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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01878214
Other study ID # 201110075
Secondary ID R21CA161169
Status Completed
Phase N/A
First received May 22, 2013
Last updated December 3, 2014
Start date April 2012
Est. completion date March 2014

Study information

Verified date December 2014
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test an innovative and sustainable intervention to increase participation in a union-sponsored smoking cessation program among carpenters and floor layers. The investigators will conduct a randomized controlled trial comparing targeted messaging versus standard messaging. All subjects will receive information about the free, union-sponsored smoking cessation program. Subjects randomized to the intervention group will receive additional targeted materials to encourage enrollment in the union's smoking cessation program. The intervention will include monthly mailed and text messages. The investigators hypothesize that subjects who receive targeted messages will be more likely to enroll in the union-sponsored smoking cessation program, be more likely to show change in readiness to quit smoking, and be more likely to quit smoking compared to subjects who receive only standard messaging.


Description:

Specific Aim 1: Develop targeted health messages based on audience segmentation to encourage smokers to enroll in a comprehensive union-sponsored smoking cessation program.

We will craft six specific health messages that appeal to four different audience segments: workers under 30 years old without children, workers under 30 with children, workers 30 years old or older without children, and workers 30 or older with children.

Specific Aim 2: Conduct a randomized controlled trial of targeted messaging based on audience segmentation versus standard smoking cessation messaging.

After conducting baseline surveys with union carpenters and floor layers, we will randomize current smokers (smoked within the last 30 days) into either the intervention or control group.

- Control subjects will receive one standard mailing informing them about the free smoking cessation program available to union members.

- Intervention subjects will receive the standard mailing in addition to six targeted smoking cessation messages delivered monthly by mail to their homes. Messages will be specific to one of four audience segments determined by age and parental status. In addition to a segment-specific anti-smoking message, each mailing will have contact information for the union smoking cessation program. Intervention subjects who consented to text messaging will also receive one booster text message each month with a shortened targeted message.


Recruitment information / eligibility

Status Completed
Enrollment 442
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Current smoker (smoked cigarettes within the last 30 days)

- Eligible for union health benefits

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Targeted messaging
6 targeted mailed messages and 6 booster text messages
Standard messaging
1 informational letter

Locations

Country Name City State
United States Washington University School of Medicine St. Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (22)

Barbeau EM, Krieger N, Soobader MJ. Working class matters: socioeconomic disadvantage, race/ethnicity, gender, and smoking in NHIS 2000. Am J Public Health. 2004 Feb;94(2):269-78. Erratum in: Am J Public Health. 2004 Aug;94(8):1295. — View Citation

Barbeau EM, Li Y, Calderon P, Hartman C, Quinn M, Markkanen P, Roelofs C, Frazier L, Levenstein C. Results of a union-based smoking cessation intervention for apprentice iron workers (United States). Cancer Causes Control. 2006 Feb;17(1):53-61. — View Citation

Bock B, Graham A, Sciamanna C, Krishnamoorthy J, Whiteley J, Carmona-Barros R, Niaura R, Abrams D. Smoking cessation treatment on the Internet: content, quality, and usability. Nicotine Tob Res. 2004 Apr;6(2):207-19. — View Citation

DiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The process of smoking cessation: an analysis of precontemplation, contemplation, and preparation stages of change. J Consult Clin Psychol. 1991 Apr;59(2):295-304. — View Citation

Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med. 1989 Apr;12(2):159-82. Review. — View Citation

Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009 Feb;36(2):165-73. doi: 10.1016/j.amepre.2008.09.040. Review. — View Citation

Ham DC, Przybeck T, Strickland JR, Luke DA, Bierut LJ, Evanoff BA. Occupation and workplace policies predict smoking behaviors: analysis of national data from the current population survey. J Occup Environ Med. 2011 Nov;53(11):1337-45. doi: 10.1097/JOM.0b013e3182337778. — View Citation

Kreuter MW, Wray RJ. Tailored and targeted health communication: strategies for enhancing information relevance. Am J Health Behav. 2003 Nov-Dec;27 Suppl 3:S227-32. Review. — View Citation

Lee DJ, Fleming LE, Arheart KL, LeBlanc WG, Caban AJ, Chung-Bridges K, Christ SL, McCollister KE, Pitman T. Smoking rate trends in U.S. occupational groups: the 1987 to 2004 National Health Interview Survey. J Occup Environ Med. 2007 Jan;49(1):75-81. — View Citation

Maibach EW, Maxfield A, Ladin K, Slater M. Translating health psychology into effective health communication: the american healthstyles audience segmentation project. J Health Psychol. 1996 Jul;1(3):261-77. doi: 10.1177/135910539600100302. — View Citation

Nigg CR, Burbank PM, Padula C, Dufresne R, Rossi JS, Velicer WF, Laforge RG, Prochaska JO. Stages of change across ten health risk behaviors for older adults. Gerontologist. 1999 Aug;39(4):473-82. — View Citation

