Smoking CessationNCT01878214
Promoting Smoking Cessation in Carpenters
A study testing Targeted messaging and Standard messaging in people with Smoking Cessation and Health Behavior, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Health Behavior, Cancer
- What is being tested?
- Targeted messaging and Standard messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current smoker (smoked cigarettes within the last 30 days)
- Eligible for union health benefits
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Effective Communication Strategies for Promoting Smoking Cessation in Carpenters
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.
Read the detailed 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.
- Conditions
- Smoking Cessation, Health Behavior, Cancer
- Being tested
- Targeted messaging, Standard messaging
- Keywords
- Health communication, Smoking cessation, Health behavior, Construction industry, Audience segmentation
- Medical subject headings
- Smoking Cessation, Health Behavior, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted messagingBehavioural
6 targeted mailed messages and 6 booster text messages
Standard messagingBehavioural
1 informational letter
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Targeted messaging Receives: Behavioral: Targeted messaging; Behavioral: Standard messaging |
| Control group | Active comparator | Standard messaging Receives: Behavioral: Standard messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment in Smoking Cessation Program
Enrollment records from the union-sponsored smoking cessation program
Measured: up to 12 months after recruitment
Secondary outcomes (4)
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.
Measured: 7 months after baseline
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.
Measured: 7 months after recruitment
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.
Measured: 7 months after recruitment
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.
Measured: 7 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bradley Evanoff, MD, MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878214
- Sponsor's protocol ID
- 201110075
- Other IDs
- R21CA161169
- Status last verified
- Dec 2014
- First submitted
- 22 May 2013
- Last updated
- 4 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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. doi: 10.2105/ajph.94.2.269.
PubMed 14759942Barbeau 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. doi: 10.1007/s10552-005-0271-0.
PubMed 16411053Bock 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. doi: 10.1080/14622200410001676332.
PubMed 15203794DiClemente 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. doi: 10.1037//0022-006x.59.2.295.
PubMed 2030191Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med. 1989 Apr;12(2):159-82. doi: 10.1007/BF00846549.
PubMed 2668531Fjeldsoe 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.
PubMed 19135907Ham 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.
PubMed 21988795Kreuter 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. doi: 10.5993/ajhb.27.1.s3.6.
PubMed 14672383Lee 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. doi: 10.1097/JOM.0b013e31802ec68c.
PubMed 17215716Maibach 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.
PubMed 22011991Nigg 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. doi: 10.1093/geront/39.4.473.
PubMed 10495586Okechukwu 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.
PubMed 19301135Okechukwu 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.
PubMed 21474634Perry 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.
PubMed 16117232Ringen 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. doi: 10.1002/ajim.10129.
PubMed 12382249
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Communication Strategies for Promoting Smoking Cessation in Carpenters
- ClinicalTrials.gov ID
- NCT01878214
- Acronym / sponsor ID
- 201110075
- Conditions
- Smoking Cessation, Health Behavior, Cancer
- Keywords
- Health communication, Smoking cessation, Health behavior, Construction industry, Audience segmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Posted 4 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Targeted messaging, Behavioral: Standard messagingTargeted messaging |
| Control group | Active comparator | Behavioral: Standard messagingStandard messaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Current smoker (smoked cigarettes within the last 30 days)
- Eligible for union health benefits
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted messaging6 targeted mailed messages and 6 booster text messages | Behavioural | Intervention group |
| Standard messaging1 informational letter | Behavioural | Control group, Intervention group |
Primary outcome
Enrollment in Smoking Cessation Program
Time frame: up to 12 months after recruitment
Enrollment records from the union-sponsored smoking cessation program
4 secondary outcomes
Quit Smoking
Time frame: 7 months after baseline
Changes in Smoking Behaviors (Frequency and Quantity)
Time frame: 7 months after recruitment
Changes in Readiness to Quit Smoking in the Next 6 Months
Time frame: 7 months after recruitment
Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking
Time frame: 7 months after recruitment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14759942Barbeau 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. doi: 10.2105/ajph.94.2.269.
- Background: PubMed 16411053Barbeau 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. doi: 10.1007/s10552-005-0271-0.
- Background: PubMed 15203794Bock 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. doi: 10.1080/14622200410001676332.
- Background: PubMed 2030191DiClemente 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. doi: 10.1037//0022-006x.59.2.295.
- Background: PubMed 2668531Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med. 1989 Apr;12(2):159-82. doi: 10.1007/BF00846549.
- Background: PubMed 19135907Fjeldsoe 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.
- Background: PubMed 21988795Ham 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.
- Background: PubMed 14672383Kreuter 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. doi: 10.5993/ajhb.27.1.s3.6.
- Background: PubMed 17215716Lee 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. doi: 10.1097/JOM.0b013e31802ec68c.
- Background: PubMed 22011991Maibach 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.
- Background: PubMed 10495586Nigg 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. doi: 10.1093/geront/39.4.473.
- Background: PubMed 19301135Okechukwu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Evanoff, MD, MPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted messaging and Standard messaging in people with Smoking Cessation and Health Behavior, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment in Smoking Cessation Program (time frame: up to 12 months after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01878214, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.