Web and Mobile Smoking Cessation (MobileQuit)

February 10, 2019 updated by: Oregon Research Institute

Web and Mobile Smoking Cessation Interventions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Web+Mobile
A best-practices Web-based smoking cessation program integrated with a tailored treatment program delivered using a smartphone application.
Behavioral: 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.
Active Comparator: Web Only
A best-practices Web-based smoking cessation program.
Behavioral: Web Only
A Web-based PC-delivered best practices smoking cessation intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in all-tobacco abstinence from enrollment to 3 months and 6 months post enrollment
Time Frame: 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.
Change from enrollment to 3 months and 6 months post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program usage, treatment acceptability, consumer satisfaction 3 months post enrollment follow-up
Time Frame: 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
3 months post enrollment
Predictors and condition moderators of tobacco abstinence at 6-months follow-up
Time Frame: 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).
Baseline to 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

July 25, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimate)

September 27, 2013

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 10, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CA172205-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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