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Improving Adherence to Web-Based Cessation Programs: A Social Network Approach

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ClinicalTrials.gov Identifier: NCT01544153
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : February 10, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Amanda L. Graham, PhD, Truth Initiative

February 28, 2012
March 5, 2012
October 25, 2016
February 10, 2017
November 13, 2017
February 2012
December 2015   (Final data collection date for primary outcome measure)
Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 9 months post-randomization ]
In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding "No", 30day point prevalence abstinence.
Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 9 months post-randomization ]
In the past 30 days, have you smoked any cigarettes at all, even a puff?
Complete list of historical versions of study NCT01544153 on ClinicalTrials.gov Archive Site
Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 3 months post-randomization ]
In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding "No", 30day point prevalence abstinence
Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 3 months post-randomization ]
In the past 30 days, have you smoked any cigarettes at all, even a puff?
Not Provided
Not Provided
 
Improving Adherence to Web-Based Cessation Programs: A Social Network Approach
Improving Adherence to Web-Based Cessation Programs: A Social Network Approach
This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT.

This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT. Using a 2 (SN integration, no SN) x 2 (access to free NRT, no access) randomized, controlled factorial design with repeated measures at baseline, 3, and 9 months, this study will recruit N=5,000 new members of a Web-based smoking cessation program and randomize them to: 1) WEB, 2) WEB+SN, 3) WEB+NRT, or 4) WEB+SN+NRT.

Aim 1: To evaluate the comparative efficacy of WEB+SN, WEB+NRT, and WEB+SN+NRT versus WEB alone with regard to self-reported 30-day point prevalence abstinence at the primary endpoint of 9 months and at secondary endpoint of 3 months. Hypothesis 1a: All three intervention conditions will outperform WEB. Hypothesis 1b: WEB+SN+NRT will outperform WEB+SN and WEB+NRT.

Aim 2: To examine whether the impact of treatment condition on cessation is mediated by greater adherence to problem solving/skills training tools, social support, and pharmacotherapy. Hypothesis 2: WEB+SN+NRT will have the greatest impact on treatment adherence, which will yield higher quit rates than the other treatments.

Exploratory Aim: To advance theory and identify the processes through which social network integration and provision of free NRT influence treatment adherence. Specifically, exploratory analyses will examine whether social support and social norms are active elements in the pathway to adherence, along with other known mediators of abstinence such as self-efficacy.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Smoking Cessation
  • Behavioral: WEB
    Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
    Other Name: BecomeAnEX
  • Behavioral: Social Network
    Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
  • Behavioral: 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.
    Other Names:
    • NicoDerm CQ
    • Nicorette Gum
    • Nicorette Lozenge
    • Nicorette Mini-Lozenge
  • WEB only
    Control group receiving no additional intervention
    Intervention: Behavioral: WEB
  • Experimental: WEB+SN
    WEB plus social network intervention.
    Interventions:
    • Behavioral: WEB
    • Behavioral: Social Network
  • Experimental: WEB+NRT
    WEB plus nicotine replacement therapy product.
    Interventions:
    • Behavioral: WEB
    • Behavioral: Nicotine Replacement Therapy (NRT)
  • Experimental: WEB+SN+NRT
    WEB plus social network intervention and nicotine replacement therapy product.
    Interventions:
    • Behavioral: WEB
    • Behavioral: Social Network
    • Behavioral: Nicotine Replacement Therapy (NRT)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5292
4000
August 2017
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 years and older
  • Current smoker
  • Registered user on BecomeAnEX.org

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Cardiovascular conditions
  • Current use of any stop smoking medication
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01544153
1R01CA155489( U.S. NIH Grant/Contract )
1R01CA155489 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: No
Plan Description: No current plans, but interested researchers may contact Principal Investigator for additional discussion.
Amanda L. Graham, PhD, Truth Initiative
Truth Initiative
National Cancer Institute (NCI)
Principal Investigator: Amanda L Graham, PhD Truth Initiative
Truth Initiative
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP