Trial Outcomes & Findings for Promoting Smoking Cessation in Carpenters (NCT NCT01878214)
NCT ID: NCT01878214
Last Updated: 2014-12-04
Results Overview
Enrollment records from the union-sponsored smoking cessation program
COMPLETED
NA
442 participants
up to 12 months after recruitment
2014-12-04
Participant Flow
We invited 1937 union members to participate; 1638 members completed the baseline survey (84.6%). Of those, 553 were current smokers, 1066 were non-smokers, and the smoking status was unknown for 19 individuals. The smoking rate was 33.8%, slightly lower than expected based on previous studies in this population.
Of 553 current smokers, 111 were not eligible for study inclusion because they either did not sign a consent form (n=49), were not eligible for union benefits (n=57), or had too much data missing at baseline (n=5). The 442 eligible smokers were separated into the four segments and then randomized into the intervention group or the control group.
Participant milestones
| Measure |
Intervention Group
Targeted messaging
Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter
|
Control Group
Standard messaging
Standard messaging: 1 informational letter
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
219
|
|
Overall Study
COMPLETED
|
170
|
175
|
|
Overall Study
NOT COMPLETED
|
53
|
44
|
Reasons for withdrawal
| Measure |
Intervention Group
Targeted messaging
Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter
|
Control Group
Standard messaging
Standard messaging: 1 informational letter
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
18
|
7
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
35
|
36
|
Baseline Characteristics
Promoting Smoking Cessation in Carpenters
Baseline characteristics by cohort
| Measure |
Intervention Group
n=223 Participants
Targeted messaging
Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter
|
Control Group
n=219 Participants
Standard messaging
Standard messaging: 1 informational letter
|
Total
n=442 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.64 years
STANDARD_DEVIATION 11.54 • n=5 Participants
|
35.18 years
STANDARD_DEVIATION 11.54 • n=7 Participants
|
35.33 years
STANDARD_DEVIATION 11.44 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
221 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
439 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
220 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
438 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
223 participants
n=5 Participants
|
219 participants
n=7 Participants
|
442 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 months after recruitmentPopulation: Includes all study subjects
Enrollment records from the union-sponsored smoking cessation program
Outcome measures
| Measure |
Intervention Group
n=223 Participants
Targeted messaging
Targeted messaging: 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter
|
Control Group
n=219 Participants
Standard messaging
Standard messaging: 1 informational letter
|
|---|---|---|
|
Enrollment in Smoking Cessation Program
|
5 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 7 months after baselinePopulation: Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey.
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.
Outcome measures
| Measure |
Intervention Group
n=170 Participants
Targeted messaging
Targeted messaging: 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter
|
Control Group
n=175 Participants
Standard messaging
Standard messaging: 1 informational letter
|
|---|---|---|
|
Quit Smoking
|
17.1 percentage of participants
|
16.0 percentage of participants
|
SECONDARY outcome
Timeframe: 7 months after recruitmentPopulation: Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).
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.
Outcome measures
| Measure |
Intervention Group
n=141 Participants
Targeted messaging
Targeted messaging: 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter
|
Control Group
n=147 Participants
Standard messaging
Standard messaging: 1 informational letter
|
|---|---|---|
|
Changes in Smoking Behaviors (Frequency and Quantity)
Smoked fewer cigarettes per day
|
24.8 percentage of participants
|
19.7 percentage of participants
|
|
Changes in Smoking Behaviors (Frequency and Quantity)
Smoked less frequently
|
14.8 percentage of participants
|
12.2 percentage of participants
|
SECONDARY outcome
Timeframe: 7 months after recruitmentPopulation: Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).
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.
Outcome measures
| Measure |
Intervention Group
n=141 Participants
Targeted messaging
Targeted messaging: 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter
|
Control Group
n=147 Participants
Standard messaging
Standard messaging: 1 informational letter
|
|---|---|---|
|
Changes in Readiness to Quit Smoking in the Next 6 Months
|
9.2 percentage of participants
|
13.6 percentage of participants
|
SECONDARY outcome
Timeframe: 7 months after recruitmentPopulation: Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).
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.
Outcome measures
| Measure |
Intervention Group
n=141 Participants
Targeted messaging
Targeted messaging: 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter
|
Control Group
n=147 Participants
Standard messaging
Standard messaging: 1 informational letter
|
|---|---|---|
|
Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking
More motivated to quit smoking
|
14.9 percentage of participants
|
23.8 percentage of participants
|
|
Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking
Greater thinking about quitting smoking
|
12.1 percentage of participants
|
22.5 percentage of participants
|
Adverse Events
Intervention Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jaime Strickland, MA
Washington University School of Medicine in St. Louis
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place