A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation (UCare-ChewFree)

September 19, 2018 updated by: Oregon Research Institute

A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation

In an earlier study, the investigators developed a guidebook that taught women supportive behaviors to help their husbands/partners quit smokeless tobacco. This study will create a website using the information in the guidebook, along with interactive features, videos, and forums. The investigators will then conduct a randomized trial comparing an intervention group (receiving website access and the printed guidebook) with a delayed treatment control condition, to learn if the support intervention can effectively teach women supportive behaviors and thereby increase their partners' smokeless tobacco cessation rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • being the wife or female domestic partner (living together) of a male who is a current user of ST products (snuff or chewing tobacco)
  • interested in having him quit ST use
  • willing to provide a phone number, mailing address, and e-mail address
  • provides informed consent
  • the woman and the chewer are both U.S. or Canadian residents age 18 or older
  • the woman and the chewer are both able to read English
  • the woman and the chewer are both able to access a computer

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimedia Support Intervention
(a) access to a website providing the content of our supporter guidebook, supplemented with interactive components, video elements, and a supporters' forum, and (b) a mailed copy of our supporter guidebook
Behavioral: Multimedia Support Intervention
No Intervention: Delayed Treatment Control
Access to the Multimedia Intervention after participant completes the final follow-up assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
smokeless tobacco cessation
Time Frame: 7.5-month follow-up
the male ST user's 6-month cessation as reported by the female partner
7.5-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tobacco quit attempts
Time Frame: 7.5 month follow-up
the male smokeless tobacco user's quit attempts, as reported by the female partner
7.5 month follow-up
supportive behaviors
Time Frame: 7.5 month follow-up
change in the female partner's supportive behaviors
7.5 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Research Institute

Investigators

  • Principal Investigator: Laura E Akers, Ph.D., Oregon Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

June 20, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (Estimate)

June 24, 2013

Study Record Updates

Last Update Posted (Actual)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 19, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DA033422

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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