Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

Phase 2

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Behavioral: Web Only; Behavioral: Phone Only; Behavioral: Web + Phone; Behavioral: Usual Care

• Registration Number: NCT00820495
• Lead Sponsor: Oregon Research Institute

Brief Summary

The purpose of this record is to test whether (a) participants who receive a Web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to be abstinent than participants who are not in a quitline intervention.

Detailed Description

Many Americans engage in the habitual use of smokeless tobacco (ST), and many wish to quit but lack resources. There is a need for innovative, validated, and easily delivered low-cost interventions to facilitate ST cessation in this under-served population of tobacco users. In our current ChewFree study, we have developed a user-friendly, interactive Web-based intervention, and in a randomized trial we have shown this website to be more efficacious than a rigorous control condition that offered Web-based basic textual information on ST cessation. We now seek to extend this proven approach by marrying it with a quitline telephone counseling service that has been used with noteworthy success for smoking abstinence but has not yet been evaluated with ST users. Our 2 x 2 design and large sample size allow us to test both main effects - Web program, phone counseling - as well as explore planned comparisons to examine the value-added contribution of the Web-based intervention to phone counseling, and vice-versa.

This project takes advantage of the opportunity to conduct a study of two tobacco cessation interventions that are growing in use. The use of tobacco help lines is now almost ubiquitous, with more than 30 state and national services now being offered. The use of the Internet for health information and behavior change (including tobacco cessation) has been growing in popularity as well. The proposed project would be an extension of both lines of research, evaluating the relative efficacy of our Internet-based program, telephone counseling, and the combination of both.

We will use a multifaceted promotional plan to recruit more than 2,000 ST users. The recruitment plan builds on the collaborative marketing efforts of a state tobacco control organization and organized promotion through media mailings, on-line advertising, and direct mailing. Follow-up assessment data will be collected electronically via the Internet supplemented by telephone follow-up. Additional data will be derived from phone counselor notes and measures of website usage.

Study Timeline

• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Study Start: 2009-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-02
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1683

Inclusion Criteria

• current users of smokeless tobacco products (snuff or chewing tobacco)
• use of smokeless tobacco products for at least 1 year
• use of at least one tin or pouch per week
• interest in quitting all tobacco
• U.S. resident 18 years of age or older
• ability to read English
• willingness to share a phone number, e-mail, and mailing address
• use of personal Internet e-mail account at least once per week
• informed consent

Exclusion criteria:

• none

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web Only	Web Only	Highly interactive tailored Web-based smokeless tobacco cessation program
Phone Only	Phone Only	Phone counseling intervention for smokeless tobacco cessation
Web + Phone	Web + Phone	Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling
Control	Usual Care	Usual care (initial call plus self-help materials)

Primary Outcome Measures

Name	Time	Method
Prolonged abstinence from all tobacco	3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
7-day point prevalence for smokeless tobacco use	3 months and 6 months
7-day point prevalence for all tobacco use	3 months and 6 months

Trial Locations

Locations (2)

University of California, San Diego; 🇺🇸 San Diego, California, United States

Oregon Research Institute; 🇺🇸 Eugene, Oregon, United States