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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: WEB
* Behavioral: Social Network
* Behavioral: Nicotine Replacement Therapy (NRT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: WEB only<br>Control group receiving no additional intervention | Behavioral: WEB<br>* Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.<br>* Other names: BecomeAnEX;|
| Experimental: WEB+SN<br>WEB plus social network intervention. | Behavioral: WEB<br>* Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.<br>* Other names: BecomeAnEX;Behavioral: Social Network<br>* Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.<br>|
| Experimental: WEB+NRT<br>WEB plus nicotine replacement therapy product. | Behavioral: WEB<br>* Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.<br>* Other names: BecomeAnEX;Behavioral: Nicotine Replacement Therapy (NRT)<br>* 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.<br>* Other names: Nicorette Mini-Lozenge;|
| Experimental: WEB+SN+NRT<br>WEB plus social network intervention and nicotine replacement therapy product. | Behavioral: WEB<br>* Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.<br>* Other names: BecomeAnEX;Behavioral: Social Network<br>* Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.<br>Behavioral: Nicotine Replacement Therapy (NRT)<br>* 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.<br>* Other names: Nicorette Mini-Lozenge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 30-day Point Prevalence Abstinence | In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence. | 9 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 30-day Point Prevalence Abstinence | In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence | 3 months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Web based behavioral intervention, Adherence, Smoking cessation, Social network, Nicotine replacement therapy, Social support