Smoking CessationNCT02585206
Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment
A study testing Personalization, Integration and Dynamic Tailoring in people with Smoking Cessation, run by Truth Initiative at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Personalization, Integration and Dynamic Tailoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,485 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2018to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Truth Initiative
Washington D.C., District of Columbia, 20001
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Personalization, Integration, Dynamic Tailoring, Message Intensity, Optimal-Adherence Text
- Keywords
- Mobile Phone, Text Messaging, Internet, Tobacco Use
- Medical subject headings
- Smoking Cessation, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PersonalizationBehavioural
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.
IntegrationBehavioural
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 TailoringBehavioural
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 IntensityBehavioural
Phase I Factor
Varying levels of text message intensity over a 12-week period.
Optimal-Adherence TextBehavioural
Also called OA_TXT
Optimal-adherence text message intervention developed in Phase I
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | No intervention | All 4 factors off - standard text message program Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity OFF |
| Arm 2 | Active comparator | Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity ON Receives: Behavioral: Message Intensity |
| Arm 3 | Active comparator | Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity OFF Receives: Behavioral: Dynamic Tailoring |
| Arm 4 | Active comparator | Personalization OFF Integration OFF Dynamic Tailoring ON Message Intensity ON Receives: Behavioral: Dynamic Tailoring; Behavioral: Message Intensity |
| Arm 5 | Active comparator | Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity OFF Receives: Behavioral: Integration |
| Arm 6 | Active comparator | Personalization OFF Integration ON Dynamic Tailoring OFF Message Intensity ON Receives: Behavioral: Integration; Behavioral: Message Intensity |
| Arm 7 | Active comparator | Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity OFF Receives: Behavioral: Integration; Behavioral: Dynamic Tailoring |
| Arm 8 | Active comparator | Personalization OFF Integration ON Dynamic Tailoring ON Message Intensity ON Receives: Behavioral: Integration; Behavioral: Dynamic Tailoring; Behavioral: Message Intensity |
| Arm 9 | Active comparator | Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity OFF Receives: Behavioral: Personalization |
| Arm 10 | Active comparator | Personalization ON Integration OFF Dynamic Tailoring OFF Message Intensity ON Receives: Behavioral: Personalization; Behavioral: Message Intensity |
| Arm 11 | Active comparator | Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity OFF Receives: Behavioral: Personalization; Behavioral: Dynamic Tailoring |
| Arm 12 | Active comparator | Personalization ON Integration OFF Dynamic Tailoring ON Message Intensity ON Receives: Behavioral: Personalization; Behavioral: Dynamic Tailoring; Behavioral: Message Intensity |
| Arm 13 | Active comparator | Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity OFF Receives: Behavioral: Personalization; Behavioral: Integration |
| Arm 14 | Active comparator | Personalization ON Integration ON Dynamic Tailoring OFF Message Intensity ON Receives: Behavioral: Personalization; Behavioral: Integration; Behavioral: Message Intensity |
| Arm 15 | Active comparator | Personalization ON Integration ON Dynamic Tailoring ON Message Intensity OFF Receives: Behavioral: Personalization; Behavioral: Integration; Behavioral: Dynamic Tailoring |
| Arm 16 | Active comparator | Personalization ON Integration ON Dynamic Tailoring ON Message Intensity ON Receives: Behavioral: Personalization; Behavioral: Integration; Behavioral: Dynamic Tailoring; Behavioral: Message Intensity |
| WEB | No intervention | Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program. |
| WEB+OA_TXT | Active comparator | Phase II arm.
Full access to standard BecomeAnEX.org web-based smoking cessation program PLUS optimal-adherence text message program from Phase I. Receives: Behavioral: Optimal-Adherence Text |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I - Composite adherence metric
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.
Measured: 3 months
Phase II - 30-day point prevalence abstinence
Self-reported 30-day point prevalence abstinence at 9 months post randomization
Measured: 9 months post randomization
Secondary outcomes (2)
Phase II - 30day point prevalence abstinence
Self-reported 30-day point prevalence abstinence at 3 months post randomization
Measured: 3 months post randomization
Phase II - 30day point prevalence abstinence
Self-reported 30-day point prevalence abstinence at 15 months post randomization
Measured: 15 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study start29 Mar 2018
- Primary completion19 Dec 2019
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Phase I: full factorial design of four factors each with 2 levels (16 arms); Phase II: 2-arm randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Truth Initiative
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda L. Graham, PhD, Truth Initiative
- Investigators
- Amanda L Graham, PhD, Principal investigator, Truth Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585206
- Sponsor's protocol ID
- 1R01DA038139
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2015
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27029775Graham 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.
PubMed 34472676Graham 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.
