Tobacco DependenceWATINCT01692730
Web Assisted Tobacco Intervention With Community Colleges
A study testing Enhanced Web Assisted Tobacco Intervention and Basic Web Assisted Tobacco Intervention in people with Tobacco Dependence, run by University of Rochester at 1 site in United States.
Trial summary
This trial will test the effectiveness of an enhanced web-based smoking cessation intervention for student smokers at 2-year Community Colleges. Young adults continue to be understudied, so more studies of cessation interventions are needed to generate an acceptable level of strength of evidence regarding quit rates… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Enhanced Web Assisted Tobacco Intervention and Basic Web Assisted Tobacco Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,452 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 or older
- Smoke at least 1 cigarette per day on average
- Attendance at Community College
Who cannot join
- Age 17 or younger
- Nonsmoker
- Not attending a Community College
Trial locations and contacts
1 site in 1 country.
About this study
This trial will test the effectiveness of an enhanced web-based smoking cessation intervention for student smokers at 2-year Community Colleges. Young adults continue to be understudied, so more studies of cessation interventions are needed to generate an acceptable level of strength of evidence regarding quit rates, particularly so for Community College students for whom little data on cessation are available. Students (research subjects) will be directed to one of two intervention websites with various levels of novel interactive and social network features, including a variety of better-practice features recommended by recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking).
Our study hypothesizes that students with access to an enhanced website will have higher rates of self-reported intention to quit, a higher number of quit attempts at 6-months compared to those in in a non-enhanced website. Overall, this study will evaluate evidence for a novel enhanced cessation intervention model and will add to our understanding of successful intervention with an understudied population of primarily young adult Community College smokers. The intervention components will be replicable and, if effective, the methodology is applicable across populations, and has the potential for broad public health impact through improved delivery of effective stop smoking interventions via the internet.
Read the detailed description
Purpose of the study. This group randomized controlled trial will test the effectiveness of an enhanced web-based cessation intervention for student smokers at 2-year Community Colleges (CC). Compared to the smoking rates of the general population (18%), smoking rates among CC students varies but remains substantially higher (28-30%). Evaluations of Web-Assisted Tobacco Interventions (WATI) for smoking cessation treatment with young adults in more traditional 4-year college settings have yielded encouraging preliminary data regarding intervention effectiveness. Young adults continue to be understudied, so additional randomized designed studies of cessation interventions are needed to generate an acceptable level of strength of evidence regarding quit rates, particularly so for CC students for whom little data on cessation are available. This critical population is likely to be increasing for several reasons, including President Obama's American Graduation Initiative, which provides resources to increase Community College enrollment by 5 million additional graduates by 2020. In the proposed trial, subjects on campuses randomized to the basic intervention arm will be directed to a minimally interactive website standardized to comply with 2008 DHHS Clinical Practice Guidelines for adult smokers. Those at campuses in the enhanced intervention arm will be directed to an enhanced site that adds novel interactive and social network features, including a variety of better-practice features recommended by WATI workshops, recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking). Our study has the following Specific Aims:
Primary Aims Aim 1:To test the effectiveness of an Enhanced interactive WATI (E-WATI) vs. a Basic WATI (B-WATI) among Community College students (primarily young adults). The online methodology will maximize population access and, if effective, can be recommended as a feasible cessation option.
Aim 2:To evaluate both WATI options for overall usability, as well as for the usability and perceived helpfulness of key features (i.e., basic, novel, high-tech, proactive and interactive components), and their relationship to cessation.
Secondary Aim Aim 3:To develop and evaluate strategies to recruit and retain an understudied population of Community College smokers using WATI interventions. Evaluation of recruitment strategies will be useful to the current trial, as well as well as to future trials with this population.
