Smoking CessationNCT03224520
Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco Interventions
A study testing Recommender CTHC, Standard CTHC and Peer Recruitment in people with Smoking Cessation, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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". 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
- What is being tested?
- Recommender CTHC, Standard CTHC and Peer Recruitment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,487 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 13 Mar 2020
- 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
- 18 years of Age or older
- Current smoker
Who cannot join
- Under 18 years of age
- Non-smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01605
About this study
Official title: Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco
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".
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Recommender CTHC, Standard CTHC, Peer Recruitment, Standard Online Recruitment
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommender CTHCBehavioural
Enhanced Messaging
Standard CTHCBehavioural
Standard Messaging
Peer RecruitmentOther
Tools to facilitate smokers' recruiting their peers
Standard Online RecruitmentOther
Search Engine and Social Media Advertisements
| Study group | Role | What they receive |
|---|---|---|
| Fully enhanced | Experimental | Peer recruitment and recommender CTHC Receives: Behavioral: Recommender CTHC; Other: Peer Recruitment |
| Recommender CTHC only | Experimental | Recommender CTHC and standard online recruitment Receives: Behavioral: Recommender CTHC; Other: Standard Online Recruitment |
| Peer recruitment only | Experimental | Peer recruitment and standard CTHC Receives: Behavioral: Standard CTHC; Other: Peer Recruitment |
| Standard | Experimental | Standard online recruitment and standard CTHC Receives: Behavioral: Standard CTHC; Other: Standard Online Recruitment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 6 months post registration
Secondary outcomes (4)
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.
Measured: At 6 months post registration
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).
Measured: Throughout study (tracked for 6 months post registration)
Recruitment of African Americans
This is measured by the proportion of African Americans in each treatment arm
Measured: At Baseline Registration
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).
Measured: At Baseline Registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start20 Dec 2017
- Primary completion1 Nov 2019
- Study completion13 Mar 2020
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 (4)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 University of Massachusetts, WorcesterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,487 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Amherst, Northwestern University, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Rajani Sadasivam, University of Massachusetts, Worcester
- Investigators
- Rajani Sadasivam, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224520
- Sponsor's protocol ID
- CDR-1603-34645
- Other IDs
- CDR160334645
- Status last verified
- Mar 2021
- First submitted
- 21 Jun 2017
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee DN, Faro JM, Stevens EM, Pbert L, Yang C, Sadasivam RS. Stopping use of E-cigarettes and smoking combustible cigarettes: findings from a large longitudinal digital smoking cessation intervention study in the United States. BMC Res Notes. 2024 Sep 27;17(1):276. doi: 10.1186/s13104-024-06939-w.
PubMed 39334264Faro JM, Chen J, Flahive J, Nagawa CS, Orvek EA, Houston TK, Allison JJ, Person SD, Smith BM, Blok AC, Sadasivam RS. Effect of a Machine Learning Recommender System and Viral Peer Marketing Intervention on Smoking Cessation: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250665. doi: 10.1001/jamanetworkopen.2022.50665.
PubMed 36633844Chen J, Houston TK, Faro JM, Nagawa CS, Orvek EA, Blok AC, Allison JJ, Person SD, Smith BM, Sadasivam RS. Evaluating the use of a recommender system for selecting optimal messages for smoking cessation: patterns and effects of user-system engagement. BMC Public Health. 2021 Sep 26;21(1):1749. doi: 10.1186/s12889-021-11803-8.
PubMed 34563161Faro JM, Nagawa CS, Orvek EA, Smith BM, Blok AC, Houston TK, Kamberi A, Allison JJ, Person SD, Sadasivam RS. Comparing recruitment strategies for a digital smoking cessation intervention: Technology-assisted peer recruitment, social media, ResearchMatch, and smokefree.gov. Contemp Clin Trials. 2021 Apr;103:106314. doi: 10.1016/j.cct.2021.106314. Epub 2021 Feb 8.
