SmokingMobileQuitNCT01952236
Web and Mobile Smoking Cessation
A study testing Web+Mobile and Web Only in people with Smoking, run by Oregon Research Institute at 1 site in United States.
Trial summary
This study seeks to develop and then perform a controlled efficacy Randomized Controlled Trial assessing tobacco abstinence of a best-practices Web-based PC-delivered smoking cessation intervention (QuitOnline) compared to a Mobile Smartphone-delivered intervention (MobileQuit). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Web+Mobile and Web Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,266 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 31 Aug 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Cigarettes are primary tobacco of use
- Smoke ≥ 5 cigs/day for the previous 6 months
- Want to quit in next 14 days
- Use a smartphone and willing to potentially receive/send up to 150 text messages over the six months of the program
- Access to the Internet
- Have a valid personal e-mail address
- Be a U.S. citizen
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Web and Mobile Smoking Cessation Interventions
This study seeks to develop and then perform a controlled efficacy Randomized Controlled Trial assessing tobacco abstinence of a best-practices Web-based PC-delivered smoking cessation intervention (QuitOnline) compared to a Mobile Smartphone-delivered intervention (MobileQuit). Study participants are randomized to one of two conditions: a Web Only intervention and the Web+Mobile intervention. The hypothesis is that the Web+Mobile approach will yield greater efficacy than the Web Only condition.
Read the detailed description
The primary aims of this project are to:
- Use an iterative formative development process to create two separate Web-based smoking cessation programs (Web+Mobile, Web Only).
- Compare the efficacy of the two smoking cessation programs in terms of tobacco abstinence. The investigators hypothesize that the Web+Mobile condition will be significantly more efficacious in terms of tobacco abstinence than the Web Only condition.
- Evaluate program usage/participant engagement, treatment acceptability, and consumer satisfaction. The investigators hypothesize that both conditions will be acceptable and that the Web+Mobile condition will have significantly greater usage and higher consumer satisfaction than the Web Only condition.
The secondary aims of this proposal are to:
- Evaluate the differences between conditions on ancillary tobacco outcomes. The investigators hypothesize that the participants assigned to the Web+Mobile condition who continue to smoke will nonetheless report a greater decline in the smoking rate and more quit attempts.
- Evaluate predictors and condition moderators of tobacco abstinence. The investigators will conduct exploratory analyses of the association of treatment outcomes to participant characteristics (e.g., baseline smoking rate, nicotine dependence level, partner's tobacco use, prior quitting attempts, prior use of pharmacological adjuncts, and other demographic factors).
- Evaluate putative mechanisms of change. The investigators will test whether change in the putative mechanisms of change (i.e., self-efficacy, program use, use of pharmacological adjuncts) mediate the association between the intervention condition and 3-month sustained abstinence from the 3 month to 6 month assessments.
- Conditions
- Smoking
- Being tested
- Web+Mobile, Web Only
- Keywords
- Smoking, Quit, Tobacco, Abstinence, Adult, Text Messaging, Web-based, Mobile phone, smartphone, internet, web
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web+MobileBehavioural
We propose to evaluate the efficacy and acceptability of a Web+Mobile tobacco cessation intervention in a 2-arm Randomized Controlled Trial with 1,271 adult study participants who agree to quit smoking within a pre-specified amount of time. Participants who meet eligibility criteria will be randomly assigned to either (a) an enhanced Web Only intervention or (b) an enhanced Web+Mobile intervention.
Web OnlyBehavioural
A Web-based PC-delivered best practices smoking cessation intervention.
| Study group | Role | What they receive |
|---|---|---|
| Web+Mobile | Experimental | A best-practices Web-based smoking cessation program integrated with a tailored treatment program delivered using a smartphone application. Receives: Behavioral: Web+Mobile |
| Web Only | Active comparator | A best-practices Web-based smoking cessation program. Receives: Behavioral: Web Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in all-tobacco abstinence from enrollment to 3 months and 6 months post enrollment
Change in all-tobacco abstinence from enrollment to 3 and 6 months. Measured using 7 day point prevalence.
Measured: Change from enrollment to 3 months and 6 months post enrollment
Secondary outcomes (2)
Program usage, treatment acceptability, consumer satisfaction 3 months post enrollment follow-up
Evaluate program usage of each condition using unobtrusive measures of website visits (both conditions: number, duration, webpages viewed, interactive activities used), use of mobile intervention components (Web+Mobile condition only: number of calls received, number of responses received, extent of data collected), treatment acceptability, and consumer satisfaction
Measured: 3 months post enrollment
Predictors and condition moderators of tobacco abstinence at 6-months follow-up
Analyses of the association of primary outcomes to participant characteristics (e.g., baseline smoking rate, nicotine dependence level, partner's tobacco use, prior quitting attempts, prior use of pharmacological adjuncts, and other demographic factors).
