Web and Mobile Smoking Cessation

Smoking Clinical Trial

— MobileQuit  

Official title:

Web and Mobile Smoking Cessation Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952236
• Other study ID #: CA172205-01
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: August 31, 2018

Study information

• Verified date: February 2019
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1266
• Est. completion date: August 31, 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Program usage, treatment acceptability, consumer satisfaction 3 months post enrollment follow-up	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
Secondary	Predictors and condition moderators of tobacco abstinence at 6-months 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

External Links

•   Oregon Research Institute