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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544153
• Other study ID #: 1R01CA155489
• Secondary ID: 1R01CA155489
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: October 10, 2017
• Start date: February 2012
• Est. completion date: August 2017

Study information

• Verified date: October 2017
• Source: Truth Initiative
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 5292
• Est. completion date: August 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• WEB
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)
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.

Locations

Country	Name	City	State
United States	Truth Initiative	Washington, D.C.	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Truth Initiative	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cha S, Erar B, Niaura RS, Graham AL. Baseline Characteristics and Generalizability of Participants in an Internet Smoking Cessation Randomized Trial. Ann Behav Med. 2016 Oct;50(5):751-761. — View Citation

Graham AL, Cha S, Cobb NK, Fang Y, Niaura RS, Mushro A. Impact of seasonality on recruitment, retention, adherence, and outcomes in a web-based smoking cessation intervention: randomized controlled trial. J Med Internet Res. 2013 Nov 7;15(11):e249. doi: 10.2196/jmir.2880. — View Citation

Graham AL, Cha S, Papandonatos GD, Cobb NK, Mushro A, Fang Y, Niaura RS, Abrams DB. Improving adherence to web-based cessation programs: a randomized controlled trial study protocol. Trials. 2013 Feb 17;14:48. doi: 10.1186/1745-6215-14-48. — View Citation

Pearson JL, Stanton CA, Cha S, Niaura RS, Luta G, Graham AL. E-Cigarettes and Smoking Cessation: Insights and Cautions From a Secondary Analysis of Data From a Study of Online Treatment-Seeking Smokers. Nicotine Tob Res. 2015 Oct;17(10):1219-27. doi: 10.1093/ntr/ntu269. Epub 2014 Dec 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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