NCT00265681

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration 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

Study Start

First participant enrolled

November 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 24, 2023

Status Verified

April 1, 2007

Enrollment Period

2.1 years

First QC Date

December 13, 2005

Last Update Submit

August 21, 2023

Conditions

Smokeless TobaccoTobacco Use Cessation

Keywords

smokeless tobacco cessationchewing tobaccooral tobaccosmokeless tobaccotelephonecounseling

Outcome Measures

Primary Outcomes (3)

  • Point prevalent abstinence from all tobacco after 3 months.

    Point prevalent abstinence from all tobacco after 3 months.

  • Prolonged abstinence from all tobacco after 3 months.

    Prolonged abstinence from all tobacco after 3 months

  • Number of subjects who abstained for at least 24 hours.

    Number of subjects who abstained for at least 24 hours.

Secondary Outcomes (2)

  • Assess the relative costs of delivering the 2 interventions.

  • Use baseline data to predict successful tobacco cessation.

Interventions

Phone counseling and written materialsBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Research Foundation

Bloomington, Minnesota, 55420, United States

Location

Related Publications (1)

  • 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.

    PMID: 15228971BACKGROUND

MeSH Terms

Conditions

Tobacco UseTobacco Use Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Nancy E Sherwood, PhD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 15, 2005

Study Start

November 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 24, 2023

Record last verified: 2007-04

Locations

US(1)