Trial Outcomes & Findings for Web Assisted Tobacco Intervention With Community Colleges (NCT NCT01692730)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1452 participants

Primary outcome timeframe

6 month follow-up

Results posted on

2017-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Enhanced Web Assisted Intervention Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation. Enhanced Web Assisted Tobacco Intervention: 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 Intervention. 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. Basic Web Assisted Tobacco Intervention: 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.
Overall Study STARTED	723	729
Overall Study COMPLETED	498	502
Overall Study NOT COMPLETED	225	227

Reasons for withdrawal

Reasons for withdrawal
Measure	Enhanced Web Assisted Intervention Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation. Enhanced Web Assisted Tobacco Intervention: 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 Intervention. 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. Basic Web Assisted Tobacco Intervention: 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.
Overall Study Lost to Follow-up	225	227

Baseline Characteristics

26 participants, 11 in EWATI and 15 in BWATI, did not provide sex/gender data.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enhanced Web Assisted Intervention n=723 Participants Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation. Enhanced Web Assisted Tobacco Intervention: 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 Intervention. n=729 Participants 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. Basic Web Assisted Tobacco Intervention: 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.	Total n=1452 Participants Total of all reporting groups
Age, Continuous	27.55048409 years STANDARD_DEVIATION 9.474060629 • n=723 Participants	28.45541838 years STANDARD_DEVIATION 9.707011106 • n=729 Participants	28.00482094 years STANDARD_DEVIATION 9.602390308 • n=1452 Participants
Sex: Female, Male Female	237 Participants n=712 Participants • 26 participants, 11 in EWATI and 15 in BWATI, did not provide sex/gender data.	256 Participants n=714 Participants • 26 participants, 11 in EWATI and 15 in BWATI, did not provide sex/gender data.	493 Participants n=1426 Participants • 26 participants, 11 in EWATI and 15 in BWATI, did not provide sex/gender data.
Sex: Female, Male Male	475 Participants n=712 Participants • 26 participants, 11 in EWATI and 15 in BWATI, did not provide sex/gender data.	458 Participants n=714 Participants • 26 participants, 11 in EWATI and 15 in BWATI, did not provide sex/gender data.	933 Participants n=1426 Participants • 26 participants, 11 in EWATI and 15 in BWATI, did not provide sex/gender data.

PRIMARY outcome

Timeframe: 6 month follow-up

Population: The primary outcome time point was six months. These 1,000 participants completed the six month time point evaluation.

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.

Outcome measures

Outcome measures
Measure	Enhanced Web Assisted Intervention n=498 Participants Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation. Enhanced Web Assisted Tobacco Intervention: 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 Intervention. n=502 Participants 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. Basic Web Assisted Tobacco Intervention: 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.
Number of Participants Who Self-report Abstinence From Tobacco	144 Participants	65 Participants

SECONDARY outcome

Timeframe: 6 month follow-up

Population: Not all participants provided saliva. Analysis was performed on a total of 109 participants.

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.

Outcome measures

Outcome measures
Measure	Enhanced Web Assisted Intervention n=64 Participants Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation. Enhanced Web Assisted Tobacco Intervention: 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 Intervention. n=45 Participants 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. Basic Web Assisted Tobacco Intervention: 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.
Number of Participants With Biochemically Verified Abstinence From Tobacco	35 Participants	21 Participants

Adverse Events

Enhanced Web Assisted Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Basic Web Assisted Intervention.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Scott McIntosh

University of Rochester

Phone: 585-275-0511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place