NCT01692730

Brief 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,452

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 20, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

3.8 years

First QC Date

September 17, 2012

Results QC Date

April 19, 2017

Last Update Submit

November 15, 2017

Conditions

Keywords

Smoking CessationWeb Assisted Tobacco Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 month follow-up

Secondary Outcomes (1)

  • Number of Participants With Biochemically Verified Abstinence From Tobacco

    6 month follow-up

Study Arms (2)

Enhanced Web Assisted Intervention

EXPERIMENTAL

Enhanced Web Assisted Tobacco Intervention. An enhanced and highly interactive website for cessation.

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.

Behavioral: Basic Web Assisted Tobacco Intervention

Interventions

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).

Also known as: Smoking Cessation Intervention, Web based smoking cessation
Enhanced Web Assisted 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.

Also known as: Static Web Assisted Tobacco Intervention, Information only
Basic Web Assisted Intervention.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Smoke at least 1 cigarette per day on average
  • Attendance at Community College

You may not qualify if:

  • Age 17 or younger
  • Nonsmoker
  • Not attending a Community College

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Tobacco Use DisorderSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Results Point of Contact

Title
Scott McIntosh
Organization
University of Rochester

Study Officials

  • Scott McIntosh, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 25, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 20, 2017

Results First Posted

November 20, 2017

Record last verified: 2017-11

Locations