PubMed 33571687
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco
- ClinicalTrials.gov ID
- NCT03224520
- Acronym / sponsor ID
- CDR-1603-34645
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,487 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- University of Massachusetts, Amherst, Northwestern University, Patient-Centered Outcomes Research Institute
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 10 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fully enhanced | Experimental | Behavioral: Recommender CTHC, Other: Peer RecruitmentPeer recruitment and recommender CTHC |
| Recommender CTHC only | Experimental | Behavioral: Recommender CTHC, Other: Standard Online RecruitmentRecommender CTHC and standard online recruitment |
| Peer recruitment only | Experimental | Behavioral: Standard CTHC, Other: Peer RecruitmentPeer recruitment and standard CTHC |
| Standard | Experimental | Behavioral: Standard CTHC, Other: Standard Online RecruitmentStandard online recruitment and standard CTHC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of Age or older
- Current smoker
Key exclusion criteria (2 listed)
- Under 18 years of age
- Non-smoker
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 |
|---|---|---|
| Recommender CTHCEnhanced Messaging | Behavioural | Fully enhanced, Recommender CTHC only |
| Standard CTHCStandard Messaging | Behavioural | Peer recruitment only, Standard |
| Peer RecruitmentTools to facilitate smokers' recruiting their peers | Other | Fully enhanced, Peer recruitment only |
| Standard Online RecruitmentSearch Engine and Social Media Advertisements | Other | Recommender CTHC only, Standard |
Primary outcome
Smoking Cessation
Time frame: 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
4 secondary outcomes
Change in the Number of Cigarettes Smoked
Time frame: At 6 months post registration
Repeated Use of Decide2Quit Functions
Time frame: Throughout study (tracked for 6 months post registration)
Recruitment of African Americans
Time frame: At Baseline Registration
Recruitment Time
Time frame: At Baseline Registration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39334264Lee DN, Faro JM, Stevens EM, Pbert L, Yang C, Sadasivam RS. Stopping use of E-cigarettes and smoking combustible cigarettes: findings from a large longitudinal digital smoking cessation intervention study in the United States. BMC Res Notes. 2024 Sep 27;17(1):276. doi: 10.1186/s13104-024-06939-w.
- Derived from this study: PubMed 36633844Faro JM, Chen J, Flahive J, Nagawa CS, Orvek EA, Houston TK, Allison JJ, Person SD, Smith BM, Blok AC, Sadasivam RS. Effect of a Machine Learning Recommender System and Viral Peer Marketing Intervention on Smoking Cessation: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250665. doi: 10.1001/jamanetworkopen.2022.50665.
- Derived from this study: PubMed 34563161Chen J, Houston TK, Faro JM, Nagawa CS, Orvek EA, Blok AC, Allison JJ, Person SD, Smith BM, Sadasivam RS. Evaluating the use of a recommender system for selecting optimal messages for smoking cessation: patterns and effects of user-system engagement. BMC Public Health. 2021 Sep 26;21(1):1749. doi: 10.1186/s12889-021-11803-8.
- Derived from this study: PubMed 33571687Faro JM, Nagawa CS, Orvek EA, Smith BM, Blok AC, Houston TK, Kamberi A, Allison JJ, Person SD, Sadasivam RS. Comparing recruitment strategies for a digital smoking cessation intervention: Technology-assisted peer recruitment, social media, ResearchMatch, and smokefree.gov. Contemp Clin Trials. 2021 Apr;103:106314. doi: 10.1016/j.cct.2021.106314. Epub 2021 Feb 8.
- Individual participant dataSharing planned: No
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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.
Rajani Sadasivam, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommender CTHC, Standard CTHC and Peer Recruitment in people with Smoking Cessation, run by University of Massachusetts, Worcester 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 2 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 26 Mar 2021. 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 10 Feb 2021). 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?
Smoking Cessation (time frame: At 6 months post registration). 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 NCT03224520, which also lists 4 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 26 Mar 2021.