NCT01952236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,266

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

2.7 years

First QC Date

July 25, 2013

Last Update Submit

February 10, 2019

Conditions

Keywords

SmokingQuitTobaccoAbstinenceAdultText MessagingWeb-basedMobile phonesmartphoneinternetweb

Outcome Measures

Primary Outcomes (1)

  • Change in all-tobacco abstinence 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 Outcomes (2)

  • Program usage, treatment acceptability, consumer satisfaction 3 months post enrollment follow-up

    3 months post enrollment

  • Predictors and condition moderators of tobacco abstinence at 6-months follow-up

    Baseline to 6-month follow-up

Study Arms (2)

Web+Mobile

EXPERIMENTAL

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

Behavioral: Web+Mobile

Web Only

ACTIVE COMPARATOR

A best-practices Web-based smoking cessation program.

Behavioral: Web Only

Interventions

Web+MobileBEHAVIORAL

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+Mobile
Web OnlyBEHAVIORAL

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

Web Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Brian G Danaher, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2013

First Posted

September 27, 2013

Study Start

February 1, 2015

Primary Completion

October 1, 2017

Study Completion

August 31, 2018

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations