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

NCT01544153 | Completed Results

• 1 other identifier: 1R01CA155489
• Study Type: interventional
• Target: 5,292
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

Web based behavioral intervention; Adherence; Smoking cessation; Social network; Nicotine replacement therapy; Social support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Self-reported 30-day Point Prevalence Abstinence

  3 months post-randomization

Study Arms (4)

WEB only

OTHER

Control group receiving no additional intervention

Behavioral: WEB

WEB+SN

EXPERIMENTAL

WEB plus social network intervention.

Behavioral: WEB; Behavioral: Social Network

WEB+NRT

EXPERIMENTAL

WEB plus nicotine replacement therapy product.

Behavioral: WEB; Behavioral: Nicotine Replacement Therapy (NRT)

WEB+SN+NRT

EXPERIMENTAL

WEB plus social network intervention and nicotine replacement therapy product.

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

Interventions

WEB BEHAVIORAL

Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.

Also known as: BecomeAnEX

WEB only; WEB+NRT; WEB+SN; WEB+SN+NRT

Social Network BEHAVIORAL

Proactive communications from established members of the community ("Integrators") designed to integrate study participants into the online social network on BecomeAnEX.org.

WEB+SN; WEB+SN+NRT

Nicotine Replacement Therapy (NRT) BEHAVIORAL

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.

Also known as: NicoDerm CQ, Nicorette Gum, Nicorette Lozenge, Nicorette Mini-Lozenge

WEB+NRT; WEB+SN+NRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Current smoker
• Registered user on BecomeAnEX.org

You may not qualify if:

• Pregnant or breastfeeding
• Cardiovascular conditions
• Current use of any stop smoking medication

Sponsors & Collaborators

• Truth Initiative: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Truth Initiative

Washington D.C., District of Columbia, 20001, United States

Location

Related Publications (5)

• 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.

  PMID: 23414086 BACKGROUND

• 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.

  PMID: 24201304 BACKGROUND

• 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.

  PMID: 25542911 BACKGROUND

• 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. doi: 10.1007/s12160-016-9804-x.

  PMID: 27283295 BACKGROUND

• Graham AL, Papandonatos GD, Cha S, Erar B, Amato MS. Improving Adherence to Smoking Cessation Treatment: Smoking Outcomes in a Web-based Randomized Trial. Ann Behav Med. 2018 Mar 15;52(4):331-341. doi: 10.1093/abm/kax023.

  PMID: 29878062 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine Replacement Therapy; Nicotine; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Amanda L. Graham, PhD
• Organization: Truth Initiative

agraham@truthinitiative.org

202-454-5938

Study Officials

• Amanda L Graham, PhD

  Truth Initiative

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Research Development

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 5, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: August 1, 2017
• Last Updated: November 13, 2017
• Results First Posted: February 10, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)