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Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00820495
Enrollment
1683
Registered
2009-01-12
Start date
2009-05-31
Completion date
2012-05-31
Last updated
2013-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use Disorder

Keywords

Smokeless tobacco, Chewing Tobacco, Internet, Adolescent

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.

Interventions

BEHAVIORALWeb + Phone

Web + Phone

BEHAVIORALWeb Only

Web Only

BEHAVIORALPhone Only

Phone Only

BEHAVIORALUsual Care

Usual Care

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of California, San Diego
CollaboratorOTHER
Oregon Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Prolonged abstinence from all tobacco3 months and 6 months

Secondary

MeasureTime frame
7-day point prevalence for smokeless tobacco use3 months and 6 months
7-day point prevalence for all tobacco use3 months and 6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026