Telephone Counseling for Snuff Users

• Sponsor: HealthPartners Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00265681
• Collaborator: Minnesota Partnership for Action Against Tobacco (Other)
• Enrollment: 400
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 16

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smokeless Tobacco; Tobacco Use Cessation	Behavioral: Phone counseling and written materials	N/A

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Proactive Telephone Counseling With Rural Smokeless Tobacco Users
• Study Start Date: Nov 1, 2004
• Actual Study Completion Date: Dec 1, 2006

Outcome Measures

Primary Outcome Measures

1. Point prevalent abstinence from all tobacco after 3 months. []

2. Prolonged abstinence from all tobacco after 3 months. []

3. Number of subjects who abstained for at least 24 hours. []

Secondary Outcome Measures

1. Assess the relative costs of delivering the 2 interventions. []

2. Use baseline data to predict successful tobacco cessation. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HealthPartners Research Foundation	Bloomington	Minnesota	United States	55420

Sponsors and Collaborators

• HealthPartners Institute
• Minnesota Partnership for Action Against Tobacco

Investigators

• Principal Investigator: Nancy E Sherwood, PhD, HealthPartners Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00265681
• Other Study ID Numbers: 03-119; RC -2004-0010
• First Posted: Dec 15, 2005
• Last Update Posted: Apr 4, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: smokeless tobacco cessation; chewing tobacco; oral tobacco; smokeless tobacco; telephone; counseling

Study Results

No Results Posted as of Apr 4, 2007