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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Oregon Research Institute
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT01885221
First received: June 20, 2013
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Tobacco Use Cessation
Behavioral: Multimedia Support Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation (ChewFree Couples)

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • smokeless tobacco cessation [ Time Frame: 7.5-month follow-up ] [ Designated as safety issue: No ]
    the male ST user's 6-month cessation as reported by the female partner


Secondary Outcome Measures:
  • tobacco quit attempts [ Time Frame: 7.5 month follow-up ] [ Designated as safety issue: No ]
    the male smokeless tobacco user's quit attempts, as reported by the female partner

  • supportive behaviors [ Time Frame: 7.5 month follow-up ] [ Designated as safety issue: No ]
    change in the female partner's supportive behaviors


Estimated Enrollment: 1100
Study Start Date: September 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01885221

Contacts
Contact: Laura E. Akers, Ph.D. 541-484-2123 lauraa@ori.org

Locations
United States, Oregon
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Contact       lauraa@ori.org   
Principal Investigator: Laura E Akers, Ph.D.         
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Laura E Akers, Ph.D. Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01885221     History of Changes
Other Study ID Numbers: DA033422
Study First Received: June 20, 2013
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Research Institute:
smokeless tobacco cessation
social support
partner support

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014