Trial Outcomes & Findings for 'Questions About Quitting' Smoking Cessation Trial (NCT NCT00992264)
NCT ID: NCT00992264
Last Updated: 2017-10-13
Results Overview
7 day point prevalent abstinence
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1865 participants
Primary outcome timeframe
12 months
Results posted on
2017-10-13
Participant Flow
Participants were recruited from Group Health, a large, non-profit health plan in the US Pacific Northwest. Data were collected between May 2010 and November 2012. All intervention and data collection occurred online.
Participant milestones
| Measure |
Randomization Arm 1
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[prescriptive\], navigation \[dictated\], proactive emails \[yes\], and testimonials \[yes\]
|
Randomization Arm 2
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[prescriptive\], navigation \[not dictated\], proactive emails \[yes\], and testimonials \[yes\]
|
Randomization Arm 3
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[prescriptive\], navigation \[dictated\], proactive emails \[no\], and testimonials \[yes\]
|
Randomization Arm 4
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[prescriptive\], navigation \[not dictated\], proactive emails \[no\], and testimonials \[yes\]
|
Randomization Arm 5
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[prescriptive\], navigation \[dictated\], proactive emails \[yes\], and testimonials \[no\]
|
Randomization Arm 6
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[prescriptive\], navigation \[not dictated\], proactive emails \[yes\], and testimonials \[no\]
|
Randomization Arm 7
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[prescriptive\], navigation \[dictated\], proactive emails \[no\], and testimonials \[no\]
|
Randomization Arm 8
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[prescriptive\], navigation \[not dictated\], proactive emails \[no\], and testimonials \[no\]
|
Randomization Arm 9
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[motivational\], navigation \[dictated\], proactive emails \[yes\], and testimonials \[yes\]
|
Randomization Arm 10
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[motivational\], navigation \[not dictated\], proactive emails \[yes\], and testimonials \[yes\]
|
Randomization Arm 11
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[motivational\], navigation \[dictated\], proactive emails \[no\], and testimonials \[yes\]
|
Randomization Arm 12
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[motivational\], navigation \[not dictated\], proactive emails \[no\], and testimonials \[yes\]
|
Randomization Arm 13
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[motivational\], navigation \[dictated\], proactive emails \[yes\], and testimonials \[no\]
|
Randomization Arm 14
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[motivational\], navigation \[not dictated\], proactive emails \[yes\], and testimonials \[no\]
|
Randomization Arm 15
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[motivational\], navigation \[dictated\], proactive emails \[no\], and testimonials \[no\]
|
Randomization Arm 16
Persons in this group are randomized to the following combination of each of the experimental factors: message tone \[motivational\], navigation \[not dictated\], proactive emails \[no\], and testimonials \[no\]
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
116
|
116
|
117
|
117
|
117
|
117
|
116
|
117
|
116
|
116
|
117
|
117
|
116
|
117
|
117
|
116
|
|
Overall Study
COMPLETED
|
116
|
116
|
117
|
117
|
117
|
117
|
116
|
117
|
116
|
116
|
117
|
117
|
116
|
117
|
117
|
116
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
'Questions About Quitting' Smoking Cessation Trial
Baseline characteristics by cohort
| Measure |
Randomization Arm: 1
n=116 Participants
Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[dictated\], proactive emails \[yes\], and testimonials \[yes\].
|
Radndomization Arm: 2
n=116 Participants
Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[not dictated\], proactive emails \[yes\], and testimonials \[yes\].
|
Randomization Arm: 3
n=117 Participants
Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[dictated\], proactive emails \[no\], and testimonials \[yes\].
|
Randomization Arm: 4
n=117 Participants
Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[not dictated\], proactive emails \[no\], and testimonials \[yes\].
|
Randomization Arm: 5
n=117 Participants
Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[dictated\], proactive emails \[yes\], and testimonials \[no\].
