Trial Outcomes & Findings for Improving Adherence to Web-Based Cessation Programs: A Social Network Approach (NCT NCT01544153)
NCT ID: NCT01544153
Last Updated: 2017-11-13
Results Overview
In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding "No", 30day point prevalence abstinence.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5292 participants
Primary outcome timeframe
9 months post-randomization
Results posted on
2017-11-13
Participant Flow
Participant milestones
| Measure |
WEB Only
Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
|
WEB+SN
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
|
WEB+NRT
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
WEB+SN+NRT
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1337
|
1324
|
1314
|
1317
|
|
Overall Study
COMPLETED
|
1337
|
1323
|
1313
|
1317
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
WEB Only
Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
|
WEB+SN
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
|
WEB+NRT
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
WEB+SN+NRT
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
|---|---|---|---|---|
|
Overall Study
Under 18
|
0
|
1
|
0
|
0
|
|
Overall Study
Non-smoker
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Improving Adherence to Web-Based Cessation Programs: A Social Network Approach
Baseline characteristics by cohort
| Measure |
WEB Only
n=1337 Participants
Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
|
WEB+SN
n=1323 Participants
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
|
WEB+NRT
n=1313 Participants
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
WEB+SN+NRT
n=1317 Participants
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
Total
n=5290 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 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
|
|
Age, Customized
18-24 years old
|
131 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
548 Participants
n=21 Participants
|
|
Age, Customized
25-44 years old
|
573 Participants
n=5 Participants
|
615 Participants
n=7 Participants
|
601 Participants
n=5 Participants
|
606 Participants
n=4 Participants
|
2395 Participants
n=21 Participants
|
|
Age, Customized
45-64 years old
|
567 Participants
n=5 Participants
|
522 Participants
n=7 Participants
|
522 Participants
n=5 Participants
|
510 Participants
n=4 Participants
|
2121 Participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
66 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
226 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
822 Participants
n=5 Participants
|
809 Participants
n=7 Participants
|
788 Participants
n=5 Participants
|
798 Participants
n=4 Participants
|
3217 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
515 Participants
n=5 Participants
|
514 Participants
n=7 Participants
|
525 Participants
n=5 Participants
|
519 Participants
n=4 Participants
|
2073 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
34 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
216 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
184 Participants
n=4 Participants
|
802 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
1060 Participants
n=5 Participants
|
1073 Participants
n=7 Participants
|
1044 Participants
n=5 Participants
|
1060 Participants
n=4 Participants
|
4237 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
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
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
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
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
80 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
294 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
1257 Participants
n=5 Participants
|
1241 Participants
n=7 Participants
|
1252 Participants
n=5 Participants
|
1246 Participants
n=4 Participants
|
4996 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1337 participants
n=5 Participants
|
1323 participants
n=7 Participants
|
1313 participants
n=5 Participants
|
1317 participants
n=4 Participants
|
5290 participants
n=21 Participants
|
|
Education
Some High School or Less
|
66 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
|
Education
High School Graduate
|
319 Participants
n=5 Participants
|
279 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
309 Participants
n=4 Participants
|
1200 Participants
n=21 Participants
|
|
Education
Some College
|
643 Participants
n=5 Participants
|
672 Participants
n=7 Participants
|
658 Participants
n=5 Participants
|
658 Participants
n=4 Participants
|
2631 Participants
n=21 Participants
|
|
Education
College Graduate
|
309 Participants
n=5 Participants
|
315 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
285 Participants
n=4 Participants
|
1212 Participants
n=21 Participants
|
|
Education
Unknown or Not Reported
|
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
|
|
Employment
Employed Full-Time
|
597 Participants
n=5 Participants
|
614 Participants
n=7 Participants
|
608 Participants
n=5 Participants
|
583 Participants
n=4 Participants
|
2402 Participants
n=21 Participants
|
|
Employment
Not Employed Full-Time
|
740 Participants
n=5 Participants
|
709 Participants
n=7 Participants
|
705 Participants
n=5 Participants
|
734 Participants
n=4 Participants
|
2888 Participants
n=21 Participants
|
|
Employment
Unkown or Not Reported
|
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
|
|
Marital Status
Has a Partner
|
695 Participants
n=5 Participants
|
714 Participants
n=7 Participants
|
665 Participants
n=5 Participants
|
661 Participants
n=4 Participants
|
2735 Participants
n=21 Participants
|
|
Marital Status
No Partner
|
642 Participants
n=5 Participants
|
609 Participants
n=7 Participants
|
648 Participants
n=5 Participants
|
656 Participants
n=4 Participants
|
2555 Participants
n=21 Participants
|
|
Marital Status
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: 9 months post-randomizationPopulation: Intent to treat
In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding "No", 30day point prevalence abstinence.
Outcome measures
| Measure |
WEB Only
n=1337 Participants
Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
|
WEB+SN
n=1323 Participants
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
|
WEB+NRT
n=1313 Participants
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
WEB+SN+NRT
n=1317 Participants
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
|---|---|---|---|---|
|
Self-reported 30-day Point Prevalence Abstinence
|
166 Participants
|
146 Participants
|
182 Participants
|
184 Participants
|
SECONDARY outcome
Timeframe: 3 months post-randomizationPopulation: Intent to treat
In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding "No", 30day point prevalence abstinence
Outcome measures
| Measure |
WEB Only
n=1337 Participants
Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
|
WEB+SN
n=1323 Participants
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
|
WEB+NRT
n=1313 Participants
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
WEB+SN+NRT
n=1317 Participants
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
|---|---|---|---|---|
|
Self-reported 30-day Point Prevalence Abstinence
|
164 Participants
|
129 Participants
|
190 Participants
|
201 Participants
|
Adverse Events
WEB Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WEB+SN
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
WEB+NRT
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
WEB+SN+NRT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
WEB Only
n=1337 participants at risk
Control group receiving no additional intervention
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
|
WEB+SN
n=1324 participants at risk
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
|
WEB+NRT
n=1314 participants at risk
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
WEB+SN+NRT
n=1317 participants at risk
WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Social Network: Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
|
|---|---|---|---|---|
|
Product Issues
Reaction to Nicotine Replacement Therapy
|
0.00%
0/1337 • Overall study
|
0.00%
0/1324 • Overall study
|
0.30%
4/1314 • Number of events 4 • Overall study
|
0.00%
0/1317 • Overall study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place