Tobacco Tactics Website for Operating Engineers

Smoking Clinical Trial

— BCBSM-OE  

Official title:

Tobacco Tactics Website for Operating Engineers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124110
• Other study ID #: N011646 - 1465.RFP
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2010
• Last updated: November 17, 2014
• Start date: January 2010
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a clustered randomized control trial to test the Tobacco Tactics intervention among Operating Engineers (heavy equipment workers). The intervention group will be directed to the Tobacco Tactics website, and the control group will be directed to the state supported 1-800 quit-now telephone hotline during routine annual safety training that all Operating Engineers are required to attend. The web-based quitting intervention includes provision of over-the-counter nicotine replacement therapy and will be followed by nurse email and/or telephone counseling. It is expected that Operating Engineers who are randomized to the Tobacco Tactics website intervention will have at least equal or greater decreases in smoking at 30-day and 6-month follow-up compared to those randomized to the 1-800-QUIT-NOW quit line. In addition, the investigators expect to find that Operating Engineers randomized to the Tobacco Tactics website intervention will: a) be able to accomplish tasks; b) be able to accomplish goals with skill and speed; c) be able to operate the system; d) be satisfied with the website; e) access the site repeatedly; and f) spend time on the site during the intervention period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: August 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• attending a training session provided by the Operating Engineers Local 324 Education Center

• greater than 18 years of age

• smoked cigarettes in the past month

• interested in participating in a program to quit smoking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking
• Tobacco Use Cessation

Intervention

Behavioral:
• Tobacco Tactics Web-Based Intervention
The Tobacco Tactics Web-Based Intervention contains website, medications, and nurse counseling.

Other:
• 1-800-QUIT-NOW Telephone Hotline
The control group receives efficacious smoking cessation treatment via the 1-800-QUIT-NOW telephone hotline. The 1-800-QUIT-NOW hotline is a national program. The first time smokers call the hotline, they receive a personal coach who assists them in setting a quit date and making an individualized quit plan. The personal coach also provides on-going support with up to five telephone coaching sessions around the caller's quit date.

Locations

Country	Name	City	State
United States	University of Michigan, School of Nursing	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Blue Cross Blue Shield of Michigan Foundation

Country where clinical trial is conducted

United States, 

References & Publications (8)

Fiore MC. US public health service clinical practice guideline: treating tobacco use and dependence. Respir Care. 2000 Oct;45(10):1200-62. Review. — View Citation

Lee DJ, Fleming LE, McCollister KE, Caban AJ, Arheart KL, LeBlanc WG, Chung-Bridges K, Christ SL, Dietz N, Clark JD 3rd. Healthcare provider smoking cessation advice among US worker groups. Tob Control. 2007 Oct;16(5):325-8. — View Citation

Lenert L, Muñoz RF, Stoddard J, Delucchi K, Bansod A, Skoczen S, Pérez-Stable EJ. Design and pilot evaluation of an internet smoking cessation program. J Am Med Inform Assoc. 2003 Jan-Feb;10(1):16-20. — View Citation

Lichtenstein E, Glasgow RE, Lando HA, Ossip-Klein DJ, Boles SM. Telephone counseling for smoking cessation: rationales and meta-analytic review of evidence. Health Educ Res. 1996 Jun;11(2):243-57. — View Citation

Moher M, Hey K, Lancaster T. Workplace interventions for smoking cessation. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003440. Review. Update in: Cochrane Database Syst Rev. 2008;(4):CD003440. — View Citation

Rice VH, Stead LF. Nursing interventions for smoking cessation. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD001188. doi: 10.1002/14651858.CD001188.pub3. Review. Update in: Cochrane Database Syst Rev. 2013;8:CD001188. — View Citation

Solomon LJ, Scharoun GM, Flynn BS, Secker-Walker RH, Sepinwall D. Free nicotine patches plus proactive telephone peer support to help low-income women stop smoking. Prev Med. 2000 Jul;31(1):68-74. — View Citation

Stern F, Haring-Sweeney M. Proportionate mortality among unionized construction operating engineers. Am J Ind Med. 1997 Jul;32(1):51-65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit Rate	The investigators will measure 7-day point prevalence abstinence by asking the well validated question, "Have you used any tobacco products (even one puff) in the past 7 days?" The investigators will also assess harm reduction (ability to quit at all, number of quit attempts, and number of cigarettes smoked per day).	30-day Follow-Up	No
Primary	Quit Rate	The investigators will measure 7-day point prevalence abstinence by asking the well validated question, "Have you used any tobacco products (even one puff) in the past 7 days?" Smoking status will be confirmed by biochemical verification in the form of urinary cotinine test strips. The investigators will also assess harm reduction (ability to quit at all, number of quit attempts, and number of cigarettes smoked per day).	6-Month Follow-Up	No

External Links

•   Front Page of the Tobacco Tactics Website