Web and Mobile Smoking Cessation

NCT ID: NCT01952236

Last Updated: 2019-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Web+Mobile

A best-practices Web-based smoking cessation program integrated with a tailored treatment program delivered using a smartphone application.

Group Type EXPERIMENTAL

Web+Mobile

Intervention Type BEHAVIORAL

We propose to evaluate the efficacy and acceptability of a Web+Mobile tobacco cessation intervention in a 2-arm Randomized Controlled Trial with 1,271 adult study participants who agree to quit smoking within a pre-specified amount of time. Participants who meet eligibility criteria will be randomly assigned to either (a) an enhanced Web Only intervention or (b) an enhanced Web+Mobile intervention.

Web Only

A best-practices Web-based smoking cessation program.

Group Type ACTIVE_COMPARATOR

Web Only

Intervention Type BEHAVIORAL

A Web-based PC-delivered best practices smoking cessation intervention.

Interventions

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Web+Mobile

We propose to evaluate the efficacy and acceptability of a Web+Mobile tobacco cessation intervention in a 2-arm Randomized Controlled Trial with 1,271 adult study participants who agree to quit smoking within a pre-specified amount of time. Participants who meet eligibility criteria will be randomly assigned to either (a) an enhanced Web Only intervention or (b) an enhanced Web+Mobile intervention.

Intervention Type BEHAVIORAL

Web Only

A Web-based PC-delivered best practices smoking cessation intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian G Danaher, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Institute

Locations

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Oregon Research Institute

Eugene, Oregon, United States

Site Status

Countries

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United States

References

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Danaher BG, Tyler MS, Crowley RC, Brendryen H, Seeley JR. Outcomes and Device Usage for Fully Automated Internet Interventions Designed for a Smartphone or Personal Computer: The MobileQuit Smoking Cessation Randomized Controlled Trial. J Med Internet Res. 2019 Jun 6;21(6):e13290. doi: 10.2196/13290.

Reference Type DERIVED
PMID: 31172967 (View on PubMed)

Related Links

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http://www.ori.org

Oregon Research Institute

Other Identifiers

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CA172205-01

Identifier Type: -

Identifier Source: org_study_id

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