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Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco Interventions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03224520
Recruitment Status : Enrolling by invitation
First Posted : July 21, 2017
Last Update Posted : December 13, 2019
Sponsor:
Collaborators:
University of Massachusetts, Amherst
Northwestern University
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Rajani Sadasivam, University of Massachusetts, Worcester

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".

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Recommender CTHC Behavioral: Standard CTHC Other: Peer Recruitment Other: Standard Online Recruitment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Smoker-to-Smoker (S2S) Peer Marketing and Messaging to Disseminate Tobacco
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : November 1, 2019
Estimated Study Completion Date : March 13, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fully enhanced
Peer recruitment and recommender CTHC
Behavioral: Recommender CTHC
Enhanced Messaging

Other: Peer Recruitment
Tools to facilitate smokers' recruiting their peers

Experimental: Recommender CTHC only
Recommender CTHC and standard online recruitment
Behavioral: Recommender CTHC
Enhanced Messaging

Other: Standard Online Recruitment
Search Engine and Social Media Advertisements

Experimental: Peer recruitment only
Peer recruitment and standard CTHC
Behavioral: Standard CTHC
Standard Messaging

Other: Peer Recruitment
Tools to facilitate smokers' recruiting their peers

Experimental: Standard
Standard online recruitment and standard CTHC
Behavioral: Standard CTHC
Standard Messaging

Other: Standard Online Recruitment
Search Engine and Social Media Advertisements




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Reduction in the number of cigarettes smoked (if still smoking) [ Time Frame: At 6 months post registration ]
    Calculated as: number of cigarettes smoked at six months minus the number of number of cigarettes smoked at baseline.

  2. Repeated use of Decide2Quit functions [ Time Frame: 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).

  3. Recruitment of African Americans [ Time Frame: At Baseline Registration ]
    This is measured by the proportion of African Americans in each treatment arm

  4. Recruitment time [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of Age or older
  • Current smoker

Exclusion Criteria:

  • Under 18 years of age
  • Non-smoker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224520


Locations
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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
University of Massachusetts, Amherst
Northwestern University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Rajani Sadasivam, PhD University of Massachusetts, Worcester

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Responsible Party: Rajani Sadasivam, Associate Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03224520    
Other Study ID Numbers: CDR-1603-34645
CDR160334645 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No