Okechukwu CA, Krieger N, Sorensen G, Li Y, Barbeau EM. MassBuilt: effectiveness of an apprenticeship site-based smoking cessation intervention for unionized building trades workers. Cancer Causes Control. 2009 Aug;20(6):887-94. doi: 10.1007/s10552-009-9324-0. Epub 2009 Mar 20. — View Citation

Okechukwu CA, Krieger N, Sorensen G, Li Y, Barbeau EM. Testing hypothesized psychosocial mediators: lessons learned in the MassBUILT study. Health Educ Behav. 2011 Aug;38(4):404-11. doi: 10.1177/1090198110380544. Epub 2011 Apr 7. — View Citation

Perry RJ, Keller PA, Fraser D, Fiore MC. Fax to quit: a model for delivery of tobacco cessation services to Wisconsin residents. WMJ. 2005 May;104(4):37-40, 44. — View Citation

Ringen K, Anderson N, McAfee T, Zbikowski SM, Fales D. Smoking cessation in a blue-collar population: results from an evidence-based pilot program. Am J Ind Med. 2002 Nov;42(5):367-77. — View Citation

Slater MD. Theory and method in health audience segmentation. J Health Commun. 1996 Jul-Sep;1(3):267-83. Review. — View Citation

Smith DR. Tobacco smoking by occupation in Australia and the United States: a review of national surveys conducted between 1970 and 2005. Ind Health. 2008 Jan;46(1):77-89. — View Citation

Sorensen G, Barbeau E, Hunt MK, Emmons K. Reducing social disparities in tobacco use: a social-contextual model for reducing tobacco use among blue-collar workers. Am J Public Health. 2004 Feb;94(2):230-9. Review. — View Citation

Sorensen G, Barbeau EM, Stoddard AM, Hunt MK, Goldman R, Smith A, Brennan AA, Wallace L. Tools for health: the efficacy of a tailored intervention targeted for construction laborers. Cancer Causes Control. 2007 Feb;18(1):51-9. — View Citation

Sorensen G, Emmons K, Hunt MK, Barbeau E, Goldman R, Peterson K, Kuntz K, Stoddard A, Berkman L. Model for incorporating social context in health behavior interventions: applications for cancer prevention for working-class, multiethnic populations. Prev Med. 2003 Sep;37(3):188-97. — View Citation

Velicer WF, DiClemente CC, Prochaska JO, Brandenburg N. Decisional balance measure for assessing and predicting smoking status. J Pers Soc Psychol. 1985 May;48(5):1279-89. — View Citation

Vladutiu CJ, Nansel TR, Weaver NL, Jacobsen HA, Kreuter MW. Differential strength of association of child injury prevention attitudes and beliefs on practices: a case for audience segmentation. Inj Prev. 2006 Feb;12(1):35-40. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Enrollment in Smoking Cessation Program Enrollment records from the union-sponsored smoking cessation program up to 12 months after recruitment No
Secondary Quit Smoking At follow-up, subjects will report current smoking status. ("Do you currently smoke (have you smoked in the last 30 days)?" [Yes, I smoked within the past 30 days; No, but I have smoked in the past 6 months; No, and I have not smoked in more than 6 months]). We will report the % of subjects who have not smoked in the last 30 days and will compare the intervention group with the control group. 7 months after baseline No
Secondary Changes in Smoking Behaviors (Frequency and Quantity) At baseline and follow-up, subjects will report smoking frequency ("How often do you smoke?" [everyday, at least 4 days/week, 1-3 days/week, less than one day/week]) and quantity ("On days that you smoke, how many cigarettes do you have per day?" [10 or less, 11-20, 21-30, 31 or more]). We will report the % of subjects who smoke less frequently and smoke fewer cigarettes per day at follow-up compared to baseline. We will compare the intervention group with the control group. 7 months after recruitment No
Secondary Changes in Readiness to Quit Smoking in the Next 6 Months Subjects will answer the following question at both baseline and follow-up surveys: "Are you seriously considering quitting smoking in the next 6 months?" [yes/no]. We will report % of subjects who said "no" at baseline and "yes" at follow-up to determine changes in readiness to quit smoking and compare between intervention and control groups. 7 months after recruitment No
Secondary Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking At baseline and follow-up, subjects will answer questions about motivation to quit smoking ("How motivated are you to quit smoking at this time? [scale: 1 (not at all) - 10 (extremely)]) and thinking about quitting smoking ("Each rung on this ladder represents where various smokers are in their thinking about quitting. Circle the number that indicates where you are now. [0 (no thoughts of quitting) -10 (taking action to quit)]). We will report the % of subjects who reported more motivation to quit and greater thinking about quitting at follow-up compared to baseline. We will compare the intervention group with the control group. 7 months after recruitment No
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