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

Not Applicable

Completed

Conditions: Smoking Cessation

Interventions: Behavioral: WEB
Behavioral: Social Network
Behavioral: Nicotine Replacement Therapy (NRT)

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.

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

Arm && Interventions

Group	Intervention	Description
WEB+SN	Social Network	WEB plus social network intervention.
WEB+SN+NRT	Nicotine Replacement Therapy (NRT)	WEB plus social network intervention and nicotine replacement therapy product.
WEB only	WEB	Control group receiving no additional intervention
WEB+SN	WEB	WEB plus social network intervention.
WEB+SN+NRT	Social Network	WEB plus social network intervention and nicotine replacement therapy product.
WEB+NRT	WEB	WEB plus nicotine replacement therapy product.
WEB+NRT	Nicotine Replacement Therapy (NRT)	WEB plus nicotine replacement therapy product.
WEB+SN+NRT	WEB	WEB plus social network intervention and nicotine replacement therapy product.

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