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

Truth Initiative

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: Nicotine Replacement Therapy (NRT); Behavioral: Social Network; Behavioral: WEB

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01544153

1R01CA155489 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,292 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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5,292 participants in 4 patient groups

WEB only

Other group

Description:

Control group receiving no additional intervention

Treatment:

Behavioral: WEB

WEB+SN

Experimental group

Description:

WEB plus social network intervention.

Treatment:

Behavioral: Social Network

Behavioral: WEB

WEB+NRT

Experimental group

Description:

WEB plus nicotine replacement therapy product.

Treatment:

Behavioral: WEB

Behavioral: Nicotine Replacement Therapy (NRT)

WEB+SN+NRT

Experimental group

Description:

WEB plus social network intervention and nicotine replacement therapy product.

Treatment:

Behavioral: Social Network

Behavioral: WEB

Behavioral: Nicotine Replacement Therapy (NRT)