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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by American Legacy Foundation
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amanda Graham, American Legacy Foundation
ClinicalTrials.gov Identifier:
NCT01544153
First received: February 28, 2012
Last updated: July 9, 2013
Last verified: July 2013

February 28, 2012
July 9, 2013
February 2012
January 2015   (final data collection date for primary outcome measure)
Self-reported 30-day point prevalence abstinence [ Time Frame: 9 months post-randomization ] [ Designated as safety issue: No ]
In the past 30 days, have you smoked any cigarettes at all, even a puff?
Same as current
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 ] [ Designated as safety issue: No ]
In the past 30 days, have you smoked any cigarettes at all, even a puff?
Same as current
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=4,000 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 Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
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
    Interventions:
    • Behavioral: WEB
    • Behavioral: Social Network
  • Experimental: WEB+NRT
    Interventions:
    • Behavioral: WEB
    • Behavioral: Nicotine Replacement Therapy (NRT)
  • Experimental: WEB+SN+NRT
    Interventions:
    • Behavioral: WEB
    • Behavioral: Social Network
    • Behavioral: Nicotine Replacement Therapy (NRT)
Graham AL, Cha S, Papandonatos GD, Cobb NK, Mushro A, Fang Y, Niaura RS, Abrams DB. Improving adherence to web-based cessation programs: a randomized controlled trial study protocol. Trials. 2013 Feb 17;14:48. doi: 10.1186/1745-6215-14-48.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
October 2015
January 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
Both
18 Years and older
No
Contact: Amanda L Graham, PhD 2027098587 ex_study@legacyforhealth.org
Contact: Sarah B Cha, MSPH 2027098587 ex_study@legacyforhealth.org
United States
 
NCT01544153
1R01CA155489, 1R01CA155489
No
Amanda Graham, American Legacy Foundation
American Legacy Foundation
National Cancer Institute (NCI)
Principal Investigator: Amanda L Graham, PhD American Legacy Foundation
American Legacy Foundation
July 2013

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