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

Not Applicable

Completed

• Conditions: Smoking Cessation

• Registration Number: NCT01544153
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-03-05
• Primary Completion: 2015-12
• Results First Submitted: 2016-10-25
• Results First Submitted QC: 2016-12-19
• Results First Posted: 2017-02-10
• Study Completion: 2017-08
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5292

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Self-reported 30-day Point Prevalence Abstinence	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

Name	Time	Method
Self-reported 30-day Point Prevalence Abstinence	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

Trial Locations

Locations (1)

Truth Initiative; 🇺🇸 Washington, D.C., District of Columbia, United States