PubMed 32238338
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Text Messaging to Improve Adherence to Web-Based Cessation Treatment
- ClinicalTrials.gov ID
- NCT02585206
- Acronym / sponsor ID
- 1R01DA038139
- Conditions
- Smoking Cessation
- Keywords
- Mobile Phone, Text Messaging, Internet, Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,485 participants (actual)
- Lead sponsor
- Truth InitiativeUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 23 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 18
- Model description
- Phase I: full factorial design of four factors each with 2 levels (16 arms); Phase II: 2-arm randomized trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | No intervention | –All 4 factors off - standard text message program Personalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity OFF |
| Arm 2 | Active comparator | Behavioral: Message IntensityPersonalization OFF Integration OFF Dynamic Tailoring OFF Message Intensity ON |
| Arm 3 | Active comparator | Behavioral: Dynamic TailoringPersonalization OFF Integration OFF Dynamic Tailoring ON Message Intensity OFF |
| Arm 4 | Active comparator | Behavioral: Dynamic Tailoring, Behavioral: Message IntensityPersonalization OFF Integration OFF Dynamic Tailoring ON Message Intensity ON |
| Arm 5 | Active comparator | Behavioral: IntegrationPersonalization OFF Integration ON Dynamic Tailoring OFF Message Intensity OFF |
| Arm 6 | Active comparator | Behavioral: Integration, Behavioral: Message IntensityPersonalization OFF Integration ON Dynamic Tailoring OFF Message Intensity ON |
| Arm 7 | Active comparator | Behavioral: Integration, Behavioral: Dynamic TailoringPersonalization OFF Integration ON Dynamic Tailoring ON Message Intensity OFF |
| Arm 8 | Active comparator | Behavioral: Integration, Behavioral: Dynamic Tailoring, Behavioral: Message IntensityPersonalization OFF Integration ON Dynamic Tailoring ON Message Intensity ON |
| Arm 9 | Active comparator | Behavioral: PersonalizationPersonalization ON Integration OFF Dynamic Tailoring OFF Message Intensity OFF |
| Arm 10 | Active comparator | Behavioral: Personalization, Behavioral: Message IntensityPersonalization ON Integration OFF Dynamic Tailoring OFF Message Intensity ON |
| Arm 11 | Active comparator | Behavioral: Personalization, Behavioral: Dynamic TailoringPersonalization ON Integration OFF Dynamic Tailoring ON Message Intensity OFF |
| Arm 12 | Active comparator | Behavioral: Personalization, Behavioral: Dynamic Tailoring, Behavioral: Message IntensityPersonalization ON Integration OFF Dynamic Tailoring ON Message Intensity ON |
| Arm 13 | Active comparator | Behavioral: Personalization, Behavioral: IntegrationPersonalization ON Integration ON Dynamic Tailoring OFF Message Intensity OFF |
| Arm 14 | Active comparator | Behavioral: Personalization, Behavioral: Integration, Behavioral: Message IntensityPersonalization ON Integration ON Dynamic Tailoring OFF Message Intensity ON |
| Arm 15 | Active comparator | Behavioral: Personalization, Behavioral: Integration, Behavioral: Dynamic TailoringPersonalization ON Integration ON Dynamic Tailoring ON Message Intensity OFF |
| Arm 16 | Active comparator | Behavioral: Personalization, Behavioral: Integration, Behavioral: Dynamic Tailoring, Behavioral: Message IntensityPersonalization ON Integration ON Dynamic Tailoring ON Message Intensity ON |
| WEB | No intervention | –Phase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program. |
| WEB+OA_TXT | Active comparator | Behavioral: Optimal-Adherence TextPhase II arm. Full access to standard BecomeAnEX.org web-based smoking cessation program PLUS optimal-adherence text message program from Phase I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PersonalizationPhase 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. | Behavioural | Arm 10, Arm 11, Arm 12, Arm 13, Arm 14, Arm 15, Arm 16, Arm 9 |
| IntegrationPhase 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. | Behavioural | Arm 13, Arm 14, Arm 15, Arm 16, Arm 5, Arm 6, Arm 7, Arm 8 |
| Dynamic TailoringIndividually 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. | Behavioural | Arm 11, Arm 12, Arm 15, Arm 16, Arm 3, Arm 4, Arm 7, Arm 8 |
| Message IntensityPhase I Factor Varying levels of text message intensity over a 12-week period. | Behavioural | Arm 10, Arm 12, Arm 14, Arm 16, Arm 2, Arm 4, Arm 6, Arm 8 |
| Optimal-Adherence TextAlso: OA_TXTOptimal-adherence text message intervention developed in Phase I | Behavioural | WEB+OA_TXT |
Primary outcome
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
2 secondary outcomes
Phase II - 30day point prevalence abstinence
Time frame: 3 months post randomization
Phase II - 30day point prevalence abstinence
Time frame: 15 months post randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 27029775Graham 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.
- Derived from this study: PubMed 34472676Graham 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.
- Derived from this study: PubMed 32238338Graham 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda L Graham, PhD principal investigator
Truth Initiative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalization, Integration and Dynamic Tailoring in people with Smoking Cessation, run by Truth Initiative at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I - Composite adherence metric (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585206, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.