Smoking Cessation
Conditions
Brief summary
The research study, Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco Interventions will test two smoker-driven, social marketing innovations to recruit and engage smokers in Decide2Quit.org (Decide2Quit), which is an evidence-based, effective Digital Intervention for Smoking Cessation.
Detailed description
S2S has many innovations that are designed to utilize the power of peers and social networks for dissemination. These include: Peer recruitment: Tools to facilitate smokers' recruiting their peers to increase Decide2Quit access; and a recommender computer tailored health communication (recommender CTHC): a Complex machine learning algorithm (recommender systems) that uses smokers' feedback (explicit and implicit) in the current and prior studies to adapt its selection of messages to smokers. Using a 2×2 factorial design, the study will compare individually and collectively the enhancements (recruitment, use, and effectiveness) offered by the S2S functions over the standard version of Decide2Quit (online recruitment and standard CTHC), an active comparison group.
Interventions
BEHAVIORALRecommender CTHC
Enhanced Messaging
BEHAVIORALStandard CTHC
Standard Messaging
OTHERPeer Recruitment
Tools to facilitate smokers' recruiting their peers
OTHERStandard Online Recruitment
Search Engine and Social Media Advertisements
Sponsors
University of Massachusetts, Amherst
Northwestern University
Patient-Centered Outcomes Research Institute
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Using a 2×2 factorial design, we will compare individually and collectively the enhancements (recruitment, use, and effectiveness) offered by the S2S functions over the standard version of Decide2Quit (online recruitment and standard CTHC), an active comparison group that was demonstrated to be effective in our previous trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of Age or older * Current smoker
Exclusion criteria
* Under 18 years of age * Non-smoker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation | At 6 months post registration | Smoking cessation measured by the 7-day point prevalence question: Six month, 7-day point prevalence : Do you currently smoke cigarettes (smoked even 1 puff in the last 7 days)? * Yes * No * Don't know/not sure * Refused |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Number of Cigarettes Smoked | At 6 months post registration | Calculated as: number of cigarettes smoked at six months minus the number of number of cigarettes smoked at baseline. |
| Repeated Use of Decide2Quit Functions | Throughout study (tracked for 6 months post registration) | As measured by, an ordinal scale of number of Decide2Quit functions used after the first DISC visit (0: no functions used; 1: use of 1-2 functions, 2: \> 2 functions used). |
| Recruitment of African Americans | At Baseline Registration | This is measured by the proportion of African Americans in each treatment arm |
| Recruitment Time | At Baseline Registration | Calculated as: each individual participant's recruitment date minus the date of the first participant's registration. Based on this formula, the first participant will have a recruitment time of 0 days and the last participant could have a maximum recruitment time of 3 years (1095 days). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fully Enhanced Peer recruitment and recommender CTHC
Recommender CTHC: Enhanced Messaging
Peer Recruitment: Tools to facilitate smokers' recruiting their peers | 371 |
| Recommender CTHC Only Recommender CTHC and standard online recruitment
Recommender CTHC: Enhanced Messaging
Standard Online Recruitment: Search Engine and Social Media Advertisements | 370 |
| Peer Recruitment Only Peer recruitment and standard CTHC
Standard CTHC: Standard Messaging
Peer Recruitment: Tools to facilitate smokers' recruiting their peers | 374 |
| Standard Standard online recruitment and standard CTHC
Standard CTHC: Standard Messaging
Standard Online Recruitment: Search Engine and Social Media Advertisements | 372 |
| Total | 1,487 |
Baseline characteristics
| Characteristic | Recommender CTHC Only | Total | Standard | Fully Enhanced | Peer Recruitment Only |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 28 Participants | 127 Participants | 29 Participants | 33 Participants | 37 Participants |
| Age, Categorical Between 18 and 65 years | 342 Participants | 1360 Participants | 343 Participants | 338 Participants | 337 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 106 Participants | 35 Participants | 22 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 327 Participants | 1291 Participants | 312 Participants | 332 Participants | 320 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 90 Participants | 25 Participants | 17 Participants | 27 Participants |
| Number of Cigarettes Smoked per day 0 | 12 Participants | 60 Participants | 16 Participants | 14 Participants | 18 Participants |
| Number of Cigarettes Smoked per day >0 & <=10 Cigarettes | 112 Participants | 458 Participants | 108 Participants | 121 Participants | 117 Participants |
| Number of Cigarettes Smoked per day >10 & <=20 Cigarettes | 163 Participants | 663 Participants | 162 Participants | 171 Participants | 167 Participants |
| Number of Cigarettes Smoked per day >20 Cigarettes | 83 Participants | 306 Participants | 86 Participants | 65 Participants | 72 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 12 Participants | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 25 Participants | 7 Participants | 6 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 42 Participants | 160 Participants | 38 Participants | 43 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 54 Participants | 15 Participants | 11 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 4 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants | 65 Participants | 16 Participants | 13 Participants | 20 Participants |
