NCT01885221

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

3.8 years

First QC Date

June 20, 2013

Last Update Submit

September 19, 2018

Conditions

Keywords

smokeless tobacco cessationsocial supportpartner support

Outcome Measures

Primary Outcomes (1)

  • smokeless tobacco cessation

    the male ST user's 6-month cessation as reported by the female partner

    7.5-month follow-up

Secondary Outcomes (2)

  • tobacco quit attempts

    7.5 month follow-up

  • supportive behaviors

    7.5 month follow-up

Study Arms (2)

Multimedia Support Intervention

EXPERIMENTAL

(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

Delayed Treatment Control

NO INTERVENTION

Access to the Multimedia Intervention after participant completes the final follow-up assessment

Interventions

Multimedia Support Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (2)

  • Akers L, Andrews JA, Lichtenstein E, Severson HH, Gordon JS. Effect of a Responsiveness-Based Support Intervention on Smokeless Tobacco Cessation: The UCare-ChewFree Randomized Clinical Trial. Nicotine Tob Res. 2020 Mar 16;22(3):381-389. doi: 10.1093/ntr/ntz074.

  • Akers L, Andrews JA, Gordon JS. A Multimedia Support Skills Intervention for Female Partners of Male Smokeless Tobacco Users: Use and Perceived Acceptability. JMIR Form Res. 2018 Jan-Jun;2(1):e10. doi: 10.2196/formative.9948.

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Laura E Akers, Ph.D.

    Oregon Research 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

June 20, 2013

First Posted

June 24, 2013

Study Start

September 1, 2012

Primary Completion

June 30, 2016

Study Completion

August 31, 2018

Last Updated

September 21, 2018

Record last verified: 2018-09

Locations