Clinical trial NCT00265681: Telephone Counseling for Snuff Users
Official title: Proactive Telephone Counseling With Rural Smokeless Tobacco Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smokeless Tobacco
Tobacco Use Cessation
Keywords: smokeless tobacco cessation
chewing tobacco
oral tobacco
smokeless tobacco
telephone
counseling
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Minnesota Partnership for Action Against Tobacco
First posted: 2005-12-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the effectiveness of telephone-based counseling in promoting smokeless tobacco cessation among residents of Minnesota. It is hypothesized that a greater proportion of individuals assigned to the proactive telephone calls will quit their use of smokeless tobacco products and all tobacco products compared to the comparison group not receiving those calls.

Detailed description: Smokeless Tobacco (ST) users have not been the focus of tobacco control campaigns in Minnesota. However, there are a significant number of adults in Minnesota who regularly use ST. There is a need for a low-cost cessation program that can be widely delivered to ST users who may have little or no access to conventional and/or group treatments. Self-help interventions can make a significant contribution in reaching this population. The telephone provides a unique low-cost delivery system that can expand the reach of a self-help cessation program to underserved groups of tobacco users. The primary objective is to evaluate the effectiveness of telephone-based counseling in promoting smokeless tobacco cessation among Minnesota residents. It is hypothesized that a greater proportion of individuals assigned to the telephone calling group will quit their use of smokeless tobacco products and all tobacco products compared to the comparison group not receiving calls. We plan to recruit 400 smokeless tobacco users who are interested in quitting their use of smokeless tobacco and randomize them to telephone counseling for smokeless tobacco cessation or to a comparison group that receives the same mailed self-help materials. All subjects will be assessed pre-intervention, and at 3- and 6-months.

Eligibility criteria: Inclusion Criteria:

Age 18 or older. Use snuff or chewing tobacco weekly. Snuff or chewing tobacco are primary tobacco use.

Exclusion Criteria:

No access to a telephone. Primary tobacco use is cigarettes, cigar or pipe tobacco.

Primary outcomes:
measure: Point prevalent abstinence from all tobacco after 3 months.
measure: Prolonged abstinence from all tobacco after 3 months.
measure: Number of subjects who abstained for at least 24 hours.
Secondary outcomes:
measure: Assess the relative costs of delivering the 2 interventions.
measure: Use baseline data to predict successful tobacco cessation.
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: HealthPartners Research Foundation
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Nancy E Sherwood, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boyle RG, Pronk NP, Enstad CJ. A randomized trial of telephone counseling with adult moist snuff users. Am J Health Behav. 2004 Jul-Aug;28(4):347-51. doi: 10.5993/ajhb.28.4.6.