This study will be conducted in three phases, using a mixed methods approach. Phase 1 qualitative research in Year 01 will help guide and refine recruitment and retention and delivery strategies. In Phase 2, a group randomized trial in Years 02-04 will randomize 16 Community Colleges (8 matched pairs; 1,440 smokers) to one of two interventions: 1) B-WATI - a basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features; or 2) E-WATI - an enhanced and highly interactive website for cessation. Phase 3 dissemination in Year 05 will involve interpretation of study results, guidance for further research, and dissemination of study findings, including recommendations for including WATI cessation for campus-based referral strategies. To address the Specific Aims, our study has these Primary Hypotheses:
H1.0: Smokers in E-WATI will have higher biochemically verified point-prevalence abstinence at 6-months compared to those in the B-WATI group. Secondary hypotheses for smoking-related outcomes explore: (H1.1) higher rates of self-reported intention to quit; (H1.2), a higher number of quit attempts at 6-months in the E-WATI group compared to those in B-WATI and higher quit rates at 12 months for the subsample available for follow-up; (H1.3) higher number of prolonged abstinence participants at 6-months, and (H1.4), greater movement through Stages of Change.
H2.0: Smokers in the E-WATI group, compared to those in B-WATI, will demonstrate more interactivity and engagement with web-based features and interventions as measured by website usability analysis and higher self-report of the number and type of selected online strategies at 6-month follow-up.
H3.0: Web-based features will be perceived as more helpful for smoking cessation by those in E-WATI compared to those in B-WATI as measured by the 6-month follow-up questionnaire.
Overall, this study will evaluate evidence for a novel enhanced cessation intervention model and will add to our understanding of successful intervention with an understudied population of primarily young adult Community College smokers. The intervention components will be replicable and, if effective, the WATI methodology is applicable across heterogeneous populations and geographic areas, and has the potential for broad public health impact through improved delivery of effective cessation interventions via the internet.
- Conditions
- Tobacco Dependence
- Being tested
- Enhanced Web Assisted Tobacco Intervention, Basic Web Assisted Tobacco Intervention
- Keywords
- Smoking Cessation, Web Assisted Tobacco Intervention
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Web Assisted Tobacco InterventionBehavioural
Also called Smoking Cessation Intervention, Web based smoking cessation
Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking).
Basic Web Assisted Tobacco InterventionBehavioural
Also called Static Web Assisted Tobacco Intervention, Information only
Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Web Assisted Intervention | Experimental | Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation. Receives: Behavioral: Enhanced Web Assisted Tobacco Intervention |
| Basic Web Assisted Intervention. | Active comparator | Basic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features. Receives: Behavioral: Basic Web Assisted Tobacco Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Self-report Abstinence From Tobacco
Our primary outcome is self-reported abstinence at the six month evaluation point. Abstinence outcomes at this time point are defined in three ways: 1) as self-reported abstinence (no cigarettes or other tobacco use) in the past 7 days prior to this six month time point, 2) or as no use in the past 30 days prior to this six-month time point (the 30 day period is the more conservative measure), or 3) self-reported prolonged abstinence from the time of a specific self-reported cessation date.
Measured: 6 month follow-up
Secondary outcomes (1)
Number of Participants With Biochemically Verified Abstinence From Tobacco
Our primary outcome is biochemically-verified point-prevalence abstinence at 6 months. If participant self-reports no cigarettes (or other tobacco use) in the past 7 days, the past 30 days, or since a specific self-reported cessation date, biochemical verification will be conducted to measure salivary cotinine (a cut off of <10ng/ml confirms self-reported abstinence for at least the previous 7 days). Using Intent-to-Treat analysis, subjects who drop out or refuse biochemical verification will be considered smokers.
Measured: 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 posted25 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,452 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Library of Medicine (NLM)
- Responsible party
- Principal investigator, Scott McIntosh, University of Rochester
- Investigators
- Scott McIntosh, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692730
- Sponsor's protocol ID
- RSRB00040730
- Other IDs
- R01CA152093, R01CA152093-01A1
- Acronym
- WATI
- Status last verified
- Nov 2017
- First submitted
- 17 Sep 2012
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McIntosh S, Johnson T, Wall AF, Prokhorov AV, Calabro KS, Ververs D, Assibey-Mensah V, Ossip DJ. Recruitment of Community College Students Into a Web-Assisted Tobacco Intervention Study. JMIR Res Protoc. 2017 May 8;6(5):e79. doi: 10.2196/resprot.6485.