Measured: Baseline to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startFeb 2015
- Primary completionOct 2017
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian G Danaher, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952236
- Sponsor's protocol ID
- CA172205-01
- Acronym
- MobileQuit
- Status last verified
- Feb 2019
- First submitted
- 25 Jul 2013
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Danaher BG, Tyler MS, Crowley RC, Brendryen H, Seeley JR. Outcomes and Device Usage for Fully Automated Internet Interventions Designed for a Smartphone or Personal Computer: The MobileQuit Smoking Cessation Randomized Controlled Trial. J Med Internet Res. 2019 Jun 6;21(6):e13290. doi: 10.2196/13290.
PubMed 31172967
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web and Mobile Smoking Cessation Interventions
- ClinicalTrials.gov ID
- NCT01952236
- Acronym / sponsor ID
- MobileQuit / CA172205-01
- Conditions
- Smoking
- Keywords
- Smoking, Quit, Tobacco, Abstinence, Adult, Text Messaging, Web-based, Mobile phone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,266 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 27 Sep 2013 (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 seeks to develop and then perform a controlled efficacy Randomized Controlled Trial assessing tobacco abstinence of a best-practices Web-based PC-delivered smoking cessation intervention (QuitOnline) compared to a Mobile Smartphone-delivered intervention (MobileQuit). Study participants are randomized to one of two conditions: a Web Only intervention and the Web+Mobile intervention. The hypothesis is that the Web+Mobile approach will yield greater efficacy than the Web Only condition.
Detailed description
The primary aims of this project are to:
- Use an iterative formative development process to create two separate Web-based smoking cessation programs (Web+Mobile, Web Only).
- Compare the efficacy of the two smoking cessation programs in terms of tobacco abstinence. The investigators hypothesize that the Web+Mobile condition will be significantly more efficacious in terms of tobacco abstinence than the Web Only condition.
- Evaluate program usage/participant engagement, treatment acceptability, and consumer satisfaction. The investigators hypothesize that both conditions will be acceptable and that the Web+Mobile condition will have significantly greater usage and higher consumer satisfaction than the Web Only condition.
The secondary aims of this proposal are to:
- Evaluate the differences between conditions on ancillary tobacco outcomes. The investigators hypothesize that the participants assigned to the Web+Mobile condition who continue to smoke will nonetheless report a greater decline in the smoking rate and more quit attempts.
- Evaluate predictors and condition moderators of tobacco abstinence. The investigators will conduct exploratory analyses of the association of treatment outcomes to participant characteristics (e.g., baseline smoking rate, nicotine dependence level, partner's tobacco use, prior quitting attempts, prior use of pharmacological adjuncts, and other demographic factors).
- Evaluate putative mechanisms of change. The investigators will test whether change in the putative mechanisms of change (i.e., self-efficacy, program use, use of pharmacological adjuncts) mediate the association between the intervention condition and 3-month sustained abstinence from the 3 month to 6 month assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web+Mobile | Experimental | Behavioral: Web+MobileA best-practices Web-based smoking cessation program integrated with a tailored treatment program delivered using a smartphone application. |
| Web Only | Active comparator | Behavioral: Web OnlyA best-practices Web-based smoking cessation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years of age
- Cigarettes are primary tobacco of use
- Smoke ≥ 5 cigs/day for the previous 6 months
- Want to quit in next 14 days
- Use a smartphone and willing to potentially receive/send up to 150 text messages over the six months of the program
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Web+MobileWe propose to evaluate the efficacy and acceptability of a Web+Mobile tobacco cessation intervention in a 2-arm Randomized Controlled Trial with 1,271 adult study participants who agree to quit smoking within a pre-specified amount of time. Participants who meet eligibility criteria will be randomly assigned to either (a) an enhanced Web Only intervention or (b) an enhanced Web+Mobile intervention. | Behavioural | Web+Mobile |
| Web OnlyA Web-based PC-delivered best practices smoking cessation intervention. | Behavioural | Web Only |
Primary outcome
Change in all-tobacco abstinence from enrollment to 3 months and 6 months post enrollment
Time frame: Change from enrollment to 3 months and 6 months post enrollment
Change in all-tobacco abstinence from enrollment to 3 and 6 months. Measured using 7 day point prevalence.
2 secondary outcomes
Program usage, treatment acceptability, consumer satisfaction 3 months post enrollment follow-up
Time frame: 3 months post enrollment
Predictors and condition moderators of tobacco abstinence at 6-months follow-up
Time frame: Baseline to 6-month follow-up
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 12 Feb 2019.
- Derived from this study: PubMed 31172967Danaher BG, Tyler MS, Crowley RC, Brendryen H, Seeley JR. Outcomes and Device Usage for Fully Automated Internet Interventions Designed for a Smartphone or Personal Computer: The MobileQuit Smoking Cessation Randomized Controlled Trial. J Med Internet Res. 2019 Jun 6;21(6):e13290. doi: 10.2196/13290.
- Oregon Research InstituteLink provided by the sponsor.
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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.
Brian G Danaher, PhD principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web+Mobile and Web Only in people with Smoking, run by Oregon Research Institute 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 8 inclusion and 0 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 12 Feb 2019. 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?
Change in all-tobacco abstinence from enrollment to 3 months and 6 months post enrollment (time frame: Change from enrollment to 3 months and 6 months post enrollment). 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 NCT01952236, which also lists 1 linked publication.
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 12 Feb 2019.