|
Randomization Arm: 6
n=117 Participants
Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[not dictated\], proactive emails \[yes\], and testimonials \[no\].
|
Randomization Arm: 7
n=116 Participants
Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[dictated\], proactive emails \[no\], and testimonials \[no\].
|
Randomization Arm: 8
n=117 Participants
Persons assigned to this arm received the following intervention combination: Tone \[prescriptive\], Navigation \[not dictated\], proactive emails \[no\], and testimonials \[no\].
|
Randomization Arm: 9
n=116 Participants
Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[dictated\], proactive emails \[yes\], and testimonials \[yes\].
|
Randomization Arm: 10
n=116 Participants
Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[not dictated\], proactive emails \[yes\], and testimonials \[yes\].
|
Randomization Arm: 11
n=117 Participants
Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[dictated\], proactive emails \[no\], and testimonials \[yes\].
|
Randomization Arm: 12
n=117 Participants
Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[not dictated\], proactive emails \[no\], and testimonials \[yes\].
|
Randomization Arm: 13
n=116 Participants
Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[dictated\], proactive emails \[yes\], and testimonials \[no\].
|
Randomization Arm: 14
n=117 Participants
Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[not dictated\], proactive emails \[yes\], and testimonials \[no\].
|
Randomization Arm: 15
n=117 Participants
Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[dictated\], proactive emails \[no\], and testimonials \[no\].
|
Randomization Arm: 16
n=116 Participants
Persons assigned to this arm received the following intervention combination: Tone \[motivational\], Navigation \[not dictated\], proactive emails \[no\], and testimonials \[no\].
|
Total
n=1865 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.34 years
STANDARD_DEVIATION 14.50 • n=5 Participants
|
44.06 years
STANDARD_DEVIATION 14.95 • n=7 Participants
|
42.83 years
STANDARD_DEVIATION 15.06 • n=5 Participants
|
45.93 years
STANDARD_DEVIATION 13.82 • n=4 Participants
|
43.49 years
STANDARD_DEVIATION 14.34 • n=21 Participants
|
43.84 years
STANDARD_DEVIATION 14.39 • n=10 Participants
|
45.19 years
STANDARD_DEVIATION 14.6 • n=115 Participants
|
44.33 years
STANDARD_DEVIATION 15.05 • n=6 Participants
|
44.56 years
STANDARD_DEVIATION 15.43 • n=6 Participants
|
43.82 years
STANDARD_DEVIATION 14.24 • n=64 Participants
|
46.09 years
STANDARD_DEVIATION 14.75 • n=17 Participants
|
45.03 years
STANDARD_DEVIATION 14.26 • n=21 Participants
|
42.29 years
STANDARD_DEVIATION 15.07 • n=22 Participants
|
43.69 years
STANDARD_DEVIATION 14.95 • n=8 Participants
|
44.39 years
STANDARD_DEVIATION 14.95 • n=16 Participants
|
43.99 years
STANDARD_DEVIATION 14.97 • n=135 Participants
|
44.2 years
STANDARD_DEVIATION 14.7 • n=136 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
76 Participants
n=10 Participants
|
73 Participants
n=115 Participants
|
69 Participants
n=6 Participants
|
74 Participants
n=6 Participants
|
77 Participants
n=64 Participants
|
72 Participants
n=17 Participants
|
76 Participants
n=21 Participants
|
65 Participants
n=22 Participants
|
69 Participants
n=8 Participants
|
76 Participants
n=16 Participants
|
77 Participants
n=135 Participants
|
1139 Participants
n=136 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
111 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
111 Participants
n=10 Participants
|
108 Participants
n=115 Participants
|
108 Participants
n=6 Participants
|
108 Participants
n=6 Participants
|
112 Participants
n=64 Participants
|
109 Participants
n=17 Participants
|
111 Participants
n=21 Participants
|
114 Participants
n=22 Participants
|
113 Participants
n=8 Participants
|
110 Participants
n=16 Participants
|
109 Participants
n=135 Participants
|
1763 Participants
n=136 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
9 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
8 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=16 Participants
|
7 Participants
n=135 Participants
|
102 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
43 Participants
n=115 Participants
|
48 Participants
n=6 Participants
|
42 Participants
n=6 Participants
|