PubMed 28483741
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web Assisted Tobacco Intervention With Community Colleges
- ClinicalTrials.gov ID
- NCT01692730
- Acronym / sponsor ID
- WATI / RSRB00040730
- Conditions
- Tobacco Dependence
- Keywords
- Smoking Cessation, Web Assisted Tobacco Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,452 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Library of Medicine (NLM)
- Study start
- Oct 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will test the effectiveness of an enhanced web-based smoking cessation intervention for student smokers at 2-year Community Colleges. Young adults continue to be understudied, so more studies of cessation interventions are needed to generate an acceptable level of strength of evidence regarding quit rates, particularly so for Community College students for whom little data on cessation are available. Students (research subjects) will be directed to one of two intervention websites with various levels of novel interactive and social network features, including a variety of better-practice features recommended by recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking).
Our study hypothesizes that students with access to an enhanced website will have higher rates of self-reported intention to quit, a higher number of quit attempts at 6-months compared to those in in a non-enhanced website. Overall, this study will evaluate evidence for a novel enhanced cessation intervention model and will add to our understanding of successful intervention with an understudied population of primarily young adult Community College smokers. The intervention components will be replicable and, if effective, the methodology is applicable across populations, and has the potential for broad public health impact through improved delivery of effective stop smoking interventions via the internet.
Detailed description
Purpose of the study. This group randomized controlled trial will test the effectiveness of an enhanced web-based cessation intervention for student smokers at 2-year Community Colleges (CC). Compared to the smoking rates of the general population (18%), smoking rates among CC students varies but remains substantially higher (28-30%). Evaluations of Web-Assisted Tobacco Interventions (WATI) for smoking cessation treatment with young adults in more traditional 4-year college settings have yielded encouraging preliminary data regarding intervention effectiveness. Young adults continue to be understudied, so additional randomized designed studies of cessation interventions are needed to generate an acceptable level of strength of evidence regarding quit rates, particularly so for CC students for whom little data on cessation are available. This critical population is likely to be increasing for several reasons, including President Obama's American Graduation Initiative, which provides resources to increase Community College enrollment by 5 million additional graduates by 2020. In the proposed trial, subjects on campuses randomized to the basic intervention arm will be directed to a minimally interactive website standardized to comply with 2008 DHHS Clinical Practice Guidelines for adult smokers. Those at campuses in the enhanced intervention arm will be directed to an enhanced site that adds novel interactive and social network features, including a variety of better-practice features recommended by WATI workshops, recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking). Our study has the following Specific Aims:
Primary Aims Aim 1:To test the effectiveness of an Enhanced interactive WATI (E-WATI) vs. a Basic WATI (B-WATI) among Community College students (primarily young adults). The online methodology will maximize population access and, if effective, can be recommended as a feasible cessation option.
Aim 2:To evaluate both WATI options for overall usability, as well as for the usability and perceived helpfulness of key features (i.e., basic, novel, high-tech, proactive and interactive components), and their relationship to cessation.
Secondary Aim Aim 3:To develop and evaluate strategies to recruit and retain an understudied population of Community College smokers using WATI interventions. Evaluation of recruitment strategies will be useful to the current trial, as well as well as to future trials with this population.
