensity over a 12-week period.

Intervention Type BEHAVIORAL

Optimal-Adherence Text

Optimal-adherence text message intervention developed in Phase I

Intervention Type BEHAVIORAL

Other Intervention Names

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OA_TXT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Truth Initiative

OTHER

Sponsor Role lead

Responsible Party

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Amanda L. Graham, PhD

Director, Research Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda L Graham, PhD

Role: PRINCIPAL_INVESTIGATOR

Truth Initiative

Locations

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Truth Initiative

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27029775 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34472676 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32238338 (View on PubMed)

Other Identifiers

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1R01DA038139

Identifier Type: NIH

Identifier Source: org_study_id

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