Overview

This trial is active, not recruiting.

Condition smoking cessation
Treatments web, social network, nicotine replacement therapy (nrt)
Sponsor Truth Initiative
Collaborator National Cancer Institute (NCI)
Start date February 2012
End date December 2015
Trial size 5292 participants
Trial identifier NCT01544153, 1R01CA155489

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Other)
Control group receiving no additional intervention
web BecomeAnEX
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
(Experimental)
web BecomeAnEX
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
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 BecomeAnEX
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
nicotine replacement therapy (nrt) NicoDerm CQ
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.
(Experimental)
web BecomeAnEX
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
social network
Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
nicotine replacement therapy (nrt) NicoDerm CQ
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.

Primary Outcomes

Measure
Self-reported 30-day point prevalence abstinence
time frame: 9 months post-randomization

Secondary Outcomes

Measure
Self-reported 30-day point prevalence abstinence
time frame: 3 months post-randomization

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Improving Adherence to Web-Based Cessation Programs: A Social Network Approach
Principal investigator Amanda L Graham, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Truth Initiative.