Web and Mobile Smoking Cessation

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: Web Only; Behavioral: Web+Mobile

• Registration Number: NCT01952236
• Lead Sponsor: Oregon Research Institute

Brief Summary

This study seeks to develop and then perform a controlled efficacy Randomized Controlled Trial assessing tobacco abstinence of a best-practices Web-based PC-delivered smoking cessation intervention (QuitOnline) compared to a Mobile Smartphone-delivered intervention (MobileQuit). Study participants are randomized to one of two conditions: a Web Only intervention and the Web+Mobile intervention. The hypothesis is that the Web+Mobile approach will yield greater efficacy than the Web Only condition.

Detailed Description

The primary aims of this project are to:

1. Use an iterative formative development process to create two separate Web-based smoking cessation programs (Web+Mobile, Web Only).

2. Compare the efficacy of the two smoking cessation programs in terms of tobacco abstinence. The investigators hypothesize that the Web+Mobile condition will be significantly more efficacious in terms of tobacco abstinence than the Web Only condition.

3. Evaluate program usage/participant engagement, treatment acceptability, and consumer satisfaction. The investigators hypothesize that both conditions will be acceptable and that the Web+Mobile condition will have significantly greater usage and higher consumer satisfaction than the Web Only condition.

The secondary aims of this proposal are to:

1. Evaluate the differences between conditions on ancillary tobacco outcomes. The investigators hypothesize that the participants assigned to the Web+Mobile condition who continue to smoke will nonetheless report a greater decline in the smoking rate and more quit attempts.

2. Evaluate predictors and condition moderators of tobacco abstinence. The investigators will conduct exploratory analyses of the association of treatment outcomes to participant characteristics (e.g., baseline smoking rate, nicotine dependence level, partner's tobacco use, prior quitting attempts, prior use of pharmacological adjuncts, and other demographic factors).

3. Evaluate putative mechanisms of change. The investigators will test whether change in the putative mechanisms of change (i.e., self-efficacy, program use, use of pharmacological adjuncts) mediate the association between the intervention condition and 3-month sustained abstinence from the 3 month to 6 month assessments.

Study Timeline

• Study First Submitted: 2013-07-25
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-09-27
• Study Start: 2015-02
• Primary Completion: 2017-10
• Study Completion: 2018-08-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1266

Inclusion Criteria

• ≥ 18 years of age
• Cigarettes are primary tobacco of use
• Smoke ≥ 5 cigs/day for the previous 6 months
• Want to quit in next 14 days
• Use a smartphone and willing to potentially receive/send up to 150 text messages over the six months of the program
• Access to the Internet
• Have a valid personal e-mail address
• Be a U.S. citizen

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Web Only	Web Only	A best-practices Web-based smoking cessation program.
Web+Mobile	Web+Mobile	A best-practices Web-based smoking cessation program integrated with a tailored treatment program delivered using a smartphone application.

Primary Outcome Measures

Name	Time	Method
Change in all-tobacco abstinence from enrollment to 3 months and 6 months post enrollment	Change from enrollment to 3 months and 6 months post enrollment	Change in all-tobacco abstinence from enrollment to 3 and 6 months. Measured using 7 day point prevalence.

Secondary Outcome Measures

Name	Time	Method
Predictors and condition moderators of tobacco abstinence at 6-months follow-up	Baseline to 6-month follow-up	Analyses of the association of primary outcomes to participant characteristics (e.g., baseline smoking rate, nicotine dependence level, partner's tobacco use, prior quitting attempts, prior use of pharmacological adjuncts, and other demographic factors).
Program usage, treatment acceptability, consumer satisfaction 3 months post enrollment follow-up	3 months post enrollment	Evaluate program usage of each condition using unobtrusive measures of website visits (both conditions: number, duration, webpages viewed, interactive activities used), use of mobile intervention components (Web+Mobile condition only: number of calls received, number of responses received, extent of data collected), treatment acceptability, and consumer satisfaction

Trial Locations

Locations (1)

Oregon Research Institute; 🇺🇸 Eugene, Oregon, United States