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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Smoking Cessation
Behavioral: WEB
Behavioral: Social Network
Behavioral: Nicotine Replacement Therapy (NRT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Improving Adherence to Web-Based Cessation Programs: A Social Network Approach

Resource links provided by NLM:


Further study details as provided by American Legacy Foundation:

Primary Outcome Measures:
  • 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?


Secondary Outcome Measures:
  • 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?


Estimated Enrollment: 5000
Study Start Date: February 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
WEB only
Control group receiving no additional intervention
Behavioral: WEB
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Other Name: BecomeAnEX
Experimental: WEB+SN 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.
Experimental: WEB+NRT Behavioral: WEB
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Other Name: BecomeAnEX
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
Experimental: WEB+SN+NRT 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544153

Contacts
Contact: Amanda L Graham, PhD 2027098587 ex_study@legacyforhealth.org
Contact: Sarah B Cha, MSPH 2027098587 ex_study@legacyforhealth.org

Locations
United States, District of Columbia
American Legacy Foundation Recruiting
Washington, District of Columbia, United States, 20036
Sponsors and Collaborators
American Legacy Foundation
Investigators
Principal Investigator: Amanda L Graham, PhD American Legacy Foundation
  More Information

Additional Information:
Publications:
Responsible Party: Amanda Graham, Director, Research Development, American Legacy Foundation
ClinicalTrials.gov Identifier: NCT01544153     History of Changes
Other Study ID Numbers: 1R01CA155489, 1R01CA155489
Study First Received: February 28, 2012
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by American Legacy Foundation:
Web based behavioral intervention
Adherence
Smoking cessation
Social network
Nicotine replacement therapy
Social support

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014