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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

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Cessation Behavioral: WEB Behavioral: Social Network Behavioral: Nicotine Replacement Therapy (NRT) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5292 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving Adherence to Web-Based Cessation Programs: A Social Network Approach
Study Start Date : February 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking

Arm Intervention/treatment
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
WEB plus social network intervention.
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
WEB plus nicotine replacement therapy product.
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
WEB plus social network intervention and nicotine replacement therapy product.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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:   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

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): NCT01544153


Locations
United States, District of Columbia
Truth Initiative
Washington, D.C., District of Columbia, United States, 20001
Sponsors and Collaborators
Truth Initiative
National Cancer Institute (NCI)
Investigators
Principal Investigator: Amanda L Graham, PhD Truth Initiative

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amanda L. Graham, PhD, Director, Research Development, Truth Initiative
ClinicalTrials.gov Identifier: NCT01544153     History of Changes
Other Study ID Numbers: 1R01CA155489 ( U.S. NIH Grant/Contract )
1R01CA155489 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2012    Key Record Dates
Results First Posted: February 10, 2017
Last Update Posted: November 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plans, but interested researchers may contact Principal Investigator for additional discussion.

Keywords provided by Amanda L. Graham, PhD, Truth Initiative:
Web based behavioral intervention
Adherence
Smoking cessation
Social network
Nicotine replacement therapy
Social support

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