39 Participants
n=64 Participants
|
45 Participants
n=17 Participants
|
41 Participants
n=21 Participants
|
51 Participants
n=22 Participants
|
48 Participants
n=8 Participants
|
41 Participants
n=16 Participants
|
39 Participants
n=135 Participants
|
726 Participants
n=136 Participants
|
|
Region of Enrollment
United States
|
116 participants
n=5 Participants
|
116 participants
n=7 Participants
|
117 participants
n=5 Participants
|
117 participants
n=4 Participants
|
117 participants
n=21 Participants
|
117 participants
n=10 Participants
|
116 participants
n=115 Participants
|
117 participants
n=6 Participants
|
116 participants
n=6 Participants
|
116 participants
n=64 Participants
|
117 participants
n=17 Participants
|
117 participants
n=21 Participants
|
116 participants
n=22 Participants
|
117 participants
n=8 Participants
|
117 participants
n=16 Participants
|
116 participants
n=135 Participants
|
1865 participants
n=136 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Missing data imputed, so all enrolled participants were included in the final intent to treat analytic sample.
7 day point prevalent abstinence
Outcome measures
| Measure |
Message Tone: Prescriptive
n=1865 Participants
Persons in the 'active' comparison group received website content written in a prescriptive message tone.
Persons in the comparison group received content written in a motivational message tone.
|
Testimonials
n=1865 Participants
Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.
Persons in the comparison group did not receive the testimonial content.
|
Navigation: Dictated
n=1865 Participants
Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.
Persons in the comparison group could freely navigate the website.
|
Proactive Outreach
n=1865 Participants
Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.
Persons in the comparison group did not receive proactive email reminders.
|
|---|---|---|---|---|
|
Smoking Abstinence
Smoking prevalence: 'active' intervention grp
|
13.0 percentage of abstinent participants
|
13.8 percentage of abstinent participants
|
14.5 percentage of abstinent participants
|
13.3 percentage of abstinent participants
|
|
Smoking Abstinence
smoking prevalence: comparison group
|
14.5 percentage of abstinent participants
|
13.6 percentage of abstinent participants
|
13.0 percentage of abstinent participants
|
14.2 percentage of abstinent participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Twenty-seven participants were excluded for not being enrolled in the health plan during the study period and not having access to the provided adjunct treatment.
confirmed use of pharmacotherapy or enrollment in health plan-sponsored counseling program
Outcome measures
| Measure |
Message Tone: Prescriptive
n=1838 Participants
Persons in the 'active' comparison group received website content written in a prescriptive message tone.
Persons in the comparison group received content written in a motivational message tone.
|
Testimonials
n=1838 Participants
Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.
Persons in the comparison group did not receive the testimonial content.
|
Navigation: Dictated
n=1838 Participants
Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.
Persons in the comparison group could freely navigate the website.
|
Proactive Outreach
n=1838 Participants
Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.
Persons in the comparison group did not receive proactive email reminders.
|
|---|---|---|---|---|
|
Treatment Utilization for Smoking Cessation
Treatment utilization: % in active intervention
|
26.1 % of participants using adjunct treatmen
|
25.3 % of participants using adjunct treatmen
|
26.0 % of participants using adjunct treatmen
|
23.7 % of participants using adjunct treatmen
|
|
Treatment Utilization for Smoking Cessation
treatment utilization: % in comparison group
|
25.8 % of participants using adjunct treatmen
|
26.6 % of participants using adjunct treatmen
|
25.9 % of participants using adjunct treatmen
|
28.2 % of participants using adjunct treatmen
|
Adverse Events
Message Tone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Testimonials
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Navigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Proactive Outreach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place