This study will be conducted in three phases, using a mixed methods approach. Phase 1 qualitative research in Year 01 will help guide and refine recruitment and retention and delivery strategies. In Phase 2, a group randomized trial in Years 02-04 will randomize 16 Community Colleges (8 matched pairs; 1,440 smokers) to one of two interventions: 1) B-WATI - a basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features; or 2) E-WATI - an enhanced and highly interactive website for cessation. Phase 3 dissemination in Year 05 will involve interpretation of study results, guidance for further research, and dissemination of study findings, including recommendations for including WATI cessation for campus-based referral strategies. To address the Specific Aims, our study has these Primary Hypotheses:
H1.0: Smokers in E-WATI will have higher biochemically verified point-prevalence abstinence at 6-months compared to those in the B-WATI group. Secondary hypotheses for smoking-related outcomes explore: (H1.1) higher rates of self-reported intention to quit; (H1.2), a higher number of quit attempts at 6-months in the E-WATI group compared to those in B-WATI and higher quit rates at 12 months for the subsample available for follow-up; (H1.3) higher number of prolonged abstinence participants at 6-months, and (H1.4), greater movement through Stages of Change.
H2.0: Smokers in the E-WATI group, compared to those in B-WATI, will demonstrate more interactivity and engagement with web-based features and interventions as measured by website usability analysis and higher self-report of the number and type of selected online strategies at 6-month follow-up.
H3.0: Web-based features will be perceived as more helpful for smoking cessation by those in E-WATI compared to those in B-WATI as measured by the 6-month follow-up questionnaire.
Overall, this study will evaluate evidence for a novel enhanced cessation intervention model and will add to our understanding of successful intervention with an understudied population of primarily young adult Community College smokers. The intervention components will be replicable and, if effective, the WATI methodology is applicable across heterogeneous populations and geographic areas, and has the potential for broad public health impact through improved delivery of effective cessation interventions via the internet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Web Assisted Intervention | Experimental | Behavioral: Enhanced Web Assisted Tobacco InterventionEnhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation. |
| Basic Web Assisted Intervention. | Active comparator | Behavioral: Basic Web Assisted Tobacco InterventionBasic Web Assisted Tobacco Intervention. A basic website for cessation comparable to those for general adult populations, including established evidence-based cessation information and features. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Smoke at least 1 cigarette per day on average
- Attendance at Community College
Key exclusion criteria (3 listed)
- Age 17 or younger
- Nonsmoker
- Not attending a Community College
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 |
|---|---|---|
| Enhanced Web Assisted Tobacco InterventionAlso: Smoking Cessation Intervention, Web based smoking cessationSubjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking). | Behavioural | Enhanced Web Assisted Intervention |
| Basic Web Assisted Tobacco InterventionAlso: Static Web Assisted Tobacco Intervention, Information onlySubjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features. | Behavioural | Basic Web Assisted Intervention. |
Primary outcome
Number of Participants Who Self-report Abstinence From Tobacco
Time frame: 6 month follow-up
Our primary outcome is self-reported abstinence at the six month evaluation point. Abstinence outcomes at this time point are defined in three ways: 1) as self-reported abstinence (no cigarettes or other tobacco use) in the past 7 days prior to this six month time point, 2) or as no use in the past 30 days prior to this six-month time point (the 30 day period is the more conservative measure), or 3) self-reported prolonged abstinence from the time of a specific self-reported cessation date.
1 secondary outcome
Number of Participants With Biochemically Verified Abstinence From Tobacco
Time frame: 6 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28483741McIntosh S, Johnson T, Wall AF, Prokhorov AV, Calabro KS, Ververs D, Assibey-Mensah V, Ossip DJ. Recruitment of Community College Students Into a Web-Assisted Tobacco Intervention Study. JMIR Res Protoc. 2017 May 8;6(5):e79. doi: 10.2196/resprot.6485.
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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.
Scott McIntosh, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Web Assisted Tobacco Intervention and Basic Web Assisted Tobacco Intervention in people with Tobacco Dependence, run by University of Rochester 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 3 inclusion and 3 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 20 Nov 2017. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Self-report Abstinence From Tobacco (time frame: 6 month follow-up). 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 NCT01692730, 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 20 Nov 2017.