Improving Adherence to Web-Based Cessation Programs: A Social Network Approach
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Smoking Cessation |
Behavioral: WEB Behavioral: Social Network Behavioral: Nicotine Replacement Therapy (NRT) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Improving Adherence to Web-Based Cessation Programs: A Social Network Approach |
- Self-reported 30-day point prevalence abstinence [ Time Frame: 9 months post-randomization ] [ Designated as safety issue: No ]In the past 30 days, have you smoked any cigarettes at all, even a puff?
- Self-reported 30-day point prevalence abstinence [ Time Frame: 3 months post-randomization ] [ Designated as safety issue: No ]In the past 30 days, have you smoked any cigarettes at all, even a puff?
| Estimated Enrollment: | 4000 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: WEB only |
Behavioral: WEB
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Other Name: BecomeAnEX
|
| Experimental: WEB+SN |
Behavioral: WEB
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Other Name: BecomeAnEX
Behavioral: Social Network
Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
|
| Experimental: WEB+NRT |
Behavioral: WEB
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Other Name: BecomeAnEX
Behavioral: 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.
Other Names:
|
| Experimental: WEB+SN+NRT |
Behavioral: WEB
Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
Other Name: BecomeAnEX
Behavioral: Social Network
Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.
Behavioral: 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.
Other Names:
|
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=4,000 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Amanda L Graham, PhD | 2027098587 | ex_study@becomeanex.org |
| Contact: Sarah B Cha, MSPH | 2027098587 | ex_study@becomeanex.org |
| United States, District of Columbia | |
| American Legacy Foundation | Recruiting |
| Washington, District of Columbia, United States, 20036 | |
| Principal Investigator: | Amanda L Graham, PhD | American Legacy Foundation |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amanda Graham, Director, Research Development, American Legacy Foundation |
| ClinicalTrials.gov Identifier: | NCT01544153 History of Changes |
| Other Study ID Numbers: | 1R01CA155489, 1R01CA155489 |
| Study First Received: | February 28, 2012 |
| Last Updated: | March 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by American Legacy Foundation:
|
Web based behavioral intervention Adherence Smoking cessation |
Social network Nicotine replacement therapy Social support |
Additional relevant MeSH terms:
|
Smoking Habits Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013