| Race (NIH/OMB) White | 293 Participants | 1167 Participants | 291 Participants | 295 Participants | 288 Participants |
| Sex: Female, Male Female | 281 Participants | 1101 Participants | 291 Participants | 259 Participants | 270 Participants |
| Sex: Female, Male Male | 89 Participants | 386 Participants | 81 Participants | 112 Participants | 104 Participants |
| Smoking Status Already quit | 56 Participants | 232 Participants | 67 Participants | 48 Participants | 61 Participants |
| Smoking Status Missing | 5 Participants | 11 Participants | 1 Participants | 3 Participants | 2 Participants |
| Smoking Status Not thinking about quitting | 10 Participants | 62 Participants | 18 Participants | 17 Participants | 17 Participants |
| Smoking Status Thinking about quitting | 299 Participants | 1182 Participants | 286 Participants | 303 Participants | 294 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Smoking Cessation
Smoking cessation measured by the 7-day point prevalence question: Six month, 7-day point prevalence : Do you currently smoke cigarettes (smoked even 1 puff in the last 7 days)? * Yes * No * Don't know/not sure * Refused
Time frame: At 6 months post registration
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fully Enhanced | Smoking Cessation | Haven't smoked in last 7 days | 89 Participants |
| Fully Enhanced | Smoking Cessation | Smoked in the last 7 days | 116 Participants |
| Recommender CTHC Only | Smoking Cessation | Smoked in the last 7 days | 150 Participants |
| Recommender CTHC Only | Smoking Cessation | Haven't smoked in last 7 days | 57 Participants |
| Peer Recruitment Only | Smoking Cessation | Haven't smoked in last 7 days | 88 Participants |
| Peer Recruitment Only | Smoking Cessation | Smoked in the last 7 days | 102 Participants |
| Standard | Smoking Cessation | Haven't smoked in last 7 days | 68 Participants |
| Standard | Smoking Cessation | Smoked in the last 7 days | 131 Participants |
Secondary
Change in the Number of Cigarettes Smoked
Calculated as: number of cigarettes smoked at six months minus the number of number of cigarettes smoked at baseline.
Time frame: At 6 months post registration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fully Enhanced | Change in the Number of Cigarettes Smoked | -9.60 cigarettes a day | Standard Deviation 10.81 |
| Recommender CTHC Only | Change in the Number of Cigarettes Smoked | -7.95 cigarettes a day | Standard Deviation 10.15 |
| Peer Recruitment Only | Change in the Number of Cigarettes Smoked | -10.63 cigarettes a day | Standard Deviation 9.99 |
| Standard | Change in the Number of Cigarettes Smoked | -9.08 cigarettes a day | Standard Deviation 11.41 |
Secondary
Recruitment of African Americans
This is measured by the proportion of African Americans in each treatment arm
Time frame: At Baseline Registration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fully Enhanced | Recruitment of African Americans | 49 Participants |
| Recommender CTHC Only | Recruitment of African Americans | 49 Participants |
| Peer Recruitment Only | Recruitment of African Americans | 47 Participants |
| Standard | Recruitment of African Americans | 44 Participants |
Secondary
Recruitment Time
Calculated as: each individual participant's recruitment date minus the date of the first participant's registration. Based on this formula, the first participant will have a recruitment time of 0 days and the last participant could have a maximum recruitment time of 3 years (1095 days).
Time frame: At Baseline Registration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fully Enhanced | Recruitment Time | 377.22 days | Standard Deviation 135.8 |
| Recommender CTHC Only | Recruitment Time | 379.29 days | Standard Deviation 133.32 |
| Peer Recruitment Only | Recruitment Time | 383.98 days | Standard Deviation 136.84 |
| Standard | Recruitment Time | 367.28 days | Standard Deviation 134.17 |
Secondary
Repeated Use of Decide2Quit Functions
As measured by, an ordinal scale of number of Decide2Quit functions used after the first DISC visit (0: no functions used; 1: use of 1-2 functions, 2: \> 2 functions used).
Time frame: Throughout study (tracked for 6 months post registration)
Population: Analysis population limited to participants who visited Decide2Quit more than one time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fully Enhanced | Repeated Use of Decide2Quit Functions | 1 or 2 Functions Used | 24 Participants |
| Fully Enhanced | Repeated Use of Decide2Quit Functions | No Use | 173 Participants |
| Fully Enhanced | Repeated Use of Decide2Quit Functions | Greater than 2 Functions Used | 34 Participants |
| Recommender CTHC Only | Repeated Use of Decide2Quit Functions | No Use | 159 Participants |
| Recommender CTHC Only | Repeated Use of Decide2Quit Functions | 1 or 2 Functions Used | 24 Participants |
| Recommender CTHC Only | Repeated Use of Decide2Quit Functions | Greater than 2 Functions Used | 45 Participants |
| Peer Recruitment Only | Repeated Use of Decide2Quit Functions | No Use | 171 Participants |
| Peer Recruitment Only | Repeated Use of Decide2Quit Functions | Greater than 2 Functions Used | 54 Participants |
| Peer Recruitment Only | Repeated Use of Decide2Quit Functions | 1 or 2 Functions Used | 26 Participants |
| Standard | Repeated Use of Decide2Quit Functions | 1 or 2 Functions Used | 34 Participants |
| Standard | Repeated Use of Decide2Quit Functions | No Use | 157 Participants |
| Standard | Repeated Use of Decide2Quit Functions | Greater than 2 Functions Used | 59 Participants |